|Court allows class action suit against Amgen; AstraZeneca and Targacept Announce First Top-line Phase 3 Results for TC-5214|
|By Staff and Wire Reports|
|Tuesday, 08 November 2011 20:39|
A U.S. appeals panel upheld the certification of a securities class action accusing biotech company Amgen (NASDAQ:AMGN) of failing to disclose safety information about two products used to treat anemia.
Amgen allegedly exaggerated the safety of its products for FDA-approved uses, according to court documents. The plaintiff, a state pension fund, also alleged Amgen misrepresented its marketing practices, claiming it promoted its products solely for on-label uses when it in fact promoted significant off-label usage.
The 9th U.S. Circuit Court of Appeals ruled on Tuesday that a lower court did not abuse its discretion in certifying the class.
In order to win class certification, the plaintiff must plausibly allege -- but need not prove -- that Amgen's misrepresentations are material, the three-judge appeals panel ruled.
An Amgen representative could not immediately comment on Tuesday.
Shares of Amgen were down just over one percent at $57.84 in afternoon trading.
AstraZeneca (NYSE:AZN) and Targacept, Inc. (NASDAQ:TRGT) announced top-line results from the first of four RENAISSANCE Phase 3 studies investigating the efficacy and tolerability of TC-5214 as an adjunct therapy to an antidepressant in patients with major depressive disorder (MDD) who do not respond adequately to initial antidepressant treatment. The study did not meet its primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS) after eight weeks of treatment with TC-5214 as compared to placebo.
TC-5214 was overall well tolerated in the study and showed an adverse event profile generally consistent with the earlier Phase 2b study. Analyses of the full data set from the RENAISSANCE 3 study remain ongoing.
The RENAISSANCE clinical trial program consists of four randomized, double blind, placebo controlled Phase 3 efficacy and tolerability studies and a fifth long-term safety study. The results announced today are from the RENAISSANCE 3 study, a flexible dose trial conducted in Europe. All RENAISSANCE Phase 3 studies have now completed enrollment, and reporting of all results is expected by the first half of 2012.
TC-5214 has the potential to be a first-in-class nicotinic channel modulator to serve as an adjunct treatment for MDD in patients with an inadequate response to initial antidepressant therapies, for example, selective serotonin reuptake inhibitors (SSRIs) or serotonin/norephinephrine reuptake inhibitors (SNRIs).
An NDA filing in the US is planned for the second half of 2012, with an MAA filing in the EU targeted for 2015.
Abbott (NYSE: ABT) today announced five-year results from the open-label extension of the ATLAS study, which evaluated the long-term impact of treatment with HUMIRA® (adalimumab) on disease activity, including spinal mobility in patients with active ankylosing spondylitis (AS).
ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP),a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes,announced it has entered into an agreement with a major player in RNAi industry to exploit its CobaCyte and CobOral technology for the targeted delivery of RNAi therapeutics.
AmbiCom Holdings, Inc. (OTCQB: ABHI), a leading designer and developer of wireless products for the medical industry, announced today that it has signed an investment agreement for up to $1 million with Kodiak Capital Group, LLC, a Newport Beach, CA institutional investor.
American Oriental Bioengineering, Inc. (NYSE: AOB), a pharmaceutical company dedicated to improving health through the development, manufacture and commercialization of a broad range of prescription and over the counter ("OTC") products, today announced that it will reschedule its release of its third quarter 2011 financial results and earnings conference call.
AmpliPhi Biosciences Corporation (APHB.PK), a leader in the development of bacteriophage-based anti-bacterial therapies, has announced the appointment of Philip J. Young as President and Chief Executive Officer (CEO).
ArQule, Inc. (Nasdaq: ARQL) today announced that the Company will present at the Lazard Capital Markets 8th Annual Healthcare Conference on November 15, 2011 at 11:00 a.m.
BioNeutral Group, Inc. (OTCBB: BONU), a specialty life science technology-based company, today announced that it has signed definitive financing and strategic distribution agreements, which will result in the assumption of, and indemnification for, $2.3 million in accounts payable and the assumption of, and indemnification for, $2 million in notes payable.
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in Europe today announced its financial results for the third quarter ended September 30, 2011 and provided a corporate update.
Boston Scientific Corporation (NYSE: BSX) reports positive long-term data from the PERSEUS clinical program, which demonstrated favorable two-year safety and effectiveness outcomes for the ION™ (TAXUS Element) Paclitaxel-Eluting Platinum Chromium Stent System versus prior-generation paclitaxel-eluting stents.
