|Marshall Edwards drops on failed ovarian cancer study. After the bell: FDA approves Amgen's osteoporosis drug, VIVUS presents ED Phase III study data|
|By BioMedReports.com Staff|
|Tuesday, 01 June 2010 18:24|
Below is a list of the companies that made news in the healthcare sector on Tuesday, June 01, 2010.
VIVUS, Inc. (Nasdaq:VVUS) after the bell announced that data from the previously reported phase 3 pivotal REVIVE (TA-301) study, evaluating the safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED), were presented at the American Urological Association (AUA) 2010 Annual Meeting. The data, "Avanafil for the Treatment of Erectile Dysfunction: Results of a Phase 3, Multi-Center, Randomized, Double Blind, Placebo-Controlled Clinical Trial," were presented by Irwin Goldstein, MD, clinical professor of surgery, University of California, San Diego and director of sexual medicine at Alvarado Hospital, San Diego, California. The presentation marks the first time these results have been shared with the medical community at a major medical meeting.
The REVIVE study met all primary endpoints across the three doses studied by demonstrating statistically significant improvements in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score. Successful intercourse was also reported in as little as 15 minutes and beyond six hours in subjects who attempted intercourse at those time points. Avanafil was well tolerated and demonstrated a favorable side-effect profile with low rates of typical PDE5 inhibitor-like adverse events.
"Many men living with ED often become frustrated by the side effects associated with currently available therapies, or by the length of time it takes for their ED therapy to become effective. Patients are continually in search of treatment options which may help provide a more satisfactory experience in less time," stated Dr. Goldstein. "The efficacy and safety seen with avanafil in this 'real world' study setting is impressive, and its fast onset of action and sustained activity differentiates this PDE5 inhibitor from other therapies. I am encouraged by these results, and the potential role avanafil may play in the lives of men living with chronic ED."
Shares of VIVUS jumped 45 cents in the after hours session.
Amgen Inc. (Nasdaq:AMGN) today announced that the U.S. Food and Drug Administration has approved Prolia (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Prolia, the first and only FDA-approved RANK Ligand inhibitor, is an every six month 60 mg subcutaneous injection administered by a health care professional.
"Today's FDA approval of Prolia is the culmination of a scientific journey that started more than 15 years ago with Amgen's discovery of an essential pathway that regulates bone metabolism," said Kevin Sharer, chairman of the board and chief executive officer of Amgen. "Prolia is the result of this discovery and offers an important new medicine for postmenopausal women with osteoporosis at high risk for fracture. Amgen is proud to make this new treatment option available to physicians and patients."
Prolia's approval is based on a pivotal three-year Phase 3 study involving 7,808 postmenopausal women with osteoporosis. Treatment with Prolia resulted in greater bone density, stronger bones, and reduced risk for vertebral, hip and non-vertebral fractures measured at three years.
"For the many osteoporosis patients who are at high risk for fracture, Prolia's approval marks the first new class of medicine introduced in nearly a decade," said Felicia Cosman, M.D., clinical director of the National Osteoporosis Foundation and medical director of the Clinical Research Center at Helen Hayes Hospital in New York. "Prolia is a new treatment that reduces the risk of fracture at key sites, including the hip and spine, and is given as a convenient twice-yearly shot just under the skin. It will be a welcome new option."
"While this is an important milestone for Amgen, it is even more important for the postmenopausal patients with osteoporosis who are at high risk for fracture," said Robert A. Bradway, president and chief operating officer of Amgen. "We have priced Prolia responsibly while reflecting its strong therapeutic value and expect to make it commercially available in the U.S. within the next week."
Shares of Amgen were up more than $2.00 in the extended session.
