|RxNews Recap for Friday 03-12-10. Intellipharmaceutics explodes on patent suit settlement. MiddleBrook Pharma restructures.|
|By BioMedReports.com Staff|
|Friday, 12 March 2010 19:45|
Below is a list of the companies that made news in the healthcare sector on Friday, March 12, 2010.
Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) today announced that Novartis Pharmaceuticals Corporation and Celgene Corporation have settled their patent suit in the U.S. District Court for the District of New Jersey, and Elan Pharma International Ltd. has settled its patent suit in the U.S. District Court for the District of Delaware, with Intellipharmaceutics Corp., a wholly-owned subsidiary of Intellipharmaceutics International, and its licensee Par Pharmaceutical, Inc. over a generic version of the Attention Deficit Hyperactivity Disorder drug Focalin XR(R) (dexmethylphenidate hydrochloride). The terms of the settlements are confidential and remain subject to regulatory and court approval. Shares soared on the news, jumping $2.62 or a whopping 172.37%, closing the day at $4.14. The stock at one point hit $5.05.
MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK) dropped after announcing its 2009 fourth quarter and full-year results, and, that it is further restructuring to reduce expenses as well as evaluating strategic alternatives to maximize shareholder value.
MiddleBrook announced that effective Monday, March 15, 2010, it will be eliminating its field sales force and significantly reducing its corporate staff to preserve cash resources as it explores its strategic options. The Company will rely on its partnership with DoctorDirectory.com, Inc. for continued MOXATAG® promotion through DoctorDirectory.com’s virtual marketing solution, IncreaseRx®, in its efforts to commercialize and gain market acceptance of MOXATAG.
As part of the reduction in force, John Thievon, the Company’s current president and chief executive officer and a director, announced his resignation effective Monday, March 15, 2010, to further reduce operating expenses. David Becker, the Company’s current chief financial officer, will assume the role of acting president and chief executive officer.
Shares dropped 38.24%, closing down 19.5 cents to close at 31.5 cents.
In other news Friday:
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today reported financial results for the three and twelve months ended December 31, 2009. "Achillion made considerable progress this past year in advancing our pipeline of HCV assets, improving our strategic position in the HCV market," said Michael Kishbauch, President and CEO of Achillion. "We achieved clinical proof-of-concept with ACH-1625, demonstrating the compound's short-term safety, tolerability and an impressive viral load reduction which was sustained seven days after completion of dosing. Further, ACH-1095, a potential first-in-class NS4A antagonist, is now advancing toward an IND. Additionally, we nominated ACH-2684, a high-potency protease inhibitor from our third proprietary HCV program, as a clinical candidate. We believe Achillion is well positioned to participate in the large and important HCV market. We believe multiple compounds with distinct profiles provide Achillion with a significant advantage, as HCV is a disease in which combination therapies are anticipated to become the standard of care.".
Aethlon Medical, Inc. (OTC Bulletin Board:AEMD.ob), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced that Richard H. Tullis, Ph.D., the company's Chief Science Officer, will present at the French Biotech Tour held at The Salk Institute in La Jolla, California, on March 15, 2010. The French Biotech Tour is a showcase of the most innovative technologies and solutions developed by Californian and French biotech companies to tackle infectious diseases and to improve patients' quality of life. Shares of Aethlon were up 16.6% on the day.
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) as reported earlier today on BioMedReports, announced that the U.S. Food and Drug Administration (FDA) has accepted the proposed proprietary name "Exelbine™" for the Company's product candidate ANX-530 (vinorelbine injectable emulsion). Shares finished the day up 13.3%.
Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) today reported financial results for the fourth quarter and full year ended December 31, 2009. Arena reported a lower net loss allocable to common stockholders in the fourth quarter of 2009 of $29.8 million, or $0.32 per share, compared to a net loss allocable to common stockholders in the fourth quarter of 2008 of $62.5 million, or $0.84 per share, and a net loss allocable to common stockholders in the full year ended December 31, 2009 of $153.2 million, or $1.82 per share, compared to a net loss allocable to common stockholders in the full year ended December 31, 2008 of $239.5 million, or $3.24 per share.
