Below is a list of the companies that made news in the healthcare sector on Wednesday, August 11, 2010.
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.
Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced the US Patent and Trademark office has issued U.S. Patent No. 7,759,360 for Androxal, the Company’s lead program for the treatment of low testosterone in men. This patent specifically claims methods and materials for the treatment of testosterone deficiency in men with secondary hypogonadism. Repros has over 35 issued or pending US and European patents involving Androxal. The term of the patent will expire on March 19, 2023. If a Patent Term Extension under the Hatch-Waxman Act is granted, patent life in the US could extend into 2028.
"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.
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.
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) announced executive management will participate in the Bank of AmericaMerrill Lynch Specialty Pharmaceuticals Conference to be held August 12-13, 2010 at The Southampton Inn, Southampton, NY.
BIOLASE Technology, Inc. (NASDAQ: BLT), the world's leading dental laser company, announced today that Chairman and Chief Executive Officer David M. Mulder is scheduled to make an investor presentation at the 2010 Southern California Investor Conference on Tuesday, August 17, at 8:00 am Pacific Time.
Bristol-Myers Squibb Company (NYSE: BMY) and the ADAP Crisis Task Force (ACTF) today announced an enhanced agreement to support the efforts of AIDS Drug Assistance Programs (ADAPs) to provide antiretroviral medicines to people living with HIV and AIDS.
Crucell N.V. (NYSE Euronext, NASDAQ: CRXL) today announced that it will release its financial results for the second quarter 2010 on Tuesday August 17, 2010 at 07:45 AM Central European Time (CET).
Dehaier Medical Systems Ltd. (Nasdaq:DHRM), an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products in China, announced today that it is participating in the International FIME 2010 Show for medical manufacturers.
Elan Corporation, plc ("Elan") (NYSE: ELN) today announced the pricing of the offering of US$200 million aggregate principal amount of 8.75% senior notes due 2016 ("Note") by its wholly-owned subsidiaries, Elan Finance public limited company and Elan Finance Corp.
Fibrocell Science, Inc. (OTC Bulletin Board:FCSC), a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today that David Pernock, Chairman and Chief Executive Officer, will present at the 2010 Global Hunter Securities Healthcare Conference at the Southern California Investor Conference on August 17, 2010 at 5:30 p.m. EDT (2:30 p.m. PDT).
Genoptix, Inc. (Nasdaq: GXDX), a specialized laboratory services provider, today announced the Company's participation at the Southern California Investor Conference to be held August 17, 2010 at The Island Hotel, Newport Beach, CA.
GeoVax Labs, Inc. (OTC Bulletin Board:GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, announces that Chief Executive Officer Dr. Robert McNally and Chief Financial Officer Mark Reynolds will be presenting at the 2010 Southern California Investor Conference on Tuesday, August 17.
Gushan Environmental Energy Limited (NYSE:GU) announces that it will submit its unaudited second quarter 2010 financial results on Form 6-K to the U.S. Securities and Exchange Commission on Wednesday, August 18, 2010, to be followed by a conference call on the same day at 8:30 a.m. Eastern Daylight Time (or 8:30 p.m. Hong Kong Time) to discuss financial results for its second quarter ended June 30, 2010.
Imaging3, Inc. (OTCBB: IMGG), developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, announced today that on Thursday August 12, 2010 at 1:00pm PST, (4:00pm EST) the company's CEO, Mr. Dean Janes, will be hosting a conference call.
MannKind Corporation (Nasdaq: MNKD) today announced that it has entered into an agreement with Seaside 88, LP, a private investment limited partnership, for the sale of 700,000 shares of common stock to Seaside 88 every two weeks over the course of a year for a total of up to 18,200,000 shares of MannKind common stock.
NeoStem, Inc. (NYSE Amex:NBS) an international biopharmaceutical company with operations in the U.S. and China, announced today that it has entered into a sponsored research agreement (SRA) with the Schepens Eye Research Institute, a charitable corporation of Massachusetts and an affiliate of Harvard Medical School.
NexMed, Inc. (Nasdaq: NEXM), backed by a revenue generating CRO business and seeking to leverage its proprietary, multi-route NexACT® drug delivery technology and int rnal pipeline through out-licensing arrangements and partnerships, announced today that management will hold a conference call to discuss 2010 second quarter financial results and ongoing corporate activities, on Friday, August 13, 2010 at 12:00 p.m. ET.
PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB:PHRGF) today announced its intention to issue up to 16,666,667 equity units, at a price per Unit of eighteen cents ($0.18) (the "Offering") for total proceeds of up to three million dollars ($3,000,000).
PetroAlgae Inc. (OTCBB: PALG) today announced that it has filed a registration statement on Form S-1 with the Securities and Exchange Commission (SEC) relating to its proposed public offering of its common stock.
OXIS INTERNATIONAL, INC. (OTC Bulletin Board: OXIS, Paris: OXI) announced today the addition of Dr. Stephen Coles as the newest member to its Scientific Advisory Board.
RXi Pharmaceuticals Corporation (Nasdaq: RXII), a recognized leader in RNAi-based therapeutic discovery and development, today reported its financial results for the second quarter ended June 30, 2010.
SeraCare Life Sciences, Inc. (NASDAQ: SRLS), a global life sciences company providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics, today reported operational and financial results for its third quarter of fiscal year 2010, ended June 30, 2010.
Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in on cology, today reported that an overview of the Company's business strategy will be given at the 2010 Southern California Investor Conference, being held at the Island Hotel in Newport Beach, California.
Stellar Pharmaceuticals Inc. (OTCBB:SLXCF) ("Stellar" or "the Company"), a Canadian pharmaceutical developer and marketer of high quality, cost-effective products for select health care markets, today announced that its President and Chief Executive Officer, Peter Riehl, is scheduled to present an update of the Company's business at the upcoming 2010 Southern California Investor Conference sponsored by Global Hunter Securities.
Temasek Life Science Ventures Pte Ltd (TLV) and Emergent BioSolutions Inc. (NYSE:EBS) today announced their agreement to form EPIC BIO Pte Ltd, a join venture to develop, manufacture, and commercialize a multivalent, cross-protective human vaccine to protect against influenza caused by a broad range of circulating H5 influenza strains.
Tengion Inc. (Nasdaq:TNGN) today provided a corporate and product development update and reported its financial results for the quarter ended June 30, 2010.
Tongjitang Chinese Medicines Company (NYSE:TCM), a leading specialty pharmaceutical company focusing on the development, manufacturing, marketing and selling of modernized traditional Chinese medicine in China, today announced that it plans to release its second quarter 2010 financial results after market close on Wednesday, August 18, 2010.
Transdel Pharmaceuticals, Inc. (OTC Bulletin Board:TDLP) is a specialty pharmaceutical company developing non-invasive, topically delivered products. The Company's innovative-patented Transdel™ cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier.
Urigen Pharmaceuticals, Inc. (OTCQB: URGP), a specialty pharmaceutical company focused on the development of treatments for urological disorders and pain, announced it has formally requested a Phase II Type C discussion with the FDA for its URG101 program for Painful Bladder Syndrome/Interstitial Cystitis.
Valeant Pharmaceuticals International (NYSE: VRX) and Biovail Corporation (NYSE/TSX: BVF) today announced that both companies will hold th ir respective special meetings of shareholders on September 27, 2010 for the purpose of considering and voting upon proposals relating to the companies' previously announced merger.
Wound Management Technologies, Inc. (OTC Bulletin Board:WNDM) is pleased to announce the sales expansion of its advanced wound care collagen product, CellerateRX, into South Africa.
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