News from earlier in the day Tuesday:
Marshall Edwards, Inc. (NASDAQ:MSHL) dropped more than 50% after the company announced today that a final analysis of its Phase 3 OVATURE trial of orally administered phenoxodiol in women with recurrent ovarian cancer determined that the trial did not show a statistically significant improvement in its primary (progression-free survival) or secondary (overall survival) endpoints. As previously announced, the trial was closed for recruitment before completion of enrolment with only 142 out of a planned 340 patients enrolled.
This multi-center, randomized, double-blind trial assessed the safety and efficacy of daily phenoxodiol in combination with weekly carboplatin versus weekly carboplatin with placebo in patients with platinum-resistant or platinum-refractory, late-stage epithelial ovarian, fallopian or primary peritoneal cancer following at least second line platinum therapy.
"Owing to the fact that this trial was significantly underpowered due to the small number of patients enrolled, we were disappointed, but not entirely surprised by the final outcome," said Dr. Daniel P. Gold, newly appointed Chief Executive Officer of Marshall Edwards. "However, we remain confident that our investigational isoflavone platform, including triphendiol, a potentially more potent, second-generation analogue of phenoxodiol, may be of benefit to women with ovarian cancer, particularly when administered intravenously.
Shares of Marshall dropped $2.01 on the news, closing the day at $1.99, down 50.25%
Accentia Biopharmaceuticals, Inc. (PINK SHEETS: ABPIQ) today announced that the Company filed its proposed Plan of Reorganization (Plan) with the U.S. Bankruptcy Court for the Middle District of Florida, Tampa Division. With this filing, Accentia is positioned to emerge from Chapter 11 protection this summer as a fully restructured company. Upon Court-ordered confirmation, the Plan is expected to support the regulatory advancement of the autoimmune disease therapy, Revimmune, a comprehensive system of care and drug regimen designed to "reboot" the immune system to potentially eliminate multiple sclerosis and significantly reduce disability. Accentia is preparing to advance a regulatory strategy in order to proceed with a planned late-stage clinical trial for Revimmune.
Accentia is also a majority stakeholder in Biovest International, Inc. (Other OTC: BVTI), and this investment may represent significant value as Biovest has completed a Phase III clinical trial and plans to seek approvals for BiovaxID, a personalized cancer vaccine to treat certain B-cell lymphomas.
BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) today announced it is initiating a Phase 2 study of BCX4208 alone and in combination with allopurinol in patients with gout. BioCryst recently reported positive results from part one of its Phase 2 monotherapy study of BCX4208 in patients with gout and is now moving forward as planned with an additional Phase 2 trial of BCX4208.
Columbia Laboratories, Inc. (Nasdaq: CBRX) jumped more than 10% today. Before the market opened the company announced the signing of a $15 million subordinated term loan with Watson Pharmaceuticals, Inc. (NYSE: WPI). The proceeds from the loan are intended to be used to finance activities related to PROCHIEVE 8% (progesterone gel), the ongoing PREGNANT Study, other development programs for the preterm birth indication and other general corporate purposes.
CombiMatrix Corporation (Nasdaq:CBMX) shares slumped today after the company announced that it has ceased work on identification and pursuit of potential purchasers of the company or its assets. For the past several months, CombiMatrix has had discussions with parties about a sale of the company or assets of the company. The Board of Directors has determined that the company should now focus exclusively on building and growing the diagnostics services business. One component of that endeavor is the recruitment and hiring of a commercially focused executive who will replace outgoing CEO Dr. Amit Kumar.
CryoLife, Inc. (NYSE:CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today that its Board of Directors has authorized the purchase of up to $15 million of its common stock over the course of the next two years.
Dehaier Medical Systems Ltd. (Nasdaq:DHRM), an emerging leader in the development, assembly, marketing and sale of medical products in China, said today that it has become the exclusive distributor in North China of a sophisticated anesthesia product manufactured by Penlon, a UK firm specializing in anesthesia and breathing equipment for 60 years.
