What happened
Shares of Momenta Pharmaceuticals, Inc. (MNTA), a biotechnology specializing in complex drugs, popped 11.6% higher this morning after signaling that the regulatory bind Glatopa's been stuck in since last February might unravel soon. The stock's gain settled to just 4.5% as of 3:20 p.m. EST on Tuesday.
So what
Momenta contracted one of Pfizer's facilities to manufacture its generic version of Copaxone 40 mg, called Glatopa 40 mg. Abbreviated new drug applications are relatively simple affairs, compared to completely new entities, but this one's been held up since last February through no fault of Momenta's.
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Momenta's big pharma partner, Novartis, hired Pfizer to fill Glatopa 40 mg syringes at a facility the FDA decided wasn't up to scratch. The stock popped this morning because Momenta announced the FDA classified a recent re-inspection of the facility as Voluntary Action Indicated.
Now what
Unfortunately for Momenta, a successful re-inspection isn't the same thing as an approval. Voluntary Action Indicated status means objectionable conditions were found, but the Agency isn't prepared to take or recommend regulatory action.
The application for Glatopa 40 mg is still under review at the FDA. Now that a manufacturing facility warning letter is no longer gumming up the works, Momenta thinks an approval and the commercial launch could happen in the first half of the year.
