|Alkermes Announces Results from Phase 2 Study of ALKS 37; Pronova Wins Heart-Drug Patent Case Against Teva, Par Pharma|
|By Staff and Wire Reports|
|Wednesday, 30 May 2012 19:59|
Alkermes plc (NASDAQ: ALKS) announced topline results from a Phase 2b dose-ranging clinical study of ALKS 37 in the treatment of opioid-induced constipation. The multicenter, randomized, double-blind, placebo-controlled, repeat-dose study was designed to assess the safety, tolerability, pharmacokinetic profile and efficacy of ALKS 37 in approximately 150 patients. ALKS 37 was generally well tolerated at all dose levels, and while subjects taking ALKS 37 demonstrated an increase in bowel movements compared to baseline, the product profile did not satisfy our pre-specified criteria for advancing into Phase 3 clinical trials. Based on this evaluation, Alkermes (ALKS) has decided not to advance ALKS 37 and will consider out-licensing opportunities.
We had predetermined the product profile we needed to observe in order to continue to advance ALKS 37 into Phase 3 clinical studies. Based on the results of this study, we will focus our future clinical development efforts on our other development programs, including ALKS 9070 for schizophrenia and ALKS 5461 for major depressive disorder, said Dr. Elliot Ehrich, Chief Medical Officer of Alkermes. We will continue to maintain a disciplined approach to R&D and focus our resources on clinical candidates that show the most promise.
A second Phase 2b study of ALKS 37 for the treatment of opioid-induced constipation is concluding, and no additional clinical studies for ALKS 37 are planned.
A Delaware court has ruled in favor of Pronova BioPharma ASA (PRON.OS, PVNAY), upholding two patents for its heart drug Lovaza against Par Pharmaceutical Cos. (NYSE:PRX) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA).
The ruling means Par Pharmaceutical and Teva can't sell generic versions of Lovaza, which lowers very high levels of triglycerides in the bloodstream, at this time. Lovaza is derived from Omega-3 fatty acids.
Shares of Par Pharmaceutical tumbled 7.8% to close at $37.70, while Teva's stock ended off 1.3% at $38.10. Pronova BioPharma's American depositary shares closed 6.3% higher at $5.31.
"Great news for us," said Hamed Brodersen, Pronova's vice president of investor relations.
Shares of Amarin Corp. (NASDAQ:AMRN) jumped 6.2% to $12.27. The ruling is good news from a pricing standpoint for the specialty pharmaceutical company as it has its own fatty acid-derived drug currently in development.
In 2009, Pronova alleged patent infringement against Par Pharmaceutical and Teva after they both filed abbreviated new drug applications with the U.S. Food and Drug Administration to bring generic versions of Lovaza to the market to treat very high triglyceride levels. The cases were consolidated.
The U.S. District Court for the District of Delaware ruled in favor of Pronova BioPharma, saying the company met its burden to prove infringement of two patents.
Generic drug maker Apotex Inc. was part of the lawsuit, but it reached a settlement agreement in March 2011. The settlement granted Apotex a license to enter the U.S. market with a generic version of Lovaza in the first quarter of 2015, or earlier depending on certain circumstances.
GlaxoSmithKline PLC (NYSE:GSK) has the marketing rights for the fish-oil-derived treatment in the U.S. In 2011, end-user sales were nearly $950 million for Lovaza in the U.S., according to Pronova, up 7% from the year prior.
Lovaza is the first Omega-3 fatty acid-derived prescription drug approved by the European Union and the FDA.
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, announced today that it has obtained commitments from certain non-affiliated and affiliated institutional investors to purchase approximately $10.0 million of its common stock in a private placement.
Acorda Therapeutics, Inc. (Nasdaq: ACOR), makers of Ampyra® (dalfampridine), today announced the launch of Ampyra Dialogues, the first-ever online talk show where patients and medical experts talk about how walking problems affect people living with MS.
Alkermes plc (NASDAQ: ALKS) today announced topline results from a phase 2b dose-ranging clinical study of ALKS 37 in the treatment of opioid-induced constipation.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today top-line results from a Phase IIb trial with ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection in lung transplant patients.
