By PETER LOFTUS
Bristol-Myers Squibb Co. said U.S. regulators are satisfied with the corrective actions the drug maker took to resolve deficiencies at a Puerto Rico manufacturing plant that drew a warning letter last year.
The resolution could clear the way for regulatory approval of two Bristol drugs that had been on hold because they will be manufactured at the Manati, Puerto Rico, plant.
Bristol expects a Food and Drug Administration decision next week on one of the drugs, belatacept, which is designed to prevent organ rejection in patients receiving kidney transplants.
In August, the FDA sent a warning letter to Bristol citing the company for insufficient procedures to prevent contamination of its drugs and other violations of manufacturing requirements.
The New York-based company said it was required to resolve the issues before the FDA would consider approving belatacept and a version of rheumatoid arthritis drug Orencia, which can be injected. Orencia is currently administered by intravenously.
Bristol spokeswoman Jennifer Mauer said Thursday the FDA is expected to make a decision by June 15 on belatacept and by Aug. 4 for the new Orencia formulation.
In a notice posted on its website this week, Bristol said the FDA decided its measures "have sufficiently addressed violations" at the plant. Bristol said the plant is now in compliance with both company and regulatory requirements.
"This lifts an overhang on BMY shares," Leerink analyst Seamus Fernandez wrote in a research note. He estimates belatacept, which Bristol proposes to sell under the brand Nulojix, could generate $600 million in annual sales in 2017.
Jun 13
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