Cardiome Pharma falls on clinical program delay. Repros awarded key patent |
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By BioMedReports.com Staff |
Wednesday, 11 August 2010 18:46 |
![]() Cardiome Pharma Corp. (NASDAQ: CRME/TSX: COM) announced today that, based on recent discussions with its development partner Merck (NYSE: MRK), the next phase of the clinical program for vernakalant (oral) is not expected to commence in the summer of 2010 as previously guided. Merck continues to work toward optimizing the clinical development plan for vernakalant (oral), and Cardiome will provide updated guidance when Merck has finalized their planning. The company also reported weaker than expected 2nd quarter results with revenue of $12.4 million being lower than analyst expectations of $16.4 million. Shares of Cardiome fell more than 13% or $1.17, ending Wednesdays trading session at $7.73. "We are pleased to strengthen our intellectual property portfolio and expect additional patent grants surrounding Androxal," stated Joseph Podolski, President and Chief Executive Officer of Repros Therapeutics. "This patent is important to the protection of our Androxal program. If Repros can successfully develop Androxal, it could become a leading treatment for low testosterone in men." Androxal is an oral therapy that restores testicular function in men experiencing low testosterone due to secondary hypogonadism. Secondary hypogonadism is a condition commonly related to aging but may result or be a co morbid state associated with a variety of conditions, including Type II diabetes. Secondary hypogonadism is not a failure of the testes, but an inability of the pituitary to respond to a low testosterone state by secreting sufficient levels of luteinizing hormone (LH) to adequately stimulate the testes. Androxal stimulates the pituitary to secret normal levels of important testicular stimulating pituitary hormones. Shares of Repros rose 9.26% on nearly triple the average daily volume. Advaxis, Inc (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company and Vibalogics GmbH, a German biologics manufacturing company, have agreed to co-develop a room temperature stable, processing technology for live vaccines originally engineered for Advaxis. Most live vaccines are stored via freeze drying called lyophilization. This drying method may not be suitable for all products, as it frequently kills most of the microorganism; depending upon the organism type and related recovery and stability issues. Based on Vibalogics’ drying experience, a new method has been found that allows for a room temperature, storage-stable form of Advaxis’ live Listeria vaccines with a very high recovery. "This process, which we are currently developing for our Listeria immunotherapeutics, shows promise in its use with other living micro-organisms," commented Advaxis Chairman/CEO Thomas A. Moore. "Although it is intended for use with Listeria, other companies and academic institutions that use living microorganisms (e.g., Salmonella, E. coli) may benefit from this process. This initiative does not require significant development funds from Advaxis, vastly increases the commercial properties of our products, and can increase our short- and long-term shareholder value." Shares of Advaxis rose more than 18% on the news. Amgen (Nasdaq:AMGN) today announced top-line results from a randomized Phase 3 trial evaluating Vectibix (panitumumab) as a first-line treatment in patients with recurrent and/or metastatic squamous cell head and neck cancer. The data showed the addition of Vectibix to platinum-based chemotherapy did not result in a statistically significant improvement in overall survival, the primary endpoint, compared to chemotherapy alone. Therefore, the study did not meet its primary endpoint. Secondary endpoints of progression-free survival [median 5.8 months versus 4.6 months], and objective response rate (36 percent versus 25 percent) were numerically improved but were not tested for statistical significance. "The outcome of this study is disappointing. However, Vectibix remains an important monotherapy treatment option for patients with metastatic colorectal cancer whose disease has progressed on other therapies," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. CardioNet, Inc. (NASDAQ:BEAT), a leading wireless medical technology company with a current focus on the diagnosis and monitoring of cardiac arrhythmias, announced today that on August 10, 2010, the United States District Court for the Eastern District of Pennsylvania granted the Company’s motion to dismiss the securities class action litigation filed in August 2009 against the Company and certain of its former officers. Joe Capper, President and Chief Executive Officer, stated, "We are pleased with the Court’s ruling and believe that the facts in the case clearly supported the Company’s position." Depomed, Inc. (Nasdaq:DEPO) announced today that it has reached agreement with the U.S. Food and Drug Administration regarding a Special Protocol Assessment (SPA) on the design and analysis of Breeze 3, a Phase 3 trial evaluating Serada for menopausal hot flashes. Depomed is initiating Breeze 3 immediately as clinical sites are all on line with more than 200 patients in the screening process already. Breeze 3 is expected to be completed by the end of the third quarter of 2011, with results to be reported in the fourth quarter. "We believe that Breeze 3 will be successful based on the new refined trial design which is expected to accurately measure Serada's drug effect, and result in a placebo effect between 45% to 55%, as seen in other published hot flash trials," said Michael Sweeney, M.D., Depomed's vice president, Research and Development. Carl A. Pelzel, president and chief executive officer of Depomed, added, "We are pleased to reach an SPA agreement with the FDA, and advance this important product candidate closer to commercialization." Ramius Value and Opportunity Advisors LLC, a subsidiary of Ramius LLC today announced that it delivered a letter to the Board of Directors of Cypress Bioscience, Inc. (Nasdaq:CYPB). In the letter, Ramius reiterated its offer to acquire the Company for $4.00 per share in cash plus a potential 50% interest in BL-1020 for total implied consideration of $4.39 per share. Ramius clarified the terms of its acquisition proposal and expressed a willingness to consider raising the value of its acquisition proposal in the event that Ramius is granted limited due diligence and the Company agrees to negotiate in good faith around consummating a transaction. Intellect Neurosciences, Inc. (OTCBB:ILNS), a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced today that its Chairman & CEO, Dr. Daniel Chain, was granted a patent by the European Patent and Trademark Office related to the use of insulin sensitizers for the prevention and treatment of memory loss and dementia. Insulin sensitizer drugs include Rosiglitazone and Pioglitazone, which have been approved for the treatment of type II diabetes mellitus. Dr. Chain is co-inventor of the patent with Professor Mike Cawthorne, Director of Metabolic Research, Clore Laboratory at The University of Buckingham and leader of the research team that originally discovered Rosiglitazone as a diabetes treatment. Dr. Chain applied for this patent prior to founding Intellect in 2005. Intellect Neurosciences holds an option to acquire the patent from its current owners. This patent is the second European patent awarded to Dr. Chain. Previously, he was granted a patent for Intellect's ANTISENILIN platform for the treatment and prevention of Alzheimer's disease (AD). The ANTISENILIN platform is the underlying technology of the Company's preclinical IN-N01 humanized monoclonal antibody, and of Ponezumab, which is in Phase 2 clinical trials, and Bapineuzumab, which is in Phase 3 clinical trials, both of which are being developed by global pharmaceutical companies. Radient Pharmaceuticals Corporation (RPC) (AMEX:RPC) announced today it will present its Onko-Sure in vitro diagnostic (IVD) cancer test to distribution partners at the annual Vietnam International Medical, Hospital and Pharmaceutical exhibition -- Vietnam Medi-Pharm Expo, held August 18-21 at the Tan Binh International Exhibition & Convention Center in Ho Chi Minh City, Vietnam. Also Wednesday: Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company and Vibalogics GmbH, a German biologics manufacturing company, have agreed to co-develop a room temperature stable, processing technology for live vaccines originally engineered for Advaxis. Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page. 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