Below is a list of the companies that made news in the healthcare sector on Tuesday, January 26, 2010.
Gilead Sciences (Nasdaq:GILD) saw its shares jump after hours on Tuesday as the company reported that its fourth-quarter net income rose to $802.2 million from $560 million in the same quarter a year earlier. The company earned 87 cents a share which was up from 59 cents a share a year ago. Excluding various items Gilead would have earned 93 cents a share.The Foster City CA-based bio-tech company reported $2.03 billion in revenue, up 42 percent from $1.43 billion in the same quarter of 2008.. Analysts surveyed by FactSet had forecast Gilead to report earnings of 82 cents a share on revenue of $1.92 billion. Shares were trading up more than 6% in the after-hours market.
In other news Wednesday:
AmerisourceBergen Corporation (NYSE:ABC) today reported that in its fiscal year 2010 first quarter, ended December 31, 2009, diluted earnings per share were $0.52, a 44 percent increase.
Array BioPharma Inc. (NASDAQ: ARRY) today announced that Bengt Bergstrom, M.D., has joined the Company as Vice President of Clinical Development.
AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR) today announced that it will release unaudited fiscal first quarter financial results for the three months ended December 31, 2009 before market open on Tuesday, February 2, 2010.
Bark Group Inc. (OTCBB: BKPG), an award-winning U.S. company with a multinational client base, announced today that Actavis Denmark has chosen Bark Copenhagen, the Company's primary subsidiary, to develop a communications strategy and creative platform for Actavis's product Lactoghurt.
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that its partner, Shionogi & Co., Ltd. will launch RAPIACTA, intravenous (i.v.) peramivir anti-viral, to treat patients with influenza in Japan, on January 27, 2010.
BrainStorm Cell Therapeutics Inc.(OTCBB:BCLI), a leading developer of adult stem cell technologies and therapeutics, is pleased to announce that it received a visit today by the Israeli Minister of Industry, Trade and Labor, Mr. Binyamin Ben-Eliezer and the Israeli Chief Scientist, Dr. Eli Opper.
BSD Medical Corporation (NASDAQ:BSDM) today reported the sale of two BSD-2000 hyperthermia systems to Dalian Orientech Co. LTD, the Company’s exclusive Chinese distributor. The BSD-2000 system non-invasively delivers localized therapeutic heating (hyperthermia) by applying radiofrequency (NYSE:RF) energy to certain cancerous tumors, including those located deep within the body. Clinical studies have shown that hyperthermia treatment can kill cancer cells directly as well as increase the effectiveness of other cancer therapies, including radiation therapy and chemotherapy, for the treatment of certain tumors.
Cardium Therapeutics (Amex:CXM) announced today that its Cardium Biologics division provided an update on plans for the continuing commercial development of Generx™ (alferminogene tadenovec, Ad5FGF-4), a DNA-based angiogenic therapy product candidate for patients with coronary artery disease. The update was presented by Gabor M. Rubanyi, M.D., Ph.D., Cardium's Chief Scientific Officer at the annual 2010 Cell & Gene Therapy Forum in Washington, D.C. on January 25, 2010.
CareFusion (NYSE:CFN), a leading, global medical device company, today announced a distribution agreement with Minimally Invasive Devices, Inc., a venture-backed Ohio medical device company, to sell and market the FloShield™ product line for laparoscopic surgeries.
CVS Caremark Corporation (NYSE:CVS) will be holding a conference call on Monday, February 8, 2010, at 8:30 a.m. (EST) with analysts and investors to discuss its fourth quarter 2009 financial results.
Cytori Therapeutics (NASDAQ:CYTX) announced today that it had received U.S. Patent No. 7,651,684 (the ‘684 patent) which covers the Company’s methods for delivering adipose-derived stem and regenerative cell-enriched fat grafts into patients. The ‘684 patent specifically covers cell-enriched fat grafts to treat soft-tissue defects and urinary incontinence. In addition, the ‘684 patent covers methods for delivering cell-enriched fat grafts to a patient’s breast, wrinkles, lips, under the eyes, cheeks, chin, and other parts of the body. “Today’s announcement broadens our current expansive patent portfolio covering adipose-derived cell therapies. The patent covers many significant applications for stem and regenerative cell-enriched fat grafting, allowing us to freely develop future generation therapeutics and pursue solutions for patients with unmet medical needs in tissue damage indications, including breast reconstruction,” said Christopher J. Calhoun, CEO of Cytori Therapeutics.
Cytori is an emerging leader in regenerative medicine, providing patients and physicians around the world with medical technologies that harness the potential of adult regenerative cells from adipose tissue. Shares opened the day higher but closed the session down nearly 2%.
Dynavax Technologies Corporation (Nasdaq: DVAX) reported data today from two studies that differentiate SD-101 from standard-of-care as well as emerging treatments for chronic HCV infection. The findings of a Phase 1b clinical trial and an in vitro study of SD-101's mechanism of action show that the second-generation TLR9 agonist (1) is well tolerated and safe and (2) induces both IFN-lambda and IFN-alpha at concentrations producing antiviral activity. The data will be presented at the 45th Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria in April 2010.