"We are pleased with the timely execution and significant progress made in our lorcaserin program," stated Jack Lief, Arena's President and Chief Executive Officer. "As we continue efforts to reach a commercial agreement for lorcaserin, we are building a strong foundation for a successful launch upon potential approval."
Sanofi-aventis U.S. and Bristol-Myers Squibb Company (NYSE: BMY) today announced revisions to the U.S. prescribing information for PLAVIX® (clopidogrel bisulfate), which include a boxed warning. The boxed warning concerns the diminished effectiveness of PLAVIX in patients who have a genetic variation leading to reduced formation of the active metabolite. These patients, who are designated as poor metabolizers, represent, according to the prescribing information, approximately 2% of whites, 4% of blacks, and 14% of Chinese. The percentage of poor metabolizers is estimated to be approximately 3% of the population, based on published studies.
Patients should continue taking PLAVIX unless told to do otherwise by their healthcare professional. They should talk with their healthcare professional if they have any concerns about PLAVIX.
Bovie Medical Corporation (NYSE-AMEX Symbol: BVX), a manufacturer and marketer of electrosurgical products, today announced the Company received clearance from the Food and Drug Administration (FDA) to market its ICON VS electrosurgical generator. The generator has been designed to perform vessel sealing procedures, providing both monopolar and bipolar energy options to the surgeon. The clearance of the ICON VS generator allows the Company to complete testing required in support of the previously filed vessel sealing instrument 510(k) application.
Cytori Therapeutics (NASDAQ:CYTX ) the maker of products used in adult stem cell harvesting and research, said Friday its fourth-quarter loss widened as sales and marketing and other expenses grew. Shares were hit hard on the news, dropping 19.73% to close at $6.02, down $1.48 on the day.
GTC Biotherapeutics, Inc. (NASDAQ: GTCB) today reported its financial results for the fourth quarter and fiscal year ended January 3, 2010. The total net loss for the fourth quarter was $1.7 million, or $0.09 per share, compared with $6.2 million, or $0.60 per share, for the fourth quarter of 2008. The total net loss for 2009 was $27.9 million, or $2.18 per share, compared to $22.7 million, or $2.31 per share, for 2008.
"GTC has maintained strong progress in its core programs in recombinant plasma proteins and follow on biologics", stated Geoffrey Cox, Ph.D., Chairman, President and CEO of GTC Biotherapeutics. "We are now on the threshold of bringing two additional programs into clinical development, rhFVIIa and rhAFP, both of which address large market opportunities". Shares dropped more than 12% on the day, closing at 95 cents.
Halozyme Therapeutics, Inc. (Nasdaq:HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets, today reported financial results for the fourth quarter and year ended December 31, 2009.
"Halozyme's pipeline programs advanced significantly in 2009 with the start of the Phase 3 pivotal study for Herceptin® SC, the achievement of full patient enrollment for the subcutaneous GAMMAGARD® with rHuPH20 Phase 3 registration trial, and the completion and presentation at major medical meetings of three clinical trials from our Ultrafast Insulin program," said Jonathan Lim, M.D., Halozyme's president and CEO. "We have important clinical and business milestones to look forward to in 2010 as we continue to build the value of our portfolio."
Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced that GlaxoSmithKline (NYSE: GSK) was granted marketing authorization from the European Commission (EC) for Revolade® (eltrombopag) for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP). Eltrombopag is indicated for adult chronic ITP splenectomized patients who have not responded (are refractory) to other treatments, such as corticosteroids and immunoglobulins. Eltrombopag may also be considered as second-line treatment for adult non-splenectomized patients where surgery is contraindicated.
