POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the second quarter ended June 30, 2012.
- The Company is currently preparing the New Drug Application (NDA) and is planning to seek approval for two dosage forms of PA, PA32540 and PA8140. As previously disclosed, during a pre-submission meeting for the Company’s NDA for PA32540, the U.S. Food and Drug Administration (FDA) suggested that the Company also seek approval for a lower dose formulation of the product containing 81 mg of aspirin.
- Following its preliminary assessment of the bioequivalence study data (115 study), the FDA informed the Company that, based on the information available, it did not agree that bioequivalence of PA32540 to enteric-coated (EC) aspirin 325 mg was demonstrated in such study. After a follow-up teleconference the FDA agreed to grant a Type A meeting with POZEN, and the Company has submitted additional information and analyses from the bioequivalence study, as well as other relevant pharmacokinetic, clinical pharmacology, and in vitro dissolution data as a Briefing Document. After the Type A meeting, POZEN expects the FDA to review and provide a written response as to whether the Company has sufficient data in totality to establish a clinical and pharmacological bridge between the product and EC aspirin 325 mg. If the outcome of this meeting is favorable, an NDA filing could be made in Q4 2012.
- POZEN has recently gained clarity from the Medicines Evaluation Board (MEB) in the Netherlands regarding the development program required for the approval in the European Union of PA32540 and a lower dosage form containing 100 mg of aspirin and 40 mg of omeprazole (PA10040). Importantly, the MEB agreed that no Phase 3 clinical trials for PA10040 to demonstrate the reduction of gastric ulcers vs. EC aspirin will be necessary. Instead, a Phase 1 pharmacodynamic study demonstrating appropriate gastric pH control with PA10040 would be required. In addition, a study to demonstrate bioequivalence of PA10040 to a currently marketed EC aspirin product using aspirin pharmacokinetics has been requested. The Company plans to discuss further the bioequivalence study design. The MEB also agreed to be the Reference Member State in a decentralized filing procedure of PA32540/PA10040.
- Q2 2012 global net sales of VIMOVO™ (naproxen / esomeprazole magnesium) delayed-release tablets were $16.6 million, up 159.4% from Q2 2011 and 4.4% vs. Q1 2012. POZEN earned a royalty of $1.3 million for the quarter. As of the end of Q2 2012, VIMOVO has been filed for regulatory approval in 78 countries, approved in 58, and commercially launched in 30 countries.
- In May, POZEN entered into a license agreement with Desitin Arzneimittel GmbH, for the development and commercialization of MT 400 for the 27 countries of the European Union, as well as Switzerland and Norway. MT 400 is POZEN’s proprietary combination of sumatriptan and naproxen sodium, the first multiple mechanism triptan therapy for the treatment of migraine.
- The United States Patent and Trademark Office has issued to POZEN U.S. Patent 8,206,741 titled “Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs”. This patent includes claims to pharmaceutical compositions that contain aspirin and a proton pump inhibitor (PPI). POZEN’s PA (PPI/aspirin) combination drug candidates are covered under this patent. The ‘741 patent is the second U.S. patent issued to POZEN for the coordinated delivery of NSAIDs, but the first in which the claims are focused on aspirin-based products.
Second Quarter Financial Results
For the second quarter of 2012, POZEN reported revenue of $1.8 million, comprised of $1.3 million VIMOVO royalty from AstraZeneca and $0.5 million license revenue of MT 400. For the second quarter of 2011, the Company reported total revenue of $4.6 million, resulting from royalty on sales of Treximet ® (sumatriptan / naproxen sodium) of $4.0 million, and $0.6 million from royalty on sales of VIMOVO. POZEN sold most of the future royalty and milestone payments under its collaboration and license agreement with Glaxo Group Limited, part of the GlaxoSmithKline group of companies (GSK), covering Treximet sales in the United States to a financial investor in November 2011.Operating expenses for the second quarter of 2012 totaled $6.9 million, as compared to $11.0 million for the comparable period in 2011. The decrease in operating expenses in the second quarter of 2012 was primarily a result of the completion of the PA32540 Phase 3 studies.