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
Related Articles:
Pozen shares soar on rich pain med deal. Report
Drug combos not a sure thing. Report
AstraZeneca faces new patent fight over Nexium. Report
Pozen shares sink on latest Trexima delay. Report
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More stories about Phase III FDA AstraZeneca Experimental Drugs Ranbaxy combination naproxen Pozen inflammatory conditions combo drug PN400 Nexium
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By Anonymous | Posted 2:18pm | September 7, 2007
This is nothing more than a waste of the stockholder's money. NSAIDs increase the risk of dyspepsia via inhibition of prostaglandins, which, besides helping to mediate pain sensitivity in the periphery, maintain integrity of the stomach's mucosal lining. There is little or no direct irritation of the stomach lining from NSAIDs. Proton pump inhibitors reduce stomach acidity, but their efficacy has been evaluated in reducing esophageal lesions due to GRD. NSAIDs don't cause GRD. If naproxen causes GI discomfort, try a different NSAID, and/or take a generic H2 blocker or the generic versions of other PPIs, like Prilosec or Aciphex. PPI's induce increases in gastrin production, which can increase the risk of colorectal polyps, and they inhibit protein absorption - not such a great idea for the elderly whose muscle mass is declining. Bottom line, this is a bad idea, and the PBM companies will exact a stiff copay penalty if its Rx'd.
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