AmbiCom Holdings, Inc. (OTCBB: ABHI), a leading designer and developer of wireless products for the medical industry and a distributor of innovative healthcare products, today announced that it has received a $1.3 million order from one of its major medical device customers, for AmbiCom WiFi cards to be used in the manufacture of this healthcare company's hospital grade glucose meters.
Anavex Life Sciences Corp. (OTCBB: AVXL) today commented on President Obama's National Alzheimer's Plan, which was unveiled earlier this month.
AptarGroup, Inc. (NYSE: ATR) today announced it has signed an agreement to acquire the Stelmi Group (“Stelmi”), a maker of elastomer primary packaging components for injectable drug delivery.
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that executive management will participate in the Jefferies 2012 Global Healthcare Conference to be held June 4-7, 2012 at the Grand Hyatt in New York City.
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that executive management will participate in the Goldman Sachs Global Healthcare Conference 2012 to be held June 5-7, 2012 at Terranea in Rancho Palos Verdes, CA.
AVEO Oncology (Nasdaq: AVEO) today announced that the AVEO management team will host a conference call on Monday, June 4, 2012 at 7:30 a.m. (CT) to review the Phase 3 TIVO-1 data that will be presented at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO).
Baxter International Inc. (NYSE: BAX) announced today that it will present at the William Blair & Company 32nd Annual Growth Stock Conference on Thursday, June 14, 2012, at 8:40 a.m. CT.
BioTime, Inc. (NYSE MKT: BTX) announced that its Chief Executive Officer, Michael D. West, Ph.D., will provide a corporate update at the Jefferies 2012 Global Healthcare Conference in New York City on Monday, June 4, 2012 at 3:30 p.m. ET.
Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers, announced that its recent research has shown that its flagship anticancer compound Kevetrin™ has potent anticancer activity in malignant glioma (brain tumor).
Dyax Corp. (NASDAQ: DYAX) announced today, based on successful antibody discovery work during a research evaluation period, Bayer Pharma AG (Bayer) has executed a license to Dyax’s antibody phage display technology for development and potential commercialization of therapeutic antibody candidates identified using the Dyax library.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, is scheduled to present at the Goldman Sachs 33rd Annual Global Healthcare Conference at Terranea in Rancho Palos Verdes, California on Wednesday, June 6, 2012.
Exact Sciences Corp. (Nasdaq: EXAS) today announced that it will present at two investor conferences during June.
Exelixis, Inc. (NASDAQ: EXEL) today announced that it has completed the filing of its rolling New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC).
Exelixis, Inc. (NASDAQ:EXEL) today announced the initiation of COMET-1, a phase 3 pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC).
Forest Laboratories, Inc. (NYSE: FRX) today issued the following statement in response to a Form 13D filing with the Securities and Exchange Commission (SEC) by High River Limited Partnership and other entities affiliated with Carl C. Icahn, stating an intention to nominate a minority slate of candidates, including Dr. Eric Ende, for election to Forest’s Board of Directors at the Company’s 2012 Annual Meeting.
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), today marked World MS Day with activities across its global network and new programs designed to mobilize and inspire people living with multiple sclerosis.
Illumina, Inc. (NASDAQ:ILMN) today announced that it will webcast the company's presentations at two upcoming investment conferences.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will be presenting at the Jefferies 2012 Global Healthcare Conference on June 6, 2012, at 3:00 p.m. ET in New York City.
Life Technologies Corporation (NASDAQ: LIFE) and OpGen, Inc., a commercial stage whole genome analysis company, today announced that they have signed a collaboration agreement to develop systems, technologies and applications intended to improve the management and surveillance of microbial outbreaks in the public health and infectious disease markets.
Luminex Corporation (NASDAQ: LMNX) today announced that management will present at the Jefferies 2012 Global Healthcare Conference to be held June 4-7 in New York.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Kenneth C. Frazier, Merck's chairman and chief executive officer is scheduled to present at the Sanford C. Bernstein 28th Strategic Decisions Conference in New York City on May 31 at 8:00 a.m. EDT.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on the development and commercialization of precision diagnostics and radiopharmaceutical agents, today announced that Dr. Thomas Tulip, Executive Vice President and Chief Business Officer, will participate at the Jeffries 2012 Global Healthcare Conference on June 4-7 at the Grand Hyatt in New York City.
