After facing disappointment when its investigational, orally inhaled migraine drug, Levadex, failed to win U.S. approval in March of this year, MAP Pharmaceuticals Inc. (MAPP) is gearing up to play its part of making resubmission for the inhalation aerosol.
Levadex is a new form of Dihydroergotamine, or DHE, which is already approved in the U.S. and available in various forms, as nasal spray and injection. Levadex is orally inhaled version of DHE delivered by MAP Pharma's proprietary, hand-held, next-generation metered dose inhaler system known as Tempo inhaler.
This will be Levadex's second go-around with the FDA if the resubmitted NDA is taken up for review by the regulatory agency. In March of this year, MAP Pharma was handed down a Complete Response letter for the Levadex NDA due to issues relating to chemistry, manufacturing and controls and observations from a facility inspection of a third party manufacturer. The FDA did not cite any clinical safety or efficacy issues, nor did it request for additional clinical studies to be conducted prior to approval.
Seeking to obtain clarity on what is needed to address the issues raised in the Complete Response letter, the company had an End-of-Review meeting with the FDA in the second quarter of 2012. A statement issued by the company in June said that based on its meeting with the FDA, the NDA will be resubmitted in the late third quarter/early fourth quarter 2012 timeframe.
The FDA will determine the type of resubmission (Class 1 or Class 2) and the resulting review timeline after the resubmission has been accepted for filing. The targeted review period of Class 1 resubmission is 2 months and that of Class 2 is 6 months.
MAP Pharma has a collaboration agreement with Allergan Inc. (AGN) that was signed in January of 2011 to market and promote Levadex to neurologists and pain specialists in the U.S. - a deal valued at $157 million, $60 million up-front payment and up to $97 million in additional payments upon meeting certain regulatory milestones.
In July 2011, Allergan exercised its option to expand the collaboration agreement to include Canada for neurologists and pain specialists. MAP Pharma retains the right to market and promote Levadex to other physicians within the United States and Canada and also retains all rights to Levadex in all other countries.
It is estimated that there are nearly 30 million migraine sufferers in the U.S., and 113 million lost work days every year due to migraine. The U.S. sales of migraine medications account for about $2 billion annually.
Migraine, a hereditary chronic neurological disorder characterized by throbbing pain in one area of the head, is often accompanied by nausea or vomiting and extreme sensitivity to light and sound.
There are two approaches to treat migraine: abortive and preventive.
The abortive approach involves taking pain-relieving drugs during migraine attacks to relieve the pain and symptoms. The preventive approach refers to taking drugs regularly, often on a daily basis, to reduce the frequency and severity of the migraine attacks.
The majority of abortive, also known as acute, migraine drugs prescribed belong to the class of Triptans. Merck and Co. Inc.'s (MRK) Maxalt, Pfizer Inc.'s (PFE) Relpax, AstraZeneca plc's (AZN) Zomig and Vernalis plc's Frova are some of the branded triptan therapies. According to MAP Pharma, Levadex has been designed to provide faster onset and longer-lasting migraine relief than the Triptans.
A quick look at MAP Pharma's balance sheet...
Since inception in July 2003, the company has incurred losses, and as of June 30, 2012 had an accumulated deficit of $303.6 million. The company has no marketed drugs and recognizes revenue from collaboration agreements with third parties for various activities, which includes nonrefundable license fees, cost reimbursements and contingent milestone payments.
In the second quarter of 2012, MAP Pharma's net loss widened to $13.29 million or $0.43 per share from $11.30 million or $0.37 per share in the year-ago quarter. Collaboration revenue in Q2, 2012 was $0.9 million compared to $0.8 million in Q2, 2011.
MAP Pharma, which ended June 30, 2012 with $68.4 million in cash, raised $55.8 million in August 2012 financing, strengthening its balance sheet.
Shares of MAP Pharma have thus far hit a low of $11.11 and a high of $17.92. The stock closed Wednesday's trading at $15.84, down 0.81%.
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June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.