Hours after the markets closed last night, Map Pharmaceuticals put out the word that the FDA had stiff-armed its application for the inhalable migraine therapy Levadex, outlining some regulatory issues with the chemistry, manufacturing and controls process as well as an inspection of a third-party manufacturer's facility and the need for more time to review the company's inhaler usability information.
Whatever those CMC issues are, Map ($MAPP) CEO Timothy Nelson underscored in a meeting with analysts this morning that there were no demands for additional data or a new trial, indicating that these were issues that could likely be worked out in the near term. Levadex is an inhaled form of dihydroergotamine, a migraine drug that has been in use for some 60 years.
Next stop? A meeting with the FDA in continued pursuit of an approval, addressing "the issues raised in the Complete Response letter as quickly as possible," said Nelson in a statement. Disappointed investors quickly drove down the value of the company's stock by about a third once the news hit. But by the time Nelson finished talking to analysts today, the loss had been trimmed to a more moderate 18%.
The setback was likely to displease Nektar Therapeutics ($NKTR), which would have won a royalty stream from an OK to market the treatment. And Allergan ($AGN), which paid $60 million upfront and promised $97 million in milestones for co-promotion rights, will also be left waiting for a green light for a product that analysts believe could earn up to about $500 million a year.
"We anticipate Map should be able to complete requirements associated with CMC and correcting observations ... within three months and resubmit the (New Drug Application) in the third quarter," Wedbush analysts noted, according to a report in Reuters. "With a rapid review, approval could occur by year-end."
Interestingly, The Street's Adam Feuerstein called the FDA rejection well ahead of Map's press release. After he was told by the FDA that he would need to get any information on the regulatory action from the biotech, Feuerstein correctly deduced that Map was left to explain a CRL. The agency announces approvals while CRLs are kept private.
- here's the release
- get the Reuters story
- read the report from Bloomberg