DexCom, Inc. (NASDAQ:DXCM) shares dropped nearly 7% today after the company announced that it has received a warning letter from the U.S. Food & Drug Administration resulting from an inspection of DexCom’s facility in San Diego, CA by the Los Angeles District Office earlier this year. The warning letter cites a deviation related to MDR reporting for complaints involving sensor wire fractures underneath a patient’s skin and recommends some specific changes to the company’s warning and precaution statements in its product labeling.
GE Healthcare, a unit of General Electric Company (NYSE:GE), today announced that the US Food and Drug Administration has approved Cysview for the detection of non-muscle-invasive papillary cancer of the bladder in patients with known or suspected bladder cancer. Cysview is an optical imaging agent indicated for use in the cystoscopic detection of non-muscle-invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy.
Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has been awarded two new patents in Japan and Ukraine..
Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) shot up today after the company announced that it has received approval from the Belgian Federal Agency for Medicines and Health Products (FAMHP) to conduct its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. This is the same trial that was agreed to by U.S. Food and Drug Administration under the Special Protocol Assessment process and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).
"Obtaining approval to conduct this trial in Belgium will allow us to expand European enrollment in the study and to access leading head and neck specialists," said Dr. Brad Thompson, President and CEO of Oncolytics. "We expect to add Belgian centers over the next quarter as they become available for inclusion in the study." The decision to pursue a Phase 3 trial in head and neck cancers was predicated on positive results seen in the Company's U.K. Phase 1 and Phase 2 combination REOLYSIN and paclitaxel/carboplatin clinical trials, as well as significant preclinical work demonstrating synergy in combination with taxane or platinum-based drugs.
Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) today announced the initiation of a Phase 1 study of ONX 0912, an oral proteasome inhibitor, in patients with advanced refractory or recurrent solid tumors.
"Based on insights gained from our ongoing carfilzomib development program and ONX 0912's favorable preclinical profile – anti-tumor activity, safety and biodistribution – we believe ONX 0912 may have the potential to expand the use of proteasome inhibitors in the treatment of cancer," said Ted W. Love, M.D., Executive Vice President and Head of Research and Development at Onyx Pharmaceuticals. "As an orally-dosed agent, ONX 0912 is designed to provide prolonged proteasome inhibition and easy combinability with other orally available therapies."
Orexigen Therapeutics, Inc. (Nasdaq:OREX), a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for Contrave, its investigational drug for the treatment of obesity. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research clinical program, which included over 4,500 patients.
"We are pleased the FDA has accepted our NDA for filing and look forward to working with the Agency during the review process," said Michael Narachi, President and CEO of Orexigen. "If approved, we believe Contrave will become an important therapeutic option for obese patients, making weight loss and weight maintenance an achievable cornerstone in the treatment of obesity and its common co-morbidities."
Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced the promotion of three members of senior management, effective immediately. Raul R. Rodriguez has been named president in addition to his position of chief operating officer; Dolly Vance assumes the title general counsel and executive vice president of Corporate Affairs; and Ryan Maynard is executive vice president and chief financial officer. Each of them has been a member of the Rigel team for approximately 10 years, and has served as a member of senior management throughout the company's clinical growth stage.
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that it has commercially launched Gianvi (Drospirenone and Ethinyl Estradiol) Tablets, the Company's generic version of Bayer's Yaz Tablets. Total sales of Yaz Tablets were approximately $782 million in the United States, for the twelve months that ended December 31, 2009, based on IMS sales data.
As the first company to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
Abraxis BioScience, Inc. (NASDAQ:ABII) announced today that findings from a phase 1 randomized trial demonstrated that the nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension) is well-tolerated and active in the second-line treatment of high-grade, non-muscle-invasive bladder cancer that has been refractory to standard intra-bladder infusion (intravesical) therapy.
Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that data on FOLOTYN® (pralatrexate injection) will be presented at two upcoming medical conferences: the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO), which will be held June 4-8 in Chicago, Illinois, and at the 15th Congress of the European Hematology Association (EHA), which will be held June 10-13 in Barcelona, Spain.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today the publication of new research findings in the journal Proceedings of the National Academy of Sciences (PNAS) by Alnylam scientists and collaborators from Mount Sinai School of Medicine.
