Top partnering deals of 2015 valued at over US$500m.
| Allergan, Teva Pharmaceutical Industries||Jul 2015|| 40500||Asset purchase agreement for generics business|
Teva Pharmaceutical Industries has signed a definitive agreement with Allergan to acquire Allergan Generics in a transaction valued at $40.5 billion.
Upon closing, Allergan will receive $33.75 billion in cash and shares of Teva valued today at $6.75 billion, representing an estimated under 10% ownership stake in Teva, with the number of Teva shares determined based on Teva’s volume weighted average trading prices during the 15 days prior to the announcement and five days following the announcement.
Teva believes the acquisition will be significantly accretive to non-GAAP EPS, including expected double-digit non-GAAP EPS accretion in 2016 and more than 20% accretion in year two and year three following the close of the transaction.
The transaction was unanimously approved by the Boards of Directors of Teva and Allergan and is expected to close in the first quarter of 2016.
| Capital One, GE Healthcare||Aug 2015|| 8500||Asset purchase agreement for healthcare finance unit|
Capital One Financial announced the signing of a definitive agreement with General Electric Capital Corporation to acquire approximately $8.5 billion of healthcare-related loans and its Healthcare Financial Services business, one of the leading capital providers in the U.S. healthcare market, for a 6 percent premium to par value of all receivables as of June 30, 2015.
| Boehringer Ingelheim, Merial, Sanofi||Dec 2015|| 5162||Asset swap agreement for animal health and consumer health businesses|
Sanofi and Boehringer Ingelheim have entered into exclusive negotiations to swap businesses.
The proposed transaction would consist of an exchange of Sanofi animal health business (“Merial”) with an enterprise value of €11.4 bn and Boehringer Ingelheim consumer healthcare (CHC) business with an enterprise value of €6.7 bn.
Boehringer Ingelheim CHC business in China would be excluded from the transaction.
The transaction would also include a gross cash payment from Boehringer Ingelheim to Sanofi of €4.7 bn.
| GO Scale Capital, Royal Philips Electronics||Mar 2015|| 3300||Asset purchase agreement for Lumiled (terminated)|
GO Scale Capital and Royal Philips announced that the parties have terminated their March 2015 agreement for GO Scale Capital to acquire 80.1% of Royal Philips' LED lighting components and automotive lighting business, Lumileds.
After close to one year of best efforts by GO Scale Capital and Royal Philips to obtain approval from the Committee on Foreign Investment in United States (CFIUS), the parties have been unable to resolve CFIUS' unspecified concerns.
Go Scale Capital had acquired 80.1% of Lumileds shares, and Philips would be retaining less than 19.9% of the shares.
The transaction value is estimated to be approximately US$ 3.3 billion, and expected to be completed in the third quarter of 2015.
| Boehringer Ingelheim, Hikma Pharmaceuticals||Jul 2015|| 2650||Asset purchase agreement for generics business|
Hikma Pharmaceuticals buy German drugmaker Boehringer Ingelheim's U.S. specialty generic drugs business for about $2.65 billion in cash and stock to bolster its presence in the United States.
Hikma said it will pay about $1.18 billion in cash and issue 40 million new Hikma shares, or about 16.71 per cent of its issued share capital, for Boehringer's Roxane Laboratories Inc and Boehringer Ingelheim Roxane Inc on closing of the deal.
| CRISPR Therapeutics, Vertex Pharmaceuticals||Oct 2015|| 2625||Collaboration agreement for CRISPR-Cas9 gene editing technology for genetic diseases|
Vertex Pharmaceuticals and CRISPR Therapeutics have entered into a strategic research collaboration focused on the use of CRISPR’s gene editing technology, known as CRISPR-Cas9, to discover and develop potential new treatments aimed at the underlying genetic causes of human disease.
The collaboration will evaluate the use of CRISPR-Cas9 across multiple diseases where targets have been validated through human genetics.
Vertex and CRISPR will focus their initial gene editing research on discovering treatments to address the mutations and genes known to cause and contribute to cystic fibrosis and sickle cell disease.
Vertex and CRISPR will also evaluate a specified number of other genetic targets as part of the collaboration.
Vertex will have exclusive rights to license up to six new CRISPR-Cas9-based treatments that emerge from the collaboration.
As part of the collaboration, Vertex made an up-front commitment of $105 million to CRISPR, including $75 million in cash and a $30 million equity investment.
CRISPR is also eligible to receive future development, regulatory and sales milestones and royalty payments on future sales.
Vertex and CRISPR will jointly use the CRISPR-Cas9 technology to discover and develop potential new treatments that correct defects in specific gene targets known to cause or contribute to particular diseases.
The initial focus of the collaboration will be on the use of CRISPR-Cas9 to potentially correct the mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene known to result in the defective protein that causes CF and to edit other genes that contribute to the disease.
Additionally, the companies will seek to discover and develop gene-based treatments for hemoglobinopathies, including sickle cell disease. Additional discovery efforts focused on a specified number of other genetic targets will also be conducted under the collaboration.
Discovery activities will be conducted primarily by CRISPR, and the related expenses will be fully funded by Vertex.
Vertex has the option to an exclusive license for up to six gene-based treatments that emerge from the four-year research collaboration.
Vertex will fund 100 percent of the development expenses of licensed treatments.
For each of the up to six treatments in-licensed for development, Vertex will pay future development, regulatory and sales milestones of up to $420 million as well as royalty payments on future sales.
Vertex and CRISPR will collaborate on the research, development and commercialization of treatments for hemoglobinopathies that emerge from the collaboration.
Specifically for hemoglobinopathies, including treatments for sickle cell disease, Vertex and CRISPR will equally share all research and development costs and sales, with CRISPR Therapeutics leading commercialization efforts in the U.S. For all other diseases, Vertex will lead all development and global commercialization activities.
Vertex will pay CRISPR $75 million in cash as part of its up-front commitment.
Vertex will also provide a $30 million investment in CRISPR, which is a private company.
The investment will provide Vertex with an ownership stake in CRISPR.
The collaboration also provides Vertex with an observer seat on the CRISPR Board of Directors, which will be filled by Dr. Altshuler.
| Regeneron Pharmaceuticals, Sanofi||Jul 2015|| 2170||Collaboration agreement for antibody cancer treatments|
Regeneron Pharmaceuticals and Sanofi announced their intent to simplify their antibody collaboration for Kevzara (sarilumab) and Praluent (alirocumab) by restructuring into a royalty-based agreement.
Sanofi is expected to gain sole global rights to Kevzara and sole ex-U.S. rights to Praluent. Regeneron is expected to gain sole U.S. rights to Praluent.
Under the proposed terms of the agreement, each party will be solely responsible for funding development and commercialization expenses in their respective territories.
These changes are expected to increase efficiency and streamline operations for the products.
The existing collaboration relating to Dupixent (dupilumab) will remain unchanged following the restructuring.
Completion of the proposed arrangement is expected to be finalized in the first quarter of 2020.
Regeneron Pharmaceuticals and Sanofi have restructured their global Immuno-oncology Discovery and Development Agreement for new immuno-oncology cancer treatments.
The 2015 Agreement was scheduled to end in approximately mid-2020, and this revision provides for ongoing collaborative development of two clinical-stage bispecific antibody programs.
The revised agreement allows Regeneron to retain all rights to its other immuno-oncology discovery and development programs and provides Sanofi increased flexibility to advance its early-stage immuno-oncology pipeline independently.
Under the terms of the restructured Agreement:
Sanofi will pay Regeneron $462 million representing the balance of payments due under the original Immuno-oncology Agreement, which covers the Sanofi share of the immuno-oncology discovery program costs for the last quarter of 2018 and up to $120 million in development costs for the two selected clinical-stage bispecific antibodies, plus the termination fee for the other programs under the original immuno-oncology agreement.
Sanofi secures the right to opt-in to the BCMAxCD3 and MUC16xCD3 bispecific programs when proof of concept is achieved or when the allocated funding is expended.
Regeneron will commit up to $70 million to further develop the BCMAxCD3 bispecific antibody for multiple myeloma and up to $50 million to further develop the MUC16xCD3 bispecific for mucin-16 expressing cancers.
Post opt-in, Sanofi will lead development and commercialization of the BCMAxCD3 bispecific and fund 100 percent of development costs, with Regeneron reimbursing up to 50 percent out of its share of collaboration profits. Sanofi and Regeneron will share global profits equally.
Post opt-in, Regeneron will lead MUC16xCD3 bispecific development and lead commercialization in the U.S. The companies will share development costs and global profits equally. Sanofi will lead commercialization outside the U.S.The companies' ongoing collaboration for the development and commercialization of Libtayo® (cemiplimab-rwlc), a PD-1 antibody, is unaffected by the amended Discovery and Development Agreement.
Regeneron retains full rights to its other immuno-oncology programs.
Under the Immuno-Oncology License and Collaboration Agreement, the companies have developed and received U.S. Food and Drug Administration approval of Libtayo for advanced cutaneous squamous cell carcinoma (CSCC).
A regulatory application for Libtayo has also been submitted in the EU. An ongoing joint clinical program is investigating Libtayo in multiple other cancers, and includes potentially pivotal trials in lung, cervical and skin cancers.
Libtayo's safety and efficacy has not been fully evaluated by any regulatory authority for indications beyond advanced CSCC.
Regeneron Pharmaceuticals and Sanofi will accelerate and expand investment for the clinical development of the PD-1 (programmed cell death protein 1) antibody cemiplimab in oncology, and the IL-4/IL-13 pathway-blocking antibody dupilumab in Type 2 allergic diseases.
Both of these breakthrough therapies have the potential to benefit a number of different patient populations, and this strategic investment will enable the companies to evaluate cemiplimab and dupilumab in broader clinical development programs.
Under the terms of the expansion, the investment in cemiplimab will be increased to a minimum of $1.64 billion, an increase of approximately $1 billion over the initial 2015 agreement, and Sanofi and Regeneron will continue to equally fund cemiplimab development.
The companies will also continue their investment in other immuno-oncology programs under their existing Immuno-oncology Discovery Agreement.
Investigational cemiplimab is being studied as monotherapy and in combination with other therapies in a wide range of cancers including advanced skin cancers, non-small cell lung cancer, cervical cancer and lymphomas, with more studies in other indications planned to begin in 2018.
The companies expect to submit U.S. and EU regulatory applications for cemiplimab in advanced cutaneous squamous cell carcinoma in the first quarter of 2018.
The additional investment in the dupilumab development program will help accelerate planned new studies in chronic obstructive pulmonary disease, peanut allergy and grass allergy, as well as in patients who have multiple allergic conditions.
These areas are in addition to ongoing dupilumab clinical development in pediatric atopic dermatitis, pediatric asthma, eosinophilic esophagitis and nasal polyposis.
Regeneron Pharmaceuticals and Sanofi have entered into a new global collaboration to discover, develop and commercialize new antibody cancer treatments in the emerging field of immuno-oncology.
As part of the agreement, the two companies will jointly develop a programmed cell death protein 1 (PD-1) inhibitor currently in Phase 1 testing and plan to initiate clinical trials in 2016 with new therapeutic candidates based on ongoing, innovative preclinical programs.
Sanofi will make an upfront payment to Regeneron of $640 million, and the companies will invest $1 billion for discovery through proof of concept (POC) development (usually a Phase 2a study) of monotherapy and novel combinations of immuno-oncology antibody candidates to be funded 25 percent by Regeneron ($250 million) and 75 percent by Sanofi ($750 million).
The companies have also committed to equally fund an additional $650 million (or $325 million per company) for development of REGN2810, a PD-1 inhibitor.
In addition, Sanofi will pay Regeneron a one-time milestone of $375 million in the event that sales of a PD-1 product and any other collaboration antibody sold for use in combination with a PD-1 product exceed, in the aggregate, $2 billion in any consecutive 12-month period.
Finally, the two companies have agreed to re-allocate $75 million (over three years) for immuno-oncology antibodies from Sanofi's $160 million annual contribution to their existing antibody collaboration, which otherwise continues as announced in November 2009.
Beyond the committed funding, additional funding will be allocated as programs enter post-POC development.
The new agreement covers both monoclonal antibodies and new bi-specific antibodies, a variation of standard antibody therapeutics in which two distinct targets within the body can be bound by the same molecule, usually the cancer cell and an immune cell.
Regeneron has developed a novel and flexible manufacturing platform that enables efficient production of bi-specific antibodies that are otherwise similar to natural antibodies.
Beyond PD-1, other programs in preclinical development include antibodies to lymphocyte-activation gene 3 (LAG3), glucocorticoid-induced tumor-necrosis-factor-receptor-related protein (GITR) and a programmed death ligand (PD-L1) inhibitor.
Finally, the collaboration is advancing bi-specific antibodies that target hematologic and solid cancers, either as monotherapies or in combination regimens with other immune modulating treatments.
The framework of the new immuno-oncology collaboration is as follows:
Regeneron will be responsible for discovery, antibody generation and development through POC, at which time Sanofi will have the ability to opt-in to further development and commercialization. In the existing antibody collaboration, Sanofi has the opportunity to opt-in at the time of an Investigational New Drug application (IND).
The companies will alternate serving as the lead development and commercialization organization after Sanofi opts-in to an antibody program.
