AstraZeneca/Pozen Target 2009 For Arthritis Combination Filing
This article was originally published in The Pink Sheet Daily
Executive Summary
Companies will initiate a Phase III clinical trial for PN400, a combination of naproxen and the esomeprazole.
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AstraZeneca and Pozen will move the investigational drug PN400, a combination of the non-steroidal anti-inflammatory naproxen and the proton pump inhibitor esomeprazole into Phase III clinical trials beginning in the third quarter, the companies announced Sept. 7. The firms are targeting an NDA filing for the arthritis pain treatment in the first half of 2009, looking to position the drug as an alternative for patients who require chronic NSAID treatment but are at risk for gastric ulcers. Pozen and AstraZeneca entered into an agreement in August 2006 to co-develop the combination in a single tablet (1 (Also see "AstraZeneca, Pozen To Partner On Fixed-Dose Naproxen/Esomeprazole" - Pink Sheet, 2 Aug, 2006.)). In connection with the decision to move the drug into Phase III, the companies also announced that they have amended the financial terms of their agreement. "As we understand [AstraZeneca's] situation, the recent expansion of their portfolio as a result of the MedImmune acquisition requires applying finite resources across more products in their pipeline over the next few years," Pozen CEO John Plachetka said during a conference call the same day. "At their request, Pozen agreed to shift certain development and regulatory milestone amounts to sales threshold milestones." In exchange, Plachetka said AstraZeneca has agreed to set the sales threshold levels for three of the four new milestones to sales levels below that required in the original contract. Under the terms of the amended agreement, AstraZeneca will pay Pozen up to $345 million in total development, regulatory and sales milestones. Pozen will receive $30 million immediately, which includes recognition of successful proof of concept. Another $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 sales thresholds are achieved. Under the original agreement, development and regulatory milestones were set at $160 million, of which $20 million was to be paid upon the successful completion of the proof of concept studies, and sales performance milestones were $175 million. Pozen announced interim results of a pilot study of PN 400 in July, showing the drug demonstrated a significant reduction in gastric ulcers relative to naproxen and that the anti-secretory profile of PN 400 met expectations for the target product profile. -Jessica Merrill ([email protected]) |