After navigating what has to be one of the most frustrating paths to Food and Drug Administration approval of a new drug, the small biopharma company Pozen and its big pharma partner GlaxoSmithKline have finally emerged victorious.
Last night the companies issued a press release announcing the agency has given the green light to their migraine treatment Treximet.
You can read about the most recent regulatory "hamster hurdle" in a few of my blogposts from last year (At the time the drug was called Trexima, but the FDA apparently wanted the name changed slightly.)
Nearly 30 million Americans are estimated to get migraines. And they cost business about $15 billion a year on lost worker productivity. Treximet combines the pain reliever Aleve with GSK's old blockbuster migraine drug Imitrex. Glaxo needs this follow-on product to replace Imitrex which is facing generic competition in the not-too-distant future.
A migraine expert says the fusing of the two drugs into one caplet makes them work better than taking the two drugs separately. The companies say Treximet should be available in about a month. Meantime, Allergan is expected to have late-stage test results soon on the use of Botox--yes, Botox--for migraines. Patients who get a few dozen shots around their head, neck and shoulders once every few months have reported being headache-free.
POZN shares, which have been on a rollercoaster over the past several months, rallied yesterday in anticipation of the FDA approval, but they're really taking off on heavy volume today.
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After so many headfakes on Treximet investors might've been nervous about jumping in ahead of the potential FDA action. GSK gives Pozen what are called milestone payments (i.e. when the drug's approved, when it goes to market, when it hits a certain revenue goal, etc.) and a six percent royalty on sales. Headache gone.
UPDATE: Pozen's royalty on Treximet starts out in the single digits, but CEO John Plachetka tells me, "It's gonna go to high teens based on sales prior to January of 2010, but starting in January of 2010 we get a high teens royalty on the sales of Treximet, all the net sales of Treximet, so it's gonna be quite a rewarding product for Pozen." You can see a clip from the interview I did with him today on the "Closing Bell" at 4 pm ET.
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