|Lilly Schizophrenia Drug Yields Negative Results; FDA Approves Watson's ARTHROTEC(R)|
|By Staff and Wire Reports|
|Wednesday, 11 July 2012 18:44|
Eli Lilly & Co. (NYSE:LLY) said results from its clinical trial investigating a drug to treat patients suffering an acute exacerbation of schizophrenia missed the study's primary endpoint.
The trial was intended to be the first of two that would support registering the drug, pomaglumetad methionil, to treat acute schizophrenia. The second clinical trial is currently ongoing and will yield results later this year.
The company also said it is awaiting results from a recently concluded study exploring the use of the drug as an adjunctive treatment with atypical antipsychotics. Data from these two studies will help Eli Lilly make decisions on the future development of pomaglumetad methionil.
Unlike all currently available antipsychotic drugs, pomaglumetad methionil doesn't interact with the central nervous system receptors thought to be responsible for issues like motor dysfunction, reproductive hormone irregularity and weight gain associated with present schizophrenia treatments, Lilly said.
Earlier this month, the company said its blockbuster antidepressant Cymbalta will have an additional six months of U.S. market exclusivity--through December 2013--because the company studied the drug's effects on children. In April, Lilly reported that first-quarter sales of Cymbalta rose 23% to $1.11 billion.
The company is grappling with a number of patent expirations for top-selling drugs, including its antipsychotic Zyprexa last October. Like other pharmaceutical companies, Lilly has been working to fill its pipeline through acquisitions, its own research labs and by collaborating with several other major drug makers--including efforts in emerging markets such as India and China.
Shares were down 35 cents to $42.51 in recent premarket trading. The stock is up 15% in the last 12 months.
Watson Pharmaceuticals, Inc. (NYSE: WPI) announced its subsidiary Watson Laboratories, Inc - Florida, has received approval from the US FDA on its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium and Misoprostol Delayed-Release Tablets, the generic equivalent to G.D. Searle's ARTHROTEC®. Watson plans to launch the product in the fourth quarter of 2012.
For the twelve months ending May 31, 2012, ARTHROTEC® had total U.S. sales of approximately $130 million according to IMS Health data. ARTHROTEC® is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.
Accelr8 Technology Corporation (NYSE: AXK), a developer of automated diagnostic systems for same-shift identification and antibiotic resistance testing of bacterial and fungal pathogens, announced today that Dr. Matthew Strobeck has been appointed to Accelr8's Board of Directors.
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that the Company will report its financial results for the second quarter ended June 30, 2012 on Wednesday, July 25, 2012 before the financial markets open.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has presented new pre-clinical data with its RNAi therapeutic for the treatment of hemophilia at the World Federation of Hemophilia World Congress being held July 8-12, 2012 in Paris.
Arrowhead Research Corporation (NASDAQ: ARWR), a targeted therapeutics company, today announced that the first patient has been dosed in a Phase 1 clinical trial with Adipotide®, a new class of treatment for obesity.
BioClinica®, Inc., (NASDAQ: BIOC), a leading global provider of clinical trial management solutions, will release its financial results for the second quarter ended June 30, 2012 on Wednesday, August 8, 2012.
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, will report financial results for the second quarter 2012 on Tuesday, August 7, 2012, after the close of the market.
CryoLife, Inc. (NYSE: CRY), a leading tissue processing and medical device Company focused on cardiac and vascular surgery, announced today that 2012 second quarter financial results will be released on Tuesday, July, 31, 2012.
Galectin Therapeutics (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that it has been added to the Russell Microcap Index effective at the close of equity markets on June 22, 2012.
Given Imaging (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) has issued reimbursement codes for the PillCam Patency Capsule for use with PillCam SB® and for the PillCam SB video capsule for expanded indications for patients with known or suspected small bowel disease, including the visualization and diagnosis of Crohn's disease.
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops anticancer therapeutics using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced the start of clinical testing with its IMGN853 product candidate.
IsoRay Inc. (NYSE MKT: ISR) (NYSE Amex: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced another step forward in international adoption of its ground-breaking GliaSite® radiation therapy system, the world's only liquid radiation balloon catheter device used in the treatment of brain cancers.
Life Technologies Corporation (NASDAQ: LIFE) today announced that its newly appointed Chief Sustainability Officer, Cristina Amorim, has been named Sustainability Executive of the Year at the Ethical Corporation's annual Responsible Business Forum awards ceremony.
Life Technologies Corporation (NASDAQ: LIFE) today announced that it will accelerate development of its Ion Torrent Semiconductor technology for a broad set of proteomic and antibody-based applications after passing internal Life Technologies R&D milestones.
Micro Imaging Technology, Inc. (OTCBB: MMTC) (OTCQB: MMTC) announced that it will unveil the first commercial unit of its Rapid Microbial Identification System, the MIT 1000, at the Annual Meeting of the International Association for Food Protection (IAFP) in Rhode Island -- July 22 through July 25, 2012.
OncoSec Medical Inc. (OTCBB:ONCS), a company developing the advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumors, announces it has established the University of California San Francisco (UCSF) as the second enrolling site for its Phase II Merkel cell carcinoma clinical trial (OMS-I110).
Announcing its third patent approval since the beginning of the calendar year, Oramed Pharmaceuticals Inc. (OTCBB:ORMP.OB) (www . oramed . com), a developer of oral drug delivery systems, announced today that its patent, titled "Methods and Compositions for Oral Administrations of Proteins," was approved by the New Zealand Patent Office.
PAREXEL International Corporation (NASDAQ: PRXL) will release financial results for the Fourth Quarter and Fiscal Year 2012 on Wednesday, August 8, 2012 after the close of the stock market.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced that the United Kingdom High Court of Justice issued a decision in favor of Teva in a patent litigation proceeding against Generics (UK) Limited, a subsidiary of Mylan Laboratories Inc., on July 11, 2012.
Vitacost.com (NASDAQ: VITC), a leading online retailer of health and wellness products, recently re-launched its mobile commerce website with significant new functionality created to satisfy the specific preferences of its loyal customer base. The new mobile website was developed in partnership with Moovweb, the leader in rapid mobile web development solutions.