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A day after gaining US approval for the cancer drug Torisel® (temsirolimus), Wyeth had fresh cause for celebration as a US state judge has overturned a $3m jury verdict in litigation over the firm’s hormone-replacement therapy Prempro® (conjugated oestrogens/
medroxyprogesterone acetate).
A judge in Pennsylvania determined that the jury’s verdict in favour of plaintiff Jennie Nelson was improper, thus cancelling out a ruling in February. Then, the jury ruled that Wyeth failed to adequately warn the plaintiff about the risks associated with Prempro, and awarded compensatory damages of $2.4m to Ms Nelson and $600,000 to her husband.
Wyeth faces at least 5,000 suits over Premarin and Prempro.
Meanwhile, Wyeth and partner Progenics Pharmaceuticals say the FDA has accepted the file for review of a new drug application for the firms’ subcutaneous methylnaltrexone for treating opioid-induced constipation (OIC) in patients receiving palliative care.
The FDA has set a Prescription Drug User Fee Act date of 30 January 2008 to complete its review of methylnaltrexone, a peripherally-acting opioid-receptor antagonist that is designed to treat OIC without interfering with pain relief. There is currently no approved medication that specifically targets the underlying cause of the condition to relieve constipation in this patient population.
Acceptance of the NDA submission results in a $5m milestone payment to Progenics by Wyeth.
PharmaTimes 1/6/2007
