The new cardiovascular drug that Pozen (NASDAQ:POZN) aims to bring to market made regulatory headway in the second quarter but so far the small drug developer has not yet landed the drug partner to sell what would become the Pozen’s third commercialized drug.
While the Chapel Hill company is still working on landing a larger partner with the experience, contacts and expertise to market a new cardiovascular drug, it’s now starting to look like Pozen might need multiple drug partners to commercialize PA8140 and PA32540 globally. Emerging markets are different from Western markets and there are differences even within Europe, CEO John Plachetka said on a conference call with analysts when asked about the global partnering possibilities.
Pozen is focusing first on securing regulatory approval in the United States and Europe for the drugs. Offering no details, Plachetka said Pozen continues to make progress in landing drug partner for PA8140 and PA323540 in the United States and is “on track to close to close that in 2013.”
The PA drugs combine the cardiovascular benefits of aspirin with the stomach-protecting benefits of omeprazole. Pozen is seeking approval of the two drugs, which represent the same drug but in different doses, for the secondary prevention of cardiovascular disease in patients at risk for gastric ulcers from aspirin. The company calls the PA drugs as “safer aspirin.”
Pozen submitted its new drug application for the two drug candidates in March. In May, Pozen announced that the Food and Drug Administration accepted the application and set a January 24 decision date.
The January date for an FDA decision comes close to the expected timing of a drug partnership deal for the PA drugs. Zacks Investment Research analyst Jason Napodano asked whether a potential partner might tentatively agree to a deal, waiting to finalize only after the drugs secure FDA approval. But Plachetka offered nothing.
“I’m not going to make any comments right now on where we are with the potential deal,” was all he said in response.
Commercialization of the PA drugs would help Pozen’s earnings. In the second quarter of 2013, Pozen reported a $4.0 million loss on revenue of $1.7 million. A year ago, Pozen reported a $5.1 million second quarter loss on $1.8 million in revenue. Right now, Pozen’s only revenue comes from royalties of arthritis drug Vimovo, whose marketing rights are held by drug partner AstraZeneca. Vimovo sales have fallen below expectations and Pozen disclosed in May that AstraZeneca would stop promoting sales of the drug. The drug is still available but discounts and coupons that had been used to promote Vimovo are going away.
Pozen does have another commercialized product, Treximet. The migraine headache treatment is marketed in the United States by drug partner GlaxoSmithKline. In 2011, Pozen sold those royalty rights for $75 million; proceeds from that sale were intended to support its PA efforts.
Pozen still has cash to spend. As of June 30, Pozen reported having cash and cash equivalents totaling $76.9 million. Plachetka has previously discussed the possibility of employing the technology used in the PA platform to develop additional drugs. But don’t expect Pozen to start on more drug candidates just yet. Plachetka said that at the moment there’s greater interest in Pozen closing on a partnership deal for the PA compounds submitted for regulatory approval. He left open the door to advancing one one or more product candidates through the drug pipeline but said that Pozen would not do so without someone else first expressing interest in those potential products.
“We’re not going to spend any money until that interest is shown,” he said.