In landing Sanofi (NYSE:SNY) as the commercialization partner for a ‘safer aspirin’ product, Pozen (NASDAQ:POZN) might have reached a deal with the best possible pharmaceutical company to sell a drug for secondary prevention of cardiovascular disease.
John Plachetka, CEO of the Chapel Hill company, said that PA32540 and PA8140 fit with the cardiovascular drug commercialization expertise that Sanofi has built with its blockbuster blood thinner Plavix.
“They know this space,” Plachetka told analysts on a conference call to discuss the deal. “They know this space better than anyone knows this space.”
Plavix peaked at more than $7 billion in sales in 2011. The PA deal is also timely for Sanofi considering that Plavix lost its patent protection in 2012. In the United States alone, Plavix’s 2012 sales dropped by 61.2 percent due to generic competition, Sanofi said in its annual report. Plachetka said that Sanofi is committed to the cardiovascular space and that the new partner sees the PA drugs as key to growing in that area.
The licensing deal for PA in the United States gives Pozen $15 million up front and promises an additional $20 million for pre-commercialization milestones, including securing Food and Drug Administration approval. An approval decision is expected in January 2014.
Sanofi’s cardiovascular drug expertise
Sanofi is already well established in researching and promoting drugs for secondary prevention of cardiovascular disease. In a post at SeekingAlpha, and Zacks Investment Research analyst Jason Napodano notes that from 1997 through 2012, Sanofi marketed and promoted Plavix for a range of cardiovascular indications. While Plavix has been shown to reduce cardiovascular death, re-infarction and stroke, studies showed only a modest efficacy improvement over aspirin. Napodano added that evidence shows aspirin’s use is limited by the GI effects of the drug. Pozen’s PA technology overcomes that limitation.
“No one knows this market better than Sanofi, and it’s hard to imagine them throwing away $35 million upfront to Pozen for a drug they don’t see as a contributor to their top-line,” Napodano wrote.
The PA drugs are combination drugs that employ Pozen’s delayed release technology to deliver aspirin in a manner that reduces gastrointestinal irritation that patients can experience with aspirin alone. Pozen’s PA pills consist of omeprazole, which reduces stomach irritation, in a layer surrounding an aspirin core. PA32540 is the 325 mg dosage; PA8140 is the 81 mg dose.
The Sanofi partnership is the third big pharma partnership reached by Pozen. The company’s migraine treatment Treximet is marketed by GlaxoSmithKline. AstraZeneca sells the osteo-arthritis drug Vimovo. Sales of both have been disappointing but Pozen has been left to do little more than watch, having ceded all control of commercialization efforts to its partners.
The earlier partnerships came on deal terms not entirely favorable to Pozen. But Pozen negotiated those deals needing the cash of a larger partner to finance late-stage clinical trials. Pozen took a different course with PA, keeping the compound in house all the way through phase III trials. In fact, Pozen originally planned to make PA the first Pozen drug that the specialty pharmaceutical company took to market on its own, enabling the company to retain all of drug’s revenue. Pozen later shifted course, reasoning that a large pharmaceutical company with an established sales force and cardiovascular contacts would be better suited to sell the drug.
Negotiating a deal
On Thursday, Plachetka said Sanofi is better positioned to sell the drug than Pozen, or anyone else, ever could. But by keeping the compound in-house all the way through phase III clinical trials Pozen was able to build the case for the drug candidate and negotiate for a better deal. Pozen’s royalty for the PA drugs will range from 12.5 percent to 22.5 percent.
It’s hard to tell how much control or influence, if any, Pozen will retain once Sanofi takes over the PA drugs. Pozen executives declined to disclose what the company stands to gain in milestones after the drug’s approval and they were similarly vague regarding the agreement terms following PA’s commercialization.
Pozen Chief Commercial Officer Liz Cermak has said numerous times that Pozen wants PA to be available at the cost of about $1 a day, a price point that would make the drug affordable to a broader range of people. She reiterated that point as a priority in the last year as she explained what Pozen was looking for in a partner. On Thursday Cermak declined to talk about pricing details, saying that Sanofi will determine PA’s price. But Cermak said Sanofi has done its own market research and Pozen is confident in Sanofi’s approach and strategy regarding pricing.
Plachetka offered no additional details on potential partnerships for PA around the world, saying only that the company is not expecting anything in the short term. But he added that a PA drug launch in the United States could help spur interest in the product in the rest of the world.
“It all comes down to pricing and health care dollars available,” Plachetka said. “Those markets are going to be very, very different than the United States market.”
