AstraZeneca, Pozen start Phase III combo drug trial

AstraZeneca and Pozen are starting Phase III trial of PN400, an experimental drug for arthritis pain that combines AstraZeneca's heartburn drug Nexium with the anti-inflammatory drug naproxen. In addition, the companies have amended their original licensing agreement for the drug. AstraZeneca will now pay Pozen up to $345 million for the achievement of development, regulatory, and sales milestones. Pozen will receive an immediate $30 million payment, which includes recognition of successful proof of concept, $55 million will be paid upon achievement of certain development and regulatory milestones, and $260 million will be paid as sales performance milestones if certain aggregate sales thresholds are achieved. Pozen and AstraZeneca hope to file an NDA by the first half of 2009.

The new pact is good news for Pozen, which just last month was dealt yet another FDA delay for its migraine drug Trexima. For its part, AstraZeneca is facing a generic threat from Ranbaxy, which wants to produce a generic version of Nexium.

- see this press release for more
- read this article

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