|Shares of Exelexis jump on potential takeover bids|
|By Staff and Wire Reports|
|Monday, 11 April 2011 19:00|
In extended trading, shares of Exelixis jumped $1.07 or 9.68% to $12.12.
Also after the bell Monday, shares of NPS Pharmaceuticals, Inc. (NASDAQ:NPSP) fell after the company announced that it has commenced an underwritten public offering of 9 million shares of its common stock pursuant to an effective shelf registration statement.
After the bell, Merck (NYSE:MRK) today announced that the U.S. Food and Drug Administration has approved SYLATRON (peginterferon alfa-2b) for injection, for subcutaneous use. SYLATRON is indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. SYLATRON is contraindicated in patients with a history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b, in patients with autoimmune hepatitis, and in patients with hepatic decompensation.
Endo Pharmaceuticals (Nasdaq:ENDP) and American Medical Systems (AMS) (Nasdaq:AMMD) announced today that they have entered into a definitive agreement under which Endo will acquire AMS, a leading provider of world-class devices and therapies for male and female pelvic health, for $30 per share, or $2.9 billion in cash, which includes the assumption and repayment of $312 million of AMS debt. The combined company will be positioned to deliver more comprehensive healthcare solutions across its diversified businesses in branded pharmaceuticals, generics and devices and services, in the key therapeutic areas of urology and pain.
American Medical Systems soared 32% or $7.17 to $29.50. Endo traded as high as $44.53 before settling at $41.06, up 21 cents.
Biogen Idec (NASDAQ:BIIB) announced today positive top-line results from DEFINE, the first of two pivotal Phase 3 clinical trials designed to evaluate the investigational oral compound BG-12 (dimethyl fumarate) as a monotherapy in people with relapsing-remitting multiple sclerosis (RRMS). Results showed that 240 mg of BG-12, administered either twice or three times a day, met the primary study endpoint, demonstrating a highly statistically significant reduction (p<0.0001) in the proportion of patients with RRMS who relapsed at two years compared with placebo. Both doses of BG-12 also met all of the secondary study endpoints, providing a statistically significant reduction in annualized relapse rate, in the number of new or newly enlarging T2 hyperintense lesions, in new gadolinium-enhancing (Gd+) lesions, and in the rate of disability progression as measured by the Expanded Disability Severity Scale (EDSS) at two years.
Shares of Biogen surged $5.26 or 7% to $78.55. Nearly 7 million shares were traded.
Pfizer Inc (NYSE:PFE) and Medivation, Inc. (NASDAQ:MDVN) today announced results from the Phase 3 HORIZON trial of the investigational drug dimebon (latrepirdine*) in patients with Huntington disease. Dimebon did not achieve statistical significance for either of the co-primary endpoints, the Mini-Mental State Examination (MMSE), which measures cognition, or the Clinician's Interview-Based Impression of Change, plus caregiver input (CIBIC-plus), which measures global function.
"We are disappointed with the results of the HORIZON trial given the high unmet need in this patient population. At this point, we will discontinue development of dimebon in Huntington disease, including the ongoing open-label extension study," said David Hung, M.D., president and chief executive officer of Medivation. "We will continue our ongoing 12-month Phase 3 CONCERT trial of dimebon and its open-label extension in patients with mild-to-moderate Alzheimer's disease. We expect to report top-line data from CONCERT in the first half of 2012."
VIVUS, Inc. (NASDAQ:VVUS) today announced that detailed results from the 56-week CONQUER study were published in The Lancet, evaluating the efficacy and safety of investigational drug QNEXA in 2,487 patients across 93 sites in the US. Data published in the peer-reviewed journal provided an in-depth look at weight loss and improvements in the full spectrum of co-morbidities studied as secondary endpoints, including cardiovascular, metabolic and inflammatory risk factors.
"Obesity is a serious medical condition associated with increased mortality from cardiovascular diseases, diabetes, cancer and other diseases, yet there is a lack of treatment options for the one-third of American adults who are obese," said Kishore Gadde, MD, director of obesity clinical trials at Duke University and lead investigator. "Half the patients in the study had at least three co-morbidities including diabetes, representing a population with the greatest medical need for weight loss. We observed significant weight loss, improvements in co-morbidities and a reduction in the need for concomitant medications in patients treated with QNEXA."
CombiMatrix Corporation (Nasdaq:CBMX) announced today that it has entered into a strategic partnership with Clarient, Inc., a GE Healthcare Company, that allows Clarient the right to commercialize the CombiMatrix DNAarray product portfolio. The DNAarray tests are based on aCGH technology, which provides physicians a comprehensive genomic profile of solid cancer tumors and blood-based cancers, helping to better guide patient treatment decisions.
DURECT Corporation (Nasdaq:DRRX) announced today top-line results from a Phase II clinical trial in chronic low back pain for ELADUR® (TRANSDUR®-Bupivacaine), DURECT's proprietary investigational transdermal bupivacaine pain patch. This study was conducted by DURECT's collaborator, King Pharmaceuticals, which is now owned by Pfizer (NYSE:PFE). In this study of 263 patients suffering from chronic low back pain, the primary efficacy endpoint of demonstrating a positive treatment difference for the mean change in pain intensity scores from baseline to the mean of weeks 11 and 12 between ELADUR as compared to placebo was not met. Complete data analysis is on-going.
GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), announced today that it is expanding its preventative HIV/AIDS vaccine development effort in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH) and the HIV Vaccine Trials Network (HVTN). Specifically, the HVTN plans to clinically test a novel vaccine product developed by GeoVax scientists that expresses human granulocyte-macrophage colony stimulating factor in combination with inactivated HIV proteins.
Hansen Medical, Inc. (NASDAQ:HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced that it has submitted a 510(k) pre-market notification application with the U.S. Food and Drug Administration on its Vascular Robotic System and Catheter.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it has received 510k clearance from the United States Food and Drug Administration (FDA) for three new spinal intervertebral body fusion devices (IBD), continuing to build its momentum in the spine market.
PROLOR Biotech, Inc. (NYSE Amex: PBTH) today reported positive interim efficacy results from a Phase II clinical trial of its long-acting CTP-modified version of human growth hormone (hGH-CTP) in growth hormone deficient adults. The interim efficacy data show that a single weekly injection of hGH-CTP, even when administered at relatively low doses, has the potential to replace seven consecutive daily injections of currently marketed human growth hormone (hGH). These positive interim data follow PROLOR's announcement in February that hGH-CTP has demonstrated a good safety profile in the Phase II trial, as confirmed in a review of interim data by the independent Data and Safety Monitoring Board.