Oncothyreon Inc. (Nasdaq:ONTY) today announced that it will restate its 2008 financial statements contained in its Annual Report on Form 10-K for the year ended December 31, 2008, and its Quarterly Reports on Form 10-Q for the quarters ended March 31, June 30 and September 30, 2009 to correct a revenue recognition error in accounting for a license agreement with Merck KGaA signed in December 2008 (the "License Agreement"). The Company is currently discussing the error with the Division of Corporation Finance of the Securities and Exchange Commission, and it is unclear whether the correction of the error will result in a restatement to provide further disclosure about the basis for the Company's accounting, or in a restatement of revenue and deferred revenue, as described in more detail below and in the Form 8-K filed by the Company today.
Orexigen® Therapeutics, Inc. (Nasdaq:OREX), a biopharmaceutical company focused on the treatment of obesity, and Patheon Inc. (TSX:PTI.to), a global provider of drug development and manufacturing services, announced today after the market closed a long-term agreement for commercial manufacturing of Contrave® (naltrexone HCL sustained release (SR)/bupropion HCL SR) as well as development of future formulations of Orexigen products. The financial terms of the deal were not disclosed.
"Patheon's manufacturing capabilities provide us a proven platform to help ensure successful market entry and stable commercial supply of Contrave in the event it is approved," said Mike Narachi, President and CEO of Orexigen. "This relationship also provides the means to accelerate the development and commercialization of next generation formulations of Orexigen products." Shares were trading higher in the after hours session by 3.5%.
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) jumped today after the company announced that it plans to advance oral methylnaltrexone for the treatment of opioid-induced constipation (OIC) into late stage clinical development and will commence a phase 2b/3 clinical trial of a methylnaltrexone tablet in chronic-pain patients in the second half of 2010. Progenics also announced data from a clinical trial of this methylnaltrexone tablet.
The tablet form of oral methylnaltrexone was developed by Progenics’ former collaboration partner Wyeth. At the time of Wyeth’s acquisition by Pfizer in October 2009, Progenics regained from Wyeth the rights to methylnaltrexone, including rights to this methylnaltrexone tablet. The transfer of data and information to Progenics regarding Wyeth’s work on oral methylnaltrexone was recently completed and Progenics has now had the opportunity to review in detail information regarding the methylnaltrexone tablet which is being reported on today.
"We believe that the activity demonstrated to date by the methylnaltrexone tablet shares the hallmarks of methylnaltrexone: both a prompt onset of action and a predictable response for a large percentage of patients," said Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and Chief Science Officer of Progenics. "Our next step is to initiate a phase 2b/3 dose-optimizing clinical trial in chronic-pain patients with OIC in the second half of this year to confirm these results."
Shares closed up 8.35%, up 41 cents to $5.32.
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced the initiation of a Phase 2 clinical trial of XOMA 052, its antibody to interleukin-1 beta (IL-1 beta), in Type 1 diabetes patients. Funding for the trial is being provided by the Juvenile Diabetes Research Foundation International (JDRF), the largest patient advocacy organization of Type 1 diabetes research worldwide. XOMA is the study sponsor and will provide XOMA 052 drug product for the trial. "We are pleased that patient enrollment has begun in this trial in Type 1 diabetes patients while XOMA continues to advance studies of XOMA 052 in patients with Type 2 diabetes and cardiovascular disease," said Steven B. Engle, XOMA's Chairman and Chief Executive Officer. "If successful, this study would be the first showing the impact of reducing inflammation in Type 1 diabetes patients with disease duration of two years or more. It would provide additional evidence of the benefit of anti-inflammatory therapy that could lead to improvement in diabetes patients' lives."
Ardea Biosciences, Inc. (Nasdaq: RDEA) a biotechnology company focused on the development of small-molecule therapeutics for the treatment of gout, cancer and human immunodeficiency virus (HIV), today reported recent accomplishments, announced fourth quarter and full-year 2009 financial results and provided key upcoming clinical development milestones and financial guidance for 2010.
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