|RxNews Recap for Thursday 03-25-10. CombinatoRx moves higher on financial results. SciClone Pharmaceuticals up on EU approval|
|By BioMedReports.com Staff|
|Thursday, 25 March 2010 20:34|
Below is a list of the companies that made news in the healthcare sector on Thursday, March 25, 2010.
CombinatoRx, Incorporated (NASDAQ: CRXX) moved higher today after reporting financial results for the fourth quarter and year-ended December 31, 2009 and provided pipeline and business goals for 2010. The company reported a $25.2 million profit in the final quarter of 2009, as it cut research costs and realized gains from the completion of its acquisition of the privately held Canadian company Neuromed Pharmaceuticals Ltd. CFO Justin Renz said the deal brought gains of $21.9 million to CombinatoRx. A gain of $3.7 million from a litigation settlement and research and development expense cuts of approximately $6 million more than the fourth quarter of 2008 helped contribute to the quarterly profit.
"With the successful approval of Exalgo and the Neuromed merger and integration complete, we are uniquely positioned to become a thriving biopharmaceutical business," commented Mark H.N. Corrigan, MD, President and CEO of CombinatoRx. "We will leverage our expertise and pipeline to develop innovative products for the treatment of pain and inflammation and have focused our portfolio and R&D efforts in these core therapeutic areas."
Shares opened the day higher at $1.47 and finally settled the day at $1.36, up 10 cents for a 7.94% gain. Volume of 9.8 million shares was 4 times the daily average.
SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN) shares jumped higher today after the company announced the European approval of ondansetron RapidFilm™, co-developed by APR Applied Pharma Research s.a. ("APR"), and Labtec GmbH and licensed to BioAlliance Pharma s.a. for European Union countries. BioAlliance was granted approval under the EU decentralized procedure in 16 major EU countries. SciClone has acquired the commercialization and distribution rights for ondansetron RapidFilm™ from APR for the People's Republic of China, Vietnam, Hong Kong, and Macau and believes that these approvals in Europe will support SciClone's efforts to secure regulatory approval for the product in these countries.
Ondansetron RapidFilm is an innovative oral thin film formulation of ondansetron, a serotonin 5-HT3 receptor antagonist that is commonly used to treat and prevent nausea and vomiting caused by chemotherapy, radiotherapy, and surgery. Ondansetron is currently marketed in China in both branded and generic products, and in a variety of formulations including injectables and oral tablets.
Based on the European approvals, SciClone plans to file for product registration with the regulatory authorities in China, Vietnam, Hong Kong, and Macau. SciClone expects to introduce the product through its existing sales organization.
Shares rose 26 cents or 7.05% to close the day at $3.95. The stock moved higher by 10 cents in the after hours session. Volume of 2.2 million shares was more than four times the daily average.
News released after the market closed Thursday:
Hana Biosciences Inc., (OTCBB:HNAB), after the market closed today reported financial results for the fourth quarter and year ended December 31, 2009, and provided a corporate update. "In 2009, we made significant advancements towards our goal of initiating submission of a New Drug Application in mid-2010 seeking accelerated approval of Marqibo(R) in adult acute lymphoblastic leukemia," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "After reporting positive results from our pivotal Phase 2 rALLy trial, we eagerly await our pre-NDA meeting in the second quarter of 2010 and are confident we will be able to submit a New Drug Application for Marqibo in our expected time frame. In addition, we look forward to receiving and presenting the final results of the rALLy study from all 65 evaluable subjects, to provide additional evidence of Marqibo's effectiveness."
Luminex Corporation (Nasdaq:LMNX), the worldwide leader in multiplexed solutions, presented new strategic initiatives at its Annual Investor Day, which was held today at the NASDAQ MarketSite in New York, NY. The event featured presentations from scientists and company executives and included a review of Luminex's innovative product pipeline, the announcement of the company's acquisition of Australian-based BSD Robotics, the unveiling of an exclusive collaboration and licensing agreement with Advanced Liquid Logic, and details regarding Luminex's biothreat initiative.
Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) shares dropped in the after hours market after the company announced that it has priced an underwritten public offering of 6,000,000 shares of its common stock at a price to the public of $8.25 per share. The net proceeds from the sale of the shares, after estimated underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $45.9 million. The offering is expected to close on or about March 31, 2010, subject to customary closing conditions. Shares traded lower by 42 cents after the close.
In news from earlier in the day:
American Medical Systems® (AMS) (Nasdaq:AMMD), a leading provider of world-class devices and therapies for both male and female pelvic health, announced the release of GreenLight MoJo, a new software upgrade for its industry-leading GreenLight HPS laser therapy treatment system. The HPS now delivers up to 400 kilojoules (kJ) for more efficient treatment of enlarged prostate or benign prostatic hyperplasia (BPH). The new GreenLight MoJo ("More Joules") delivers 45% more joules for the same price and lasts longer, allowing physicians to remove more tissue and/or treat larger glands (greater than 80g) with a single fiber. GreenLight MoJo can speed procedural time and reduce treatment costs by eliminating fiber changes during each case.
AspenBio Pharma, Inc. (NASDAQ:APPY) reported that Steve Lundy has joined the company as Chief Executive Officer and will become a member of the Board of Directors. The addition of Mr. Lundy is part of succession and organizational planning that was initiated in the latter half of 2009. Daryl Faulkner, who served as Interim CEO in 2009 will relinquish that role but will continue as Executive Chairman of the company and will focus more on strategic matters..