Array BioPharma Inc. (Nasdaq: ARRY) today announced that its Chief Executive Officer, Robert E. Conway, will speak at the Jefferies 2010 Global Life Sciences Conference in New York City.
AstraZeneca (NYSE:AZN) announced today it has received the 2010 EcoLeadership Award by the Alliance for Workplace Excellence (AWE) for the second consecutive year.
Auxilium Pharmaceuticals, Inc. (NASDAQ:AUXL) today announced that executive management will participate in the Goldman Sachs 31st Annual Global Healthcare Conference to be held June 14 - June 17, 2010 at The Century Plaza Hyatt Regency in Los Angeles, CA
AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR) today announced that the Company will present at the Jefferies & Company, Inc. 2010 Global Life Sciences Conference on Tuesday, June 8th at 2:00 p.m. Eastern time (11:00 a.m. Pacific time) in New York.
Baxter International Inc. (NYSE:BAX) announced today two executive changes. Robert M. Davis, has been appointed corporate vice president and president of Baxter's Renal business, filling a role vacated by Bruce H. McGillivray, who is retiring after 30 years of service to the company.
Bruker Corporation (NASDAQ: BRKR) announced today that it will present at the Jefferies 2010 Global Life Sciences Conference on Friday, June 11th, 2010, at 9:30a.m. Eastern Daylight Time at the Grand Hyatt in New York. Bill Knight, COO and Brian Monahan, CFO, will present on behalf of the company.
CANTEL MEDICAL CORP. (NYSE:CMN) announced today that Andrew A. Krakauer, President & CEO, will be presenting at the Needham & Company, LLC 9th Annual Healthcare Conference. The formal presentation is scheduled for 10:00 AM ET on Thursday, June 10, 2010 at The New York Palace Hotel in New York City, with a Q & A session immediately following the presentation.
CTD Holdings, Inc. (OTCBB: CTDH) (FRANKFURT: CDJ) today confirmed that CTD's, Trappsol® Cyclo™, has been awarded orphan drug status for the treatment of Niemann Pick Type C (NPC) disease by the U.S. FDA in a letter received by Dr. Caroline Hastings of the Children's Hospital Oakland Research Institute (CHORI).
Covidien (NYSE: COV), a leading global provider of healthcare products, announced that it will hold a conference call and webcast for investors on Tuesday, June 1, 2010, at 8:00AM ET. Today the company announced that it is buying medical device maker ev3 for $2.6 billion in cash.
Dehaier Medical Systems Ltd. (Nasdaq: DHRM), an emerging leader in the development, assembly, marketing and sale of medical products in China, said today that it has become the exclusive distributor in North China of a sophisticated anesthesia product manufactured by Penlon, a UK firm specializing in anesthesia and breathing equipment for 60 years.
Dendreon Corporation (Nasdaq: DNDN) today announced the presentation of safety data from the integrated analysis of four randomized PROVENGE® (sipuleucel-T) clinical trials of an autologous cellular immunotherapy in prostate cancer at the 105th Annual Scientific Meeting of the American Urological Association (AUA) in San Francisco.
Elan Corporation, plc (NYSE: ELN) today announced that it will present at the Jefferies Global Life Sciences Conference on Tuesday, June 8, 2010, at 3:30 p.m. Eastern Time and 8:30 p.m. GMT.
Emerging Healthcare Solutions, Inc. (Pink Sheets:EHSI) announced today that a new breakthrough iPhone app is being developed to dramatically reduce medication errors for senior citizens.
Martek Biosciences Corporation (Nasdaq: MATK) announced today that it will be presenting at the Jefferies & Company Global Life Sciences Conference scheduled to take place June 8-11, 2010 in New York City.
