Savient Pharmaceuticals has hit some new snags in its bid to roll out its first drug, the gout treatment Krystexxa. Several batches of the new drug failed to pass muster, some of them at a Merck Biomanufacturing Network plant Savient is hoping to certify as a secondary contract manufacturer. The company will have to re-run its validation campaign at Merck, adding $9 million to $10 million to its rollout costs, Reuters reports.
Approved to much fanfare in September, the drug hit the U.S. market Dec. 1. But the FDA nod didn't bring Savient the sale offer it wanted, in part to help finance the launch. So, the rollout is proceeding at a less dramatic pace than initially hoped. Meanwhile, it's delaying its application for European approval until the end of this quarter and continuing to build its sales and marketing teams; Savient says it has more than 60 percent of its territory sales force already on board.
Analysts weren't too fussed about the batch problems, despite the company's assessment that the failure rate was too high to be acceptable for normal operations. "It is not a big event," Collins Stewart analyst Salveen Richter said. Similarly, Soleil's Gene Mack told the news service that the troubles aren't "immediately a crisis." The company has 12 months of inventory on hand, and folks had already dialed back expectations for the launch, Mack said, adding, "But it is something to watch."
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