Key Developments: POZEN Inc (POZN.OQ)
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Latest Key Developments (Source: Significant Developments)
POZEN Inc Announces FDA Acceptance Of Filing Of New Drug Application For PA32540/PA8140 Tablets
POZEN Inc announced that the U.S. Food and Drug Administration (FDA) has accepted for review, the New Drug Application (NDA) for PA32540/PA8140. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor (PPI), layered around a pH-sensitive coating of an aspirin core. The FDA also indicated the review classification is Standard; therefore, the user fee goal date is January 24, 2014. Pending FDA review and approval, an indication is sought for PA tablets for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. The NDA submission is based on data from a comprehensive clinical trials program that POZEN conducted. This program included two pivotal Phase 3 studies (PA32540 - 301/PA32540 - 302) for PA32540, conducted under special protocol assessment (SPA) agreed with the FDA, which met their primary and secondary endpoints, as well as Phase 1 studies for both PA32540 and PA8140. In the 301 and 302 studies, significantly fewer subjects taking PA32540 experienced endoscopically confirmed gastric ulcers compared to subjects receiving enteric-coated (EC) aspirin alone (Study 301: 3.8% vs. 8.7%, p=0.02; Study 302: 2.7% vs. 8.5%, p=0.005, respectively). Full Article
POZEN Inc Announces Results Of PA32540 Phase 3 Post-Hoc Analysis Presented At DDW 2013 Also Revealed That Over 4% of These Patients May Have Gastric Ulcers Without Knowing It
POZEN Inc announced that it presented the Abstract, Prevalence of Gastric Ulcers in Aspirin Users/Does the Presence of Erosions Foreshadow Ulcer Development, from a post-hoc analysis of Phase 3 data from the investigational compound PA32540. The analysis of patients screened for the Phase 3 studies demonstrated that at any time point, over 4% of subjects on low dose aspirin (ASA) for cardiovascular and cerebrovascular disease have endoscopic gastric ulcers (GUs) that go undetected. In addition, the analysis demonstrated that even the presence of small lesions known as endoscopic gastric erosions in aspirin-users was associated with a 2-fold increased risk of future development of endoscopic gastric ulcers. These data highlight the need for physicians to identify aspirin patients at risk, and, where appropriate, prescribe gastroprotective agents. Based on American Heart Association (AHA) and American College of Gastroenterology (ACG) recommendations, the preferred gastroprotective agents are proton pump inhibitors (PPIs). In patients with gastric erosions at baseline, PA32540, a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), layered around a pH-sensitive coating of a 325 mg ASA core, resulted in significantly fewer gastric ulcers at six months vs. EC-ASA (325 mg) (4.2% vs. 13.0%; p=0.001) These data were presented for the first time at Digestive Disease Week (DDW) 2013 in Orlando, Florida at the Orange County Convention Center on May 20, 2013. Full Article
POZEN Inc Submits New Drug Application For PA32540/PA8140
POZEN Inc announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of PA32540/PA8140. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor (PPI), layered around a pH-sensitive coating of an aspirin core. Pending regulatory approval, an indication is sought for the use of PA tablets for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers. The NDA submission is based on data from a comprehensive clinical trials program that POZEN conducted. This program included two pivotal Phase 3 studies (PA32540 - 301/PA32540 - 302) for PA32540, conducted under special protocol assessment (SPA) agreed with the FDA, which met their primary and secondary endpoints, as well as Phase 1 studies for both PA32540 and PA8140. In the 301 and 302 studies, significantly fewer subjects taking PA32540 experienced endoscopically confirmed gastric ulcers compared to subjects receiving enteric-coated (EC) aspirin alone (Study 301: 3.8% vs. 8.7%, p=0.02; Study 302: 2.7% vs. 8.5%, p=0.005, respectively). Full Article
POZEN Inc Announces Positive PA32540 Pivotal Phase 3 Data
POZEN Inc announced positive results from two pivotal Phase 3 clinical trials of the investigational product, PA32540. Treatment Continuation and Cardiovascular Safety of Antiplatelet Therapy with PA32540, A Tablet with Enteric-Coated Aspirin and Immediate-Release Omeprazole: Results of Two 6-Month, Phase 3 Studies. Each study achieved individual primary endpoint, as patients on PA32540 experienced fewer gastric ulcers compared to those taking enteric-coated aspirin (325 mg) alone. In addition, the results from the combined data from the two studies demonstrated that patients on PA32540, compared to those on enteric-coated aspirin (325 mg), were able to stay on therapy longer due to fewer discontinuations to any adverse events (6.7% vs. 11.2%). In the combined data from the two trials, 85.1% of subjects on enteric-coated aspirin (325 mg) reported adverse events compared to 71.8% of subjects on PA32540. The commonly reported adverse events with PA32540 and enteric-coated aspirin (325 mg) were of the GI tract and include dyspepsia (11.3% vs. 30.2%), erosive gastritis (11.5% vs. 26.3%), and gastritis (17.5% vs. 16.0%) respectively. The incidence and nature of adjudicated Major Adverse Cardiac Events (MACE) such as heart attacks was similar between the 2 treatment arms: 9 subjects (1.7%) on PA32540 experienced adjudicated MACE compared to 13 subjects (2.5%) on aspirin (325 mg). Full Article
POZEN Inc. Receives Patent on PA Products For Treatment Of Cardiovascular Disease And Osteoarthritis
POZEN Inc. announced that 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. Full Article
FDA Says POZEN Inc. Ulcer Drug May Need More Data-Reuters
Reuters reported that U.S. health regulators informed Pozen Inc that they have come to a preliminary determination that the Company's experimental stomach ulcer drug did not show bioequivalence with 325 mg aspirin, further jeopardizing the drug's chances to win approval soon. Pozen had said In April that it did not intend to conduct a new study for the lower dose and would instead submit existing data in support of the application. Full Article