Chief Medical Officer, J. Tyler Martin, M.D. said; "The unique and highly potent pattern of IFN-lambda and IFN-alpha induction by SD-101 represents a novel, differentiated approach for HCV. The safety and antiviral activity demonstrated in this Phase 1b study compares favorably to current treatments, and we believe that further study may support a role for SD-101 as a supplement to current or emerging therapies to treat HCV." Shares of Dynavax shot up nearly 9% to close the day at $1.62
EpiCept Corporation (Nasdaq and OMX Stockholm Exchange: EPCT) announced today that the Swedish AML Group which comprises the leading hematology experts in Sweden has included Ceplene® (histamine dihydrochloride) in its Guidelines entitled “National Guidelines for Diagnosis and Treatment of Acute Myeloid Leukemia in Adults.”
Geron Corporation (Nasdaq:GERN) reported today that it has entered into a jointly funded collaboration by Geron and a University of California Discovery Research and Training Grant to investigate the therapeutic potential of its human embryonic stem cell (hESC)-based product, GRNOPC1, for Alzheimer’s disease. The company is currently developing GRNOPC1 for the potential treatment of spinal cord injury.
GRNOPC1 will be evaluated in models of Alzheimer’s disease. The study is designed to assess whether memory, which is impaired in the rodent models as it is in human patients, shows recovery after transplantation of GRNOPC1. The research will be led by Professor Frank M. LaFerla, Director of the Institute for Brain Aging and Dementia at the University of California, Irvine.
“We are exploring a number of potential applications for GRNOPC1 in neurological disease in addition to spinal cord injury,” said Jane S. Lebkowski, Ph.D., Geron’s senior vice president and chief scientific officer, regenerative medicine. “There are striking parallels between recent data on mouse stem cells in Alzheimer’s disease models and what we know about GRNOPC1. We are looking forward to testing GRNOPC1 in Alzheimer’s models.”
Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced the election of Malcolm MacCoss, Ph.D., FRSC, to the Company's Board of Directors as a class II director. Dr. MacCoss has nearly 30 years of drug discovery and development experience with large international pharmaceutical companies.
McKesson Corporation (NYSE:MCK) today reported that revenues for the third quarter ended December 31, 2009 were $28.3 billion compared to $27.1 billion a year ago.
MDRNA, Inc. (NASDAQ:MRNA), a leading RNAi-based drug discovery and development company, announced today that the State Intellectual Property Office of the People's Republic of China (PRC) has issued a Notification of Granting Patent Rights for PRC 200480018784 which includes the use of nucleic acids, e.g., an siRNA, for the treatment of cancer. The patent describes modulation of claudins, which are proteins implicated in tumor progression and metastasis. "China's pharmaceutical markets are growing nearly 20% a year," said J. Michael French, President and CEO of MDRNA. "China has seen significant expansion in both the pharmaceutical and biotech sectors, which provides an ideal environment for our ongoing efforts to seek international R&D collaborations and investment opportunities. With this patent and our recent allowance of a patent covering RNAi-based modulation of JAM-1 for the treatment of cancer we continue to extend our oncology patent estate worldwide."
Medifocus, Inc. (OTC:MDFZF.PK and TSXV:MFS) is pleased to announce that it has filed on January 22, 2010, its response to two (2) remaining questions with the FDA in the United States of America (NYSE:USA) to obtain clearance to initiate a pivotal phase III clinical trial using the Company’s Microfocus APA 1000 System for the treatment of breast cancer in the USA and worldwide.
Oculus Innovative Sciences, Inc. (NASDAQ:OCLS), today announced that the financial results for its fiscal third quarter ended December 31, 2009, will be releasedafter the U.S. market closes on February 4, 2010.
Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, announced today that it has completed a license amendment with The Dow Chemical Company (NYSE: DOW) for a variety of antibodies used in its proprietary surgical oncology system called radioimmunoguided surgery or RIGS®.
OncoVista Innovative Therapies, Inc. (OTCBB:OVIT) announced today that its wholly owned subsidiary, AdnaGen AG, the manufacturer of CE-certified circulating tumor cell (NYSE:CTC) diagnostic assays, has entered into an agreement with TATAA Molecular Diagnostics, for the exclusive use of its Adnatest™ BreastCancer assays in an international breast cancer research COHERTA project.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (NASDAQ:ANDA) to market its generic version of Schering-Plough’s brain tumor treatment Temodar® (temozolomide).
YM BioSciences Inc. (Amex:YMI, TSX:YM), reported on Tuesday that the FDA has advised the Company that it may now enroll patients at US clinical sites into two ongoing randomized, double-blind Phase II trials of its lead product, nimotuzumab. One of the two trials is in non-small-cell lung cancer (NSCLC) patients who are ineligible for curative treatment and being treated palliatively and the other in patients with brain metastases from NSCLC. Current NSCLC palliative treatment and treatment for brain metastases is radiation alone. "Nimotuzumab has been demonstrating efficacy in trials throughout the world and this clearance from the FDA is an important milestone in our US development program," said David Allan, Chairman & CEO of YM BioSciences Inc. "We are very pleased that US patients will now have the opportunity to receive nimotuzumab and that a broader group of US oncologists will gain experience with it. While the rarity of any of the severe toxicities generally attributed to this class of drug has been a challenge for the credibility of nimotuzumab's efficacy, the growing recognition of our data, which support the unique selectivity of nimotuzumab for the overexpressed receptors on tumor that uniquely permit it to discriminate between normal tissue and tumor EGFR, has heightened investigator interest in advancing nimotuzumab." Shares of YM opened higher on the news and closed up nearly 6% on the day.
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for Application Serial No. 11/257,766 entitled “Salts of Isophosphoramide mustard and analogs thereof as anti-tumor agents” with claims directed to compounds, pharmaceutical compositions, and lyophilisates.