Pozen, Sanofi Terminate Drug Pact Ahead of FDA Approval Decision

Xconomy Raleigh-Durham — 

Pozen (NASDAQ: POZN) is once again hunting for a drug commercialization partner just 15 months after Sanofi (NYSE: SNY) agreed to bring the company’s cardiovascular disease drug to market.

Pozen’s announcement Monday that its partnership with Sanofi has been terminated comes less than a month before a scheduled Food and Drug Administration decision on whether to approve the Chapel Hill, NC company’s drug for secondary prevention of cardiovascular disease. Pozen CEO John Plachetka says the companies mutually agreed to terminate the partnership. But in a conference call with analysts to discuss the termination, Plachetka suggested that the decision was sudden.

“This is just a matter of days here,” Plachetka said, when asked how long the companies had talked about walking away from the deal. “That’s all I can say, here. Just days.”

Pozen’s cardiovascular drug candidate is not actually a new drug, rather it is aspirin delivered using Pozen’s proprietary drug delivery technology. Pozen billed its drug candidate as “safer aspirin.” A coating surrounding an aspirin core delays absorption of aspirin in the gut. The combination is intended to deliver the cardiovascular benefits of aspirin in a manner that avoids the gastrointestinal irritation associated with aspirin alone. PA32540 is the 325 mg dosage; PA8140 is the 81 mg dose. The FDA has given provisional clearance to the trade name “Yosprala” pending approval of the drug.

In September 2013, Pozen and Sanofi, which is the fifth-largest drug company in the world when measured by prescription sales, announced a commercialization agreement that paid Pozen $15 million up front for U.S. rights to the drug. Pozen was also eligible for an additional $20 million in pre-commercialization milestone payments plus royalties on future sales. Sanofi expected the Pozen drug to fill a gap left by its own blockbuster blood thinner clopidrogel (Plavix), a drug that peaked at more than $7 billion in sales in 2011 before losing patent protection in 2012.

At the time the Pozen/Sanofi partnership was announced, an FDA approval decision on the Pozen drug was expected in January of this year. But that decision date was pushed to April after discussions with the FDA led Pozen to decide on conducting a Phase 1 study comparing how its two doses of the drug are absorbed, distributed, and metabolized in the body. In April, the FDA declined to approve Pozen’s drug, citing issues at a facility of a third-party supplier of an active ingredient. Pozen resubmitted its drug application to the FDA in July, and a new FDA decision date was set for Dec. 30. Plachetka says that Pozen believes that the manufacturing issues that led the FDA to decline approval earlier this year can be resolved, but the delays apparently tried Sanofi’s patience.

“The regulatory timeline took longer than any of us expected and that timing no longer works for Sanofi,” Plachetka said on the call.

The termination of the Sanofi deal comes as Pozen has partnered off much of its remaining drug portfolio. Horizon Pharma (NASDAQ: HZNP) acquired U.S. rights to Pozen arthritis drug naproxen/esomeprazole magnesium (Vimovo) last year. Pernix Therapeutics acquired “rest of world” rights to Pozen’s sumatriptan/naproxen (Treximet) combination drug for migraine headaches. With no drugs candidates left to develop in its pipeline, Pozen was ramping down on its expenses and pledging not to work on any new drug candidates unless the program were fully funded by a pharma partner.

Plachetka says Pozen currently has $40 million in cash and that the royalty streams for its partnered arthritis drug are more valuable now than they were a year ago.

Pozen will keep the $15 million upfront payment from Sanofi, and the drug giant is also returning all rights to the cardiovascular drug. Plachetka says Pozen will talk with companies that Pozen had previously spoken to about possible partnerships, though he acknowledged that the drug portfolio needs of those companies might have since changed.

Plachetka says Pozen will “explore all options” including going to market alone, an option that Pozen had initially considered before deciding that a large pharma partner with experience and connections in the cardiovascular space would offer the best opportunity to commercialize the drug. Plachetka says there is no timeline for when decisions on the Pozen drug would be made. A meeting of Pozen’s board of directors is scheduled for Wednesday.