|Cardiome Pharma shares up on EU approval. Inhibitex reports positive Phase1a results. IVAX sells majority interest|
|By BioMedReports.com Staff|
|Wednesday, 01 September 2010 17:58|
Cardiome Pharma Corp. (NASDAQ: CRME/ TSX: COM) and Merck (NYSE:MRK) today announced that the intravenous (IV) formulation of BRINAVESS (vernakalant) has been granted marketing approval in the European Union (EU), Iceland and Norway for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults: for non-surgery patients with AF of seven days or less and for post-cardiac surgery patients with AF of three days or less.
BRINAVESS acts preferentially in the atria and is the first product in a new class of pharmacologic agents for cardioversion of AF to launch in the EU.
"This medicine offers physicians, patients and hospitals an important new therapy option to use for the rapid treatment of recent-onset AF, and we are pleased to add this to our strong portfolio of medicines for cardiovascular disease," said Patrick Magri, senior vice president, general manager, Cardiovascular Franchise, Merck. "We welcome this important milestone in our collaboration with Cardiome and we look forward to launching BRINAVESS in the EU beginning in the fourth quarter of 2010."
"European approval of BRINAVESS and Merck’s subsequent launch represent an exciting juncture in Cardiome’s evolution which will provide us with our first commercial product revenues," said Doug Janzen, president and chief executive officer of Cardiome. "This success was made possible through the commitment and hard work of our employees and our partner Merck, the support of our shareholders, and the efforts of many dedicated medical professionals and patients who have taken part in the clinical program."
On heavy volume, shares of Cardiome were trading higher by more than 13% or 81 cents after the bell.
Inhibitex, Inc. (Nasdaq: INHX), announced today that it has successfully completed a Phase1a, first-in-man, single ascending dose trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV) infections. In this trial, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo. The Company plans to present detailed results from this trial during a future scientific meeting. Preliminary data from the trial are as follows: *INX-189 was generally well tolerated at all dose levels; *No drug-related serious adverse events; *No dose-related trends in frequency or type of adverse events; adverse events occurring in more than one subject were headache and nasal congestion; *No grade II or higher laboratory abnormality adverse events or clinically significant changes in ECGs; and *Pharmacokinetic data supports INX-189’s potential for once daily (QD) dosing.
"We are encouraged with the initial safety and pharmacokinetic profile of INX-189 in this first-in-man trial," stated Dr. Joseph Patti, Senior Vice President and Chief Scientific Officer of Inhibitex, Inc. "Based upon the pharmacokinetics observed in this study, we continue to believe that INX-189 has the potential to demonstrate antiviral activity with a low once-daily dose, and we look forward to assessing its ability to reduce HCV RNA viral loads in patients with chronic hepatitis C in a Phase 1b multiple ascending dose trial we plan to start in the fourth quarter."
Shares rose 14.79% or 21 cents to $1.63.
IVAX Diagnostics, Inc. (NYSE Amex: IVD), a fully integrated in vitro diagnostics company, announced that today ERBA Diagnostics Mannheim GmbH purchased from a group controlled by Patrice Debregeas and Paul Kennedy all of the approximately 72% of the outstanding shares of IVAX Diagnostics owned by their group for $0.75 per share, or an aggregate purchase price of approximately $15 million. ERBA Diagnostics Mannheim, headquartered in Mannheim, Germany, is an emerging player in the in vitro diagnostics market.
Shares of IVAX shot up 11 cents or more than 20% to 66 cents on the news.
Abbott (NYSE:ABT) announced today it has received approval from the U.S. Food and Drug Administration to market the Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus (HBV) in a patient's blood. It is the first and only approved test capable of automating HBV viral load testing from sample extraction to final results.
Allergan, Inc. (NYSE: AGN) today announced that it has reached a resolution with the United States Department of Justice (DOJ) regarding the previously reported Government investigation into Allergan's past U.S. sales and marketing practices relating to certain therapeutic uses of BOTOX® (onabotulinumtoxinA).
BSD Medical Corporation (NASDAQ: BSDM) today reported that the Company has received certification that the MicroThermX Microwave Ablation System (MTX-180) meets all requirements for safety and performance needed for compliance with the IEC 60601-1, safety standard, "Medical Electrical Equipment Part 1: General Requirements for Safety." IEC 60601-1 is the global benchmark for safety of medical equipment and is a crucial tool for demonstrating compliance with regulatory requirements around the world, including the requirements for CE Marking and FDA clearance. Receipt of this certification will allow BSD to add the TUV safety mark to the MTX-180 system. Nearly all hospitals and clinics in the U.S. require a safety mark on equipment prior to purchase.