For programs where Regeneron is the lead, including REGN2810, Regeneron will serve as the U.S. commercial lead, including recording U.S. sales, and the companies will equally fund post-POC development. Sanofi will record sales and serve as the commercial lead for all countries outside the U.S. Sanofi will retain the right to co-promote in the U.S. and Regeneron will retain the right to co-promote outside the U.S.
For programs where Sanofi is the lead, Sanofi will serve as the U.S. commercial lead and fund 100 percent of post-POC development, with Regeneron reimbursing up to 50 percent of such costs through the IO collaboration development balance, which represents the amount of development funding that Regeneron is obligated to repay out of its share of profits as described below. Sanofi will record sales and serve as the commercial lead for all countries outside the U.S. Regeneron will retain the right to co-promote in the U.S. and outside the U.S.
Sanofi and Regeneron will share equally in worldwide profits from sale of collaboration immuno-oncology antibodies.
As in the existing antibody agreement, Regeneron will repay the immuno-oncology collaboration development balance from its share of overall profits of the immuno-oncology antibodies, in an annual amount equal to 10 percent of the Regeneron share of profits.
The exclusive collaboration to discover and develop potential monotherapy or novel combination immuno-oncology antibody candidates through POC will last five years with an ability to extend the collaboration for selected ongoing programs for an additional three years.
The agreement does not include Chimeric Antigen Receptors.
Additional terms, including potential therapeutic targets or mechanisms, were not disclosed.
| Galapagos, Gilead Sciences||Dec 2015|| 2075||Development and marketing agreement for filgotinib for inflammatory diseases|
Gilead Sciences and Galapagos had inked a deal to develop and commercialize filgotinib for inflammatory diseases.
Gilead will pay Galapagos an upfront payment of $725 million, which is made up of a $300 million license fee and a $425 million equity investment in Galapagos. Gilead will also pay Galapagos up to $1.35 billion in milestone payments, as well as tiered royalties starting at 20 percent.
Filgotinib is a JAK1-selective inhibitor.
In a Phase II clinical trial, it has proven to be effective and safe for rheumatoid arthritis (RA) and Crohn’s disease.
The two companies plan to begin Phase III clinical trials in RA and Crohn’s in 2016.
| Sosei, Sosei Heptares, Teva Pharmaceuticals USA||Nov 2015|| 1990||Licensing agreement for calcitonin gene-related peptide (CGRP) antagonists (terminated)|
Sosei has regained worldwide rights from Teva Pharmaceutical to develop and commercialize lead candidate HTL0022562 and other novel small molecule CGRP antagonists for the treatment of migraine and other severe headaches.
HTL0022562 is a novel, potent, and highly selective small molecule CGRP antagonist designed by Sosei’s wholly-owned subsidiary Heptares Therapeutics using its proprietary structure-based drug design platform.
The candidate emerged from a rigorous selection process under the alliance with Teva based on its highly differentiated preclinical data.
The first dosing in a Phase 1 clinical trial in healthy volunteers was expected in late 2018.
Sosei will now undertake a detailed review of the programs and update the market later this year on the new expected timing for HTL0022562’s entry into Phase 1 clinical trials following a formal handover from Teva.
The termination of the 2015 licensing and drug discovery agreement between Heptares and Teva is a result of Teva’s recent portfolio prioritization.
All licensed rights relating to the CGRP antagonist programs will be returned to Sosei.
As part of the reversion package, Sosei will also receive the full preclinical data set generated by Teva under the partnership.
In regaining the worldwide development and commercialization rights there is no immediate or material financial impact to Sosei.
Going forward, as a wholly-owned pipeline program, Sosei will be responsible for the costs associated with developing HTL0022562 or any other small molecule CGRP antagonists.
Heptares Therapeutics, a wholly owned subsidiary of Sosei Group Corporation , has been notified by its partner Teva that a preclinical candidate calcitonin gene-related peptide (CGRP) antagonist has been nominated for advancement into further preclinical studies as an investigational treatment for migraine.
Nomination of this small-molecule candidate, discovered by Heptares using its structure-based design approach in partnership with Teva, has triggered a US$5 million payment from Teva to Heptares under the terms of their licensing and drug-discovery agreement signed in 2015.
The nominated compound emerged from a rigorous Teva candidate selection process and has a highly differentiated profile from other investigational small-molecule CGRP antagonists, representing the first milestone in a partnership to generate novel candidates for the treatment of episodic and chronic migraine.
Heptares Therapeutics has entered into a strategic drug discovery collaboration with Pfizer to research and develop potential new medicines directed at up to 10 G protein-coupled receptor (GPCR) targets across multiple therapeutic areas.
Heptares will use its proprietary GPCR structure-guided platform to help deliver stabilised GPCRs (StaR proteins), high-resolution crystal structures and other technologies to support the discovery of potential novel agents directed to the GPCR targets selected by Pfizer.
Pfizer will be responsible for developing and commercialising any potential therapeutic agents (small molecules or biologics derived from StaR antigens) for each target and will have exclusive global rights to any potential resulting agents.
Heptares will receive an initial payment on signing the agreement in return for delivering certain StaR proteins and structures for targets selected by Pfizer that it has already generated.
Heptares is eligible to receive potential research, development, regulatory and commercial milestone payments of up to USD189 million per target.
In addition, Heptares is eligible to receive potential tiered royalties on the net sales of any products that are commercialised by Pfizer.
| Cardinal Health, Cordis, Johnson & Johnson||Mar 2015|| 1944||Asset purchase agreement for Cordis unit|
05 October 2015
Johnson & Johnson announced the completion of the divestiture of its Cordis business to Cardinal Health for an approximate value of $2 billion, subject to customary adjustments.
The Cordis business is a global leader in the development and manufacture of interventional vascular technology and generated net revenues of approximately $780 million in 2014.
25 May 2015
Cardinal Health announced that its March 1, 2015 binding offer to acquire Johnson & Johnson's Cordis business for $1.944 billion in cash was formally accepted. The offer was accepted after consultations with relevant works councils and trade unions.
The transaction is expected to close in the United States and key non-U.S. countries towards the end of 2015, subject to regulatory clearances and other customary closing conditions.
2 March 2015
Cardinal Health announced plans to acquire Johnson & Johnson's Cordis business, a leading global manufacturer of cardiology and endovascular devices, for $1.944 billion in cash, or approximately $1.594 billion, net of the present value of tax benefits.
The acquisition is expected to be financed with a combination of $1.0 billion in new senior unsecured notes and the remainder with existing cash.
The transaction is expected to close in the United States and key non-U.S. countries towards the end of calendar 2015.
| Roche, SQZ Biotech||Dec 2015|| 1875||Collaboration agreement for cell therapy platform for cancer|
SQZ Biotechnologies announced the expansion of its collaboration with Roche in cellular therapy.
The expanded partnership furthers the synergistic combination of SQZ's innovation and expertise in cell therapy with Roche's cancer immunotherapy expertise.
SQZ and Roche will jointly develop and commercialize certain products based on antigen presenting cells (APCs) created by the SQZ platform for the treatment of oncology indications.
SQZ may receive up to $125 million in upfront payment and near-term milestones.
SQZ could earn up to $250 million in clinical, regulatory and sales milestones per product that emerges from the collaboration.
SQZ may receive development milestone payments of over $1 billion.
Within the collaboration, SQZ and Roche could share commercial rights for certain approved products.
The companies will expand the 2015 Roche collaboration to jointly develop therapeutics derived from peripheral blood mononuclear cells (PBMCs).
SQZ Biotech announced a partnership with Roche to develop a cell therapy platform that would empower a patient’s own immune cells to fight a broad range of cancers.
The deal leverages SQZ’s pioneering technology to engineer B cells as a therapeutic platform for oncology – a novel approach with the potential to overcome many of the shortcomings of current cell-based therapies.
The agreement provides for over $500M in upfront and potential clinical, regulatory and sales milestone-based payments for advancement of all products across all planned indications, in addition to royalties on potential future products.
| Lexicon Pharmaceuticals, Sanofi||Nov 2015|| 1800||Collaboration agreement for sotagliflozin|
Lexicon Pharmaceuticals announced the termination of its alliance with Sanofi for the development and commercialization of ZynquistaTM (sotagliflozin) and the settlement of its related disputes with Sanofi, each effective September 9, 2019.
In connection with the termination, Lexicon will regain all rights to Zynquista and assume full responsibility for the worldwide development and commercialization of Zynquista in both type 1 and type 2 diabetes.
Under the terms of the settlement, Sanofi will pay Lexicon $260 million, of which $208 million is payable upfront and the remainder is payable within twelve months, and coordinate with Lexicon in the transition of responsibility for ongoing clinical studies and other activities.
Sanofi and Lexicon Pharmaceuticals have entered into a collaboration and license agreement for the development and commercialization of sotagliflozin, an investigational new oral dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT-1 and SGLT-2), which could be a potential treatment option for people with diabetes.
Lexicon will receive an upfront payment of $300 million and is eligible to receive development, regulatory and sales milestone payments of up to $1.4 billion.
Lexicon is also entitled to tiered, escalating double digit percentage royalties of net sales of sotagliflozin.
Sanofi obtains an exclusive worldwide license to develop, manufacture and commercialize sotagliflozin.
Lexicon will continue to be responsible for all clinical development activities relating to type 1 diabetes and will retain an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the United States.
Sanofi will be responsible for all clinical development and commercialization activities of sotagliflozin for the treatment of type 2 diabetes worldwide and will be solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the United States.
Lexicon will share in the funding of a portion of the planned type 2 diabetes development costs over the next three years, up to an aggregate of $100 million.
| Amgen, Xencor||Sep 2015|| 1745||Research, development and licensing agreement for therapeutics in areas of cancer immunotherapy and inflammation|
Amgen and Xencor have entered into a research and license agreement to develop and commercialize novel therapeutics in the areas of cancer immunotherapy and inflammation.
The research collaboration brings together Amgen's capabilities in target discovery and protein therapeutics with Xencor's XmAb bispecific technology platform.
The collaboration includes molecular engineering by Xencor and the preclinical development of bispecific molecules for five programs proposed by Amgen, leveraging XmAb bispecific Fc domains to make half-life extended T cell engagers and dual targeting bispecific antibodies.
The agreement also includes a preclinical bispecific T cell engager program directed at CD38 and CD3 for multiple myeloma.
Amgen will be fully responsible for preclinical and clinical development and commercialization worldwide.
Xencor will receive a $45 million upfront payment and up to $1.7 billion in clinical, regulatory and sales milestone payments in total for the six programs.
Xencor is eligible to receive mid to high single-digit royalties for candidates directed against Amgen's targets, and high single to low double-digit royalties for Xencor's CD38 bispecific T cell engager.
| Bristol-Myers Squibb, Five Prime Therapeutics||Oct 2015|| 1740||Collaboration and licensing agreement for CSF1R antibody (FPA008) in combination with Opdivo (nivolumab) and other therapies|
Five Prime Therapeutics announced that a development milestone for cabiralizumab has been achieved, triggering a $25 million payment from Bristol-Myers Squibb Company (BMS) (NYSE:BMY) under the license and collaboration agreement between the companies established in 2015.
The milestone was triggered by initiation of a multi-arm Phase 2 clinical trial (NCT03336216), sponsored by Bristol-Myers Squibb Company, evaluating cabiralizumab and Opdivo (nivolumab) with and without chemotherapy in patients with advanced pancreatic cancer.
Bristol-Myers Squibb and Five Prime Therapeutics have entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of Five Prime's colony stimulating factor 1 receptor (CSF1R) antibody program, including FPA008 which is in Phase 1 development for immunology and oncology indications.
This agreement replaces the companies' existing clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of combining Opdivo (nivolumab), Bristol-Myers Squibb's programmed-death 1 (PD-1) immune checkpoint inhibitor, with FPA008 in six tumor types.
Under the terms of the license and collaboration agreement, Bristol-Myers Squibb will make an upfront payment of $350 million to Five Prime.
Bristol-Myers Squibb will be responsible for development and manufacturing of FPA008 for all indications, subject to Five Prime's option to conduct, at its own cost, certain future studies including registrational studies to support approval of FPA008 in PVNS and FPA008 in combination with Five Prime's internal pipeline assets in immuno-oncology.
Five Prime will continue to conduct the current Phase 1a/1b trial evaluating the combination of Opdivo and FPA008 in six tumor settings, which was announced as part of the companies' initial clinical collaboration in November 2014, through to completion.
Bristol-Myers Squibb will be responsible for global commercialization, and Five Prime will retain rights to a U.S. co-promotion option.
In addition to the upfront payment, Five Prime will be eligible to receive up to $1.05 billion in development and regulatory milestone payments per anti-CSF1R product for oncology indications (including combinations with Opdivo and any other agent), and up to $340 million in development and regulatory milestone payments per anti-CSF1R product for non-oncology indications, as well as double digit royalties, such royalties to be enhanced in the U.S. in the event that Five Prime exercises its co-promotion option.
| Boston Scientific, Endo International||Mar 2015|| 1650||Asset purchase agreement for men’s health and prostate businesses|
Endo International has entered into a definitive agreement with Boston Scientific, under which Boston Scientific will acquire Endo's American Medical Systems' (AMS) Men's and Prostate Health businesses for up to $1.65 billion, with $1.6 billion in cash payable at closing.
