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Licensing agreement for ALS-2200 and ALS-2158

Posted on 13 June 2011

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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.

The goal of the first clinical studies of these compounds is to generate data to enable the initiation of Phase 2 studies as early as the end of 2012.

These Phase 2 studies are expected to evaluate multiple combination regimens of ALS-2200, ALS-2158, INCIVEK and VX-222.

The combination studies would be designed to generate sustained viral response (SVR or viral cure) data.

Additional details on the clinical development program for ALS-2200 and ALS-2158 will be provided later in 2011 upon initiation of the first clinical study.

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