|Acura Submits Investigational New Drug; Merck Says Study of TREDAPTIVE Did Not Achieve Primary Endpoint|
|By Staff and Wire Reports|
|Thursday, 20 December 2012 19:52|
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) announced that an Investigational New Drug application ("IND") has been filed with the U.S. Food and Drug Administration (FDA) to allow clinical testing of Acura's hydrocodone bitartrate with acetaminophen formulated with Aversion(R) Technology. Clinical testing can commence under the IND 30 days following the IND filing unless questions are raised by the FDA. An open IND is required for Acura to initiate intranasal abuse liability testing in recreational drug users of the crushed drug product. This study is part of a comprehensive development program we intend to complete in anticipation of submitting a 505(b)(2) NDA for our hydrocodone/acetaminophen product in the first half of 2014.
The plan also includes: -- a pharmacokinetic study demonstrating dose proportionality and evaluating the food effect; -- a battery of laboratory studies demonstrating extraction, syringing and particle size characteristics; -- a pharmacokinetic study to establish a bridge to a new contract manufacturer; and -- an assessment of the routes of abuse of hydrocodone products. Acura continues to evaluate possible partnering of our Aversion development products with alternative strategic partners.
Merck (NYSE: MRK), known outside the United States and Canada as MSD, announced the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of TREDAPTIVE™(extended-release niacin/laropiprant) did not meet its primary endpoint. Merck and the investigators are informing regulatory agencies of these results. The company is also preparing communications to health care providers in countries where the medicine is currently available, and will continue to work with regulators to provide updated information to health care providers. Based on the current understanding of these new data and until further analyses can be completed, Merck is recommending that providers not start new patients on TREDAPTIVE. Merck does not plan to seek regulatory approval for the medicine in the United States.
HPS2-THRIVE was independently conducted by the Clinical Trial Service Unit at Oxford University and funded by Merck. The study enrolled 25,673 patients considered to be at high risk for cardiovascular events. Of those enrolled, 14,741 were from Europe (the United Kingdom and Scandinavia) and 10,932 were from China. Patients in the study were followed for a median of 3.9 years. HPS2-THRIVE compared extended -release niacin and laropiprant plus statin therapy versus statin therapy. It was not designed to assess directly the separate effects of either extended-release niacin or laropiprant.
In the study, adding the combination of extended-release niacin and laropiprant to statin therapy did not significantly further reduce the risk of the combination of coronary deaths, non-fatal heart attacks, strokes or revascularizations compared to statin therapy. In addition, there was a statistically significant increase in the incidence of some types of non-fatal serious adverse events in the group that received extended-release niacin/laropiprant.
With the agreement of the independent research team at Oxford University, Merck is sharing results from the study with regulatory agencies in countries where the medicine is approved (under the brand names TREDAPTIVE or CORDAPTIVE) and in other countries as well. The investigators are conducting additional analyses, including regional analyses, to further understand the results. They anticipate reporting the detailed study results in the first quarter of 2013.
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it will receive funding from Fast Forward, LLC, a not-for-profit organization established by the National Multiple Sclerosis Society, and EMD Serono, a subsidiary of Merck KGaA, Darmstadt, Germany.
ActiveCare, Inc. (OTCBB: ACAR), the service leader in disease and diabetes management, today reported the expansion of its customer contract with Southern Benefit Services, LLC.
Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, today announced that its iPS cell-derived human platelet program has been named as one of the “10 Ideas That Will Shape The Year” in the ‘Christmas and New Year Special’ issue of the New Scientist, widely considered to be one of the most influential science and technology news magazines in the world.
Amarantus BioScience, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments for diseases associated with protein misfolding and apoptosis, today announced that Dr. John W. Commissiong, CSO will present results of its Parkinson's disease neurorestoration animal studies at the OneMedForum SF 2013 conference on Tuesday, January 8, 2013 at 1:40pm PT.
BioClinica®, Inc. (NASDAQ: BIOC), a leading global provider of clinical trial management solutions, today announced Mark L. Weinstein, President and Chief Executive Officer will be presenting at the Conference in New York City on Monday, January 7, 2013 at 1:30 p.m. EST.