Endo is also eligible to receive a potential milestone payment of $50 million in cash conditioned on Boston Scientific achieving certain product revenue milestones in the Men's Health and Prostate Health businesses in 2016.
In addition, Endo is currently evaluating strategic alternatives for the AMS Women's Health business.
| BioNTech, Sanofi||Nov 2015|| 1560||Collaboration and licensing agreement for cancer immunotherapies consisting of a mixture of synthetic messenger RNAs (mRNAs)|
BioNTech has extended its research collaboration with Sanofi initiated in late 2015 and Sanofi is investing EUR 80 million (approximately USD 91.5 million) in equity in BioNTech.
Sanofi and BioNTech have entered into a multiyear exclusive collaboration and license agreement.
This research collaboration between Sanofi and BioNTech will leverage the scientific expertise of the two organizations to discover and develop up to five cancer immunotherapies, each consisting of a mixture of synthetic messenger RNAs (mRNAs).
Sanofi and BioNTech have agreed to $60 million in upfront and near-term milestone payments, payable to BioNTech under the terms of the agreement.
BioNTech could receive over $300 million in development, regulatory and commercial milestones and other payments per product.
If commercialized successfully, BioNTech would also be eligible for tiered royalties on net sales up to double digits.
BioNTech has the option to co-develop and co-commercialize two of the five mRNA therapeutics products with Sanofi in the European Union and the United States.
Complementing Sanofi’s global oncology footprint and scientific expertise, BioNTech will combine the use of its proprietary mRNA technology platform with its extensive capabilities in developing immune-stimulating pharmaceuticals.
As part of this effort, BioNTech will utilize its mRNA formulation technology, which enables targeted mRNA delivery in vivo, to generate novel cancer immunotherapies.
BioNTech will also supply part of the mRNA material needed for development activities from its in-house GMP manufacturing unit.
| Eli Lilly, Innovent Biologics||Mar 2015|| 1456||Collaboration agreement for three cancer treatments|
Eli Lilly and Innovent Biologics announced an expansion of their drug development collaboration, already one of the largest in China between a multi-national and domestic biopharmaceutical company.
Below are details of the expanded agreement:
The companies will collaborate to support the development and potential commercialization of up to three anti-PD-1 based bispecific antibodies for cancer treatments over the next decade, both inside and outside of China.
Under the previous agreement, Lilly will exercise its rights to develop, manufacture and commercialize these potential cancer treatments outside of China.
Innovent will now have the rights to develop, manufacture and commercialize these potential cancer treatments for China, subject to a Lilly opt-in right for co-development and commercialization.
Under the terms of the expanded agreement, Innovent could receive additional milestones totaling more than $1 billion if the products reach certain development, regulatory and sales milestones, both inside and outside of China.
Sales royalties and other payments would occur on certain products if commercialized outside China.
Further financial terms were not disclosed.
Lilly will create the three preclinical anti-PD-1 based bispecific antibodies using an antibody sequence contributed by Innovent.
Eli Lilly and Innovent Biologics announced one of the largest biotech drug development collaborations in China to date between a multi-national and domestic company.
Lilly and Innovent will collaborate to support the development and potential commercialization of at least three cancer treatments over the next decade.
The agreement creates possible new treatment options for cancer patients, while strengthening the presence of both companies in the Chinese oncology market.
As a part of the agreement, Innovent will lead the development and manufacturing for the China market, while Lilly will be responsible for commercialization of the three potential medicines.
Innovent also has co-promotion rights.
Lilly will contribute its cMet monoclonal antibody gene for possible treatment of non-small cell lung cancer.
Separate from this collaboration, Lilly will continue the development of its cMet monoclonal antibody program outside of China.
Innovent will contribute its monoclonal antibody targeting protein CD-20 for investigation in hematologic malignancies.
Innovent has received investigational new drug approval in China to begin Phase I development of this potential therapy.
Innovent will contribute a pre-clinical immuno-oncology molecule for development in China.
The companies have agreed that Lilly will be responsible for development, manufacturing and commercialization of this molecule outside of China.
Lilly will also receive rights to develop and commercialize up to three pre-clinical bispecific immuno-oncology molecules outside of China.
Under the terms of the agreement, Innovent will receive a total upfront payment of $56 million.
Lilly could also issue future payments exceeding $400 million for the pre-clinical immuno-oncology molecule if the product reaches certain development, regulatory and sales milestones.
Sales royalties and other payments would occur on certain products if commercialized.
Further financial terms were not disclosed.
| Bristol-Myers Squibb, GlaxoSmithKline, ViiV Healthcare||Dec 2015|| 1455||Asset purchase agreement for fostemsavir (BMS-663068)|
GlaxoSmithKline announced that its global HIV business, ViiV Healthcare, has reached two separate agreements with Bristol-Myers Squibb, to acquire its late-stage HIV R&D assets; and to acquire Bristol-Myers Squibb’s portfolio of preclinical and discovery stage HIV research assets.
Under the terms agreed in the two transactions, ViiV Healthcare will acquire:
Late stage assets, including fostemsavir (BMS-663068), an attachment inhibitor, currently in phase III development for heavily treatment experienced patients. Fostemsavir has received a Breakthrough Therapy Designation from the FDA and is expected to be filed for regulatory approval in 2018.
The second late stage asset is a maturation inhibitor (BMS-955176), currently in phase IIb development for both treatment-naive and treatment experienced patients.
A back-up maturation inhibitor candidate (BMS-986173) is also included in the purchase.
Assets in preclinical and discovery phases of development including a novel biologic (BMS-986197) with a triple mechanism of action, a further maturation inhibitor, an allosteric integrase inhibitor and a capsid inhibitor.
A number of Bristol-Myers Squibb drug discovery employees will also be offered the opportunity to transfer to ViiV Healthcare.
These potential therapies have novel modes of action and would offer significant new treatment options to patients with HIV.
In addition to being developed as standalone treatment options, these new assets complement ViiV Healthcare’s existing portfolio and therefore offer multiple opportunities for development as combination therapies.
The late-stage asset purchase comprises an upfront payment of $317 million, followed by development and first commercial sale milestones of up to $518M, and tiered royalties on sales.
The purchase of preclinical and discovery stage research assets comprises an upfront payment of $33 million, followed by development and first commercial sales milestones of up to $587M, and further consideration contingent on future sales performance.
| NantPharma, Sorrento Therapeutics||May 2015|| 1320.05||Asset purchase agreement for Cynviloq|
Sorrento Therapeutics announced that NantPharma agreed to acquire the rights to Cynviloq through the acquisition of Igdrasol, a wholly-owned subsidiary of Sorrento, which has been developing Cynviloq (paclitaxel nanoparticle polymeric micelle) in a bio-equivalence trial.
Dr. Soon-Shiong was the founder of Abraxis BioScience and inventor and developer of the blockbuster drug Abraxane (albumin-bound paclitaxel), currently approved for the treatment of breast, lung, and pancreatic cancers.
Sorrento will receive more than $90 million in an up-front cash payment plus the potential for more than $600 million in regulatory and $600 million in sales milestone payments.
Sorrento will also receive additional transfer pricing payments from total unit sales.
Furthermore, Sorrento has the option to co-develop and/or co-market Cynviloq on terms to be negotiated.
In May 2015, Sorrento entered into a stock sale and purchase agreement with NantPharma pursuant to which we agreed to sell to NantPharma all of our equity interests in IgDraSol, a wholly-owned subsidiary of ours and the holder of the rights to Cynviloq, a polymeric micelle based Cremophor free paclitaxel injectable finished formulation.
NantPharma agreed to pay us an upfront payment of $90.05 million, of which $80 million is obligated to fund the Company’s joint ventures.
In addition, we will be entitled to receive up to $620 million in regulatory milestone payments and up to $600 million in sales milestone payments should certain events occur.
We will also receive specified additional per unit payments in excess of cost of supply from total unit sales.
In addition, during the first three years after closing, we have the option to co-develop and/or co-market Cynviloq on terms to be negotiated.
The Agreement contains customary representations, warranties and covenants for us and NantPharma.
Upon the closing of the agreement in July, the specified development milestone was satisfied and we issued 1,306,272 million shares to former IgDraSol shareholders.
| NantBioScience, Sorrento Therapeutics||Jul 2015|| 1290||Collaboration agreement for developing Moonshot program|
Sorrento Therapeutics will team up with NantBioScience to develop 'first-in-class' small molecules as way to head off cancer growth using therapies like stem cells, the companies said Thursday.
The project has been dubbed “Moonshot.”
The deal will give Sorrento $90 million in an upfront cash payment plus the potential for more than $600 million in regulatory and $600 million in sales milestone payments.
The statement said NantWorks plans to use the drug in multiple cancer indications as part of its buyout of Igdrasol
Today’s partnership will build on that relationship.
| AstraZeneca, Innate Pharma, MedImmune||Apr 2015|| 1275||Co-development and licensing agreement for IPH2201|
Innate Pharma has signed a co-development and commercialization agreement with AstraZeneca, along with MedImmune, to accelerate and broaden the development of Innate Pharma's proprietary anti-NKG2A antibody, IPH2201, including in combination with MEDI4736, an anti-PD-L1 immune checkpoint inhibitor developed by MedImmune. Currently in Phase II development, IPH2201 is a potential first-in-class humanized IgG4 antibody.
NKG2A is a checkpoint receptor that inhibits the anti-cancer functions of Natural Killer (NK) and cytotoxic T-cells.
The financial terms of the signed agreement include cash payments of up to $1.275 billion to Innate Pharma as well as double digit royalties on sales.
The initial payment is $250 million, which includes a consideration for the exclusive global rights to AstraZeneca to co-develop and commercialize IPH2201 in combination with MEDI4736 and access to IPH2201 in monotherapy and other combinations in certain areas.
AstraZeneca will pay to Innate a further $100 million prior to initiation of Phase III development, as well as additional regulatory and sales-related milestones of up to $925 million.
AstraZeneca will book all sales and will pay Innate double-digit royalties on net sales.
The arrangement includes the right for Innate to co-promote in Europe for a 50% profit share in the territory.
The initial development plan includes: Phase II combination clinical trials with MEDI4736 in solid tumors; multiple Phase II trials planned by Innate to study IPH2201 both as monotherapy and in combination with currently approved treatments across a range of cancers; and the development of associated biomarkers.
The combination of IPH2201 with MEDI4736 adds to the broad programme of immuno-oncology combination trials that AstraZeneca and MedImmune have planned and underway.
The studies aim to address multiple immune pathways, harnessing AstraZeneca's own extensive pipeline and working in partnership to explore the significant potential of immunotherapies in transforming the way cancer patients are treated.
| South Carolina Research Authority, U.S. Army Contracting Command-New Jersey (ACC-NJ)||Jun 2015|| 1250||Contract service agreement for electromagnetic spectrum|
SCRA Applied R&D announced that the National Spectrum Consortium has entered into a 5-year, $1.25B, Section 845 Prototype Other Transaction Agreement (OT) with U.S. Army Contracting Command-New Jersey (ACC-NJ).
This agreement enables SCRA, acting on behalf of the NSC, to execute and administer the efforts for this program. Dr. Vanu Bose of Vanu, Inc. will serve as the consortium’s industry lead.
The group will work to meet the increasing demands for using the existing electromagnetic spectrums.
The Consortium will mature technologies that assist in improved electromagnetic spectrum awareness, sharing and use; experiment to better inform the best allocation of equipment for public and private objectives; validate new innovations to increase trust among spectrum stakeholders and develop policies to ensure new technology does not outpace the appropriate guidance for its best use.
| AGTC, Biogen||Jul 2015|| 1219||Licensing and option agreement for developing gene therapy for X-linked Retinoschisis|
Biogen and AGTC announced a broad collaboration and license agreement to develop gene-based therapies for multiple ophthalmic diseases.
The collaboration will focus on the development of a portfolio of AGTC’s therapeutic programs, including both a clinical stage candidate and a pre-clinical candidate for orphan diseases of the retina that can lead to blindness in children and adults.
The agreement also includes options for early stage discovery programs in two ophthalmic diseases and one non-ophthalmic condition, as well as an equity investment in AGTC by Biogen and a license agreement for manufacturing rights.
The lead development programs in the collaboration include a clinical candidate for X-linked Retinoschisis (XLRS) and a pre-clinical candidate for the treatment of X-Linked Retinitis Pigmentosa (XLRP).
XLRS, a disease affecting young males beginning during the teenage years, can lead to serious complications such as vitreous hemorrhage or retinal detachment during adulthood.
XLRP usually causes night blindness by the age of ten and progresses to legal blindness by an individual’s early forties.
Both conditions represent significant unmet needs that may be addressed by replacing the single, faulty gene causing each disease.
Biogen will make an upfront payment in the amount of $124 million to AGTC, which includes a $30 million equity investment in AGTC at a price equal to $20.63 per share and certain prepaid research and development expenditures.
Biogen will be granted a license to the XLRS and XLRP programs and the option to license discovery programs for three additional indications at the time of clinical candidate selection.
