|Vivus, Orexigen move higher on new data. After the bell: Cubist soars on Teva settlement, Questcor surges on higher revenue forecast|
|By Mary Davila|
|Monday, 04 April 2011 18:51|
After the bell Monday shares of Cubist Pharmaceuticals, Inc. (NASDAQ:CBST) soared more than 14% after announcing that it has resolved a patent suit Teva Pharmaceutical Industries Ltd. which will allow Teva to sell a generic version of Cubicin. Cubicin is indicated to treat sever skin infections caused by drug-resistant microorganisms and is Cubist’s only marketed drug. Under the terms of the agreement, Teva will have license to sell a generic version of the antibiotic by 2018. Cubist CEO Mike Bonney said he anticipates the drug will take in as much as $1 billion in U.S. revenue before Teva’s version goes on sale.
Shares of Questcor Pharmaceuticals, Inc. (NASDAQ:QCOR) shot up in extended trading Monday after the company today announced preliminary operating metrics for its first quarter ended March 31, 2011. The company said it expects higher than expected Q1 gross revenue due to higher paid prescriptions Acthar gel which is primarily used in the treatment of multiple sclerosis and infantile spasms. The company expects gross sales of $48.6 million for the first quarter.
Questcor soared $2.68 or 18% to $17.60 in extended trading.
Shares of Orexigen Therapeutics, Inc. (Nasdaq:OREX) gained 14% after the company reported additional data that showed that overweight and obese patients treated with Contrave maintained normal 24-hour blood pressure patterns around the clock during a year of treatment.
"The observation that patients in this sub-study maintained normal circadian variation of blood pressure may be particularly relevant since a loss of the nocturnal lowering in blood pressure may predict a poor cardiovascular outcome," said Jorge Plutzky, M.D., Director of the Vascular Disease Prevention Program at Brigham and Women's Hospital.
The FDA rejected Contrave citing concerns over heart side effects. Shares jumped 14 cents to $3.29. More than 11 million shares traded hands.
VIVUS, Inc. (Nasdaq:VVUS) today announced long-term data that demonstrated patients treated with the investigational drug QNEXA for two years showed reductions in blood pressure and the use of antihypertensive medications as well as improvements in lipid levels following significant reductions in weight loss as compared to those in the placebo group over two years.
The data – additional results from the SEQUEL study – were presented Sunday at the 60th Annual Scientific Meeting of The American College of Cardiology by Michael Davidson, M.D., clinical professor and director of preventive cardiology at The University of Chicago.
Aastrom Biosciences, Inc. (Nasdaq:ASTM), moved higher today after the leading developer of expanded, patient-specific cellular therapies for the treatment of severe, chronic cardiovascular diseases, announced that it has completed an important product manufacturing milestone with the transfer of cell cassette manufacturing to ATEK Medical under the strategic partnership announced in October 2010. These single-use cell cassettes are the central component used in Aastrom's proprietary culturing process at its cell manufacturing facility in Ann Arbor, Michigan.
"As a result of this milestone, which we achieved ahead of schedule, we now have a fully validated and reliable manufacturing partner to support our late stage clinical development programs," said Tim Mayleben, president and CEO of Aastrom. "This will ensure that Aastrom has the inventory of high-quality cell cassettes necessary for the planned mid-2011 start of our Phase 3 clinical program in critical limb ischemia."
In addition, Aastrom announced today that ixmyelocel-T has been formally accepted by the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research and the United States Adopted Names Council as the non-proprietary name for Aastrom's investigational cell therapy product.
"We also reached an important product development milestone with the selection of ixmyelocel-T as the generic name of our expanded cell therapy product," Mr. Mayleben added. "This name was reviewed and accepted by the FDA and USAN Council and will be used by us and our collaborators going forward."
Shares of Aastrom jumped 22 cents or 9% to $2.76.
PLC Systems Inc. (OTCBB:PLCSF.ob), a company focused on innovative medical device technologies, announced that final results from the REMEDIAL II investigator-sponsored clinical trial of RenalGuard in Italy were presented today. The results showed that RenalGuard was much more effective than the current standard of care at preventing Contrast-Induced Nephropathy (CIN) and Dialysis in at-risk patients.
PLC jumped 5 cents or 26% to $0.24.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announced today that the Company has received 510(k) clearance from the FDA for its Solus Anterior Lumbar Interbody Fusion (ALIF) system.
The Solus ALIF device features an integrated fixation method based on intellectual property previously acquired by the Company. The patented fixation technology allows for enhanced segmental stability with a simplified surgical technique, while providing for substantial spacing to add bone graft.
Avanir Pharmaceuticals, Inc. (NASDAQ:AVNR) today announced that it has filed an Investigational New Drug IND application with the FDA to begin a large Phase II clinical trial of AVP-923, an investigational drug for the treatment of central neuropathic pain in patients with multiple sclerosis. The FDA has acknowledged receipt of the submission and the company expects that the IND filing will be subject to standard 30-day review.
"Over half of MS patients suffer from chronic and debilitating pain, with a substantial negative impact on their quality of life. With no FDA-approved therapies to treat central neuropathic pain in MS patients, this represents an area of high unmet medical need," said Randall Kaye, MD, Chief Medical Officer of Avanir Pharmaceuticals
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced the presentation of positive preclinical data supporting development of its novel, non-peptidic cathepsin L inhibitors as anticancer agents. "The discovery of new chemotherapeutic strategies for inhibiting the growth and spread of cancer, such as our novel class of cathepsin inhibitors, represents an important achievement in the effort to enhance both cancer patient quality of life and survival. We are very encouraged by the preclinical safety and efficacy data presented at the AACR meeting with our small molecule cathepsin L inhibitors. Our goal is to advance these promising agents towards clinical evaluation," said Dr. Dai Chaplin, OXiGENE's Chief Scientific Officer
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced data from its Phase Ib dose escalation safety study of bavituximab in patients coinfected with chronic hepatitis C virus (HCV) and HIV. In a poster presented at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL), data show bavituximab administered as a single agent for 8 weeks was generally safe and well tolerated at all four dose levels.
"Bavituximab used as a single agent has demonstrated a consistent, acceptable safety profile in three Phase I HCV trials to date, and we have seen enhanced antiviral activity when using bavituximab in combination with the antiviral agent ribavirin in several preclinical viral disease models," said Joseph S. Shan, vice president of clinical and regulatory affairs at Peregrine Pharmaceuticals. "Our recently initiated randomized Phase II trial will assess early virology response of genotype 1 HCV patients after 12 weeks of therapy combining bavituximab with ribavirin as a potential alternative to the current interferon-based regimen."
Pfizer (NYSE: PFE) and Kohlberg Kravis Roberts & Co L.P. today announced that KKR will acquire Pfizer’s Capsugel business for $2.375 billion in cash. Capsugel, the world leader in hard capsules and an innovator in drug-delivery systems, generated approximately $750 million in revenue and manufactured more than 180 billion hard capsules in 2010.
Allezoe (OTCBB:ALZM) announced that members of the Organ Transport Systems leadership team will attend the annual meeting of the International Society for Heart and Lung Transplantation (ISHLT) April 13-16, 2011 in San Diego, California, where OTS collaborators will be presenting results from their latest preclinical studies.