Insight journal - Therapy

The Hep C club: the new dealmakers hot spot

Posted on 06 March 2012

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Recent months have seen increased activity in the field of hepatitis C partnering.

Hepatitis C is currently treated using interferon and its derivatives. The virus is thought to infect as many as 170 million people worldwide, with more than 350,000 dying from the disease every year, according to data from WHO.

Activity has been triggered by the development of novel treatments that do away with the need for injection of the drug, instead replacing with a simple pill.

Key hep C deals

The following is an overview of significant hep C deals announced in recent months:

Collaboration, manufacturing and licensing agreement for EDP-239

Headline value: $440 million

February 2012: Novartis, Enanta - Infectives > Hepatitis C

Enanta Pharmaceuticals has entered into an exclusive collaboration and license agreement with Novartis for the worldwide development, manufacture and commercialization of its lead development candidate, EDP-239, from its NS5A hepatitis C virus (HCV) inhibitor program.

NS5A, a clinically validated target, is a non-structural viral protein that is essential to viral replication.

Research efforts have shown that targeting NS5A gives rise to profound antiviral activity, and as a result, this protein has emerged as an important target for antiviral drug development.

Enanta's NS5A program and intellectual property estate in the HCV field were derived from its internal drug discovery efforts.

Under the terms of the agreement, Enanta will receive an upfront payment of $34 million and is eligible to receive up to $406 million if certain clinical, regulatory, and commercial milestones are met.

Enanta is also eligible to receive tiered double-digit royalties on worldwide sales of products, and retains co-detail rights in the United States.

Novartis will be responsible for all costs associated with the development, manufacture and commercialization of EDP-239 and will fund Enanta's drug discovery efforts on certain additional compounds targeting NS5A.

Acquisition agreement for Inhibitex

Headline value: $2,500 million

January 2012: BMS, Inhibitex - Infectives > Hepatitis C

Bristol-Myers Squibb Company announced the successful completion of the tender offer by Bristol-Myers Squibb Company for all of the outstanding shares of common stock of Inhibitex at a purchase price of $26.00 per share.

“The acquisition of Inhibitex builds on Bristol-Myers Squibb’s long history of discovering, developing and delivering innovative new medicines in virology and enriches our portfolio of investigational medicines for hepatitis C,” said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. “There is significant unmet medical need in hepatitis C. This acquisition represents an important investment in the long-term growth of the company.”

Acquisition agreement for Avila Therapeutics

Headline value: January 2012

Celgene, Avila - Infectives > Hepatitis C

Celgene Corporation and Avila Therapeutics announced a definitive merger agreement under which Celgene Corporation will acquire Avila Therapeutics.

The acquisition positions Celgene to expand its leading role in the future treatment of hematologic cancers with Avila’s AVL-292, a highly-selective Bruton’s tyrosine kinase (Btk) inhibitor, currently in phase I clinical development.

Collaborative R&D agreement for daclatasvir / TMC435 combination therapy

Headline value: N/a

December 2011: BMS, Tibotec - Infectives > Hepatitis C

Clinical collaboration agreement with Tibotec Pharmaceuticals to evaluate the utility of daclatasvir (BMS-790052), Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals' investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus (HCV).

Under the agreement the companies will evaluate the potential to achieve sustained viral response 12 and 24 weeks post treatment in patients with HCV genotype 1 in a study with three treatment regimens: an oral, once-daily treatment regimen of daclatasvir and TMC435 with pegylated-interferon alpha plus ribavirin; an oral, once-daily treatment regimen of daclatasvir and TMC435 with ribavirin and an oral, once-daily treatment regimen of daclatasvir and TMC435 alone.

Acquisition agreement for Pharmasset

Headline value: November 2011

Gilead, Pharmasset - Infectives > Hepatitis C

Definitive agreement under which Gilead will acquire Pharmasset for $137 per share in cash.

The transaction, which values Pharmasset at approximately $11 billion, was unanimously approved by Pharmasset’s Board of Directors.

Gilead plans to finance the transaction with cash on hand, bank debt and senior unsecured notes.

Pharmasset’s compounds are complementary to Gilead’s existing HCV portfolio, and the transaction will help advance Gilead's effort to develop an all-oral regimen for the treatment of HCV.

Acquisition agreement for Anadys

Headline value: $230 million

October 2011: Roche, Anadys - Infectives > Hepatitis C

Definitive merger agreement to be acquired by Roche.

Roche will commence an all cash tender offer for all outstanding shares of common stock of Anadys at USD 3.70 per share.

Steve Worland, President and Chief Executive Officer of Anadys, said: "Since Anadys' formation, our focus has been on driving forward research and development that would make a real difference to the lives of patients, especially those with hepatitis. With Roche's considerable capabilities and experience in HCV, we believe this acquisition provides the best chance of success for the new potential treatments to reach patients. I would like to thank all our contributors for their dedicated efforts to advance the compounds to their current position."