AGTC is eligible to receive upfront and milestone payments exceeding $1 billion.
This includes up to $472.5 million collectively for the two lead programs, which also will carry royalties in the high single digit to mid-teen percentages of annual net sales.
In addition, Biogen will make payments up to $592.5 million across the discovery programs, along with royalties in the mid single digits to low teen percentages of annual net sales.
Biogen obtains worldwide commercialization rights for the XLRS and XLRP programs.
AGTC has an option to share development costs and profits after the initial clinical trial data are available, and an option to co-promote the second of these products to be approved in the United States.
AGTC will lead the clinical development programs of XLRS through product approval and of XLRP through the completion of first-in-human trials.
Biogen will support the clinical development costs, subject to certain conditions, following the first-in-human study for XLRS and IND-enabling studies for XLRP.
Under the manufacturing license, Biogen will receive an exclusive license to use AGTC’s proprietary technology platform to make AAV vectors for up to six genes, three of which are in AGTC’s discretion, in exchange for payment of milestones and royalties.
| Concordia Healthcare, Covis Pharmaceutical||Mar 2015|| 1200||Asset purchase agreement for commercial assets|
21 April 2015
Concordia Healthcare has completed the previously announced acquisition by the Company of 18 products, being comprised of 12 branded products and five authorized generic contracts and a product distributed by a third party in Australia pursuant to the terms of a distribution agreement, from Covis Pharma for $1.2 billion in cash (the "Acquisition").
All financial references are in U.S. dollars unless otherwise noted.
9 March 2015
Concordia Healthcare has entered into a definitive asset purchase agreement to acquire substantially all of the commercial assets of privately held Covis Pharma and Covis Injectables for US$1.2 billion in cash.
The Covis drug portfolio being acquired consists of 18 branded and authorized generic products with stable revenue, strong margins and free cash flow.
The distinctive product portfolio includes branded pharmaceuticals, injectables and authorized generics that address life threatening and other serious medical conditions in various therapeutic areas including cardiovascular, central nervous system, oncology and acute care markets.
Key products are Nilandron, for the treatment of metastatic prostate cancer; Dibenzyline, for the treatment of pheochromocytoma; Lanoxin, for the treatment of mild-to-moderate heart failure and atrial fibrillation; and, Plaquenil, for the treatment of lupus and rheumatoid arthritis.
The acquisition is structured as an all-cash transaction with a purchase price of US$1.2 billion for the Portfolio being acquired.
The Company plans to pay for the acquisition through a mix of term loans, bonds and equity.
The Company has entered into a commitment letter with Royal Bank of Canada (“RBC”), pursuant to which, RBC has agreed to provide credit facilities and bridge commitments of up to US$1.6 billion (the “Credit Facilities”) to fully pay for the acquisition price and refinance all outstanding Concordia debt.
The Credit Facilities are subject to a number of customary conditions.
All obligations of the Company under the term loans will be secured by first priority perfected security interests in the assets of the Company and the assets of and equity interests in its subsidiaries.
The bridge commitments will be unsecured.
The Company is targeting leverage to be below 5x at the closing of the acquisition and expects net leverage to fall to ~3x by year end 2016.
The transaction is expected to be over 50% accretive to Concordia Adjusted EPS in 2015.
The acquisition, which is expected to close in the second quarter of 2015, is subject to satisfaction of customary closing conditions (including receipt of required regulatory approvals).
The Board of Directors of all parties to the transaction have approved the acquisition.
| Abbvie, Halozyme Therapeutics||Jun 2015|| 1190||Collaboration agreement for integrating Enhanze platform with targeted therapeutics|
Halozyme Therapeutics has inked a $1.19 billion deal with AbbVie to develop and sell treatments that marry AbbVie’s drugs to Halozyme’s drug delivery technology.
News of the deal push Halozyme’s shares up 7 percent in premarket trading, a gain that continued into mid-morning.
Halozyme will receive $23 million upfront, with potential milestone payments of around $130 million per collaboration target met, with as many as nine possible targets.
| Parion Sciences, Vertex Pharmaceuticals||Jun 2015|| 1170||Licensing agreement for P-1037 and P-1055|
Vertex Pharmaceuticals has added cystic fibrosis fighting drugs it $80 million for the rights to two promising drugs from Parion Sciences.
The drugs, dubbed P-1037 and P-1055, are epithelial sodium channel (ENaC) inhibitors that have shown some initial success in treating cystic fibrosis.
It also has the option to buy a third, similar drug for an additional $230 million.
P-1037 is currently being tested as a monotherapy in a Phase IIa, but Vertex said today it hopes to combine it with its own lead candidates, ivacaftor and lumacaftor, in a combo mid-stage trial.
That study will treat patients who have duplicate copies of a genetic mutation that has been linked to CF, F508del.
Vertex will also offer tiered royalties based on milestones met at the regulatory and clinical levels.
Vertex agreed to pay Parion $80 million upfront, and up to an additional $490 million in payments tied to development and regulatory milestones—a figure that includes $360 million related to global filing and approval milestones.
Parion could also receive up to $370 million in development and regulatory milestone payments for P-1037 and P-1055 in non-CF pulmonary indications; plus another $230 million in development and regulatory milestones should Vertex develop an additional ENaC inhibitor from Parion's research program.
| Bayer, Panasonic Healthcare||Jun 2015|| 1150||Asset purchase agreement for diabetes business of Bayer|
Bayer will sell its diabetes business to Panasonic’s healthcare unit for around $1.15 billion, as the company begins shedding nonessential assets as part of a mission to refocus on life sciences.
The deal will close in the first quarter of 2016, said the companies.
The products included in the sale include Bayer’s Contour portfolio, including Contour Next, Contour Plus, Contour and Contour TS.
It also encompasses the sale of Breeze2, Brio, Entrust, Elite and Microlet lancing devices.
| Amgen, Kite Pharma||Jan 2015|| 1110||Collaboration and licensing agreement for Chimeric Antigen Receptor (CAR) T cell immunotherapies|
Amgen and Kite Pharma have entered into a strategic research collaboration and license agreement to develop and commercialize the next generation of novel Chimeric Antigen Receptor (CAR) T cell immunotherapies based on Kite's engineered autologous cell therapy (eACT) platform and Amgen's extensive array of cancer targets.
The collaboration brings together Amgen's commitment to and capabilities in advancing new approaches in immuno-oncology and Kite's industry-leading presence in CAR T cell therapy.
Under the terms of the agreement, Amgen will contribute cancer targets, and Kite will leverage its proprietary CAR platform, research and development (R&D) and manufacturing capabilities, and expertise.
Kite will be responsible for conducting all preclinical research and cell manufacturing and processing through Investigational New Drug (IND) filing.
Each company will then be responsible for clinical development and commercialization of their respective CAR therapeutic candidates, including all related expenses.
Kite will receive from Amgen an upfront payment of $60 million, as well as funding for R&D costs through IND filing.
Kite will be eligible to receive up to $525 million in milestone payments per Amgen program based on the successful completion of regulatory and commercialization milestones, plus tiered high single- to double-digit royalties for sales and the license of Kite's intellectual property for CAR T cell products.
Amgen is eligible to receive up to $525 million in milestone payments per Kite program, plus tiered single-digit sales royalties.
Further terms of the agreement are not being disclosed.
| Achillion Pharmaceuticals, Janssen Pharmaceuticals||May 2015|| 1100||Licensing agreement for developing ACH-3102, ACH-3422, and sovaprevir|
Achillion Pharmaceuticals has entered into a worldwide license and collaboration arrangement with Janssen Pharmaceuticals to develop and commercialize one or more of Achillion's lead hepatitis C virus (HCV) assets which include ACH-3102, ACH-3422, and sovaprevir.
Achillion will grant Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets.
Achillion is eligible to receive a number of payments based upon achievement of specified development, regulatory and sales milestones.
Achillion is also eligible to receive tiered royalty percentages between mid-teens and low-twenties based upon future worldwide sales.
Janssen will be responsible for all of the development costs within the collaboration and all subsequent costs related to commercialization of the HCV assets.
A key objective of the collaboration will be to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV.
An initial regimen that will be explored will feature Achillion's ACH-3102, a second-generation NS5A inhibitor currently in Phase 2 clinical studies that has been granted Fast Track designation by the U.S. Food and Drug Administration, in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration.
Johnson & Johnson Innovation will invest $225 million in Achillion and, in return, receive approximately 18.4 million newly issued, unregistered shares of Achillion at a price of $12.25 per share.
| DepoMed, Grunenthal, Johnson & Johnson||Jan 2015|| 1050||Asset purchase and licensing agreement for Nucynta portfolio|
Depomed has entered into a definitive agreement to acquire the U.S. rights to the NUCYNTA franchise from Janssen Pharmaceuticals for $1.05 billion.
The NUCYNTA franchise includes NUCYNTA ER (tapentadol) extended release tablets indicated for the management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN), severe enough to require daily, around-the-clock, long-term opioid treatment, and NUCYNTA (tapentadol), an immediate release version of tapentadol, for management of moderate to severe acute pain in adults.
NUCYNTA (tapentadol) oral solution is an approved oral form of tapentadol that has not been launched. The deal will make NUCYNTA the flagship asset in Depomed's growing portfolio of pain and neurology specialty pharmaceuticals.
Depomed will make a cash payment to Janssen of $1.05 billion.
In return, Depomed will assume the U.S. license and related royalty obligations for NUCYNTA to Grunenthal, the originator of tapentadol.
At signing, Depomed placed $500 million into an escrow account which will be released to Janssen upon closing of the transaction.
Depomed expects to raise the remaining capital to complete the transaction through a combination of debt, equity and equity-linked financing prior to closing, with the goal of limiting the dilution impact for existing shareholders.
The transaction has been unanimously approved by Depomed's board of directors.
The deal is expected to close in the second quarter of 2015, following termination or expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 and completion of financing and other customary closing conditions.
The transaction is expected to be immediately accretive and to significantly increase Depomed's product revenue, cash flow, earnings before interest, taxes, depreciation and amortization (EBITDA) and adjusted earnings per share for 2015, 2016 and beyond.
Depomed intends to provide investors with guidance for the combined company promptly after the completion of the transaction.
| GlaxoSmithKline, Novartis||Aug 2015|| 1034||Licensing agreement for ofatumumab|
GlaxoSmithKline announced an agreement with Novartis Pharma to divest its rights in ofatumumab for auto-immune indications, including multiple sclerosis.
The consideration payable by Novartis Pharma to GSK may reach up to $1,034 million and comprises a series of milestone payments as follows:
$300 million payable at closing;
$200 million payable subject to the start of a phase III study in relapsing remitting multiple sclerosis by Novartis;
further contingent payments of up to $534 million payable on the achievement of certain other development milestones.
Novartis Pharma will also pay royalties of up to 12 per cent to GSK on any future net sales of ofatumumab in auto-immune indications.
| Bristol-Myers Squibb, UniQure||Apr 2015|| 1002||Collaboration agreement for gene therapy technology platform for multiple targets in cardiovascular diseases|
Bristol-Myers Squibb and uniQure announced an agreement that provides Bristol-Myers Squibb with exclusive access to uniQure’s gene therapy technology platform for multiple targets in cardiovascular diseases.
The collaboration includes uniQure’s proprietary gene therapy program for congestive heart failure that is intended to restore the heart’s ability to synthesize S100A1, a calcium sensor and master regulator of heart function, and thereby improve clinical outcomes for patients with reduced ejection fraction.
Beyond cardiovascular diseases, the agreement also includes the potential for target-exclusive collaboration in other disease areas.
In total, the companies may collaborate on ten targets, including S100A1.
uniQure will lead discovery efforts and be responsible for manufacturing of clinical and commercial supplies using its vector technologies and its industrial, proprietary insect-cell based manufacturing platform.
Bristol-Myers Squibb will lead development and regulatory activities across all programs and be responsible for all research and development costs.
Bristol-Myers Squibb will be solely responsible for commercialization of all products from the collaboration.
Bristol-Myers Squibb will make near-term payments of approximately $100 million, including an upfront payment of $50 million to be made at the closing of the transaction, a $15 million payment for the selection of three collaboration targets, in addition to S100A1, to be made within three months of the closing and an initial equity investment in uniQure for a number of shares that will equal 4.9% of the total number of shares outstanding following such issuance, at a purchase price of $33.84 per share, or at least $32 million in total.
Bristol-Myers-Squibb will acquire an additional 5.0% ownership before December 31, 2015, at a 10% premium, and will be granted two warrants to acquire up to an additional 10% equity interest, at a premium, based on additional targets being introduced into the collaboration.
The parties have also agreed to enter into a supply contract, under which uniQure will undertake manufacturing of all gene therapy products under the collaboration.
uniQure will be eligible to receive research, development and regulatory milestone payments, including up to $254 million for the lead S100A1 therapeutic and up to $217 million for each other gene therapy product potentially developed under the collaboration.
uniQure is also eligible to receive net sales based milestone payments and tiered single to double-digit royalties on product sales.
| Esteve, Mundipharma, Purdue Pharma||Jan 2015|| 1000||Collaboration agreement for next generation products for pain (updated)|
Mundipharma Medical Company Limited and its independent associated company, Purdue Pharma L.P., announced that, following completion of Phase II studies, they have exercised their option and taken over full responsibility from Laboratorios Esteve, S.A.U. (ESTEVE) for the clinical, regulatory and commercial development of a potential first-in-class sigma-1 antagonist (S1A or MR309/E-52862).
