Migraine is a hereditary chronic neurological disorder characterized by throbbing pain in one area of the head and is often accompanied by nausea or vomiting and extreme sensitivity to light and sound.
The National Headache Foundation estimates that about 30 million Americans suffer from migraine. Since migraine prevalence is the highest during peak productive ages of 25 to 55, its economic burden is substantial - direct and indirect costs in the United States estimated at over $20 billion annually.
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.
One of the abortive migraine medications approved in the U.S. and available in various forms, as nasal spray and injection, is Dihydroergotamine, or DHE.
Developing a new formulation of Dihydroergotamine is Mountain View, California-based MAP Pharmaceuticals Inc. (MAPP). This new formulation of Dihydroergotamine is under FDA review with a decision expected next year.
For readers who are new to MAP Pharma, here's what to expect in the coming months...
The company's new form of Dihydroergotamine, branded as Levadex, is an orally inhaled investigational drug for the acute treatment of migraine in adults. DHE is delivered by MAP Pharma's proprietary, hand-held, next-generation metered dose inhaler system known as Tempo inhaler.
In clinical trials, statistically significant improvement in pain relief, light sensitivity, sound sensitivity, nausea and vomiting has been reported two hours after dosing with Levadex. In addition, clinical trials have shown that the drug candidate provided rapid and sustained pain relief for up to 48 hours after dosing.
MAP Pharma's New Drug Application for Levadex, which was accepted by the FDA in August of this year, has a decision date set for March 26, 2012.
In January of this year, MAP Pharma entered into a collaboration with Allergan Inc. (AGN) within the U.S. for Levadex in a deal valued at $157 million - $60 million up-front payment and up to $97 million in additional payments upon meeting certain regulatory milestones. Pursuant to the terms of the agreement, MAP Pharma granted Allergan a co-exclusive license to market and promote Levadex to neurologists and pain specialists in the United States.
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.
As per the terms of the deal, so far, MAP Pharma has been paid $60 million upfront in February and another $20.0 million as milestone payment by Allergan, following the Levadex NDA acceptance by the FDA.
MAP Pharma is entitled to receive up to an additional $77.0 million in milestone payments, including a $50.0 million milestone for the first commercial sale associated with the initial indication (the acute treatment of migraine), $25.0 million in milestones for the achievement of certain FDA-approved product labeling in the United States and a $2.0 million milestone for regulatory approval of the initial indication for Levadex in Canada.
A quick look at the company's balance sheet...
MAP Pharma is in the development stage and has not generated any product revenue. Since inception in July 2003 through September 30, 2011, the company had an accumulated deficit of $219.4 million.
In the third quarter ended September 30, 2011 MAP Pharma's net income was $11.2 million or $0.35 per share, compared to a net loss of $14.2 million or $0.53 per share in the year-ago quarter. Revenue in the third quarter of 2011 was $23.9 million, which included upfront payment and milestone payment received from Allergan, while no revenue was recorded last year.
Cash at the end of third quarter 2011 was $111.8 million.
MAP Pharma went public in October 2007 pricing its shares at $12 each. Over the past 1 year, the stock has traded in a range of $10.54 to $17.35. MAPP closed Wednesday's trading at $14.63.
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. In 2010, the Triptan market in the United States totaled about $1.6 billion in revenues.
According to MAP Pharma, Levadex has been designed to provide faster onset and longer-lasting migraine relief than Triptans. Will Levadex be able to pass the FDA muster with ease or will it experience a regulatory pain? Stay tuned...
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