|Biogen achieves top line results from second phase 3 study of MS drug; Human Genome sinks 20% on weak Lupus Drug Sales|
|By Staff and Wire Reports|
|Wednesday, 26 October 2011 18:40|
Biogen Idec (NASDAQ:BIIB) reported it achieved top line results from its second phase three clinical trial of its BG-12 drug, intended to reduce relapses and disability progression in patients suffering from multiple sclerosis (MS).
The global, randomized, double-blind, placebo-controlled, dose-comparison study achieved its primary endpoint - the reduction in annual relapse rate (ARR) after two years. Secondary endpoints, which the trial also confirmed, included the reduction in number or size of lesions associated with the disease, as well as safety and tolerability.
The study enrolled 1,430 patients with MS. Patients received either two or three daily 240 milligram (mg) doses of BG-12, or the standard of care, glatiramer acetate (GA), or a placebo.
After two years, ARR was reduced by 44 percent, compared to the placebo, in patients who received two doses of BG-12 per day, and by 51 percent in patients who received three doses per day. The GA comparator reduced ARR by 29 percent, compared to placebo.
Biogen's Executive Vice President of Research and Development Dr. Doug Williams said: "We now have strong positive results for BG-12 in two robust pivotal clinical trials with more than 2,600 patients.
The BG-12 drug reduces the impact of inflammatory cells on those in the central nervous system by producing a protective response.
Shares of Biogen Idec rose 11.35 percent as of 11:50 am EDT, to trade at $119.
Shares of Human Genome Sciences (NASDAQ:HGSI) +1.72% sank 20% to $10.18 the day after the biotech firm reported weaker-than-expected sales of its new lupus drug Benlysta.
According to analysts at Leerink Swann, Benlysta's net sales of $18.8 million for the quarter were in line with its lowered estimate of $19 million, but about 6% below the Wall Street consensus of $20.1 million.
The first drug approved to treat lupus in over 50 years, industry watchers have estimated that Benlysta could be a blockbuster. As a result, Human Genome shares have been pushed markedly higher in recent weeks on rumors that it might be bought by Benlysta's co-marketer, GlaxoSmithKline PLC (NYSE: GSK) -1.83% , for around $25 a share.
Accuray Incorporated (Nasdaq: ARAY), the premier radiation oncology company, announced today significant momentum in global adoption of its TomoDirect treatment modality.
AdCare Health Systems, Inc.(NYSE Amex: ADK), a leading nursing home and assisted living provider, will hold a conference call on Wednesday, November 9, 2011 at 5:00 p.m. Eastern time to discuss results for the third quarter ended September 30, 2011. Financial results will be issued in a press release prior to the call.
BIOLASE Technology, Inc. (NASDAQ: BLTI), the World's leading dental laser manufacturer and distributor, announced today that the Company will host a conference call on Monday, November 7th, at 11:00 a.m. Eastern Time to discuss its operating results for the third quarter and nine months ended September 30, 2011, and to answer questions.
Bristol-Myers Squibb Company (NYSE: BMY) and Gilead Sciences, Inc. (Nasdaq: GILD) today announced a licensing agreement for Bristol-Myers Squibb to develop and commercialize a fixed-dose combination containing Bristol-Myers Squibb’s protease inhibitor REYATAZ® (atazanavir sulfate) and Gilead’s cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of certain HIV medicines to potentially allow for one pill once daily dosing.
Cytori Therapeutics (NASDAQ: CYTX) will provide a live webcast of its third quarter financial results and quarterly business update on Thursday, November 3, 2011 at 5:00 PM Eastern Time.
The following is a letter to shareholders from Ophir Shahaf, CEO of Hadasit Bio-Holdings, Ltd. (OTCBB: HADSY), a publicly traded portfolio of biotech companies based on intellectual property developed and owned by Hadassah University Hospital.
eHealthInsurance (NASDAQ: EHTH), the leading online source of health insurance for individuals, families and small businesses, published tips to help small business owners navigate cost and coverage concerns for open enrollment season.
