Savient Reports Batch Failures With New Gout Medicine
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.
“It will remain a slow launch,” said Gene Mack, an analyst at Soleil Securities in New York, in a note to clients.
Savient, of East Brunswick, New Jersey, fell 22 cents, or 2 percent, to $10.74 at 4 p.m. New York time in Nasdaq Stock Market composite trading. The stock plunged the most in two years on Oct. 25 after the company said it failed to find a buyer.
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