|POZEN Announces Positive Top-Line Results from Two Pivotal Phase 3 Studies; Endocyte Receives USAN Approval for Nonproprietary|
|By Staff and Wire Reports|
|Thursday, 22 March 2012 17:33|
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced positive top-line results from two pivotal Phase 3 clinical trials of PA32540, a novel, 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.
We are encouraged by the strength of the data and I commend the clinical team here at POZEN (POZN) and all our associates for their dedication and hard work, said John R. Plachetka, Pharm.D., the Companys Chairman, President and Chief Executive Officer. This information is essential to progress our PA32540 partnership discussions for the United States, and to allow us to continue to move forward with our preparations for a third quarter NDA submission for this product candidate.
Endocyte, Inc. (Nasdaq: ECYT) announced the World Health Organization and the United States Adopted Names Council have approved the nonproprietary name "vintafolide" (pronounced vin ta foe' lide) for Endocyte's therapeutic drug candidate EC145 and the nonproprietary name of "etarfolatide" for Endocyte's companion imaging agent EC20. Vintafolide and etarfolatide are currently being evaluated in the Phase 3 PROCEED trial for the treatment of women with folate-receptor positive platinum-resistant ovarian cancer.
Etarfolatide is being used to select patients with tumors that over-express folate receptors and who are most likely to benefit from vintafolide therapy. Endocyte intends to file European Marketing Authorisation Applications for both agents based on positive Phase 2 results.
AstraZeneca (NYSE: AZN) today announced that BRILINTA® (ticagrelor) tablets received Plan Preferred Tier 2 formulary access on Medco Health Solutions’ National commercial formulary and Preferred Brand formulary status on its Medicare Part D drug list.
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, today reported its results for the fourth quarter and year ended December 31, 2011.
BioTime, Inc. (NYSE Amex: BTX) and BioTime’s subsidiary OncoCyte Corporation today provided a progress report on the development of PanC-DxTM, a novel diagnostic device developed at BioTime and OncoCyte to detect the presence of various human cancers, including cancers of the breast, lung, bladder, uterus, stomach, and colon, during routine check-ups.
Boston Therapeutics, Inc. (OTCBB: BTHE), a developer of diabetes therapeutics, is pleased to announce that the Company's common stock was quoted on March 20, 2012 by Glendale Securities, Inc. on the OTC Bulletin Board under the symbol BTHE.
Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care announced today that the Company will hold a conference call on March 29, 2012 to discuss the financial results for the fourth quarter and year ended December 31, 2011.
EPIC Corporation (PINKSHEETS: EPOR) announced the GRAND OPENING of the EPIC iSTORE (www.epicistore.com), and in celebration it declared a 100% stock dividend (1:1) to shareholders of record on April 27, 2012, payable May, 17, 2012.
Fallon Community Health Plan (FCHP) and Magellan Health Services (NASDAQ: MGLN) today announced they are forming a joint venture to apply to participate in a new demonstration program that will provide integrated health care to individuals aged 21 to 64 years who are dually-eligible for Medicare and Medicaid.
ImmunoCellular Therapeutics (OTCBB: IMUC) today announced that it has entered into an agreement with University of Pittsburgh (Pitt) under which Pitt has licensed to the Company intellectual property surrounding EphA2, a tyrosine kinase receptor that is highly expressed by ovarian cancer and other advanced and metastatic malignancies.
Mallinckrodt, the pharmaceuticals business of Covidien (NYSE: COV), a leading global provider of healthcare products, today announced the launch of its morphine sulfate oral solution for the relief of moderate-to-severe acute and chronic pain in opioid-tolerant patients.
MELA Sciences, Inc. (NASDAQ: MELA), the medical device company that has developed MelaFind®, today announced that the company has entered into a two-year agreement with Quintiles (Quintiles Commercial Germany GmbH) for commercialization support for MelaFind in Germany.
OptumRx, a leading pharmacy benefits management (PBM) organization and one of the Optum companies of UnitedHealth Group (NYSE:UNH), said it will create at least 400 new jobs in Tucson over the next 12-18 months.
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today positive top-line results from two pivotal Phase 3 clinical trials of PA32540, a novel, coordinated-delivery tablet of immediate-release omeprazole (40 mg) and delayed release aspirin (325 mg).
Quidel Corporation (NASDAQ: QDEL), a leading provider of diagnostic testing solutions, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Quidel Molecular™ Influenza A+B Assay for the detection of influenza A and B for use with Cepheid's SmartCycler® PCR system.