Plaintiff seeks to recover damages on behalf of the Class. If you are a member of the Class as described above, you may move the Court no later than Tuesday, October 9, 2007, to serve as a lead plaintiff for the Class. However, in order to do so, you must meet certain legal requirements pursuant to the Private Securities Litigation Reform Act of 1995.
POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. With less than 40 employees, POZEN is focused in the pain area of innovative drug development and in creating strategic, high-value partnerships with larger pharmaceutical companies for the commercialization of the company’s drug candidates.
Lead Product Candidate
POZEN’s lead product candidate is Trexima™, which is being developed by POZEN in collaboration with GlaxoSmithKline (GSK) for the treatment of acute migraine. Trexima is GSK’s proposed brand name for a proprietary single tablet containing sumatriptan succinate, a 5-HT 1B/1D agonist formulated with GSK’s RT Technology™, and naproxen sodium, a non-steroidal anti-inflammatory drug (NSAID). Trexima incorporates POZEN’s MT 400 technology, which refers to POZEN’s proprietary combinations of a triptan and an NSAID. The New Drug Application (NDA) for Trexima was submitted to the FDA in August 2005 and accepted for review by the FDA in October 2005. The company received an Approvable letter in June 2006. The company expects to submit a full response to the FDA during the fourth quarter of 2006. The FDA will have up to six months to review the information contained in the full response.
Robust Pipeline of Product Candidates
Today, 60 million Americans regularly use NSAIDs to manage their pain. There are approximately 16,500 deaths and 100,000 hospitalizations yearly resulting from gastrointestinal complications attributed to the use of NSAIDs. POZEN is responding to this unmet medical need to provide a ”safer NSAID” through its development of a suite of proprietary product candidates, designated PN, for the treatment of conditions such as osteoarthritis in patients who are at risk for developing NSAID-associated gastric ulcers. The PN tablet is designed to contain an immediate release acid inhibitor with a delayed release NSAID in a single dosage form. The Company signed an exclusive global collaboration agreement in August 2006 with AstraZeneca. In addition, the company is exploring several combinations of an immediate release acid inhibitor with aspirin, designated PA, that may provide a safer low-dose aspirin therapy for cardiovascular and stroke prevention.
In addition to the PN and PA programs, POZEN is exploring oral and parenteral NSAID therapy with product candidates containing lornoxicam. POZEN has licensed rights to develop and commercialize product candidates containing lornoxicam, an NSAID currently marketed in Europe and Japan, from Nycomed Danmark ApS. Lornoxicam has demonstrated a good efficacy and safety profile in clinical use outside the United States since market introduction in 1995. In laboratory tests, lornoxicam has been shown to be the most potent balanced inhibitor of human COX-1 and COX-2 enzymes when compared with other non-selective NSAIDs, including meloxicam, ketorolac, and aspirin. The company has completed a Phase I study evaluating oral lornoxicam and plans to initiate further development activities to evaluate combinations including lornoxicam as well as a program to evaluate parenteral lornoxicam in the management of acute pain conditions.