Nektar Therapeutics' (Nasdaq: NKTR) President and Chief Executive Officer, Howard W. Robin, is scheduled to present at the Jefferies 2012 Global Healthcare Conference at The Grand Hyatt New York on Tuesday, June 5, 2012 at 11:30 a.m. Eastern Time.
PerkinElmer, Inc. (NYSE: PKI), a global leader focused on improving the health and safety of people and the environment, today announced that the Company will present at the Goldman Sachs Global Healthcare Conference on Tuesday, June 5, 2012, at 9:20 am Pacific Time at Terranea in Rancho Palos Verdes, California.
PROLOR Biotech, Inc. (NYSE MKT: PBTH), a clinical stage company developing next generation biobetter therapeutic proteins, today announced that company management will give a corporate presentation at the Jefferies 2012 Global Health Care Conference, being held at the Grand Hyatt Hotel in New York City.
Puma Biotechnology, Inc. (OTCBB: PBYI), a development stage biopharmaceutical company, announced that Alan H. Auerbach, its Chairman, Chief Executive Officer, President and Founder, will present an overview of the Company at 9:30 a.m. EDT on Wednesday, June 6, at the Jefferies 2012 Global Healthcare Conference.
Repligen Corporation (NASDAQ:RGEN) today announced that Walter C. Herlihy, Ph.D., President and Chief Executive Officer, will present a corporate update at the Jefferies 2012 Global Healthcare Conference in New York.
Response Genetics, Inc. (NASDAQ:RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer, announced today four presentations to be held during the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL from June 1 to June 5, 2012.
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced the publication of a research article in Journal of Medicinal Chemistry [55: 4521-4525, 2012] on the anti-tumor activity of its RX-3117 compound.
Stiefel, a GSK (NYSE: GSK) company, and Welichem Biotech, Inc. (WBI:CN), have entered into an agreement for the acquisition by Stiefel of exclusive development and commercialization rights to the novel anti-inflammatory agent, WBI-1001, in all territories outside of China, Taiwan, Macao and Hong Kong.
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) announced today that the International Court of Arbitration, International Chamber of Commerce (ICC), has notified the Company of a change in the anticipated date of the arbitration decision related to its demand for arbitration under the applicable provisions of the Collaboration and License Agreement with Takeda Pharmaceuticals Company Limited, or Takeda.
Synageva BioPharma Corp. (NASDAQ:GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, will present at the Jefferies 2012 Global Health Care Conference being held in New York City.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that the Company will be presenting at the Jefferies 2012 Global Healthcare Conference on Wednesday, June 6 at 4:30 p.m. (ET) in New York.
Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, announced today that Louis P. Scafuri, Chief Executive Officer, and Asaf Alperovitz, Chief Financial Officer, are scheduled to participate at two upcoming investor conferences.
Teleflex Incorporated (NYSE:TFX) announced today the Arrow FlexTip Plus Closed Tip, Multi-Port epidural catheter has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) will host a live audio webcast at the Sanford C. Bernstein Twenty-Eighth Annual Strategic Decisions Conference in New York.
TheraBiogen, Inc. (OTCBB: TRAB), a manufacturer and distributor of homeopathic nasal sprays for aiding in the relief of allergies, cold and flu symptoms and migraine headaches, announced today that Dean Blechman, founding family member and former Executive Vice President of Sales at TWINLAB Corporation, agreed to become a consultant to the Company and assist the Company primarily in Sales & Marketing.
Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced that Dr. Barry Selick, Chief Executive Officer of Threshold, is scheduled to present at the Jefferies 2012 Global Healthcare Conference on Wednesday, June 6, at 4:30 p.m. Eastern time in New York City.
Dr. Phillip Frost, Chairman of the Board of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), and Dr. Jeremy Levin, the Company’s President and CEO, along with a group of employees representing Teva’s businesses around the world, rang the Opening Bell at the New York Stock Exchange to celebrate the Company’s transfer to the NYSE.
Tikcro Technologies Ltd. (OTC PK: TIKRF) today reported results for the first quarter ended March 31, 2012.
Walgreens (NYSE: WAG) (NASDAQ: WAG) subsidiary Take Care Health Systems and The Valley Health System today announced a new relationship that will facilitate greater clinical coordination and enhance access to high-quality, convenient and affordable health care options available at Take Care Clinics in Southern Nevada.