Relief may be on the way for cardiac patients who can't tolerate aspirin. Pozen Inc., of Chapel Hill, N.C., reported positive results from two Phase III pivotal trials showing that treatment with PA32540, a formulation of aspirin combined with the proton pump inhibitor omeprazole, led to a significant reduction in gastric ulcers compared to enteric-coated aspirin.

The news bumped Pozen's stock (NASDAQ:POZN) up 42 cents, to close Thursday at $5.22.

The trials were double-blind and randomized, enrolling 1,049 subjects at risk for developing aspirin-associated ulcers who had already been taking 325-mg aspirin daily for at least three months. In addition to hitting the primary endpoint, the trials also achieved secondary endpoints of reduction in gastroduodenal ulceration and reduction in discontinuation due to upper gastrointestinal adverse events.

PA32540 is the first candidate in Pozen's pipeline of aspirin therapies. The tablet delivers immediate-release omeprazole in its outside layer. Beneath that is pH-sensitive aspirin. The product is intended to provide the same treatment benefit as daily aspirin in prevention of cardiovascular events, but with fewer gastrointestinal side effects and complications.

Its new drug application is targeted for the third quarter, and it will be indicated for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers. In addition to the two Phase III trials, Pozen has completed a long-term safety study.

Pozen executives were not available to comment Thursday, but the firm's approved product, Vimovo, uses the same strategy of combining a proton pump inhibitor (esomeprazole) and a drug that can cause gastrointestinal side effects (naproxen).

Vimovo is approved for osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease risk of gastric ulcers. Pozen's Phase III studies of Vimovo showed incidences of 4.1 percent and 7.1 percent of gastric ulcers in patients taking Vimovo, compared to 23.1 percent and 24.3 percent in patients taking enteric-coated naproxen.

Pozen partnered with AstraZeneca plc in 2006 for $40 million up front for the development of Vimovo. (See BioWorld Today, Aug. 3, 2006.)

Pozen also markets Treximet (sumatriptan and naproxen sodium) for migraine. Treximet is a combination of a triptan and a nonsteroidal anti-inflammatory drug plus a formulation technology from GlaxoSmithKline plc.

GSK partnered with Pozen in 2003 to commercialize that product for $25 million up front, and in 2008, Pozen transferred the investigational new drug and new drug applications for Treximet to GSK.

It now receives royalties of 18 percent from GSK on the drug. (See BioWorld Today, June 13, 2003.)

PA32540 is also in studies for some other indications. A Phase I open-label study of PA32450 in combination with clopidogrel showed better inhibition of ADP-induced platelet aggregation compared to the current standard of care, with about a 20 percent improvement in anti-clotting.

In another Phase I trial, PA32540 showed greater platelet inhibition when dosed 10 hours apart from Plavix (clopidogrel, Sanofi SA and Bristol-Myers Squibb Co.) compared to synchronous administration of aspirin, clopidogrel and delayed-release omeprazole at day seven (46.5 percent vs. 39.3 percent; p = 0.004). Those findings were relevant to patients with gastrointestinal risk who required dual antiplatelet therapy and gastroprotection.

In November 2011, Pozen added $75 million in cash by trading about six-and-a-half years' full royalties, plus ongoing partial royalties, for Treximet to CPPIB Credit Investments Inc. After 2018, Pozen regains rights to 20 percent of the royalties paid in net sales.

Pozen is seeking partners for PA32450 and some of its other portfolio assets.