CMC and manufacturing issues have tripped up Map Pharmaceuticals ($MAPP) before it has even gotten out of the gate with its new inhaled treatment for migraines, and they're not even problems at a facility it controls.
Problems with chemistry, manufacturing and controls (CMC), as well as questions about its third-party manufacturer noted in a recent inspection, led the FDA to forestall approval of Levadex. Map did not disclose who it hired to make the product but said problems will be quickly addressed.
The company says it will be meeting with the FDA to discuss how to proceed. After hearing from CEO Timothy Nelson, Wedbush Securities analysts told investors that they expected the company could get a handle on the CMC and manufacturing issues within three months, resubmit the application in the third quarter and get approval before year's end, Reuters reports.
Of course, the CMC and manufacturing shortcomings promise to be costly to the project, and not only for Map. Analysts have pegged annual sales of the new product at half a billion dollars. Nektar Therapeutics ($NKTR) is to get a royalty when the drug is approved, while Allergan ($AGN), which invested $60 million upfront for rights to co-promote the drug, promised another $97 million in milestones.
- read Map's release
- here's the Reuters story