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Regulators Reject Chapel Hill, N.C., Firm's Experimental Migraine Treatment.
Byline: David Ranii
Jun. 2--Federal regulators have rejected an experimental migraine headache treatment developed by Pozen, in the second regulatory setback for the Chapel Hill company in eight months.
Pozen, which was banking on the drug, known as MT 100, to become its first product, said Tuesday that the U.S. Food and Drug Administration declined to approve the treatment because of concerns about its safety and effectiveness.
Pozen's shares fell 37 percent.
Unfortunately for Pozen, there was an element of deja vu in the FDA's decision -- and in the stock market's reaction. In October, the FDA rejected another of Pozen's experimental migraine drugs, MT 300. Shares plummeted 33 percent then.
"It's not a good track record," said analyst Jason Zhang of Independent Research Group.
Tuesday's news was a harder blow because MT 100 has much greater sales potential than MT 300, which is viewed as a niche product because it is delivered by injections. Analysts projected that annual sales of MT…
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- Press release article from: Business Wire October 20, 2003 700+ words
...the Phase III trials. POZEN submitted data indicating that MT 300 provided statistically...clinicians worldwide. The MT 300 New Drug Application...submitted to the FDA by POZEN in December 2002 and...Application (MAA) for MT 100. POZEN submitted the MAA to...
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...Further Development of MT 100; Will Concentrate...Families of Products POZEN Inc. (NASDAQ: POZN...further development of MT 100 in the U.S...John R. Plachetka, POZEN's chairman, president...risk associated with MT 100." POZEN has licensed Trexima...
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- Press release article from: PR Newswire September 19, 2001 700+ words
...began last month, after NDA approval of MT 100." POZEN believes that MT 100 is the only new migraine treatment providing...development today with a similar profile to MT 100. North Carolina-based POZEN Inc. is a pharmaceutical development company...
- Pozen and Xcel announce receipt of not-approvable letter for MT 300; Pozen...
- News wire article from: Asia Africa Intelligence Wire October 20, 2003 700+ words
...Inc announced that Pozen received a not...Application for MT 300. The letter...Phase III trials. Pozen submitted data indicating that MT 300 provided statistically...Phase III trials. MT 300 is being developed...filled syringe. Pozen is a pharmaceutical...
- Pozen receives new patent for MT 100.
- News wire article from: Asia Africa Intelligence Wire November 21, 2002 700+ words
...designed for first-line migraine therapy. Pozen now owns two patents in the US and one patent in Australia for MT 100. Pozen has completed all planned Phase III pivotal trials for MT 100, which have consistently demonstrated...
- Pozen provides results of FDA advisory committee meeting on MT 100 (naproxen...
- News wire article from: Asia Africa Intelligence Wire August 5, 2005 700+ words
...Aug 2005's meeting, Pozen has decided to discontinue further development of MT 100 in the US. Part of the reason for this is that Pozen expects to file the Trexima...metoclopramide risk associated with MT 100. Pozen has licensed Trexima to...
- POZEN to Submit MT 100 Carcinogenicity Study Results To FDA In Early 2002.
- Newspaper article from: Pain & Central Nervous System Week October 22, 2001 700+ words
...vivo genotoxicity data supporting the safety of MT 100. POZEN would not comment on when or if it will be successful...which began last month, after NDA approval of MT 100." POZEN believes that MT 100 is the only new migraine treatment providing...
- Pozen receives new patent for MT 300.
- News wire article from: Asia Africa Intelligence Wire January 7, 2003 700+ words
...dihydroergotamine in a pre-filled syringe. This is Pozen's first issued patent covering MT 300. Pozen announced on 17 Dec 2002, that it has submitted...Administration for marketing approval of MT 300. Pozen is a pharmaceutical development company committed...
- Pozen to stop development of MT 100 in the U.S.
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...hydrochloride, one of the components of MT 100. Pozen also attributed its decision to stop development of MT 100 to its expectation that it will soon...the metoclopramide risk associated with MT 100, Pozen said.
- POZEN and Xcel Pharmaceuticals Announce Licensing Agreement to Commercialize...
- Press release article from: Business Wire September 4, 2003 700+ words
...States to commercialize MT 300. Xcel will pay POZEN an upfront fee of $2...predetermined sales threshold on MT 300. Xcel will also pay POZEN royalties on combined...have been selected as POZEN's commercial partner for MT 300. The addition of...
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