BMS faces approval block unless GMP issues are resolved
pharmafile | November 2, 2010 | News story | Manufacturing and Production |Â Â BMS, Bristol-Myers Squibb, FDA, Puerto Rico, belatacept, manufacturing compliance, pharma manufacturingÂ
Bristol-Myers Squibb has been threatened with a block on approvals of certain new drugs, including a biologic for preventing organ transplant rejection, if it does not resolve ongoing problems at a manufacturing facility in Puerto Rico.
The manufacturing plant at Manati was cited by the FDA in a warning letter earlier this year for a number of quality issues at the plant, including glass particles in drug vials and possible contamination of sterile drug products.
BMS’ chief executive Lamberto Andreotti discussed the problems on a conference call to discuss the group’s third-quarter results, but said that for the moment “manufacturing continues uninterrupted in Manati”.
The company has hired a consultancy firm to help bring the plant back into Good Manufacturing Practice (GMP) compliance, fulfilling one of the recommendations laid out in the FDA’s warning letter.
“We have provided a response to the FDA warning letter, including details of the actions that we are taking, and we expect that Manati facility will be inspection-rated by the end of the year,” said Andreotti.
The product most likely to be impacted by the manufacturing problems is BMS’ belatacept, which is manufactured at a different facility but filled-and-finished at Manati.
Belatacept has been developed initially to prevent rejection in kidney transplant patients and was recommended for approval by an FDA advisory committee in March. However, subsequently the FDA asked for additional, three-year data from BMS’ clinical trials programme in order to complete its review.
On the conference call, BMS’ chief scientific officer Elliott Sigal said the company has filed the requested data and that it supports the benefit/risk profile of belatacept.
“We expect to present this data at the American Transplant Congress meeting in May of 2011,” commented Sigal. If approved, analysts have suggested belatacept could achieve peak year sales of up to $500 million.
The Manati plant is also used for filling-and-finishing of Orencia (abatacept), BMS’ biologic for moderate to severe rheumatoid arthritis, while other drugs made there include cardiovascular Coumadin (warfarin sodium) and an intramuscular formulation of Abilify (aripiprazole) for schizophrenia.
Phil Taylor
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