|FDA Will Not Approve Merck's Experimental Drug For Now; ACADIA Announces Collaboration With Allergan|
|By Staff and Wire Reports|
|Monday, 05 March 2012 20:53|
Federal regulators have rejected Merck & Co.’s (NYSE:MRK) new combination cholesterol drug, which includes a generic version of the mega-blockbuster Lipitor — at least for now.
It’s unclear how long the ruling, announced Monday, might delay approval of the drug, as the Food and Drug Administration is requiring additional study data on the compound. It combines generic Lipitor, the top-selling drug of all time, with Merck’s cholesterol medicine Zetia.
Approval could boost Merck’s sagging cholesterol franchise by essentially replacing its existing combo pill, Vytorin, with one likely to be seen as more powerful. Vytorin sales have been dwindling for a few years due to concerns about how well it works, and now Merck has to contend with patients possibly defecting to the generic versions of Pfizer Inc.’s Lipitor that came on the market at the end of November.
Merck said that company officials will talk with the FDA to determine the next steps, adding that some new data expected later this year may address the FDA’s concerns.
Wall Street seemed unfazed by the news, perhaps because the FDA increasingly asks for additional data before approving many new drugs. In morning trading, Merck shares were up 38 cents at $38.31.
The experimental drug, still known only as MK-0653C, contains medicines that fight high cholesterol in two different ways to reduce risk of heart attack and stroke.
Lipitor, known chemically as atorvastatin, is part of the widely used class of drugs called statins that reduce the amount of cholesterol naturally produced in the liver.
Zetia, on the other hand, reduces the amount of cholesterol absorbed from the food the patient eats.
Vytorin includes Zetia and an older statin, Merck’s Zocor, also called simvastatin.
Sales of Vytorin and Zetia both were hurt when Merck, under pressure from a congressional probe, in early 2008 finally released unfavorable results from a study it had hoped would bolster Vytorin sales. Instead, it showed that Vytorin was no better at reducing plaque buildup in neck arteries than just Zocor, which had been available as a cheap generic since 2006. Zetia, also known as ezetimibe, is protected by patent in the U.S. until 2017.
Lipitor, which had peak sales of around $13 billion, is a more powerful statin then Zocor. That could mean that if the new combination drug is approved, it would be tried by at least some patients who have not been able to get their cholesterol numbers to their goal with Vytorin or other treatments.
Meanwhile, last year Lipitor maker Pfizer, Inc. (NYSE:PFE) sued, alleging Merck’s application for the FDA to approve the Zetia-atorvastatin combination infringed on a Pfizer patent covering atorvastatin.
A Merck spokeswoman said Monday that the lawsuit “has the potential for holding up FDA approval of the Merck product until” the first quarter of 2014.
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) announced it has extended its drug discovery and development collaboration with Allergan, Inc. (NYSE: AGN). The collaboration is currently focused on the discovery of new therapeutics for glaucoma and other ophthalmic indications and was originally established in March 2003. The research term of this collaboration has now been extended by the parties for an additional year through March 2013. ACADIA also has two other collaboration agreements with Allergan, which have led to clinical programs in the areas of chronic pain and glaucoma.
“We are pleased to extend our longstanding drug discovery collaboration with Allergan,” said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. “This productive alliance has continued to lead to interesting discoveries, which we hope to be able to translate into potential new therapies for glaucoma and related ophthalmic conditions.”
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 has extended its drug discovery and development collaboration with Allergan, Inc. (NYSE: AGN).
Agilent Technologies Inc. (NYSE: A) today introduced Agilent SureFISH probes, the next generation of fluorescent in situ hybridization (FISH) assays, delivering a comprehensive menu of the industry’s highest resolution probes for a wide range of molecular analysis applications.
Alkermes plc (NASDAQ: ALKS) today announced that Mark Stejbach has been appointed Chief Commercial Officer. In this newly created role, Mr. Stejbach will be responsible for Alkermes’ commercial activities, including marketing and sales of VIVITROL® (naltrexone for extended-release injectable suspension) and developing and executing commercial strategies for Alkermes’ late-stage pipeline assets, namely ALKS 9070 (for schizophrenia), ALKS 37 (for opioid-induced constipation) and ALKS 5461 (for treatment-resistant depression).
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2011.
Antares Pharma, Inc. (NYSE Amex: AIS) today announced it will release its fourth quarter and full year 2011 financial results before the market opens on Monday, March 12, 2012, and host a conference call shortly thereafter at 8:00 a.m. ET (Eastern Time) to discuss the results.
Assisted Living Concepts, Inc. (NYSE: ALC) announced that it will participate in the 2012 Sidoti Emerging Growth Institutional Investor Forum on March 19, 2012 at the Grand Hyatt New York located at 109 East 42nd Street, Grand Central Terminal, New York, NY 10017.
Astex Pharmaceuticals, Inc. (NASDAQ:ASTX), today reported financial results for the fourth quarter and year ended December 31, 2011.
BioClinica®, Inc. (NASDAQ: BIOC), a global provider of clinical trial management solutions, today announced that Grünenthal GmbH has signed a global license agreement for BioClinica OnPoint CTMS to support its ongoing clinical trials.
BioLineRx (NASDAQ:BLRX) (TASE:BLRX) a biopharmaceutical development company, announced today that it has received approval from the Israeli Ministry of Health for commencing a Phase II clinical trial of BL-7040, an orally available molecule for treating Inflammatory Bowel Disease (IBD).
