PHARMACY

Dey awards Critical Theraputics $5 million milestone payment for Zyflo

BY Drew Buono

LEXINGTON, Mass. Critical Therapeutics has received $5 million as part of a milestone payment from Dey as part of their co-promotional agreement between the companies for Zyflo CR, a drug for the prophylaxis and chronic treatment of asthma in adults 12 years of age and older.

“We are seeing steady growth in new prescriptions of Zyflo CR and are encouraged by the progress we have achieved since the launch of Zyflo CR in late September,” said Frank Thomas, president and chief executive officer of Critical Therapeutics. “Critical Therapeutics and Dey’s combined sales forces of 240 representatives are promoting Zyflo CR to approximately 18,000 allergists, pulmonologists and primary care physicians across the country.”

Dey’s $5 million milestone payment to Critical Therapeutics was triggered by the commercial launch of Zyflo CR. Critical Therapeutics has now received a total of $12 million from Dey as part of the companies’ co-promotional agreement. Critical Therapeutics received $3 million from Dey upon signing the co-promotional agreement in the first quarter of 2007 and $4 million upon the Food and Drug Administration’s approval of Zyflo CR in the second quarter of 2007.

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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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