BioTime, Inc. (NYSE MKT: BTX) today announced the appointment of Jeffrey Janus as its Vice President of Sales and Marketing. Mr. Janus’ primary focus will be to create, market, and sell research products for BioTime and its subsidiaries in the expanding field of regenerative medicine.
China Cord Blood Corporation (NYSE: CO) ("CCBC" or the "Company"), the first and largest cord blood banking operator in China, today announced the results of its 2012 Annual General Meeting, which was held on December 19, 2012, in Hong Kong.
Covidien (NYSE:COV), a leading global provider of healthcare products, today announced the five-year results of the ClosureFast™ Long-Term European Multi-Center Study in patients with Chronic Venous Insufficiency (CVI).
Critical Diagnostics, a U.S.-based biomarker company focused on cardiovascular diseases and Quest Diagnostics (NYSE: DGX) and its subsidiary Berkeley HeartLab, announced today an agreement under which both Quest and Berkeley HeartLab will offer ST2 testing services based on Critical Diagnostics’ Presage ST2 Assay.
Dendreon Corporation (NASDAQ: DNDN) today announced the sale of its immunotherapy manufacturing facility (IMF) based in Morris Plains, New Jersey, to Novartis Pharmaceuticals Corporation for $43 million in cash.
EasyMed Services, Inc. (CNSX:EZM) (OTCBB:EMYSF) (MUN:EY6) (the "Company" or "EasyMed") is pleased to announce that further to its news release of December 10, 2012, it has closed a non-brokered private placement of 1,470,588 units ("Units") at a price of Cdn. $0.85 per Unit for gross proceeds of up to Cdn. $1,250,000 (the "Offering").
Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, will host a conference call to discuss its fourth-quarter and full-year 2012 results and projections for 2013 on Wednesday, Feb. 13, 2013, at 8 a.m. Central time.
Humedica, Inc. and Pfizer Inc. (NYSE: PFE) today announced a multi-year strategic alliance to jointly advance capabilities to derive insights from real world data.
Inovio Pharmaceuticals, Inc. (NYSE MKT: INO), which is revolutionizing vaccines to combat cancers and infectious diseases, announced today that Dr. J. Joseph Kim, President and CEO, will be presenting a corporate overview of the company at the Biotech Showcase 2013 investor conference.
InspireMD, Inc. (OTC: NSPR) announced that it is effectuating a one-for-four reverse stock split of the Company's common stock.
Merck (NYSE:MRK), known outside the United States and Canada as MSD, today announced that the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of TREDAPTIVE™(extended-release niacin/laropiprant) did not meet its primary endpoint. Merck and the investigators are informing regulatory agencies of these results.
Mylan Inc. (Nasdaq: MYL) today announced that its Mylan Institutional business is conducting a voluntary nationwide recall to the retail level of three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Lots 3037841, 3040859 and 3042573).
Neogen Corporation (NASDAQ: NEOG) announced today that its net income for the second quarter of FY 2013, which ended Nov. 30, increased 30% to $6,793,000, from the previous year's second quarter net income of $5,237,000.
Novation Holdings (OTCBB:NOHO) today announced that the company's stock trading symbol has been changed by FINRA to NOHO from the prior symbol ALZM, effective today.
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced that Paul Sawin, M.D., performed the first PCM Cervical Disc surgery on a patient in Orlando, Florida, today.
Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced that the Company will present at the 31st Annual J.P. Morgan Healthcare conference on Tuesday, January 8, 2013 at 8:00 AM Pacific Time and provide a business overview and update.
Rite Aid Corporation (NYSE: RAD) today reported improved financial results for its fiscal third quarter ended Dec. 1, 2012.
Trovagene, Inc. (NASDAQ: TROV) today announced it has granted Genoptix, Inc. (a Novartis Group Company) a worldwide, non-exclusive license to incorporate nucleophosmin protein (NPM1) into research and clinical testing services for acute myelogenous leukemia (AML).
TRIMEDYNE, INC. ("Trimedyne") (OTCBB: TMED) today announced that Robert S. Cowles, III, M.D. has agreed to serve as Co-Chairman with Dr. Marvin P. Loeb of the Boards of Directors and as Medical Director of Urodyne, Inc. ("Urodyne") and Hyperdyne, Inc. ("Hyperdyne"), two subsidiaries Trimedyne plans to organize. (See Trimedyne's Press Release of November 28, 2012).