PHARMACY

GSK inks potential $1.4 billion development deal with OncoMed

BY Drew Buono

LONDON and PHILADELPHIA GlaxoSmithKline and OncoMed Pharmaceuticals have entered into an agreement to discover, develop and market novel antibody therapeutics to target cancer stem cells, which are believed to be key in the metastasis and recurrence of cancer cells.

Under the terms of the deal, OncoMed can earn milestone payments from GSK of up to $1.4 billion, based on the achievement of specified discovery, development, regulatory and commercial milestones. OncoMed will also receive double-digit royalties on all collaboration product sales. In addition, GSK will have an option to invest in a future initial public offering by OncoMed.

Under the partnership, GSK received an option to license four OncoMed product candidates directed at multiple cancer stem cell targets. The alliance with GSK includes OncoMed’s lead antibody product candidate, OMP-21M18, a monoclonal antibody, which is scheduled to enter the clinic in 2008.

“This alliance confirms GSK’s growing status as a world leader in the development of new oncology medicines for use in the treatment, prevention and supportive care of cancer patients and provides us access to an exciting new area of drug discovery. We believe that targeting cancer stem cells has the potential to change the paradigm of how oncology patients are treated and we are very excited to be working with OncoMed to develop novel and innovative medicines in this regard,” said Hugh Cowley, senior vice president and head of the company’s Center of Excellence for External Drug Discovery.

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Court overturns $3 million jury award against Wyeth’s Prempro

BY Drew Buono

PHILADELPHIA A judge has overturned a jury’s decision to award a woman $3 million for claiming that Wyeth’s hormone-replacement drug Prempro caused her breast cancer, according to the Associated Press. The judge said the plaintiff did not have sufficient evidence to show that the company acted negligently.

Only four of about 1,500 cases pending in Philadelphia have gone to trial. Each time, a jury sided with the plaintiff only to have the judge reverse the verdict, lawyer Tobi Millrood said. The plaintiff, Jennie Nelson plans on appealing the decision to the state Superior Court.

Nelson had claimed that she was diagnosed in 2001 after taking the drug for five years to treat symptoms of menopause. Her lawyers argued that the manufacturer Wyeth had knowledge the drug caused cancer, yet failed to issue adequate warnings.

This is in contrast to a recent decision in Nevada that saw Wyeth lose a verdict to three women who made the same claims. The women won $134 million in that case.

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Sun Pharma, Novartis reach agreement on Exelon

BY Drew Buono

MUMBAI, India Sun Pharmaceuticals and Novartis have reached an out-of-court settlement in relation to Novartis’ Alzheimer’s drug Exelon, according to published reports.

“Under the terms of the settlement, Sun Pharma will not market generic Exelon in the U.S. until sometime prior to the expiration of the patents covering Exelon. The specific date on which Sun may launch and the other terms of the agreement are confidential,” said Sun Pharma in a statement.

Sun Pharma, being one of the first to file an application to sell generic Exelon in the U.S, was eligible to share a 180-day marketing exclusivity on the drug. However, had it launched its generic version of Exelon before reaching an agreement with Novartis, it would have done so at risk of damage claims by Novartis for patent infringement.

Exelon had sales of about $200 million last year in the U.S.

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