Healthcare Industry News: LB84451
News Release - November 6, 2007
Gilead and LG Life Sciences Announce Global License Agreement to Advance Novel Drug Candidates for Treatment of Fibrotic DiseasesFOSTER CITY, Calif. & SEOUL, South Korea--(HSMN NewsFeed)--Gilead Sciences, Inc. (Nasdaq:GILD ) and LG Life Sciences, Ltd. (LGLS) today announced that the companies have entered into an exclusive license agreement focused on the development of caspase inhibitors for the treatment of fibrotic diseases. The agreement grants Gilead commercialization rights to LGLS’ caspase inhibitors, including LB84451, LGLS’ lead compound. LB84451 is an investigational pan-caspase inhibitor currently being evaluated in a Phase IIa clinical trial in patients chronically infected with the hepatitis C virus.
Under the terms of the agreement, Gilead will pay LGLS a USD 20 million upfront license payment and royalties on net sales. LGLS also could earn up to USD 182 million in payments based upon the achievement of certain development, regulatory and commercial milestones. Gilead’s license is worldwide, with the exception of Korea, China and India where LGLS has retained rights. LGLS also has the worldwide right to develop and commercialize caspase inhibitors for ophthalmic and topical uses.
As a result of the USD 20 million up front licensing fee, Gilead is increasing its guidance (previously updated on October 18, 2007) for Research and Development expenses for the full year 2007 from a range of USD 490 million to USD 500 million to a range of USD 510 million to USD 520 million to reflect this payment.
Caspases are cellular proteases involved in processes such as apoptosis (cell death) and inflammation. By inhibiting various caspases, it may be possible to slow or stop the progression of fibrosis in the liver for patients with chronic viral hepatitis and non-alcoholic steatohepatitis (NASH), as well as potentially in other fibrotic diseases such as idiopathic pulmonary fibrosis (IPF).
“We look forward to working closely with the LG Life Sciences team to advance their clinical program for patients with hepatic fibrosis and to explore other potential indications,” said John C. Martin, Ph.D., President and Chief Executive Officer of Gilead Sciences. “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.”
“We’re pleased to be working with Gilead on our caspase inhibitor program,” said In-Chull Kim, Ph.D., President and Chief Executive Officer of LGLS. “Based on the preclinical and clinical profile demonstrated by the lead compound LB84451, we believe this program represents an important advancement in the field. With a wealth of experience, expertise and global resources Gilead will bring to the program, we anticipate significant achievements in the treatment of fibrosis and other diseases.”
LB84451 is an oral, once-daily pan-caspase inhibitor that demonstrated safety and tolerability in healthy volunteers in a 14-day Phase I study. A Phase IIa study designed to assess the safety, tolerability, efficacy and pharmacokinetics of the compound among hepatitis C infected individuals is currently ongoing in Europe.
About LG Life Sciences
LG Life Sciences, Ltd. (LGLS), an LG affiliate, is a leading pharmaceutical company headquartered in Seoul, Korea. LGLS is committed to developing a leading portfolio of drugs that prevent, treat and cure diseases across a broad range of therapeutic areas and delivering values and quality medicines to patients.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
Gilead Forward-Looking Statement
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that Gilead may be unable to advance the development of LB84451 for the treatment of hepatic fibrosis or any other indication. For example, further data from additional clinical studies may not support the evaluation of LB84451 and we may decide to cease our efforts to commercialize this compound. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2006 and Quarterly Reports on Form 10-Q for the first, second and third quarters of 2007, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company’s web site at www.gilead.com or call the Gilead Public Affairs Department at 1-800-GILEAD-5 or 1-650-574-3000.
For more information on LG Life Sciences, please visit the company’s web site at www.lgls.com or call the LGLS Investor Relations Team at 82-2-3773-1114.
Source: Gilead Sciences
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