Mundipharma Laboratories, Purdue Pharmaceuticals have entered into a global multi programme discovery and development collaboration with Laboratorios Esteve, to bring to market important next generation products for the management of pain.
Under the agreements Mundipharma and Purdue could potentially make payments to Esteve exceeding $ 1 bn if all development, regulatory and sales milestones are met across the different programmes.
The agreements bring together mid-sized, privately owned companies in a strategic collaboration that leverages their individual strengths, combining Mundipharma’s and Purdue’s commitment to the development and commercialisation of novel pain treatments together with Esteve’s extensive pain focused research and development expertise, particularly in the field of sigma-1 receptor biology, where they have been R&D leaders for over 10 years.
One of the highly innovative assets covered by the collaboration is E-52862, a first-in-class new chemical entity targeting the sigma-1 receptor pathway, which is currently in Phase 2 trials covering multiple neuropathic pain indications.
The collaboration also includes access to MuMo-1, the lead asset of Esteve´s Multi-Modal (MuMo) technology platform which is currently in preclinical development with the potential to enhance sigma-1 asset properties through the introduction of additional characteristics that are tailored for specific disease states. Mundipharma and Purdue will have primary commercial rights for this asset and Esteve retains rights in certain territories.
Also included in the agreement is E-58425, a novel first-in-class patented API:API co-crystal of tramadol and celecoxib, which leverages the efficacy properties of both compounds while lowering the component dosages and associated adverse effects.
A Phase 2 study in acute postoperative pain has shown that E-58425 demonstrated superior efficacy and safety over both placebo and a standard of care. The collaboration envisages Esteve commercialising E-58425 in the USA and Mundipharma in the rest of the world.
For Mundipharma and Purdue, the partnership will see the companies expand their pain franchise into neuropathic, acute and moderate pain in addition to existing expertise in opioids and severe pain.
For Esteve, the agreements validate its consistent investment into innovative R&D as well as its continued emphasis on identifying novel approaches to treat the significant unmet medical needs of people living with pain.
| 3M, Polypore||Feb 2015|| 1000||Asset purchase agreement for Separations Media business|
3M announced has entered into a definitive agreement with Polypore International Inc. to acquire the assets and liabilities associated with Polypore’s Separations Media business for a total purchase price of $1.0 billion.
Polypore’s Separations Media business is a leading provider of microporous membranes and modules for filtration in the life sciences, industrial and specialty segments with trailing 12-month sales of $210 million as of Sept. 27, 2014.
| BioAtla, Pfizer||Dec 2015|| 1000||Licensing and option agreement for antibody therapeutics|
BioAtla LLC has entered into a license and option agreement with Pfizer to advance the development and commercialization of a new class of antibody therapeutics based on BioAtla's CAB platform and utilizing Pfizer's proprietary antibody drug conjugate payloads.
Under the agreement, BioAtla and Pfizer will each have a license to the other's respective technology to pursue the development and commercialization of several CAB-ADC antibodies.
Pfizer also gains an exclusive option to develop and commercialize BioAtla CAB antibodies that target CTLA4, a validated immuno-oncology target in humans.
BioAtla and Pfizer are both eligible to receive milestone payments and royalties based on individual CAB-ADC antibody candidates developed and commercialized by the other party.
Including the CTLA4 option and license, BioAtla is eligible to receive a potential total of more than $1.0 billion in up-front, regulatory and sales milestone payments as well as tiered marginal royalties reaching double digits on potential future product sales.
| Celgene, Juno Therapeutics||Jun 2015|| 1000||Collaboration and option agreement for developing immunotherapies for cancer and autoimmune|
Celgene and Juno Therapeutics have launched a 10-year global collaboration to develop and commercialize cancer and autoimmune diseases immunotherapies.
The deal will generate about $1 billion for Juno, which could see Celgene's investment stake in the company grow from 10% to almost one-third.
The companies will develop treatments with an initial focus on chimeric antigen receptor technology (CAR-T) and T cell receptor (TCR) technologies.
Celgene has the option to serve as commercialization partner for Juno's oncology and cell therapy autoimmune product candidates, including Juno's CD19- and CD22-directed CAR-T product candidates.
The collaboration will not develop products targeting B-cell maturation antigen (BCMA), the focus of a Celgene collaboration with bluebird bio that the companies revised nearly a month ago.
For Juno-originated programs co-developed through the collaboration, Juno will oversee R&D in North America and will retain commercialization rights there.
Celgene will be responsible for development and commercialization elsewhere in the world, and has agreed to pay Juno high single-digit to mid-teens royalties on sales in those territories depending on development stage, the companies said.
Celgene has initial rights to select two programs—except for CD19 and CD22—with both subject to a global profit sharing agreement under which the companies will share worldwide expenses and profits equally, except in China.
Celgene may also select a third program, subject to additional obligations, the companies said.
Juno will have the option to enter into a co-development and co-commercialization agreement on some Celgene-originated development candidates that target T cells.
For any such programs, the companies have agreed to share global costs and profits with 70% for Celgene and the remaining 30% for Juno.
Celgene will lead global development and commercialization efforts, subject to a Juno co-promote option in the U.S. and certain EU territories.
In addition to the $150 million in upfront cash, Celgene agreed to buy more than 9.1 million shares of Juno's common stock—roughly 10% of the company’s shares as of June 26—at an aggregate price of about $850 million, or $93 per share.
| Bavarian Nordic, Bristol-Myers Squibb||Mar 2015|| 975||Licensing agreement for Prostvac|
Bavarian Nordic and Bristol-Myers Squibb announced an agreement that provides Bristol-Myers Squibb an exclusive option to license and commercialize PROSTVAC, Bavarian Nordic’s investigational Phase 3 prostate-specific antigen (PSA)-targeting cancer immunotherapy in development for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).
Bavarian Nordic will receive an upfront payment of $60 million.
Bristol-Myers Squibb can exercise the option in its sole discretion within a designated time after data is available from the ongoing Phase 3 trial.
Bavarian Nordic would be entitled to a payment of $80 million upon exercise of the option plus additional incremental payments starting at $50 million, but with a potential to exceed $230 million should the median overall survival benefit of PROSTVAC exceed the efficacy seen in Phase 2 results.
Furthermore, Bavarian Nordic could receive regulatory milestone payments of $110 million, up to $495 million in sales milestones as well as tiered double-digit royalties on future sales of PROSTVAC.
The parties have also agreed to enter into a supply contract, under which Bavarian Nordic will undertake the future commercial manufacturing of PROSTVAC.
| Intrexon, Merck Serono||Mar 2015|| 941||Collaboration and licensing agreement for Chimeric Antigen Receptor T-cell (CAR-T) cancer therapies|
Intrexon and Merck Serono announced an exclusive strategic collaboration and license agreement to develop and commercialize Chimeric Antigen Receptor T-cell (CAR-T) cancer therapies.
This collaboration advances Merck Serono's comprehensive, science-driven strategy to develop innovative therapies that modulate the immune system's natural ability to fight tumors.
Utilizing Intrexon's cell engineering techniques and RheoSwitch platform, the collaboration aims to develop leading-edge products that empower the immune system in a regulated manner to overcome the current challenges of CAR-T therapy.
The agreement provides Merck Serono exclusive access to Intrexon's proprietary and complementary suite of technologies to engineer T-cells with optimized and inducible gene expression, as recently strengthened by a license agreement with the University of Texas MD Anderson Cancer Center.
Intrexon will be responsible for all platform and product developments until IND filing.
Merck will nominate targets of interest for which CAR-T products will be developed.
Merck will also lead the IND filing and pre-IND interactions, clinical development and commercialization.
In addition, Intrexon has the opportunity to explore targets independently, granting Merck opt-in rights during clinical development.
Intrexon will receive an upfront payment of $115 million.
For the first two targets of interest selected by Merck Serono, Intrexon will receive research funding and is eligible to receive up to $826 million development, regulatory and commercial milestones, as well as tiered royalties on product sales.
In addition, Intrexon is also eligible to receive further payments upon achievement of certain technology development milestones.
| Hanmi Pharmaceutical, Janssen Pharmaceuticals||Nov 2015|| 915||Development and marketing agreement for oxyntomodulin-based drugs that improve metabolism|
Janssen Pharmaceuticals, Inc.announced that it has obtained worldwide rights, excluding China and Korea, to develop and commercialize oxyntomodulin-based therapies including HM12525A, a biologic that is completing phase 1 and expected to enter phase 2 studies next year, from Hanmi Pharmaceutical Co., Ltd.
HM12525A is an oxyntomodulin-based therapy (GLP-1/glucagon receptor dual agonist) that has shown evidence of improving multiple metabolic parameters that lead to improved blood glucose, body weight, and insulin sensitivity.
This asset has the potential, as a once weekly therapy, to be a best-in-class oxyntomodulin-based therapy.
| Baxalta, Sigma-Tau||Jul 2015|| 900||Asset purchase agreement for ONCASPAR|
Baxalta has completed the acquisition of the ONCASPAR (pegaspargase) portfolio from Sigma-Tau.
The acquisition includes ONCASPAR, an important biologic treatment for patients with acute lymphoblastic leukemia (ALL), the novel investigational biologic calaspargase pegol, and established global clinical and commercial resources.
Baxalta announced plans to acquire the portfolio for approximately $900 million.
ONCASPAR is a biologic cancer therapy used as a component of multi-agent chemotherapeutic regimens to treat acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the white blood cells responsible for more than 80 percent of childhood leukemia cases.
ONCASPAR is primarily marketed in the United States, Germany, Poland and certain other countries and is currently under centralized marketing authorization review with the European Medicines Agency.
Baxalta will pursue a number of opportunities to expand the value of the ONCASPAR portfolio for the oncology community, including the development of new formulations and new indications, as well as calaspargase pegol.
Baxalta will also leverage its global presence to seek marketing authorizations in additional countries.
| Genzyme, Sanofi, Voyager Therapeutics||Feb 2015|| 845||Collaboration agreement for AAV gene therapies|
Voyager Therapeutics announced a restructuring of its gene therapy relationship with Sanofi Genzyme.
Voyager gains worldwide rights to the VY-HTT01 Huntington’s disease program and ex-U.S. rights to the VY-FXN01 Friedreich’s ataxia program.
The ex-U.S. rights to VY-FXN01 are, in turn, transferred from Voyager to Neurocrine Biosciences under the terms of the collaboration agreement between Voyager and Neurocrine Biosciences announced in January 2019.
Sanofi Genzyme obtains exclusive option rights to select novel AAV capsids owned or controlled by Voyager for exclusive use for up to two non-central nervous system (non-CNS) indications.
In consideration of the rights returned, Voyager has agreed to make a $10 million upfront payment to Sanofi Genzyme.
This upfront payment is partially offset by a $5 million payment from Neurocrine Biosciences to Voyager to facilitate the transfer of the ex-U.S. rights to VY-FXN01 from Voyager to Neurocrine Biosciences.
An additional $10 million milestone payment is due to Sanofi Genzyme from Voyager upon filing of an investigational new drug (IND) application for VY-HTT01 or, if applicable, certain backup compounds for the treatment of Huntington’s disease.
Preclinical studies are underway with VY-HTT01 which, if successful, are expected to support a potential filing of an IND application in late 2019.
In connection with the restructuring of the gene therapy relationship with Sanofi Genzyme, and to focus its resources on the now wholly owned Huntington’s disease program and additional new discovery efforts, Voyager intends to seek a partner to advance its preclinical program for SOD1 ALS.
Given this portfolio decision, Voyager no longer expects to file an IND application for VY-SOD102 in 2019.
Voyager Therapeutics announced an update to its VY-AADC program for advanced Parkinson’s disease.
Under Voyager’s Collaboration Agreement with Sanofi Genzyme, Sanofi Genzyme had an exclusive option for ex-U.S. development and commercial rights to VY-AADC.
Based on Voyager’s understanding that because this option did not include rights in the U.S., Sanofi Genzyme informed Voyager that it has decided not to exercise its rights to this program.
As a result, Voyager gains full worldwide development and commercial rights to VY-AADC for the treatment of advanced Parkinson’s disease.
Voyager Therapeutics and Genzyme announced a major strategic collaboration to discover, develop and commercialize novel gene therapies for severe CNS disorders.
The collaboration will leverage Genzyme’s long-standing commitment and scientific leadership in the field of adeno-associated virus (AAV) gene therapy and Voyager’s industry-leading AAV product engine to develop breakthrough therapies for patients suffering from severe CNS disorders.
The alliance will encompass multiple gene therapy programs, including programs for Parkinson’s disease, Friedreich’s ataxia and Huntington’s disease, as well as other CNS disorders.
Each program targets a severe, debilitating disease and has the potential to deliver transformational therapeutic benefit for patients.
The collaboration portfolio created will combine programs and intellectual property from both companies.
Voyager will drive research and development activities for all programs, working with Genzyme in a highly collaborative way.
Genzyme will have the option to license several programs following completion of an initial proof-of-concept human clinical trial.