Genetic Technologies Limited (ASX: GTG, NASDAQ: GENE) today reported their quarterly activities report for the quarter ended 30 September, 2011.
Global Pharm Holdings Group, Inc. (OTCBB: GPHG), a China-based, growing vertically integrated pharmaceutical company engaged in pharmaceutical-related products distribution, Traditional Chinese Medicine ("TCM") herbs cultivation and processing business through its subsidiaries in Anhui, Jilin, Guangdong and Shandong provinces, today announced that it has completed the entire US$15 million redeemable convertible bonds financing (the "Financing") by Blazer Delight Limited, an investment vehicle owned by a fund managed by Asia-based Gen2 Partners Limited ("Gen2 Partners").
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that it will be participating in the Brean Murray, Carret & Co. 2011 Life Sciences Summit on Monday, November 14, 2011, and in the Lazard Capital Markets 8th Annual Healthcare Conference on Tuesday, November 15, 2011. Both conferences will take place in New York City.
Intellect Neurosciences, Inc. (OTCBB: ILNS), a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment of Alzheimer's and other neurological diseases announces today the commencement of the initial development of its new CONJUMAB-A platform technology for a novel class of therapeutics for treatment of Alzheimer's disease and other proteinopathies based on antibody-drug conjugates (ADCs).
Medtronic Inc. (NYSE: MDT) announced today the start of SYMPLICITY HTN-3, the company’s U.S. clinical trial of the Symplicity® Renal Denervation System™for treatment-resistant hypertension.
Nektar Therapeutics (Nasdaq: NKTR) will announce its financial results for the third quarter ended September 30, 2011 on Wednesday, November 2, 2011, after the close of U.S.-based financial markets.
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that the Company will report its third quarter 2011 financial results after the Nasdaq market closes on Monday, October 31, 2011.
Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions and cell-based virology assays, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its Sofia™ Analyzer and its Sofia Influenza A+B FIA.
Repligen Corporation (NASDAQ: RGEN) announced today that Dr. Walter C. Herlihy, President and Chief Executive Officer of Repligen will host a conference call and webcast on Friday, October 28, 2011 at 8:30 am EDT, to discuss the second quarter financial results for fiscal year 2012 and provide a quarterly update of the company.
Safeguard Scientifics, Inc. (NYSE: SFE), a holding company that builds value in growth-stage life sciences and technology companies, today announced that aggregate partner company revenue for the three months and nine months ended September 30, 2011 was $46 million and $131 million, respectively.
Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced that it will release third quarter 2011 financial results after market close on Monday, November 7, 2011.
Seattle Genetics, Inc. (Nasdaq: SGEN) today announced the appointment of James Kyle Bryan, M.D., as Vice President, Medical Affairs.
Senesco Technologies, Inc. (NYSE AMEX: SNT) provided an update on Company activities.
Spherix Incorporated (NASDAQ: SPEX) – an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis, and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies – today announced that it has entered into definitive agreements to sell $1.25 million of shares of its common stock together with warrants to purchase additional shares of its common stock in a private placement transaction.
Stellar Biotechnologies, Inc. (TSX-V: KLH) (PINKSHEETS: SBOTF) and Life Diagnostics, Inc. are pleased to announce they have entered into an exclusive manufacturing and supply agreement. Life Diagnostics (www.lifediagnostics.com) is a leader in the manufacture and sale of ELISA kits, purified biomarkers and antibodies for cardiovascular, inflammation, immunotoxicity and immunology research.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the third quarter ended October 1, 2011.
XOMA Ltd. (Nasdaq: XOMA), a leader in the discovery and development of therapeutic antibodies, and Aragen Bioscience, Inc., a provider of high-content preclinical research and development services, have entered into an agreement under which Aragen Bioscience will provide its clients access to XOMA’s proprietary Human Engineering™ technology for antibody humanization. Financial terms were not disclosed.