Pharma

Aspirin reimagined and Pozen’s new drug partnership possibilities

As drug partnering auditions go, Pozen (NASDAQ:POZN) has played this role before: The small drug […]

As drug partnering auditions go, Pozen (NASDAQ:POZN) has played this role before: The small drug developer flirts with a large pharmaceutical company who has the resources and the reach to take its promising drug candidate global.

Many companies audition without so much as a callback from Big Pharma. Chapel Hill, North Carolina-based Pozen has already come away with two deals, one with GlaxoSmithKline (NYSE:GSK) and another with AstraZeneca (NYSE:AZN). While landing even one Big Pharma partnership is an accomplishment, Pozen CEO John Platchetka insists the company’s third act will be different. Later this year, the company expects full phase 3 clinical trial results on PA32540, an aspirin combination drug that the company developed for cardiovascular indications. With lessons learned from previous partnerships, Pozen has different expectations for a PA32540 deal. And this time the company isn’t looking to just partner a pill. Pozen wants to partner an entire platform.

The PA platform is Pozen’s technology to deliver safely a drug that would otherwise cause gastrointestinal irritation. The technology can apply to any GI irritant and Pozen used it in developing Vimovo, a nonsteroidal anti-inflammatory drug (NSAID) indicated for arthritis that is delivered with AstraZeneca’s stomach acid reducer Nexium. Pozen is applying its technology to aspirin, a drug chosen because of its applications in a number of indications and its familiarity to patients and clinicians. Platchetka notes that 40 years ago, aspirin was the world’s most commonly prescribed pain reliever. It continues to be widely used today. But for all of its benefits, GI irritation remains aspirin’s main limiting factor.

“If we can diminish this flaw, we think we can unleash some really wonderful properties of aspirin that have been abandoned because of its toxicity,” Platchetka said.

The “P” in the PA platform stands for proton pump inhibitor, which reduces the gastric acid-causing stomach irritation and ulcers. “A” stands for aspirin. More than just combining the compounds, it’s the delayed-release delivery that minimizes GI irritation. Platchetka explains in this video:

Although Pozen has experience with drug partnerships, those partnerships were not without obstacles. The 2003 deal with GSK for Treximet was driven by Pozen’s need to find a partner who could finance phase 3 trials. Pozen was in the same position when it partnered with AstraZeneca on Vimovo. That deal presented another setback. AstraZeneca wanted Vimovo to use the active ingredient in its drug Nexium rather than the proton pump inhibitor Pozen had studied. That meant another phase 3 trial and an 18-month delay. Vimovo won regulatory approval in 2010, but so far the drug’s sales have disappointed. Yet Pozen is limited in what it can do to boost Vimovo sales because the partnership gives AstraZeneca control over sales and marketing.

Pozen has taken steps to avoid some of those issues with PA32540. Compared to the previous partnerships, Pozen has done far more to date on PA32540. Pozen has already paid to take the drug through phase 3 trials and will make the new drug application filing. Pre-commercialization market research has started. Many of these steps were taken because Pozen initially planned to commercialize PA32540 on its own. But as chief commercial officer Liz Cermak explains in this video, a partner broadens PA32540’s commercialization possibilities.

Studies continue to show that aspirin’s benefits are countered by its GI toxicity. Researchers in London this month published in the Archives of Internal Medicine results of an aspirin study that evaluated more than 100,000 patients in nine randomized trials in the United States, Europe and Japan. Researchers concluded that while aspirin reduced cardiovascular disease risks, it also increased risk of GI bleeding — findings that support a cardiovascular opportunity for PA32540.

Pozen chose the 325 mg dosage for PA32540 for a reason. It’s the effective dose not only for cardiovascular disease and stroke prevention, but also for prevention of colorectal and breast cancers in previous clinical studies. However, that London study in the Archives of Internal Medicine said results showed no such cancer prevention benefit. That indication will require more clinical research. Although Pozen financed phase 3 studies on the cardiovascular applications for PA32540, Platchetka said the company needs a partner for cancer studies, a longer and more expensive endeavor.

Cermak says partnership talks have touched on the range of PA aspirin applications, including cancer prevention. PA32540 is expected to launch in the third quarter of 2013. Cermak said that Bayer’s sales for consumer cardiovascular aspirin are $600 million. Pozen believes PA32540 could equal or even surpass that mark. If the PA platform can be successfully developed for other indications, such as cancer prevention, Pozen believes PA aspirin can top $1 billion in sales. It’s those kinds of numbers that put Pozen in a position to negotiate a very different kind of partnering deal.

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