However, Voyager will retain all U.S. rights to its lead product programs in Parkinson’s disease (VY-AADC01) and Friedreich’s ataxia (VY-FXN01).
Voyager will split U.S. profits with Genzyme for the Huntington’s disease program (VY-HTT01).
In addition, Voyager’s lead amyotrophic lateral sclerosis (ALS) program (VY-SOD101) is not part of the collaboration and Voyager retains worldwide rights to this program.
Genzyme will make an upfront commitment of $100 million to Voyager, including $65 million in cash, a $30 million equity investment in Voyager and additional in-kind contributions.
Voyager is eligible to receive future potential development and sales milestone payments of up to $745 million, as well as tiered royalties on product sales.
| Ionis Pharmaceuticals, Janssen Biotech||Jan 2015|| 835||Collaboration agreement for RNA-targeted therapeutics for autoimmune diseases in GI tract|
Isis Pharmaceuticals has entered into a global collaboration with Janssen Biotech to discover and develop antisense drugs to treat autoimmune disorders of the gastrointestinal (GI) tract.
The collaboration brings together Isis' RNA-targeted technology platform and the expertise of Janssen in autoimmune disorders and therapeutic formulation to discover and develop antisense drugs that can be locally administered, including oral delivery, to treat autoimmune disorders in the GI tract.
Under the terms of the agreement, which covers three programs, Isis will receive $35 million in upfront payments, including a payment to initiate human lead optimization on the first collaboration target.
Isis is eligible to receive nearly $800 million in development, regulatory and sales milestone payments and license fees for these programs.
In addition, Isis will receive tiered royalties that on average are double-digits on sales from any product that is successfully commercialized.
Janssen has the option to license a drug from each of the programs once a development candidate is identified.
If Janssen exercises its option, it will assume global development, regulatory and commercialization responsibilities.
| AstraZeneca, Daiichi Sankyo||Mar 2015|| 825||Co-promotion agreement for Movantik|
AstraZeneca announced a co-commercialisation agreement with Daiichi Sankyo for MOVANTIK (naloxegol) in the US, in line with the Company’s strategy of delivering value through its own development and commercial capabilities as well as through external collaboration.
MOVANTIK is a first-in-class once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
MOVANTIK was approved by the US Food and Drug Administration in September 2014.
It was descheduled by the US Drug Enforcement Administration in January 2015 and is no longer labelled as a controlled substance.
The launch of MOVANTIK in the US is planned for early April 2015.
Daiichi Sankyo will pay a $200 million up-front fee and subsequent sales-related payments of up to $625 million.
AstraZeneca will be responsible for manufacturing, will book all sales and will make sales-related commission payments to Daiichi Sankyo.
Both companies will be jointly responsible for commercial activities.
AstraZeneca’s 2015 financial guidance, provided on 6 March 2015, is unaffected by today’s announcement.
| Eli Lilly, Halozyme Therapeutics||Dec 2015|| 825||Collaboration and licensing agreement to develop products using ENHANZE platform|
Halozyme Therapeutics announced a global collaboration and license agreement with Eli Lilly and Company (NYSE: LLY) to develop and commercialize products combining proprietary Lilly compounds with Halozyme's ENHANZE platform.
Under the terms of the agreement, Halozyme will receive an initial $25 million payment, followed by milestone payments of up to $160 million for each of up to five collaboration targets valued at up to $800 million.
These payments are subject to Lilly's achievement of specified development, regulatory and sales-based milestones.
In addition, Lilly will pay Halozyme mid-single digit royalties if products under the collaboration are commercialized.
The Halozyme ENHANZE platform is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan -- a chain of natural sugars in the body -- to aid in the dispersion and absorption of other injected therapeutic drugs.
ENHANZE is Halozyme's proprietary drug delivery platform based on its patented recombinant human hyaluronidase enzyme (rHuPH20).
| Famy Care, Mylan Laboratories||Feb 2015|| 800||Asset purchase agreement for female reproductive health care businesses|
Mylan has, through its Indian subsidiary Mylan Laboratories Limited, signed a definitive agreement to acquire certain female health care businesses from Famy Care Limited, a specialty women's health care company with global leadership in generic oral contraceptive products for $750 million in cash plus additional contingent payments of up to $50 million.
The acquisition will build on Mylan's existing partnerships with Famy Care in North America, Europe and Australia, and provide Mylan with an enhanced and now vertically integrated platform that will accelerate the company's growth in the important global women's health care space.
This transaction especially complements Mylan's pending acquisition of Abbott's non-U.S. developed markets specialty and branded generics business, which also includes a women's health care portfolio and sales and marketing capabilities.
Additionally, the acquisition of the Famy Care businesses will make Mylan a hormonal contraceptives leader in high-growth emerging markets around the world.
Under the terms of the transaction, which has been unanimously approved by both companies' boards of directors, Mylan will acquire certain female reproductive health care businesses from Famy Care for $750 million in cash at closing, subject to certain adjustments, plus an additional payment of up to $50 million, contingent upon achievement of certain development and regulatory milestones.
Under the proposed transaction structure, Famy Care will spin off its female health care businesses under a court approved scheme of demerger.
| AstraZeneca, Wuxi Apptec Laboratory Services||Dec 2015|| 800||Collaboration agreement for faster treatments in China|
AstraZeneca aims to build up its already strong position in China by making and developing more medicines locally, and will invest more than $800 million (527.8 million pounds) in the country over the next 10 years.
The British drugmaker's decision to step up investment in China, notably through a strategic alliance with local firm WuXi AppTec, chimes with Beijing's desire to see more treatments made in China.
The upside for AstraZeneca should be that locally produced medicines win faster approval from the China Food and Drug Administration, rather than being delayed for years as often happens with imported products.
In future foreign firms will be more reliant on new, patented medicines, analysts believe, although the scale of demand for such expensive products is uncertain in a country with only basic health insurance cover.
One element involves WuXi AppTec producing new biotech medicines locally in China, with AstraZeneca having the option to acquire WuXi’s manufacturing capacity through an overall investment of $100 million.
AstraZeneca is also spending $50 million on developing traditional "small molecule" drugs in China and is creating a new global hub for pharmaceutical development in and around Shanghai.
| Incyte, Jiangsu Hengrui Medicine||Sep 2015|| 795||Licensing and collaboration agreement for SHR-1210 anti-PD-1 monoclonal antibody|
Incyte Corporation announced a global license and collaboration agreement with Jiangsu Hengrui Medicine Co., Ltd. for the development and commercialization of SHR-1210, an investigational anti-PD-1 monoclonal antibody.
Under the agreement, Incyte will have the exclusive development and commercialization rights to SHR-1210 worldwide, with the exception of Mainland China, Hong Kong, Macau, and Taiwan.
SHR-1210 is expected to enter proof-of-concept studies for the treatment of patients with advanced solid tumors in the coming months.
Under the terms of the agreement, Incyte will acquire development and commercialization rights to SHR-1210 worldwide, with the exception of Mainland China, Hong Kong, Macau, and Taiwan, in exchange for an upfront payment of $25 million.
The terms also include potential milestone payments of up to $770 million to Hengrui, consisting of $90 million for regulatory approval milestones, $530 million for commercial performance milestones, and $150 million based on clinical superiority.
The terms also include tiered royalties to Hengrui on net sales of SHR-1210 in Incyte territories.
Under the Agreement, Incyte and Hengrui will assume all financial obligations associated with the development and commercialization of SHR-1210 in their respective territories.
Monoclonal antibodies targeting PD-1 enhance anti-tumoral immunity and are being developed for the treatment of cancer.
| Incyte, Jiangsu Hengrui Medicine||Sep 2015|| 795||Licensing agreement for SHR-1210|
Incyte announced a global license and collaboration agreement with Jiangsu Hengrui Medicine for the development and commercialization of SHR-1210, an investigational anti-PD-1 monoclonal antibody.
Incyte will have the exclusive development and commercialization rights to SHR-1210 worldwide, with the exception of Mainland China, Hong Kong, Macau, and Taiwan.
SHR-1210 is expected to enter proof-of-concept studies for the treatment of patients with advanced solid tumors in the coming months.
Incyte will acquire development and commercialization rights to SHR-1210 worldwide, with the exception of Mainland China, Hong Kong, Macau, and Taiwan, in exchange for an upfront payment of $25 million.
The terms also include potential milestone payments of up to $770 million to Hengrui, consisting of $90 million for regulatory approval milestones, $530 million for commercial performance milestones, and $150 million based on clinical superiority.
The terms also include tiered royalties to Hengrui on net sales of SHR-1210 in Incyte territories.
Under the Agreement, Incyte and Hengrui will assume all financial obligations associated with the development and commercialization of SHR-1210 in their respective territories.
| Anokion, Astellas Pharma, Kanyos||Jun 2015|| 786||Joint venture agreement for Kanyos|
Astellas Pharma and Anokion announced an agreement to collaborate in the fields of type 1 diabetes and celiac disease.
Key components of the agreement include:
A new company, Kanyos Bio has been created to develop clinical candidates in the two selected indications, with an option for Astellas to add a third autoimmune indication as part of the collaboration.
Astellas will provide non-dilutive research funding to Kanyos and holds an option to acquire Kanyos after reaching certain milestones.
Total potential deal value of about $760 Million includes R&D funding, option exercise and milestone payments.
Astellas will also participate, along with Anokion’s existing investors, in a $16 Million equity financing for Kanyos.
The creation of Kanyos will enable preclinical development of products for type 1 diabetes and celiac disease.
| Fedora Pharmaceuticals, Meiji Seika, Roche||Jan 2015|| 750||Licensing agreement for OP0595|
Roche, Meiji Seika Pharma and Fedora have entered into a license agreement for the development and commercialization of OP0595, a beta-lactamase inhibitor in phase I clinical development.
Roche obtains worldwide rights from both companies for development and commercialization with the exception of Japan, where Meiji will retain sole commercialization rights.
Beta-lactamase inhibitors restore or potentiate the activity of beta-lactam antibiotics.
The combination of OP0595 with a beta-lactam antibiotic targets severe infections caused by Enterobacteriaceae, including multi-drug-resistant strains.
Meiji and Fedora will receive upfront plus development, regulatory and sales event milestone payments totaling potentially up to $750 million.
In addition, Meiji and Fedora are entitled to receive tiered royalties on sales of products originating from this collaboration.
| Aduro BioTech, Novartis||Mar 2015|| 750||Collaboration agreement for immuno-oncology products from cyclic dinucleotide (CDN) approach to target STING receptor|
Aduro Biotech announced the establishment of a major collaboration with Novartis for the worldwide research, development and commercialization of novel immuno-oncology products derived from Aduro’s cyclic dinucleotide (CDN) approach to target the STING (Stimulator of Interferon Genes) receptor, that, when activated, is known to initiate broad innate and adaptive tumor-specific immune responses.
Novartis will make an upfront payment of $200 million to Aduro and, if all development milestones are met, Aduro is eligible to receive up to an additional aggregate amount of $500 million.
In addition, Novartis has made an initial 2.7 percent equity investment in Aduro for $25 million, with a commitment for another $25 million investment at a future date.
Aduro will lead commercialization activities and will book sales in the United States for any products developed and commercialized pursuant to this collaboration, with Novartis leading commercialization activities in all other regions.
The companies will share in profits, if any, in the United States, Japan and major European countries.
Novartis will pay Aduro a mid-teens royalty for sales in the rest of the world.
| Boehringer Ingelheim, Genentech, Hanmi Pharmaceutical||Jul 2015|| 730||Licensing agreement for developing HM61713 (terminated)|
Just a day after Seoul, South Korea-based Hanmi Pharmaceutical Co. announced a deal with Genentech (RHHBY), a member of the Roche Group (RHO), Boehringer Ingelheim terminated a license deal because of patient deaths.
In July 2015, the two companies announced a license and collaboration deal to develop a third-generation EGFR drug to treat EGFR mutation positive lung cancer. Under that deal, Hanmi received a $50 million (US) upfront fee and was entitled to milestone payments up to $680 million, as well as tiered double-digit royalties on future net sales.
It was at that time being investigated in a Phase II trial in patients with non-small cell lung cancer (NSCLC) with T790M mutations that had developed resistance to other EGFR targeting drugs.
In a filing, Hanmi indicates that Boehringer Ingelheim ended the deal after two patients died because of a serious skin reaction.
Boehringer returned the license, but Hanmi is not required to return the $65 million it has received so far.
Boehringer Ingelheim and Hanmi Pharmaceutical announced an exclusive license and collaboration agreement for the development and global commercialization rights, except South Korea, China and Hong Kong, of HM61713, a novel 3rd generation EGFR targeted therapy for the treatment of a specific type of lung cancer.
Hanmi will receive an initial payment of USD 50 million and is entitled to potential milestone payments of USD 680 million plus tiered double-digit royalties on future net sales.
The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act, similar requirements outside the U.S., and other customary closing conditions.
HM61713 is a novel 3rd generation, orally active, irreversible EGFR mutation selective tyrosine kinase inhibitor (TKI).
At this year's ASCO Annual Meeting, interim results of the Phase I/II clinical trial were presented and showed strong efficacy signals, combined with a favorable safety profile.