David B. Snow Jr., chairman and CEO, of Medco Health Solutions, Inc. (NYSE:MHS), is scheduled to address the Sanford C. Bernstein & Co., LLC 26th Annual Strategic Decisions Conference 2010 in New York on Wednesday, June 2, 2010.
Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Australian contract research organization (CRO) Novotech has joined Medidata's ASPire to Win® channel partner program.
NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) announced today that Francois Nader, M.D., president and chief executive officer, is scheduled to present at the 9th Annual Needham Healthcare Conference in New York on Wednesday, June 9, 2010 at 10:40 a.m. ET and the Jefferies 2010 Global Life Sciences Conference in New York on Friday, June 11, 2010 at 10:00 a.m. ET.
OmniComm Systems, Inc. (OTCBB: OMCM), a global provider of eClinical solutions and services, announced today that Stephen Johnson has been promoted to president and chief operating officer.Johnson, who was most recently OmniComm's chief operating officer (COO) and executive vice president of business development, will continue to oversee operations and business development, but will take on additional executive responsibilities as well and will continue to report to chief executive officer (CEO) Cornelis F. Wit.
PharmaGap Inc. (TSX VENTURE:GAP) (OTCBB:PHRGF) today announced the appointment of Dr. Kenneth K. Sokoll, PhD., to the Company's Clinical Development Group.
Positron Corporation (OTCBB:POSC) will exhibit at the upcoming Society of Nuclear Medicine Meeting (SNM) in Salt Lake City, UT June 5th-9th to promote their cardiac optimized PET scanner, the Attrius.
Prana Biotechnology (NASDAQ: PRAN) (ASX: PBT) today announced that Professor Ashley Bush, Prana's co-founder and a member of the Company's R&D Advisory Board, will present at the 39th Annual Meeting of the American Aging Association (AGE) in Portland, Oregon on Monday, June 7th at 10:15 (PT) regarding the effects of PBT2 on Alzheimer's Disease sufferers as well as potential benefits for cognitive impaired aged individuals.
Proteonomix, Inc. (PINKSHEETS:PROT) concentrates its R & D resources on its subsidiary StromalCel, Inc. in order to developits portfolio of intellectual properties and global partnerships.
Sinovac Biotech Ltd. (Nasdaq: SVA), a leading China-based vaccine manufacturer, announced today that it has received the confirmation from the China International Tendering Company that Sinovac was selected by the Beijing Centers for Diseases Control and Prevention (Beijing CDC) to supply the Company's hepatitis A vaccine, Healive, to the Beijing Expanded Program of Immunization (EPI).
Targeted Genetics Corporation (Pink Sheets:TGEN) announced that its partner, Celladon Corporation, presented full data today that show the first Phase II trial with MYDICAR® for the treatment of advanced heart failure has met its primary safety and efficacy endpoints, as prospectively defined in the Phase II trial protocol.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) will host a live audio webcast at the UBS Global Specialty Pharmaceuticals Conference with Eyal Desheh, Teva's Chief Financial Officer, presenting on Wednesday, June 2, 2010 in London.
The Independent Committee of the Board of Directors of Tongjitang Chinese Medicines Company (NYSE:TCM), comprised of the Company's three independent directors, Dr. Harry K. Genant, Mr. David R. White and Mr. Yongcun Chen, announced today that Morgan Stanley Asia Limited has been appointed as its independent financial advisor.
Universal American Corp. (NYSE: UAM) and the National Association of Rural Health Clinics announced today a multi-year agreement to deliver quality health care to Medicare beneficiaries who live in rural communities.
Watson Pharmaceuticals, Inc. (NYSE:WPI) today confirmed that Columbia Laboratories, Inc. has filed with the Securities and Exchange Commission a definitive proxy seeking Columbia shareholder approval of the previously announced agreement under which Watson would acquire the U.S. rights to Columbia's CRINONE® and PROCHIEVE® product line and 11,200,000 shares of Columbia common stock.
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