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Savient Reports Batch Failures With New U.S. Gout Medication Krystexxa
By Catherine Larkin - Jan 7, 2011 9:15 AM ET
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Business ExchangeBuzz up!DiggPrint Email .Savient Pharmaceuticals Inc., the drug developer that failed to find a buyer last year, said the manufacturers hired to produce its gout medicine Krystexxa made some batches that failed.
Savient said in a statement today it expects to pay $9 million to $10 million in the next two years to repeat efforts to validate manufacturing at Merck Biomanufacturing Network, a unit of Merck & Co. based in Billingham, U.K. Another contract manufacturer in Israel also reported failures, and remediation is under way, the statement said. The latest two batches there have met specifications, according to Savient.
Krystexxa became available in December to U.S. patients with gout, a type of arthritis in which deposits of uric acid build up around joints, causing pain, swelling and stiffness.
Savient, of East Brunswick, New Jersey, fell 35 cents, or 2.9 percent, to $10.59 at 8:57 a.m. in early trading before the Nasdaq Stock Market opened. The shares fell the most in two years Oct. 25 after the company said it failed to find a buyer.
To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.
By Catherine Larkin - Jan 7, 2011 9:15 AM ET
inShare.0More
Business ExchangeBuzz up!DiggPrint Email .Savient Pharmaceuticals Inc., the drug developer that failed to find a buyer last year, said the manufacturers hired to produce its gout medicine Krystexxa made some batches that failed.
Savient said in a statement today it expects to pay $9 million to $10 million in the next two years to repeat efforts to validate manufacturing at Merck Biomanufacturing Network, a unit of Merck & Co. based in Billingham, U.K. Another contract manufacturer in Israel also reported failures, and remediation is under way, the statement said. The latest two batches there have met specifications, according to Savient.
Krystexxa became available in December to U.S. patients with gout, a type of arthritis in which deposits of uric acid build up around joints, causing pain, swelling and stiffness.
Savient, of East Brunswick, New Jersey, fell 35 cents, or 2.9 percent, to $10.59 at 8:57 a.m. in early trading before the Nasdaq Stock Market opened. The shares fell the most in two years Oct. 25 after the company said it failed to find a buyer.
To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.