The compound is currently in Phase II clinical development for patients with non-small cell lung cancer (NSCLC) with T790M mutations who have developed resistance to previous EGFR targeting agents.
Preparations have begun for a broader Phase III trial program to be initiated in 2016.
HM61713 is another important pillar in Boehringer Ingelheim's global lung cancer franchise, which builds on two products, GIOTRIF/GILOTRIF (afatinib) and VARGATEF® (nintedanib), approved in various countries.
With the inclusion of HM61713, Boehringer Ingelheim now has more than 10 compounds in clinical development in a wide variety of oncology indications, including immune oncology approaches like an mRNA based therapeutic vaccine under development in collaboration with CureVac.
| Celgene, Editas Medicine, Juno Therapeutics||May 2015|| 727||Collaborative R&D agreement for integrating CRISPR/Ca9 with CAR AND TCR techology|
Editas Medicine announced an amended collaboration with Celgene under which the parties may research, develop, and commercialize autologous and allogeneic alpha-beta T cell medicines for the treatment of cancer and autoimmune diseases.
Under the terms of the amended agreement, Editas Medicine will receive a payment of $70 million.
Editas Medicine may develop genome editing tools and Celgene will have rights to opt-in to such genome editing tools for development of gene edited alpha-beta T cell therapies.
For each new experimental medicine that Celgene develops and commercializes using opted-into genome editing tools, Celgene will pay Editas Medicine potential future milestone and royalty payments.
Juno Therapeutics and Editas Medicine announced an exclusive collaboration focused on creating chimeric antigen receptor (CAR T) and high-affinity T cell receptor (TCR) therapies to treat cancer.
The companies will pursue three research programs together utilizing Editas’ genome editing technologies, including CRISPR/Cas9, with Juno’s CAR and TCR technologies.
Juno will pay Editas an upfront payment of $25 million and up to $22 million in research support over the next five years across the three programs in the alliance.
Editas is also eligible to receive future research, regulatory, and commercial sales milestones in excess of $230 million for each program.
Following the approval of any products resulting from the alliance, Editas is also eligible to receive tiered royalties.
| AstraZeneca, Inovio Pharmaceuticals, MedImmune||Aug 2015|| 725||Collaboration and licensing agreement for INO-3112 HPV cancer vaccine and DNA-based immunotherapies|
AstraZeneca announced that MedImmune, its global biologics research and development arm, has entered into a license agreement and collaboration with Inovio Pharmaceuticals, a biotechnology company developing DNA-based immunotherapies for cancer and infectious diseases.
MedImmune will acquire exclusive rights to Inovio’s INO-3112 immunotherapy, which targets cancers caused by human papillomavirus (HPV) types 16 and 18.
INO-3112, which is in phase I/II clinical trials for cervical and head and neck cancers, works by generating killer T-cell responses that are able to destroy HPV 16- and 18-driven tumours.
These HPV types are responsible for more than 70 per cent of cervical pre-cancers and cancers.
MedImmune intends to study INO-3112 in combination with selected immunotherapy molecules within its pipeline in HPV-driven cancers.
Emerging evidence suggests that the benefits from immuno-oncology molecules, such as those in MedImmune’s portfolio, can be enhanced when they are used in combination with cancer vaccines that generate tumour-specific T-cells.
MedImmune will make an upfront payment of $27.5 million to Inovio as well as potential future payments upon reaching development and commercial milestones totaling up to $700 million.
MedImmune will fund all development costs.
Inovio is entitled to receive up to double-digit tiered royalties on INO-3112 product sales.
Within the broader collaboration, MedImmune and Inovio will develop up to two additional DNA-based cancer vaccine products not included in Inovio’s current product pipeline, which MedImmune will have the exclusive rights to develop and commercialise.
Inovio will receive development, regulatory and commercialisation milestone payments and will be eligible to receive royalties on worldwide net sales for these additional cancer vaccine products.
| Madison Dearborn Partners, Patterson Companies||Jul 2015|| 715||Asset purchase agreement for medical business|
Patterson Companies announced a definitive agreement to sell its medical business (Patterson Medical) to Madison Dearborn Partners (MDP), a leading private equity firm based in Chicago, for gross proceeds of approximately $715 million in cash.
The sale is expected to close in the fiscal second quarter, following the satisfaction of regulatory requirements and other customary closing conditions.
| Actavis (name changed to Allergan), AstraZeneca||Feb 2015|| 700||Asset purchase agreement for branded respiratory portfolio|
AstraZeneca and Actavis have entered into a definitive agreement under which AstraZeneca will acquire the rights to Actavis’ branded respiratory business in the US and Canada for an initial consideration of $600 million on completion and low single-digit royalties above a certain revenue threshold.
Upon completion of the transaction, AstraZeneca will own the development and commercial rights in the US and Canada to Tudorza Pressair (aclidinium bromide inhalation powder), a twice-daily long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease, and Daliresp (roflumilast), the only once-daily oral PDE4 inhibitor currently on the market for COPD.
AstraZeneca will also own development rights in the US and Canada for LAS40464, the combination of a fixed dose of aclidinium with formoterol long acting beta agonist (LAMA/LABA) in a dry powder inhaler, which is approved in the EU under the brand name Duaklir Genuair.
The strategic transaction strengthens AstraZeneca’s respiratory franchise globally and builds on the acquisition of Almirall’s respiratory portfolio in 2014 by extending the company’s development and commercialisation rights into the US for both Tudorza Pressair and Duaklir Genuair.
The acquisition of Tudorza Pressair and Daliresp will immediately add on-market revenues and complements AstraZeneca’s respiratory portfolio by broadening the choice of treatments and formulations offered to patients and physicians.
AstraZeneca will also pay Actavis an additional $100 million and Actavis has agreed to a number of contractual consents and approvals, including certain amendments to the ongoing collaboration agreements between AstraZeneca and Actavis.
| Alligator Bioscience, Janssen Biotech, Johnson & Johnson Innovation||Aug 2015|| 695||Licensing agreement for ADC-1013|
Alligator Bioscience announced that a development milestone payment of USD 6 million has been triggered under the partnership agreement for ADC-1013 (JNJ-64457107) with Janssen Biotech.
The milestone payment is for the partnership agreement to initiate a clinical combination study of ADC-1013 with one of Janssen's proprietary PD-1 inhibitors.
This is the first out of a number of pre-defined milestones, related to the start of combination or phase II studies as part of the ADC-1013 clinical program, which all together have an aggregated potential value of 35 MUSD.
The licensing agreement with Janssen Biotech encompasses milestone payments up to a potential total value of USD 695 million.
Alligator is also eligible to receive tiered royalties on worldwide net sales upon successful launch and commercialization of ADC-1013.
Janssen Biotech announced an exclusive, worldwide license agreement with Alligator Bioscience AB for ADC-1013, an immuno-oncology agent currently in Phase 1 clinical studies.
The agreement was facilitated by Johnson & Johnson Innovation, London.
Janssen will attain rights to develop and commercialize ADC-1013, an agonistic fully human monoclonal antibody.
ADC-1013 targets CD40, an immuno-stimulatory receptor found on antigen-presenting cells such as dendritic cells. Stimulating this receptor initiates a process leading to an increase in T cells attacking a tumor.
Alligator Bioscience will receive an upfront payment plus additional milestone payments contingent upon reaching certain pre-determined development, regulatory and commercial milestones.
Alligator Bioscience will complete the current Phase 1 dose escalation study and Janssen will be responsible for all subsequent development of ADC-1013, including research, development, manufacturing, regulatory and commercialization activities.
In a separate transaction, Johnson & Johnson Innovation - JJDC will subscribe for new shares of Alligator stock.
| Eli Lilly, Hanmi Pharmaceutical||Mar 2015|| 690||Collaboration and licensing agreement for HM71224|
Eli Lilly and Hanmi Pharmaceutical have entered into an exclusive license and collaboration agreement for the development and commercialization of Hanmi's oral Bruton's tyrosine kinase (BTK) inhibitor, HM71224, for the treatment of autoimmune and other diseases.
The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act, similar requirements outside the U.S., and other customary closing conditions.
This small molecule is ready to enter Phase II and the parties plan to investigate the molecule for the potential treatment of rheumatoid arthritis, lupus, lupus nephritis, Sjögren's syndrome, and other related conditions.
Lilly will receive worldwide rights to the molecule for all indications excluding China, Hong Kong, Taiwan, and Korea. Lilly will take development, regulatory, manufacturing, and commercial leadership for the molecule in the Lilly territories.
Hanmi will receive an initial payment of $50 million and is eligible for up to $640 million in potential development, regulatory, and sales milestones.
If the BTK inhibitor is successfully commercialized, Hanmi would also be eligible for tiered double-digit royalty payments.
| Arvinas, Genentech||Oct 2015|| 650||Licensing agreement for Protac technology|
Arvinas has expanded its ongoing license agreement with Genentech for the development of new therapeutics using Arvinas’ novel PROTAC technology.
The multi-year strategic license agreement, initiated in October 2015, will encompass additional disease targets and expand the collaboration.
Under the revised terms of the agreement, Arvinas is eligible to receive development and commercialization milestone payments in excess of $650 million based on achievement of certain predetermined milestones.
In addition, Arvinas is eligible to receive tiered-royalties on sales of products resulting from the license agreement.
Full financial terms have not been disclosed.
Arvinas entered into a license agreement with Genentech for the development of new therapeutics using Arvinas’ novel PROTAC technology.
The multi-year strategic license agreement encompasses multiple disease targets.
Arvinas will receive an undisclosed upfront payment.
Arvinas is eligible to receive development and commercialization milestone payments in excess of $300 million based on achievement of certain predetermined milestones.
In addition, Arvinas is eligible to receive tiered-royalties on sales of products resulting from the license agreement.
Full financial terms have not been disclosed.
At Genentech’s discretion, it may elect to expand the collaboration to include additional disease targets for additional consideration.
| Seattle Genetics, Unum Therapeutics||Jun 2015|| 645||Collaboration and licensing agreement for ACTR therapies for cancer|
Seattle Genetics and Unum Therapeutics have entered into a strategic collaboration and license agreement to develop and commercialize novel antibody-coupled T-cell receptor (ACTR) therapies for cancer.
Unum’s proprietary ACTR technology enables programming of a patient’s T-cells to attack tumor cells when co-administered with tumor-specific therapeutic antibodies.
Seattle Genetics, through its extensive work in the field of antibody-drug conjugates, has a substantial portfolio of cancer targets and tumor-specific monoclonal antibodies from which programs will be selected for the collaboration.
Seattle Genetics will make an upfront payment of $25 million and an equity investment of $5 million in Unum’s next round of private financing.
The companies will initially develop two ACTR products incorporating Seattle Genetics’ antibodies, and Seattle Genetics has an option to expand the collaboration to include a third ACTR product.
Unum will conduct preclinical research and clinical development activities through phase 1 with funding from Seattle Genetics.
The companies will work together to co-develop and jointly fund programs after phase 1 unless either company opts out.
Seattle Genetics and Unum will co-commercialize and share profits 50/50 on any co-developed programs in the United States.
Seattle Genetics will retain exclusive commercial rights outside of the United States, paying Unum high single to mid-double digit royalties on ex-U.S. sales.
Potential option fee and progress-dependent milestone payments to Unum under the collaboration may total up to $615 million across all three ACTR programs.
As a result of the amounts paid up front and the additional development activities expected under this deal, Seattle Genetics will provide revised 2015 financial guidance in connection with announcing its second quarter financial results currently planned for July 30, 2015.
| AM-Pharma, Pfizer||May 2015|| 600||Asset purchase and option to acquire AM-Pharma|
Pfizer has acquired a minority equity interest in AM-Pharma and secured an exclusive option to acquire the remaining equity in the company.
The option becomes exercisable upon completion of a Phase II trial of recAP in the treatment of Acute Kidney Injury (AKI) related to sepsis.
Under the terms of the agreement, Pfizer has made an upfront payment of $87.5 million for the minority equity interest and exclusive option, with additional potential payments of up to $512.5 million upon option exercise and potential launch of any product that may result from this agreement.
Other terms of the transaction were not disclosed.
| Abbvie, Boehringer Ingelheim||Mar 2015|| 595||Collaboration agreement for BI 655066 and BI 655064|
AbbVie and Boehringer Ingelheim that they have inked a global collaboration deal to develop and market BI 655066 for psoriasis.
AbbVie is paying Boehringer Ingelheim $595 million upfront with additional development and regulatory milestones and royalties if the product makes it to market.
BI 655066 is an anti-IL-23 monoclonal biologic antibody that is currently being studied for psoriasis in a Phase III clinical trial.
It is also in a Phase II trial for Crohn’s disease and asthma, and is expected to start a Phase II trial for psoriatic arthritis.
In addition to BI 655066, AbbVie gained the rights to BI 655064, an anti-CD-40 antibody that is currently in Phase I development.
It is being studied as a potential treatment for lupus nephritis, Crohn’s disease and ulcerative colitis.
| AstraZeneca, Takeda Pharmaceutical||Dec 2015|| 575||Asset purchase agreement for respiratory business|
AstraZeneca has entered into a definitive agreement to acquire the core respiratory business of Takeda Pharmaceutical Company.