Licensing agreement for ALS-2200 and ALS-2158

Headline value: $1,525 million

June 2011: Vertex, Alios - Infectives > Hepatitis C

Exclusive worldwide licensing agreement that will add two distinct nucleotide analogues to Vertex’s hepatitis C portfolio.

The compounds, which were discovered by Alios and are known as ALS-2200 and ALS-2158, have shown in in vitro studies to be potent inhibitors of the hepatitis C virus (HCV) polymerase, an enzyme essential for replication of the virus.

The addition of these compounds provides Vertex with multiple opportunities to develop potential, new, all-oral combination regimens for chronic hepatitis C.

Vertex expects ALS-2200 and ALS-2158 to enter clinical development later this year.

Alios will receive a $60 million up-front payment from Vertex for the worldwide rights to ALS-2200 and ALS-2158.

Vertex is responsible for development costs related to ALS-2200 and ALS-2158 and will also provide research funding to Alios.

In addition, Alios would be eligible to receive research and development milestone payments up to $715 million if both compounds are approved.

Vertex expects to pay approximately $35 million in development milestones in 2011.

Alios is also eligible to receive up to $750 million in sales milestones on sales of all approved medicines under the collaboration.

The agreement also includes tiered royalties on product sales.

As part of this agreement, Vertex gains worldwide rights to both compounds, further enabling the company to potentially expand development and commercialization efforts in hepatitis C to areas outside North America over the coming years.

The agreement also includes a research program that will focus on the discovery of additional nucleotide analogues that act on the hepatitis C polymerase.

Vertex will have the option to select compounds for development emerging from the research program.

Alios and Vertex plan to initiate clinical development of each compound in the fourth quarter of 2011, which is expected to include studies of the compounds in healthy volunteers followed by short-duration safety and viral kinetic studies in people with hepatitis C.

What's next?

With the clamber to be part of the hepatitis C revolution there are several obvious candidates for acquisition:

Achillion - the company has openly canvassed for acquisition suitors. The company has three hepatitis therapies in development. It is reported to be in advanced discussions with several partners and acquirors.

Idenix – the company has five candidate hepatitis C treatments in development. The most advanced candidate, IDX184 is a nucleotide polymerase inhibitor, the same type of drug as the Pharmasset lead product. The product is currently in clinical trials with initial results expected by year end.

In addition, there are several companies with hepatitis C assets in development. A search of the partnering opportunities up for discussion at the forthcoming Bio-Europe Spring meeting in Amsterdam twenty-four companies are attending the event that work in the area of hepatitis C, offering forty-two product or technologies with application to hepatitis C.

As companies race to be part of the hepatitis C treatment revolution, the coming months promise new partnering and M&A deals - watch this space as we update when new deals emerge.

Steve Poile

 

Related links:

The following link to recent hepatitis C deal stories at Current Partnering:

Licensing agreement for ALS-2200 and ALS-2158

Vertex inks $1.5bn deal with Alios to mix hep C cocktails

BMS and Tibotec to develop hepatitis C combination therapy

Drugmakers including Achillion Pharmaceuticals and Bristol-Myers Squibb seek deals to gain share of future Hep C combo pill

Merck Hepatitis C Drug May ‘Anchor’ Future Worldwide Regimen (link no longer available)

Who’s next in the hepatitis C acquisition trail?

BMS snaps up Inhibitex for $2.5 billion for hep C portfolio

Pharma pays up for scarce assets

Gilead acquires Pharmasset in $11 billion mega bet on interferon-free drugs

Avila Therapeutics to be acquired by Celgene for $925 million

Search Current Agreements for hepatitis deals (subscription required)

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3 Responses to “The Hep C club: the new dealmakers hot spot”

  1. Kevin Eastwood says:

    An additional deal for consideration: Enanta – Novartis collaboration for the pre-clinical NS5a inhibitor

  2. Steve Poile says:

    Hi Kevin

    Thanks for this. I believe it is already there – first deal at the top of the page. Let me know if you are thinking about another one and I’ll search it out.

  3. Joe Patti says:

    Jan. 24, 2012-BioLineRx signed an “exclusive license agreement” with Genoscience for its BL-8020 oral treatment for Hepatitis C, it said in a filing with the Tel Aviv Stock Exchange

    Preclinical asset, terms not disclosed

    Also, Feb. 6, 2012

    BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today it has signed a worldwide, exclusive license agreement with Genoscience and RFS Pharma to develop and commercialize BL-8030, an orally available treatment for Hepatitis C. The agreement includes upfront license fees, milestones and royalties payable to both companies, which terms are consistent with BioLineRx’s standard in-license agreements.


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