Gilead Expands Hep C Portfolio With LG Life Sciences Deal
Gilead Sciences is gaining a Phase II pan-caspase inhibitor for hepatitis C through a licensing agreement with LG Life Sciences worth up to $202 million announced Nov. 7.
The deal gives Gilead commercialization rights to LG Life Sciences' caspase inhibitors to treat fibrotic diseases. They include lead compound LB84451, in Phase IIa clinical trials in patients chronically infected with hepatitis C.
"Treatment of fibrosis represents an area of significant unmet medical need and one that we believe aligns well with our interest and experience in both liver and pulmonary diseases," Gilead CEO John C. Martin stated.
Pfizer also is developing a pan-caspase inhibitor, PF-3491390, in Phase II for liver fibrosis. The firm gained the candidate when it acquired Idun Pharmaceuticals in 2005 ("The Pink Sheet" DAILY, Feb. 24, 2005).
LB84451 is an oral, once-daily pan-caspase inhibitor that demonstrated safety and tolerability in healthy volunteers in a 14-day Phase I study, according to Gilead. The Phase IIa European study is evaluating the safety, tolerability, efficacy and pharmacokinetics of the compound in hepatitis C infected patients.
Gilead will pay Seoul, South Korea-based LG Life Sciences $20 million upfront, as well as royalties on net sales. The firm also could receive $182 million in payments for development, regulatory and commercial milestones.
LG Life Sciences retains rights in China India and Korea and keeps the worldwide right to develop and commercialize caspase inhibitors for ophthalmic and topical uses.
Caspases are thought to control apoptosis and inflammation. Inhibiting caspases may "slow or stop the progression of fibrosis in the liver for patients with chronic viral hepatitis and non-alcoholic steatohepatitis as well as potentially in other fibrotic diseases such as idiopathic pulmonary fibrosis," according to Gilead.
Gilead has one other candidate for treatment of hepatitis C in its pipeline, the Phase I polymerase inhibitor GS-9190. Pfizer and Roche also have polymerase candidates in Phase II ("The Pink Sheet" DAILY, Sept. 19, 2007).
The Foster City, Calif., company has submitted an sNDA for its HIV therapy Viread (tenofovir) in the treatment of chronic hepatitis B in adults ("The Pink Sheet" DAILY, Oct. 12, 2007).
-Brooke McManus
This article is reprinted from "The Pink Sheet" DAILY – November 8, 2007
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