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced publication of results from a Phase I dose escalation clinical study that show its GVAX Prostate cancer vaccine in treating metastatic castration-resistant prostate cancer patients (mCRPC) in combination with ipilimumab (Ipi; Yervoy; BMS), resulted in 53 percent of patients achieving at least stable disease, with two patients showing clear regression of metastases.
Cannabis Science, Inc. (OTCBB:CBIS.ob), a pioneering US biotech company developing pharmaceutical cannabis products, is pleased to announce final negotiations to target an immediate European expansion with opportune acquisitions & licensing deals.
Catalyst Health Solutions, Inc., (NASDAQ: CHSI) today announced that it was named to Fortune’s “World’s Most Admired Companies” list for 2012.
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the Solitaire™ FR revascularization device has been cleared by the U.S. Food and Drug Administration.
CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that President and Chief Executive Officer Steven A. Kriegsman and Vice President of Business Development David J. Haen will present a business update at the Roth Capital Partners 24th Annual OC Growth Stock Conference on Monday, March 12 at 12:30 p.m. Pacific time (3:30 p.m. Eastern time).
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, reported that on March 3, 2012, the company filed its official response to the Centers for Medicare & Medicaid Services (CMS) on its Proposed National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR).
Exelixis Inc. (NASDAQ:EXEL) today announced the initiation of a phase 1 dose-finding trial of cabozantinib in combination with abiraterone in men with metastatic castration-resistant prostate cancer (CRPC) who have disease progression following treatment with up to two prior chemotherapy regimens.
Galectin Therapeutics Inc. (OTC: GALT) (the “Company”) announced today that it has appointed Thomas A. McGauley as the Acting Chief Financial Officer of the Company, effective March 6, 2012.
ICON plc, (NASDAQ: ICLR), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has been selected by Roche as its technology partner for storing and managing medical images collected during the company’s clinical research programs.
ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, announced that its president and CEO, Manish Singh Ph.D., will be presenting at the Cowen and Company’s 32nd Annual Health Care Conference on Monday, March 5th, at 2:10 p.m., on the 4th floor, Salon C of the Marriot Hotel in Boston, Massachusetts.
InSite Vision Incorporated (OTCBB:INSV), a company developing ophthalmic products for unmet eye care needs, today announced that the company’s Annual Meeting of Stockholders will be held at 10:00 a.m. Pacific Time on Thursday, May 31, 2012, for shareholders of record on April 6, 2012.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that John Higgins, President and Chief Executive Officer and Matt Foehr, Chief Operating Officer and Executive Vice President of Ligand, will present at the 24th Annual Roth Conference on Monday, March 12, 2012 at 2:00 p.m. Pacific (5:00 p.m. Eastern Time).
Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS clinical technology solutions that enhance the efficiency of clinical development, today announced an update with respect to its tax position and litigation settlement with DataSci.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the results from a Phase III clinical study of its investigational allergy immunotherapy tablet (AIT) for ragweed pollen.
Medtronic, Inc. (NYSE: MDT) today announced the receipt of CE Mark (Conformité Européenne) and launch of the CapSure Sense MRI™ SureScan® pacing leads, which are approved for use during Magnetic Resonance Imaging (MRI). Medtronic introduced the first MR-Conditional pacemaker system in the world in 2008 and in the U.S. in 2011.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Peter Kim, president of Merck Research Laboratories, is scheduled to present at the Cowen & Company 32nd Annual Health Care Conference in Boston, Mass. on March 6 at 8:40 a.m. EST.
Metabolix, Inc. (NASDAQ: MBLX), a bioscience company focused on developing clean, sustainable solutions for plastics, chemicals and energy, today announced that it has appointed Matthew Strobeck, Ph.D., to its board of directors.
NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that March 29th, 2012 has been confirmed by the US FDA as the date for its initial meeting with the Company’s scientists.
Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, released information today about the company’s cell encapsulation technology and the breakthrough in stem cell research which overcomes specific fundamental challenges faced in stem cell therapy—host rejection and migration of implanted cells away from the target site.
Pall Corporation (NYSE:PLL) will present its new Acrodisc® MS Syringe Filter, the first syringe filter certified for low extractables in high performance liquid chromatography/mass spectrometry (LCMS) applications, at the 2012 Pittcon Conference and Expo.
Repligen Corporation (NASDAQ:RGEN) announced today that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for SecreFlo™ to improve detection of pancreatic duct abnormalities in patients with pancreatitis.
Santarus, Inc. (NASDAQ: SNTS) today reported financial and operating results for the three and 12 month periods ended December 31, 2011.
Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today reported preliminary revenues for its second quarter of fiscal year 2012 ended February 29, 2012 (2QFY12).
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced positive findings from four Phase III clinical studies that examined the efficacy and safety profile as well as impact on quality of life (QoL) of QNASLTM (beclomethasone dipropionate [BDP]) Nasal Aerosol.
VistaGen Therapeutics, Inc. (OTCBB: VSTA) (OTCQB: VSTA), a biotechnology company applying stem cell technology for drug rescue, and Duke University, one of the country's premier academic research institutions, have entered into a strategic research collaboration aimed at combining their complementary expertise at the forefront of cardiac stem cell technology, electrophysiology and tissue engineering.
XenoPort, Inc. (Nasdaq: XNPT) announced today that it will provide access via the World Wide Web to its presentation at the Cowen and Company 32nd Annual Health Care Conference.
Zalicus Inc. (NASDAQ: ZLCS) a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases today announced the successful completion of a Phase 1 clinical trial evaluating the pharmacokinetics and safety of a new formulation of Z160, a novel oral N-type calcium channel blocker.