U.S. regulators didn’t reject Map Pharmaceuticals Inc. (MAPP)’s inhalable migraine drug because of safety or effectiveness, and they don’t want new studies, Chief Executive Officer Tim Nelson said today.
It was mostly about manufacturing issues, he told analysts on a conference call. Map, based in Mountain View, California, fell 4.1 percent to $16.44 at the close of trading in New York. The shares have gained 25 percent this year.
Map’s Levadex is an inhaled form of dihydroergotamine, a 60-year-old migraine drug usually given by injection. The Mountain View, California-based company is seeking approval for its use in patients with fewer than 15 migraine attacks a month. If cleared, it would be Map’s first marketed product. The FDA asked Map to respond to issues related to a contractor’s manufacturing plant and questions about use of the inhaler, the company said yesterday in a statement.
The shares’ earlier drop of as much as 20 percent was an “initial knee-jerk reaction,” said Liana Moussatos, an San Francisco-based analyst with Wedbush Securities, in a telephone interview. “It sounds like there are just manufacturing issues, no clinical safety issues. That was a big fear of investors because it’s an inhaled drug.”
Map plans to request a meeting to discuss the FDA’s concerns, Nelson said. He declined to identify the manufacturer, and said Map is lining up a second supplier. There were also questions on chemistry, manufacturing and controls, some of which have been addressed, Nelson said on the conference call.
“The FDA has some items they want us to give them more information on, and we’re going to work hard to get that to them,” Nelson said in an interview after the call. “Obviously we’re disappointed.”
More than 36 million Americans suffer from migraines, a collection of neurological symptoms that can include searing headaches, dizziness, nausea, as well as sensitivity to sound and light. Dihydroergotamine works by narrowing blood vessels in the brain that swell during a migraine.
The present form of the drug, approved by the FDA in 1946, is proven to be effective against severe pain as an injection.
Map signed a profit-sharing agreement with Botox maker Allergan Inc. (AGN) to help sell Levadex. While Botox, a purified form of the poison botulinum, is best known as a cosmetic therapy for smoothing wrinkles, it was approved in October for patients with chronic migraines. These patients suffer attacks at least 15 days a month, with pain lasting at least four hours.
The global market for migraine treatments should increase 38 percent to $4.4 billion from $3.2 billion in 2013, according to Burlington, Massachusetts-based Decision Resources. If approved, Levadex may be worth $1 billion a year by 2020, the firm said.
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