Sanofi is no longer partnering to commercialize two Pozen-developed, advanced versions of aspirin, with the biotech saying today the companies “mutually agreed to terminate” their up-to-$35 million-plus partnership agreement inked more than a year ago.

The termination ends a partnership launched in September 2013, in which Sanofi agreed to pay Pozen $15 million upfront, plus up to $20 million in payments tied to pre-commercialization milestones, and other “future milestone payments and royalties on product sales,” for PA8140 and PA32540, according to the companies’ announcement.

In return, Sanofi won exclusive rights to commercialize all combinations of Pozen’s coordinated-delivery tablets combining immediate-release omeprazole, a proton pump inhibitor (PPI), and enteric-coated (EC) aspirin in a single tablet (“PA”)—a license that applied to all PA combinations containing 325 mg or less of enteric-coated aspirin in the U.S.

“Sanofi has a strong heritage and expertise in the cardiovascular space, with Lovenox, Plavix, and most recently Multaq, and the PA products are an important addition to our already strong CV portfolio,” Anne Whitaker, president, North America pharmaceuticals at Sanofi US, stated last year.

PA8140 and PA32540 are the subjects of an NDA under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) target decision date of December 30, 2014. Both drug candidates consist of a coordinated-delivery tablet that combines immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core.

The products are indicated for secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. PA8140 and PA32540 are designed to significantly reduce GI ulcers and other GI complications compared to taking enteric-coated or plain aspirin alone.

Just last month, following the release of third-quarter results, John Plachetka, Pharm.D., Pozen’s chairman, president and CEO, told analysts the milestone payments “will occur in the first half of 2015 assuming approval or launch of PA,” and that its royalty on U.S. sales “will range from 12.5% to 22.5% of net sales,” according to a transcript of the November 6 conference call compiled by SeekingAlpha.

Pozen included a $2 million amortization of its upfront payment from Sanofi as part of the $7.4 million in revenue recorded by the company in the third quarter, Dr. Plachetka added.

However, during the call, he would not comment when asked by an analyst whether talks with the FDA “on labeling or any other issues” was “where it would be” to anticipate an FDA decision before the PDUFA data—though he added: “In our opinion we are done on the label…in our opinion we’re done with what we can do.”

Pending a final decision on that NDA, Pozen said, the FDA has approved trade names for the experimental drugs: PA8140 will be developed going forward under the name Yosprala 81/40 (enteric-coated aspirin 81 mg/immediate release omeprazole 40 mg); and PA32540, Yosprala 325/40 (enteric-coated aspirin 325 mg/immediate release omeprazole 40 mg).

Pozen said Yosprala 325/40 generated positive results in two Phase III trials, in which a total 1,049 patients were randomized to either the experimental drug or EC aspirn 325 mg for six months of treatment. Patients using Yosprala 325/40 reported 63% fewer gastric ulcers and 82% fewer discontinuations due to pre-specified upper gastrointestinal (GI) adverse events, compared with patients taking 325 mg enteric-coated aspirin.

Major adverse cardiac events occurred in 1.7% of patients on Yosprala 325/40 compared with 2.5% on enteric-coated aspirin 325 mg. Percentages of patients reporting adverse effects were 72% of users of Yosprala 325/40, and 85% on EC aspirin 325 mg. The most commonly reported adverse events with Yosprala 325/40 were gastritis, erosive gastritis, dyspepsia, duodenitis, nausea, esophagitis, diarrhea, gastric polyps, and non-cardiac chest pain, Pozen said.

“Our goal at Pozen continues to be to maximize shareholder return. Management and the Board of Directors are taking this opportunity to evaluate all strategic options for Yosprala and Pozen,” Dr. Plachetka said today. Given that the target population for Yosprala could exceed 20 million patients in the U.S., we will be fully engaged in the near term evaluating strategic options available to the company.”








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