|POZEN to Offer Phase 3 Data on PA32540; St. Jude's RESPECT Trial for PFO Closure|
|By Staff and Wire Reports|
|Friday, 08 February 2013 20:14|
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, presented data from the combined results of two Phase 3 studies of PA32540, an antiplatelet therapy of enteric-coated (EC) and immediate-release omeprazole, in patients with previous cerebrovascular disease. These data were presented at the American Heart Association 2013 International Stroke Conference on Thursday, February 7 at 4:15 p.m. (HST) in Honolulu, Hawaii at the Hawaii Convention Center as poster board number MP103.
According to the studies, in the post-hoc analysis of subjects with a history of transient ischemic attack (TIA) or stroke, long-term (6 months) treatment with PA32540, compared to EC-ASA (325 mg), was associated with a significantly reduced rate of endoscopic gastroduodenal ulcers (2.0% vs. 12.4% respectively; p=0.005), and study discontinuation due to adverse pre-specified upper GI events (0% vs. 8.0% respectively; p=0.006). The incidence of adjudicated major adverse cardiac events was similar for PA32540 (2.9%) and EC-ASA (325 mg) (4.4%).
“Discontinuation of aspirin therapy is often due to the adverse GI effects of aspirin,” said Mark J. Alberts, MD, UT Southwestern Medical Center, Dallas, Texas. “In these pivotal studies, PA32540 was associated with a significantly lower rate of treatment discontinuation than aspirin alone. Patient adherence to aspirin therapy saves lives, as aspirin discontinuation increases the likelihood of potential adverse cardiovascular and cerebrovascular events.”
AHA guidelines state that the use of an antiplatelet agent, such as aspirin, is recommended to reduce risk of recurrent stroke and other cardiovascular events.
St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, announced the presentation of additional data from its landmark RESPECT trial at the American Stroke Association's International Stroke Conference 2013 in Honolulu. The RESPECT trial evaluated whether closing an opening in the heart, called a patent foramen ovale or PFO, with the AMPLATZER^™ PFO Occluder lowered the patient's risk of having another stroke.
“Data from the RESPECT trial indicates that patients with a device were less likely to suffer stroke, had smaller strokes, and were less likely to have the type of stroke linked to paradoxical embolism,” said Dr. Jeffrey L. Saver, director of the UCLA Stroke Center and professor of Neurology at the David Geffen School of Medicine. “Indications of preventing strokes on the surface of the brain and large strokes provide additional evidence of a genuine biological effect of closure with the AMPLATZER PFO Occluder in preventing recurrent cerebral infarcts due to a blood clot crossing through the PFO.”
An ischemic stroke occurs when a blood clot blocks a vessel, interrupting blood flow to an area of the brain (the other type of stroke is hemorrhagic, which occurs when a blood vessel in the brain ruptures). When a blood clot blocks a vessel, brain cells begin to die and brain damage can occur. The origin of the blood clot can impact where it becomes lodged in the brain, thereby creating strokes in different areas. A paradoxical embolism occurs when a blood clot travels from the right side of the heart to the left side of the heart, often through a PFO, and can then travel directly to the brain, causing an ischemic stroke. Statistics from the World Health Organization show an estimated 15 million strokes occur worldwide each year, of which approximately 80 percent are ischemic.
The purpose of analyzing these additional data from the RESPECT trial was to determine if patients in the device and medical therapy group suffered different types of recurrent strokes, and to identify the potential origin of the strokes. The results confirm that patients with a device in place were less likely to suffer another stroke and patients in the medical group experienced larger strokes. PFO closure with the AMPLATZER PFO Occluder demonstrates clinical evidence of risk reduction and is an important option for the prevention of recurrent stroke in carefully selected patients over conventional medical management alone.
“The overall trial demonstrates that PFO closure with the AMPLATZER PFO Occluder for these relatively young, otherwise healthy patients substantially reduces their risks of suffering another stroke,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division.
3SBio Inc. (NASDAQ: SSRX) ("3SBio" or the "Company"), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that it has entered into an agreement and plan of merger (the "Merger Agreement") with Decade Sunshine Limited, an exempted company with limited liability incorporated under the laws of the Cayman Islands ("Parent"), and Decade Sunshine Merger Sub, an exempted company with limited liability incorporated under the laws of the Cayman Islands and a direct wholly owned subsidiary of Parent ("Merger Sub").
Amarantus BioScience, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with the neurodegeneration and apoptosis centered around its patented therapeutic protein MANF, today announced that Gerald E. Commissiong, President and Chief Executive Officer will present a corporate update at the 15th Annual BIO CEO & Investor Conference hosted by the Biotechnology Industry Organization (BIO).
Amgen (NASDAQ: AMGN) today announced the call for nominations for Breakaway from Cancer® Champions.
Anthera Pharmaceuticals, Inc.(Nasdaq: ANTH) a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced Paul F. Truex, Anthera's President and Chief Executive Officer, will present at the 2013 Leerink Global Healthcare Conference in New York, NY on Thursday, February 14, 2013 at approximately 8:00 am Eastern Time.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will present at the Leerink Swann Global Healthcare Conference being held in New York City.
Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (Sobi) (STO: SOBI) released data that confirmed the ability of investigational recombinant factors VIII Fc fusion protein (rFVIIIFc) and IX Fc fusion protein (rFIXFc) to provide long-lasting protection from bleeding with fewer injections than are required with the current standard of care for people with hemophilia.
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it has settled all pending litigation with Shire LLC and Shire Laboratories, Inc. (collectively Shire) relating to supply of its authorized generic Adderall XR® under the parties’ License and Distribution Agreement that was signed in January 2006.
Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, announced plans to release its financial results for the fourth quarter and full year 2012 on February 27, 2013 after the close of the financial markets.
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at the 15th Annual BIO CEO & Investor Conference, being held February 11-12, 2013, in New York City. Mr. Bentsur's presentation is scheduled to take place on Monday, February 11th, at 2:30 PM ET.
LiveWire Ergogenics, Inc. (OTCQB: LVVV) has provided a corporate update of the company's activities and accomplishments in 2012 during which LiveWire completed the transition from a private company to a fully reporting public company with audited financials.
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced its financial results for the quarter and year ended December 31, 2012.
Oncolytics Biotech Inc. ("Oncolytics") (TSX: ONC) (NASDAQ: ONCY) today announced results examining percent overall tumour shrinkage data from its U.S. Phase 2 clinical trial in patients with squamous cell carcinoma of the lung (SCCLC) using intravenous administration of REOLYSIN® in combination with carboplatin and paclitaxel (REO 021).
OPKO Health, Inc. (NYSE:OPK), in response to statements regarding the sale of Company common stock by Mr. Adam E. Logal, OPKO’s Vice President, Chief Accounting Officer and Treasurer, would like to clarify that no other Company officer has exercised common stock options or sold any shares of Company common stock during the last twelve months and that the nominal exercise of 50,000 common stock options and sale of such common stock by Mr. Logal was done to address pressing family circumstances.
Parametric Sound Corporation (NASDAQ: PAMT), a leading innovator of audio technology and solutions, today announced financial results for its first fiscal quarter ended December 31, 2012.
Palatin Technologies, Inc. (NYSE-MKT: PTN) will announce its second quarter, fiscal year 2013 financial results on Thursday, February 14, 2013 before the open of the U.S. financial markets.
Palatin Technologies, Inc. (NYSE MKT: PTN) announced that it will be presenting at the 15th Annual BIO CEO & Investor Conference.
Shire plc (LSE: SHP, NASDAQ: SHPG), today announced the initiation of a Phase 3 study designed to evaluate the efficacy and safety of ABH001, its dermal substitute therapy, for the treatment of non-healing wounds in patients with Epidermolysis Bullosa (EB), a group of rare genetic skin disorders that begin to manifest at birth or early childhood and occur in approximately 19 per 1 million live births in the US.
SOHM, Inc. (PINKSHEETS: SHMN) was searching for a prestigious event for the U.S. launch of its flagship skincare product FōHM by SOHM™, a rejuvenating, cleansing, and clarifying facial foam powered by the proprietary formula of Salic2™.
Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that its President and Chief Executive Officer, Christopher J. Schaber, PhD, will give a corporate presentation at the 2013 BIO CEO & Investor Conference on Tuesday, February 12, at 3:00 PM Eastern Standard Time.
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the presentation of additional data from its landmark RESPECT trial at the American Stroke Association’s International Stroke Conference 2013 in Honolulu.
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that it, its affiliate Sucampo AG, R-Tech Ueno, Ltd., Takeda Pharmaceutical Company Limited (Takeda), and certain affiliates of Takeda have filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Anchen Pharmaceuticals, Inc., Par Pharmaceuticals, Inc. and Par Pharmaceutical Companies, Inc. (collectively, Anchen) related to an Abbreviated New Drug Application (ANDA) that Anchen filed with the U.S. Food and Drug Administration (FDA) to market a generic version of AMITIZA® (lubiprostone) oral capsules, 8 mcg and 24 mcg.
Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (“Taro”) and Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (together with its subsidiaries, “Sun Pharma”) announced today that they have mutually agreed to terminate their merger agreement, announced in August 2012, pursuant to which all shareholders of Taro (other than Sun Pharma and its affiliates) would have received a cash payment of $39.50 per share upon the closing of the merger.
Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF) (FRANKFURT:V3T) (the "Company" or "Verisante"), a leader in cancer detection technology, announced today that it has retained Hamza Thindal Capital Corp. (the "Firm" or "Hamza Thindal") for investor relations to help broaden investor awareness via the Firm's established network of investors in North America, Europe and the Gulf/MENA Region.
WuXi PharmaTech (Cayman) Inc. (NYSE: WX), a leading pharmaceutical, biotechnology and medical device R&D outsourcing company with operations in China and the United States, today announced that it will release financial results for the fourth quarter of 2012 after the New York Stock Exchange closes on Thursday, March 7, 2013 (which will be Friday morning, March 8, 2013 Shanghai time).
YaFarm Technologies, Inc. (OTC Pink: YFRM) (YaFarm, or the Company) announced today that the Integrative Stem Cell Institute (ISCI), a premier provider of point-of-care, stem cell- based therapies, is initiating design and development of a new, world-class cell processing and culture laboratory in Cancun, Mexico.