The deal will include the expansion of rights to roflumilast (marketed as Daliresp in the US and Daxas in other countries), the only approved oral PDE4 inhibitor for the treatment of chronic obstructive pulmonary disease (COPD).
AstraZeneca will make a payment of $575 million.
Approximately 200 staff will transfer to AstraZeneca upon completion.
| BioMarin Pharmaceutical, Medivation, Pfizer||Aug 2015|| 570||Asset purchase agreement for talazoparib|
BioMarin Pharmaceutical earned a $15 million milestone payment from Pfizer.
This milestone payment was triggered by the European Commission (EC) approval of TALZENNA (talazoparib) as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA) 1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC).
Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments.
Patients with hormone receptor-positive (HR+) breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.
This milestone payment is part of an agreement made with Medivation when Medivation purchased talazoparib.
Medivation was acquired by Pfizer in September 2016.
BioMarin Pharmaceutical received $20 million in milestone payments from Pfizer.
These milestone payments were triggered by the U.S. Food and Drug Administration (FDA) acceptance of Pfizer's New Drug Application (NDA) submission for talazoparib and by the European Medicines Agency (EMA) acceptance of Pfizer's submission of a Marketing Authorization Application (MAA) for talazoparib.
These milestone payments are part of an agreement made with Medivation when the company purchased talazoparib.
Medivation was acquired by Pfizer.
Medivation and BioMarin Pharmaceutical have entered into an asset purchase agreement under which Medivation will acquire all worldwide rights to talazoparib (formerly referred to as BMN 673), a highly-potent, orally-available poly ADP ribose polymerase (PARP) inhibitor currently in a Phase 3 study for the treatment of patients with deleterious germline BRCA 1 or BRCA 2 mutations and locally advanced and/or metastatic breast cancer.
Medivation will be responsible for all research, development, regulatory and commercialization activities for all indications on a global basis.
Medivation will pay BioMarin $410 million upfront, up to an additional $160 million upon the achievement of regulatory and sales-based milestones and mid-single digit royalties for talazoparib.
At the closing of the transaction, Medivation will assume all financial obligations associated with the development and commercialization of talazoparib.
| Curadev Pharma, Roche||Apr 2015|| 555||Collaboration and licensing agreement for IDO1 and TDO inhibitors|
Curadev Pharma has entered into a research collaboration and exclusive license agreement with Roche for the development and commercialization of IDO1 and TDO inhibitors.
The agreement covers the development of the lead preclinical immune tolerance inhibitor and a research collaboration with Roche's research and early development organization to further explore the IDO and TDO pathways.
Under the terms of agreement, which includes a research collaboration with Roche's research and early development organization to further extend Curadev's findings, Curadev will receive an upfront payment of $25 million and will be eligible to receive up to $530 million in milestone payments based on achievement of certain predetermined events and sales levels as well as escalating royalties potentially reaching double digits for the first product from the collaboration developed and commercialized by Roche.
Curadev would also be eligible for milestones and royalties on any additional products resulting from the research collaboration.
Roche will fund future research, development, manufacturing and commercialization costs and will also provide additional research funding to Curadev for support of the research collaboration.
| Celgene, Nurix||Sep 2015|| 555||Collaboration agreement for targeting protein homeostasis|
Nurix has entered into a strategic collaboration with Celgene for the discovery, development and commercialization of novel small molecule therapeutics in oncology, inflammation and immunology, including the rapidly evolving field of immuno-oncology.
Nurix will work exclusively with Celgene in these therapeutic areas to advance new therapies that function through the ubiquitin proteasome system (UPS) to modulate protein homeostasis, a fundamental cellular process controlling protein levels.
Mutations in UPS genes are common drivers of many human cancers. In addition, certain UPS genes function in normal physiology encoding key checkpoints in the immune response.
Celgene will make an upfront payment to Nurix of $150 million, plus an undisclosed equity investment, for an option to license future programs, with the ability to extend the option to license term for additional payments.
During the option to license term, Nurix may focus on investigating E3 ubiquitin ligases and E2 conjugating enzymes to identify the most promising drug discovery programs for use in oncology or inflammation and immunology therapeutic applications.
Nurix will control and is responsible for all drug discovery and development activities through the end of Phase 1 clinical trials.
Celgene may license global development and commercialization rights to a program in exchange for an option fee, potential clinical, regulatory and sales milestone payments totaling up to $405 million, as well as future tiered single-digit to low double-digit royalties on global sales.
Celgene will have worldwide rights to collaboration products, with the exception of certain collaboration products for which Nurix retains U.S. development and commercialization rights.
These rights include the opportunity for the companies to co-develop and co-commercialize up to two programs in the U.S. (50:50 profit / loss split), with Celgene retaining ex-US rights, in exchange for an option fee, milestone payments and royalties on ex-U.S. sales on a program-by-program basis. For candidates not optioned by Celgene under the collaboration, Nurix retains worldwide rights.
| Biogen, Mitsubishi Tanabe Pharma||Sep 2015|| 544||Licensing agreement for MT-1303|
Biogen announced an agreement to exclusively license MT-1303, a late stage experimental medicine with potential in multiple autoimmune indications, from Mitsubishi Tanabe Pharma.
MT-1303 is an oral compound that targets the sphingosine 1-phosphate (S1P) receptor.
Biogen will receive worldwide rights to MT-1303, excluding Asia.
Biogen will be responsible for global commercialization and also cover development costs outside of Asian territories.
MTPC will receive an upfront payment of $60 million from Biogen and may receive up to $484 million in additional milestone payments for multiple indications and territories.
MTPC has the right to participate in Biogen’s global clinical trials and has an option to co-promote non-MS indications in the U.S.
| Alpine Immune Sciences, Kite Pharma||Oct 2015|| 535||Collaboration and licensing agreement for transmembrane immunomodulatory protein technology for applications to CAR and TCR programs|
Kite Pharma has entered into a worldwide research and license agreement with Alpine Immune Sciences to discover and develop protein-based immunotherapies targeting the immune synapse to treat cancer.
AIS will grant Kite an exclusive license to two programs from its transmembrane immunomodulatory protein (TIP) technology, which Kite plans to further engineer into chimeric antigen receptor (CAR) and T cell receptor (TCR) product candidates.
This collaboration will accelerate Kite's efforts to establish the next generation of engineered T cell therapies specifically designed to overcome the inhibitory mechanisms present in the tumor microenvironment.
Kite will make an upfront payment to AIS of $5 million and additional payments to support AIS' research.
AIS will be eligible to receive milestone payments based upon the successful achievement of pre-specified research, clinical, and regulatory milestones totaling $530 million plus low single-digit royalty payments on product sales.
Kite will receive an exclusive, worldwide license to research, develop and commercialize engineered autologous T cell therapies incorporating two programs coming from the AIS platform.
| Astellas Pharma, Chromocell||Sep 2015|| 515||Collaboration and licensing agreement for NaV1.7 antagonist CC8464|
Astellas Pharma and Chromocell have entered into a license and collaboration agreement for the development and commercialization of therapeutics to treat neuropathic and other pain conditions.
Astellas obtains worldwide rights to commercialize CC8464 and back-up drug candidates to treat pain that have been identified through Chromocell's Chromovert technology platform.
Chromocell receives $15 million as an up-front payment and is eligible to receive over $500 million, including development and commercial milestones, as well as double digit royalties on sales if CC8464 is successfully commercialized.
Chromocell will conduct all development of CC8464 through the initial Phase 2a proof-of-concept clinical trial in neuropathic pain.
Astellas will lead all further development activities through to commercialization of CC8464 for the treatment of peripheral neuropathic pain.
Aside from those development activities, Chromocell may propose, and may initiate, studies for certain additional indications such as rare diseases and non-oral formulations of the drug candidate.
Astellas has the right to opt-in for development for such additional indications, which triggers additional payments to Chromocell, and, in certain cases, co-promotion rights in the U.S.
| Novartis, Xoma||Oct 2015|| 513||Development and licensing agreement for anti-transforming growth factor-beta (TGFb) antibody program|
XOMA has exclusively licensed the global development and commercialization rights to its anti-transforming growth factor-beta (TGFb) antibody program to Novartis.
XOMA will receive $37.0 million in the form of an upfront payment and is eligible to receive up to $480.0 million if all development, regulatory, and commercial milestones are met.
XOMA is eligible to receive royalties on product sales that range from the mid-single digits to the low double digits.
In connection with this license agreement, Novartis has agreed to extend the maturity date on the approximately $13.5 million of outstanding debt under the secured note agreement, which bears interest at the six-month LIBOR plus 2% (currently 2.53%), to September 30, 2020.
XOMA has also agreed to reduce the royalty rate to XOMA associated with Novartis' clinical stage anti-CD40 antibodies.
| AstraZeneca, Sosei Heptares||Aug 2015|| 510||Licensing agreement for HTL-1071 (updated)|
Sosei Group announced that its immuno-oncology collaboration with AstraZeneca is progressing well.
The first patient has been dosed in an expansion cohort in the Phase 1b segment of the Phase 1 study in advanced solid tumours.
Furthermore, a new clinical study including AZD4635 to investigate novel combination therapies in EGFRm non-small cell lung cancer is expected to begin in the first quarter 2018.
Sosei Group reported that its subsidiary, Heptares Therapeutics has announced that it has achieved an important milestone in its immuno-oncology collaboration with AstraZeneca, which is focused on the development of AZD4635 (HTL-1071) as a potential new treatment for a range of cancers.
As a result, Heptares has been notified today that the achievement has triggered a US$12 million payment from AstraZeneca.
AZD4635 is a potent and selective, orally available, small molecule adenosine A2A receptor antagonist discovered by Heptares and licensed to AstraZeneca in 2015.
The milestone was triggered by the successful completion of a preclinical programme that demonstrated a clear effect of AZD4635 in reversing adenosine-mediated T-cell suppression and enhancing anti-tumour immunity.
AZD4635 is currently in a Phase 1 clinical trial as a single agent and in combination with AstraZeneca’s durvalumab (anti-PD-1L antibody) in patients with solid malignancies.
Heptares Therapeutics , announces it has been notified by its partner AstraZeneca that the first subject has been dosed with immuno-oncology candidate HTL1071 (AZD4635) in a Phase 1 clinical study, triggering a US$10 million payment from AstraZeneca.
Heptares Therapeutics has entered into a licensing agreement with AstraZeneca under which AstraZeneca will acquire exclusive global rights to develop, manufacture and commercialise the adenosine A2A receptor antagonist, HTL-1071, a small molecule immuno-oncology candidate, and potential additional A2A receptor-blocking compounds.
AstraZeneca will focus on exploring HTL-1071 and any additional compounds across a range of cancers, including in combination with its existing portfolio of immunotherapies.
Heptares will grant AstraZeneca an exclusive license to research, develop, manufacture and commercialise HTL-1071.
The companies will also collaborate to discover further A2A receptor-blocking compounds for development in cancer immunotherapy.
Heptares will receive an upfront payment of $10 million and is eligible to receive additional, significant near term milestone payments based on agreed pre-clinical and/or clinical events.
Subject to successful completion of development and commercialisation milestones, Heptares is also eligible to receive more than $500 million, as well as up to double-digit tiered royalties on net sales.
| Royal Philips Electronics, Westchester Medical Center Health Network||Jun 2015|| 500||Collaboration agreement for improving and transforming healthcare|
Royal Philips announced a multi-year, USD 500 million partnership to transform and improve healthcare for millions of patients across New York’s Hudson Valley.
The partnership is based on an enterprise managed services model through which Philips will provide WMCHealth with a comprehensive range of clinical and business consulting services, as well as advanced medical technologies such as imaging systems, patient monitoring, telehealth and clinical informatics solutions.
Moreover, the collaboration aims to redefine how quality care is delivered in all areas, including radiology, cardiology, neurology, oncology and pediatrics, as WMCHealth expands beyond a single-campus academic medical center into a multi-location regional healthcare provider.
The partnership underscores Philips’ commitment to provide new solutions for hospitals and health systems driven by a fundamental shift in U.S. healthcare management towards strategic partnerships for creating long-term patient value, while managing costs, complexity and risk. In similar long-term partnerships with Philips, hospitals have been able to significantly improve radiology volumes and cut MRI waiting times in half.
| Gencia Biotech, Takeda Pharmaceutical||Sep 2015|| 500||Development agreement for mitochondrial therapeutics|
Gencia and Takeda Pharmaceutical announced a partnership to develop a new class of small molecule drugs as potential treatments for hematological and inflammatory diseases.
Called Mitochondrial Agonists of the Glucocorticoid Receptor (MAGR), such compounds may offer the therapeutic potential of conventional glucocorticoid drugs (steroids).
However, MAGR are chemically distinct and may function differently than steroids.
The initial aim of the collaboration will be joint research and development leading to two preclinical drug candidates, one each in the areas of inflammation and oncology.
Takeda will explore opportunities to conduct clinical trials for drug candidates identified by the partnership.
Gencia will receive upfront payments and preclinical milestones for the two compounds and aggregate clinical, commercialization and sales milestones with the potential for approximately $500 million in payments by Takeda.
Gencia also will receive royalties on sales of any successfully commercialized products arising from the partnership.
Further details of the agreement were not disclosed.