Friday, December 9, 2011

Initiation of ALS-2200/ALS-2158 in clinical studies this data may enable initiation study of interferon-free combination by Vertex and Alios BioPharma

Vertex and Alios BioPharma Begin Clinical Studies of Nucleotide Drug Candidates ALS-2200 and ALS-2158 for the Treatment of Hepatitis C

Vertex begins joint studies on hepatitis C compounds
By Michelle Lang
Vertex Pharmaceuticals Inc. has launched two clinical studies with California biotech Alios BioPharma Inc. to test treatments for hepatitis C virus.

The Cambridge biotech holds global development and commercialization rights to Alios-discovered compounds, ALS-2200 and ALS-2158, through a licensing deal made in June. The trials, to be conducted jointly by Vertex and Alios, are designed to measure the safety and tolerability of ascending doses of each of the compounds in healthy patients and in patients with chronic genotype-1 hepatitis C. A secondary evaluation will measure the compounds’ effects on viral kinetics.

Vertex said in a news release that it plans to move ALS-2200 and ALS-2158 into Phase 2 studies in the second half of 2012 that will evaluate the compounds in combinations with Vertex hepatitis C drug, Incivek (teleprevir), approved in the U.S. in May, or with VX-222, a Vertex-developed oral drug that is a non-nucleoside inhibitor of the HCV NS5B polymerase.

The June licensing agreement Vertex formed with Alios calls for the Cambridge company to pay Alios a $60 million up front payment, plus research and development costs of the ALS-2200 and ALS-2158 compounds, in exchange for worldwide rights to the drug candidates. If both drugs are approved, Vertex could ultimately pay up to $715 million in R&D milestone payments, as well as up to $750 million more in both drug candidates meet sales milestones.

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