Shares of BSD Medical jumped as high as $2.49 before pulling back and closing at $2.30, up 10 cents or 4.55%.
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract valued at up to $28.7 million with the National Institute of Allergy and Infectious Diseases (NIAID), an institute within the National Institutes of Health (NIH), for advanced development of the company’s third generation anthrax vaccine candidate. The award of this contract increases to over $58 million the total potential development funding from NIAID for this product. This product candidate, one of two third generation vaccines being developed as part of Emergent’s anthrax franchise, consists of BioThrax (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatory compound, CPG 7909 (VaxImmune).
"Emergent applauds the U.S. government’s commitment to protecting the nation against biological threats by supporting critical development of advanced vaccine and therapeutic candidates," said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions.
Genzyme Corp.(NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) announced that data from the phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH) were presented today at the European Society of Cardiology’s Congress 2010 in Stockholm, Sweden. The study met its primary endpoint with a 28 percent reduction in LDL-cholesterol, compared with an increase of 5 percent for placebo. The trial also met all of its secondary and tertiary endpoints. Frequently observed adverse events were injection site reactions, flu-like symptoms and elevations in liver transaminases, as seen in other mipomersen studies.
iBio, Inc. (OTCBB: IBPM), its development collaborator, Fraunhofer USA Center for Molecular Biotechnology (CMB), and GE Healthcare, a unit of General Electric Company (NYSE: GE), today announced their entry into an agreement to jointly develop and globally market manufacturing solutions for biopharmaceuticals and vaccines based upon their respective proprietary technologies. Financial terms are not being disclosed.
Intellect Neurosciences, Inc. (OTCBB:ILNS), a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and licenses with major pharmaceutical companies covering products in late-stage trials to treat and prevent Alzheimer's disease (AD), has announced that Daniel G. Chain, Ph.D., the company's chief executive officer and chairman of the board, will speak at the Rodman & Renshaw Annual Global Investment Conference in New York City on September 14, 2010.
Nabi Biopharmaceuticals (Nasdaq:NABI) announced today that it has entered into a long-term commercial manufacturing agreement with Diosynth RTP, Inc. (Diosynth) for the manufacture of Drug Substance integral to the production of NicVAX, Nabi's innovative and proprietary investigational vaccine for the treatment of nicotine addiction and prevention of smoking relapse.
PDL BioPharma, Inc. (PDL) (Nasdaq:PDLI) today announced revenue guidance for the third quarter ended September 30, 2010 of approximately $86 million, as compared with actual results of $71.4 million for the third quarter of 2009, a 20 percent year-over-year increase. The growth is primarily driven by increased second quarter 2010 sales of Avastin®, Herceptin®, Lucentis® and Tysabri® for which PDL receives royalties in the third quarter of 2010. Also included in third quarter 2010 guidance is $2.9 million earned on Eurodollar foreign currency hedging contracts that the Company initiated in January 2010. The royalty payment from Genentech included royalties generated on both U.S. and ex-U.S. manufactured products and sales.
Pfizer Inc. (NYSE:PFE) and FoldRx Pharmaceuticals, Inc., a privately held drug discovery and clinical development company, today announced that they have entered into an agreement under which Pfizer will acquire FoldRx. FoldRx's portfolio includes clinical and pre-clinical programs for investigational compounds to treat diseases caused by protein misfolding, which is increasingly recognized as an underlying cause in many chronic degenerative diseases. The company's lead product candidate, tafamidis meglumine, is in registration as an oral, disease-modifying therapy for TTR amyloid polyneuropathy (ATTR-PN), a progressively fatal genetic neurodegenerative disease, for which liver transplant is the only treatment option that is currently available. While specific financial terms were not disclosed, Pfizer will make an upfront payment and contingent payments if certain milestones are achieved.
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex:ANX) today announced that the Company's Chief Executive Officer, Brian M. Culley, will present at the Rodman & Renshaw Annual Global Investment Conference on Tuesday September 14, 2010 at 11:40 a.m. Eastern time, in the Hubbard Salon at the New York Palace Hotel in New York.
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