Pozen confident Trexima will be approved in 2007

By Jennifer Lanning Drey

Portland, Ore., Nov. 7 - Pozen Inc. is confident that it will gain regulatory approval for Trexima in 2007, William Hodges, Pozen's chief financial officer, said Tuesday at the Cowen and Co. 7th Annual Global Health Care Conference.

Pozen plans to submit a complete response this month to the Food and Drug Administration's approvable letter, which the company received for Trexima in June, he said.

Trexima is the proposed brand name for a tablet containing sumatriptan 85 mg formulated with RT Technology and naproxen sodium 500 mg. The drug is intended to treat acute migraine in adults.

GlaxoSmithKline plc (GSK), which is co-developing Trexima with Pozen, is planning a third-quarter 2007 launch of the drug, Hodges said.

"We think Trexima is a potential blockbuster in the hands of GSK, as they are the dominant market leader in the migraine space," he said.

Pozen has received $60 million of the $160 million in upfront and milestone Trexima-related payments that it expects to eventually receive from GSK.

If the drug is approved next year, the company will receive an additional $20 million in 2007 and could also earn two sales performance milestones totaling another $80 million, Hodges said.

In September, Pozen also received a $40 million milestone payment in connection with a separate agreement the company has with AstraZeneca.

Pozen and AstraZeneca have a global collaboration related to Pozen's PN program for arthritis that includes a total of $375 million in upfront and milestone payments, Hodges said.

During the third quarter, the companies started a proof-of-concept study of PN 200 (omeprazole combination) that will lead to the development of a new product candidate, PN 400 (esomeprazole/naproxen).

Phase 1 and phase 2 dose finding studies will be conducted following formulation development, and phase 3 clinical trials are expected to begin in the third quarter of 2007, Hodges said.

Pozen is a pharmaceutical company located in Chapel Hill, N.C.

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