POZEN Inc. Presents Phase 1 Data; PA32540 Provides Faster Gastric Acid Reduction Than Enteric-Coated Omeprazole (40 mg)
POZEN Inc. presented data from a Phase 1 study that found that the investigational compound, PA32540, provides faster protection compared with delayed-release, enteric-coated omeprazole (40 mg), as measured by mean time to gastric pH. Study 112 is a Phase 1, single-center, open-label, randomized, two-way crossover study that examined 26 healthy male and female volunteers who were H. pylori negative. The study rationale was to gain an understanding of the anti-secretory and gastrointestinal (GI) therapeutic effect of the immediate-release omeprazole in PA32540. Subjects received either PA32540 once daily for seven days or enteric-coated aspirin (325 mg) plus enteric-coated omeprazole (40 mg) administered concomitantly once daily for seven days. After at least a seven-day washout, subjects were crossed over to the alternate treatment. Gastric pH and pharmacokinetics were measured over 24 hours on day seven of each treatment period. Key Findings; Mean time to first gastric pH >4 was significantly faster with PA32540 compared to the enteric-coated aspirin + enteric-coated omeprazole group (PA32540: 17 minutes; enteric-coated aspirin + enteric-coated omeprazole: 36 minutes; p=0.011). The percent time gastric pH >4 was 50.6% for PA32540 and 57.6% for enteric-coated aspirin + enteric-coated omeprazole group (p=0.004). The relative bioavailability of omeprazole following seven daily doses with PA32540 was 43% lower than that from enteric-coated omeprazole 40 mg. Full Article
POZEN Inc. Announces Licensing Deal With Desitin Arzneimittel GMBH For MT 400 Migraine Treatment in 29 European Countries
POZEN Inc. announced that it has 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 combination of sumatriptan and naproxen sodium, the first multiple mechanism triptan therapy for the treatment of migraine. POZEN previously licensed rights of the same dosage strength of MT 400 to Cilag GmbH International, a division of Johnson & Johnson, for four Latin American countries. POZEN also licensed U.S.-only rights to MT 400 to GlaxoSmithKline, which markets a different dose of MT 400 known as Treximet (sumatriptan and naproxen sodium). Under the terms of the agreement, Desitin will be POZEN’s exclusive licensee for MT 400 in the licensed territory and will be responsible for the remaining clinical development, manufacturing, and commercialization of MT 400. Desitin will make an initial upfront payment to POZEN, followed by payments related to the development and launch of MT 400 in certain specified countries. The pre-commercialization payments will total $3.0 million, $0.5 million of which is due on signing. The agreement will expire on a country-by-country basis upon the 15th anniversary of the first commercial sale of MT 400 in each country, unless terminated earlier. Desitin will pay POZEN a double digit royalty on net sales of MT 400 that increases based on annual sales volume. Full Article
POZEN Inc. Announces Positive Top-Line Results From Two Pivotal Phase 3 Studies Of PA32540
POZEN Inc. announced positive top-line results from two pivotal Phase 3 clinical trials of PA32540, a coordinated-delivery tablet of immediate-release omeprazole (40 mg) and delayed release aspirin (325 mg). The two Phase 3 pivotal trials were randomized, double-blind, multi-center studies in which a total of 1,049 subjects at risk for developing aspirin-associated ulcers and already taking aspirin at a dose of 325 mg once daily for at least three months for secondary prevention of cardiovascular events were randomly assigned to treatment with either PA32540 or 325 mg enteric-coated aspirin once daily. The primary endpoint, a significant reduction in the cumulative incidence of gastric ulcers following administration of PA32540 vs. 325 mg enteric-coated aspirin over six months, was met in both studies. Additionally, the studies met their key secondary endpoints, including a reduction in gastroduodenal ulceration as well as a reduction in discontinuation due to upper gastrointestinal adverse events in subjects taking PA32540 compared to 325 mg enteric-coated aspirin. Reported adverse events were consistent with the trial population and the known adverse event profile of aspirin and omeprazole. Further analyses of the data will be conducted, and presentation of the data at an appropriate upcoming scientific meeting, as well as publication of the full results, is planned. Full Article
POZEN Inc. Monetizes Its Treximet Royalty Stream For $75 Million; Revises FY 2011 Guidance
POZEN Inc. announced that it has 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 (sumatriptan/naproxen sodium) sales in the United States to a financial investor for $75 million. By virtue of the agreement, the financial investor will be entitled to receive royalties on net sales of Treximet and any other products containing sumatriptan and naproxen sodium developed and sold by GSK under the collaboration and license agreement in the United States on or after October 1, 2011. POZEN retains rights to 20% of royalties paid on net sales of Treximet and such other products in the United States, beginning in the second quarter of 2018. This agreement has no effect on any future royalties from MT400 that might originate from sales of the product outside of the United States. Morgan Stanley & Co. LLC acted as financial advisor to the Company in connection with this transaction. The Company also announced that it will record the $75 million purchase price, less transaction costs, as revenue in the fourth quarter of 2011. Therefore, the Company is revising its earlier estimated fiscal 2011 revenue to be in the range of $86-$87 million and operating expenses to be in the range of $45-$47 million and after-tax net income of $39.5-$41.5 million. Full Article

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