POZEN Inc., headquartered in Chapel Hill, NC, is a pharmaceutical company committed to transforming medicine that transforms lives. Since its founding in 1996, POZEN has successfully created novel pharmacologic agents primarily for pain and pain-related conditions by combining existing drug therapies that result in superior patient outcomes. Moving forward, POZEN is poised to become a model 21st century pharmaceutical company dedicated to ensuring that they produce cost-effective, evidence-based medicines; take a fresh approach to sales, marketing and medical education; and deliver high-quality, affordable pharmaceuticals to their customers.
Since its founding in 1996, POZEN has had a long, successful history of creating novel pharmacologic agents by combining existing drug therapies that result in superior patient outcomes, primarily for pain and pain-related conditions. This approach allows for a potentially higher success rate than NCE (new chemical entity) development.
POZEN pioneered the concept of a strategic outsource drug development company whose products would be marketed by strong commercial partners. This model has allowed POZEN to commit nearly all its resources to developing new products while avoiding the high costs associated with basic research, manufacturing, and marketing. By virtue of the initial upfront payments, milestone payments, and ongoing royalties from partnerships, POZEN has been totally self-funding since the 2000 Initial Public Offering (IPO).
POZEN is currently engaged in a strategic partner search for PA32540, currently in late stage Phase 3 development. The NDA program is on schedule for submission in the second half of 2012, and as POZEN will be initiating submission discussions with regulators in other key territories, a commercial partner launch to maximize the sales potential for PA32540 has begun. POZEN has added substantial value to this asset by executing the critical NDA development and pre-commercialization phases, and now intends to secure a relationship with one or more strategic partners in order to maximize the sales potential of PA32540, both in the United States and globally. We believe this model will allow us to increase POZEN’s future potential revenues and profits and deliver better shareholder value.
Licensed Products
Treximet®
In April 2008, the Food and Drug Administration (FDA) approved Treximet®(sumatriptan and naproxen sodium) for the acute treatment of migraine attacks, with or without aura, in adults. The product is formulated with POZEN’s patented technology of combining a triptan with a non-steroidal anti-inflammatory drug (NSAID) and GlaxoSmithKline’s (GSK) RT Technology™. This migraine medication works in two ways – the triptan component shrinks the swollen blood vessels in the head, which correlates to the relief of migraine pain, while the NSAID component inhibits the enzyme responsible for the production of prostaglandins, which are the mediators of pain and inflammation. As a result of this dual mechanism of action,Treximet® has been shown to provide superior sustained pain relief compared to placebo and to both of the single mechanism of action components. The FDA approval was an important milestone for the partnership between the two companies. The partnership began in 2003, when GSK signed an agreement with POZEN for the development and commercialization of this product.
In May 2008, POZEN officially transferred the Investigational New Drug (IND) and New Drug Application (NDA) for the product to GSK. GSK is responsible for the commercialization of Treximet® in the US. POZEN receives royalties based on net sales of Treximet® from GSK and, beginning January 1, 2010, that royalty rate more than tripled to 18 percent.
For Full Prescribing Information, see www.treximet.com.
POZEN also has ex-US rights to develop and market a lower dose sumatriptan and naproxen combination.
VIMOVO™
Another major licensed product program is for VIMOVO, (naproxen and esomeprazole magnesium) delayed release tablets, co-developed by POZEN Inc. and AstraZeneca, a fixed-dose combination of delayed-release enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug (NSAID), and immediate release esomeprazole, a proton pump inhibitor (PPI). On April 30, 2010, the Company announced that the U.S. Food and Drug Administration (FDA) approved VIMOVO delayed-release tablets for the relief of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS), and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to the absorption from other naproxen-containing products. Controlled studies do not extend beyond six months.
VIMOVO received positive agreement for approval in 23 countries across the European Union in October 2010, which was followed by marketing and pricing approval in the United Kingdom, the first major ex-U.S. territory. In June 2010, POZEN officially transferred to AstraZeneca the Investigational New Drug (IND) and New Drug Application (NDA) for the product. AstraZeneca is responsible for the commercialization of VIMOVO.
For Full Prescribing Information see www.vimovo.com.
Product Pipeline
POZEN is creating a safer form of aspirin franchise of product candidates – the PA product platform. The PA family of product candidates is intended to significantly reduce GI ulcers and other GI complications compared to taking aspirin alone.
The first candidate is PA32540. It is a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a PPI, layered around pH-sensitive enteric-coated aspirin (325 mg). This novel, patented product candidate is in Phase 3, and is administered orally once a day and will be indicated for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers. POZEN has completed enrollment of patients in two pivotal Phase 3 trials. A long-term, open-label safety trial for secondary cardiovascular disease (CVD) prevention was completed in 2011.
The POZEN pipeline also includes earlier-stage work evaluating the application of aspirin combinations for pain and pain-related conditions.