Callidus Software Inc. (NASDAQ: CALD), the leader in Sales Performance Management (SPM), announced today that Callidus' iCentera, the leading provider of on-demand portal software for sales enablement, has been awarded the new US. Patent No. 8,046,387 for its sales enablement platform.
Cerus Corporation (NASDAQ:CERS) announced today that Laurence Corash, chief medical officer, is scheduled to present a corporate update at the Lazard Capital Markets 8th Annual Healthcare Conference in New York at 10:00 AM EDT on Tuesday, November 15, 2011.
Codexis, Inc. (Nasdaq: CDXS) today announced the company will present at the 2nd Annual Baird Clean Technology Conference, to be held in San Francisco, CA on November 30 – December 1, 2011.
Compugen Ltd. (NASDAQ: CGEN) today reported financial results for the third quarter ending September 30, 2011.
CONMED Corporation (NASDAQ: CNMD), a medical technology company specializing in medical devices for surgical and patient monitoring markets, announced today that the Company will participate in the Lazard Capital Markets 8th Annual Healthcare Conference on Wednesday, November 16, 2011 at 1:00 PM Eastern time, in New York City.
CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today reported financial results for the three months and nine months ended September 30, 2011, and provided a business update.
Daxor Corporation, (NYSE Amex: DXR), a medical instrumentation and biotechnology company, announced today that a dividend will be paid during the fourth quarter of 2011.
Discovery Laboratories, Inc. (Nasdaq: DSCO) today announced that newdata supporting AFECTAIR™, the Company's newest product candidate, was presented at the American Association for Respiratory Care (AARC) Congress 2011, internationally recognized as the most relevant medical meeting dedicated to advancing the science and practice of respiratory care.
Fibrocell Science, Inc. (OTCBB: FCSC), an autologous cellular therapeutic company focused on the development of innovative products for aesthetic, medical and scientific applications, announced today that David Pernock, the Company’s Chairman and CEO, will host an investor conference call to discuss Fibrocell’s business update for the third quarter ended September 30, 2011 on Thursday, November 17, 2011 at 4:30 PM Eastern Time.
Given Imaging (NASDAQ: GIVN) today announced that Yuval Yanai, Chief Financial Officer, will present at the Lazard Capital Markets 8th Annual Healthcare Conference taking place November 15 - 16, 2011 in New York City.
Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today reported financial results for the third quarter and nine-months ended September 30, 2011.
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 that the Japanese Patent Office has granted the company two new patents for its Alzheimer's immunotherapy programs.
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced financial results for the third quarter ended September 30, 2011.
MELA Sciences, Inc. (NASDAQ: MELA) announced today that Joseph V. Gulfo, MD, President and CEO, will present at upcoming investor conferences in New York City.
Micromet, Inc. (NASDAQ: MITI), a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of cancer, today announced that data on its lead product candidate blinatumomab (MT103) will be reported at the 53rd Annual American Society of Hematology (ASH) Annual Meeting, to be held December 10 – 13 in San Diego, California.
Omeros Corporation (NASDAQ: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system, today announced its financial results for the third quarter of 2011.
Oncothyreon Inc. (Nasdaq: ONTY) announced today that the company will be presenting at the Lazard Capital Markets 8th Annual Healthcare Conference in New York on Tuesday, November 15, 2011 at 9:30 a.m. Eastern Standard Time.
Opexa Therapeutics, Inc. (NASDAQ: OPXA), announced today that its lead drug candidate Tovaxin® has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Secondary Progressive Multiple Sclerosis (SPMS).
PROLOR Biotech, Inc. (NYSE Amex: PBTH), a clinical stage company developing next generation biobetter therapeutic proteins, today announced that company management will give a corporate presentation at the Lazard Capital Markets 8th Annual Healthcare Conference at 9:00 AM EST on November 15, 2011.
ShangPharma Corporation (NYSE: SHP), a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced that it has, through its wholly-owned Chinese subsidiary, Shanghai ChemPartner Co. Ltd. ("ChemPartner"), achieved a major milestone in the research and development of Sangamides, a new class of cyclophilin-inhibiting host-targeted anti-virals for the treatment of Hepatitis C virus (HCV) infection.
Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of vaccines in China, today announced that management is scheduled to present at the Cowen and Company China Opportunity Conference that will be held on November 15 – 16 at The St. Regis Beijing.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that the Company will be presenting at the Lazard Capital Markets 8th Annual Healthcare Conference on Tuesday, November 15 at 3:30 p.m. (ET) in New York.