BSD Medical Corporation (NASDAQ:BSDM) today reported that hyperthermia research was recently highlighted in a television segment that aired on WRAL-TV5, Raleigh’s CBS affiliated television station. The segment previews the innovative and exciting research being conducted on hyperthermia at Duke University Medical Center. The research reported in the segment utilizes BSD’s hyperthermia systems.
DARA BioSciences, Inc. (Nasdaq:DARA) announced that it has initiated a Phase I clinical study for DB959, its PPAR (peroxisome proliferator activated receptor) delta/gamma agonist, an oral drug in development for the treatment of Type 2 Diabetes. The study will enroll approximately 75 volunteers and will be conducted at Quintiles' Overland Park facility. This study's main objectives are to determine the safety and pharmacokinetics of single ascending oral doses of DB959. The Company expects to report the results of the study during the second half of 2010.
Dyax Corp. (NASDAQ: DYAX) today announced the pricing of an underwritten public offering of 17,000,000 shares of its common stock at a price to the public of $3.25 per share. The gross proceeds from the sale of shares, after underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $51.8 million. Dyax intends to use the net proceeds from this offering to fund commercialization and distribution activities for KALBITOR® (ecallantide), their lead product for the treatment of acute attacks for hereditary angioedema, to fund other research and preclinical development activities, and for general corporate purposes.
Genomic Health, Inc. (Nasdaq:GHDX) today announced that the company has entered into an exclusive agreement with Palex Medical S.A., one of Europe's leading distributors of medical device and diagnostic services to hospitals, to distribute its Oncotype DX® breast cancer test in Spain and Portugal. The distribution agreement, announced in conjunction with positive data presented today at the 7th European Breast Cancer Conference (EBCC), further expands the global presence of Oncotype DX, providing for increased physician and patient access to this advanced diagnostic test in the European market.
Oculus Innovative Sciences, Inc. (Nasdaq: OCLS), a commercial medical technology company that designs, produces and markets safe and effective tissue care products based upon the Microcyn® Technology platform, today commercially introduced the Microcyn Dermatology HydroGel for the U.S. professional healthcare market. Oculus announced two weeks ago that it had received FDA 510(k) clearance for the Microcyn Dermatology HydroGel, which under the supervision of a healthcare professional, is intended for management of wounds including itch and pain relief associated with dermal irritation, sores, injuries and ulcers of dermal tissue.
OncoGenex Pharmaceuticals, Inc. (NASDAQ:OGXI) announced today that final results from a Phase 1 study evaluating OncoGenex' product candidate, OGX-427, will be presented as part of the Scientific Program in a General Poster Session at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting. These final data, including results combining OGX-427 with docetaxel, will update preliminary data that was featured in an oral presentation at ASCO 2009.
Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic tests, announced today it has been awarded accreditation by the Laboratory Accreditation Program of the College of American Pathologists (CAP). This accreditation is in addition to the CLIA certification held by Rosetta Genomics’ Philadelphia laboratory under the Clinical Laboratory Improvement Amendments (CLIA), and the ISO 13485 accreditation of Rosetta Genomics R&D lab in Israel.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the publication of results from the Company’s pivotal Phase 3 efficacy and safety study of XIFAXAN® (rifaximin) 550 mg tablets in The New England Journal of Medicine. The study showed XIFAXAN 550 mg tablets significantly reduced the risk of overt hepatic encephalopathy (HE) recurrence over a six month period, maintaining remission more effectively than placebo. Additionally in this study, XIFAXAN 550 mg treatment significantly reduced the risk of hospitalization for HE. HE is a serious disorder caused by chronic liver failure, resulting in cognitive, psychiatric and motor impairments.i On March 24, 2010 the FDA approved the use of XIFAXAN 550 mg tablets for reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. XIFAXAN has been granted Orphan Drug designation by the FDA for use in hepatic encephalopathy. With XIFAXAN 550 mg tablets now approved by the FDA, Salix believes this designation should provide seven years of marketing exclusivity in the United States.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market a generic version of the anticoagulant, Argatroban® injection, 100mg/mL. The drug is part of an ongoing patent lawsuit with the owner Encysive, Teva said. Barr Pharmaceuticals is also involved in patent dispute with Encysive over Argatroban. Tentative approval is usually given when there is still a patent in effect on a drug or there is an ongoing patent dispute.
Transcept Pharmaceuticals, Inc. (Nasdaq:TSPT) shot up more than 9% today as the company announced its plan for the resubmission for the Intermezzo® New Drug Application (NDA) based on a teleconference with the U.S. Food and Drug Administration (FDA) held earlier today. The key component of the resubmission plan is an Intermezzo® highway driving study to assess next day residual effects, for which Transcept now expects to begin enrollment in the late second quarter of 2010. Based on the teleconference with FDA, and pending a positive highway driving study outcome, Transcept estimates that it will resubmit the Intermezzo® NDA in the late fourth quarter of 2010. During the teleconference, the FDA agreed that the Transcept proposal submitted on February 16, 2010 to conduct a highway driving study is a reasonable way to measure potential next day driving impairment as a result of dosing Intermezzo® in the middle of the night with four hours or less remaining in bed. This study will be conducted at the University of Maastricht in the Netherlands, a leading center of research on the effects of drugs and alcohol on driving performance.