• ARCA Discovery Inc., of Denver, said investigators presented several new analyses of the beta-blocker and vasodilator bucindolol at the American Heart Association Scientific Sessions 2007. An analysis from the 2,708-patient Phase III BEST heart failure trial showed the drug caused a significant reduction in cardiovascular hospitalizations, and a subgroup analysis showed that genetic targeting of the beta-1 AR 389 polymorphism may improve clinical responses to the drug. Additional data showed a positive effect of bucindolol in atrial fibrillation and ventricular arrhythmias. ARCA plans to file a new drug application for the drug and a companion diagnostic.

• Astellas Pharma US Inc., of Deerfield, Ill., presented data demonstrating that vernakalant hydrochloride increased the conversion to normal heart rhythm in patients with atrial fibrillation following coronary artery bypass graft or valvular surgeries. The data were presented at the American Heart Association Scientific Sessions 2007. Vernakalant hydrochloride is partnered with Cardiome Pharma Corp., of Vancouver, British Columbia, and has been submitted for FDA approval. (See BioWorld Today, June 5, 2007.)

• BioMarin Pharmaceutical Inc., of Novato, Calif., said that its partner Merck Serono, of Darmstadt, Germany, has submitted the marketing authorization application to the European Medicines Agency for sapropterin dihydrochloride as an oral treatment for patients suffering from significant hyperphenylalaninemia due to phenylketonuria or tetrahydrobiopterin deficiency. Acceptance of the MAA filing by the EMEA triggers a $15 million milestone payment to BioMarin, which is expected in the fourth quarter of 2007. Sapropterin has received orphan medicinal product designation in the European Union.

• Biopure Corp., of Cambridge, Mass., submitted a complete response to questions from the UK Commission on Human Medicines regarding potential marketing approval for Hemopure in acutely anemic orthopedic surgery patients. Biopure originally submitted its marketing application in July 2006, received a provisional opinion letter in December 2006 and met with the agency to review proposed responses in September 2007. The company expects a final decision in four to six months. Hemopure, a purified hemoglobin blood substitute, also is in clinical trials and used under "compassionate use" provisions in the U.S.

• CombinatoRx Inc., of Cambridge, Mass., entered a research collaboration with nonprofit groups Charley's Fund and the Nash Avery Foundation to identify disease-modifying, multi-targeted treatments for Duchenne muscular dystrophy. CombinatoRx will receive up to $3 million in research funding to conduct drug discovery work and will own intellectual property and all rights to resulting product candidates.

• Dyax Corp., of Cambridge, Mass., expanded its antibody library collaboration with ImClone Systems Inc., of New York, giving ImClone access to Dyax's phage display technology for an additional four years. Specific terms were not disclosed, although Dyax will continue to receive annual license fees from ImClone as well as potential milestones and royalties on resulting products. Thus far, ImClone has advanced into Phase II trials three fully human monoclonal antibodies identified using Dyax's technology.

• Emergent BioSolutions Inc., of Rockville, Md., said that it has been advised that the Department of Defense intends to pursue a collaborative arrangement with the Department of Health and Human Services to facilitate the use by the military of stockpiled doses of BioThrax (anthrax vaccine adsorbed) to prevent future waste of government funding and resources and that the DoD is cancelling its previously announced request for proposal. The DoD advised the company that the actions were in response to a recent Government Accountability Office report in which it was recommended that HHS and DoD develop a single integrated inventory system to improve efficiency. The firm said that the action by DoD has no impact on the Emergent's current multi-year contract with HHS worth $448 million, which was signed in September.

• GlobeImmune Inc., of Louisville, Colo., presented additional data from a Phase Ib trial of GI-5005 in hepatitis C virus infection. The drug demonstrated a favorable safety profile, trends toward a dose-dependent response, viral load reductions in six patients and immune responses. The data were presented at the Annual Meeting of the American Association for the Study of Liver Diseases. GI-5005, an active immunotherapy product, is now in a Phase II trial.

• Inverness Medical Innovations Inc., of Waltham, Mass., entered an agreement with Chemogen Inc., of South Portland, Maine, for the worldwide manufacture and distribution of tests for rapidly detecting Mycobacterium, the primary causative agent of tuberculosis. Those tests will use Chemogen's antibodies to detect Lipoarabinomannan antigen in urine to help diagnose current mycobacterial infection, especially in HIV-positive patients. Financial terms were not disclosed.

• Kedrion SpA, of Lucca, Italy, and ProMetic BioTherapeutics Inc., of Montreal, reached a preliminary agreement for multiple hyperimmunes, under which Kedrion will license technologies from ProMetic to enable hyperimmune manufacturing in Europe. The agreement, expected to close shortly, is based on license fees, service fees and royalties to be pay to ProMetic. Specific terms were not disclosed.

• Metabolon Inc., of Research Triangle Park, N.C., said it has signed a contract with the U.S. Army Medical Research Institute of Infectious Diseases to use the firm's metabolomics platform to study the biochemical profiles of humans given the AVA anthrax vaccine. The AVA vaccine is the only FDA-licensed anthrax vaccine for humans. Financial terms were not disclosed.

• Neurochem Inc., of Laval, Quebec, discontinued its European Phase III trial of Alzhemed (tramiprosate) in Alzheimer's disease and said it instead plans to commercialize the product as a branded nutraceutical as early as next year. Alzhemed previously failed a U.S. Phase III trial, but the follow-on portion of the study is ongoing. Neurochem said it also plans to advance the prodrug NRM-8499 into preclinical studies for Alzheimer's and initiate a Phase II trial with Kiacta (eprodisate) in Type II diabetes early next year. Kiacta has received two approvable letters from the FDA for AA amyloidosis and is under review again in the U.S. and in Europe. (See BioWorld Today, July 19, 2007, and Aug. 28, 2007.)

• NicOx SA, of Sophia Antipolis, France, presented data from an exploratory blood pressure study of anti-inflammatory drug naproxcinod. The study showed that patients receiving naproxcinod had lower blood pressure than those receiving the nonsteroidal anti-inflammatory agent naproxen, with the findings reaching statistical significance for diastolic blood pressure but not for systolic blood pressure. The data were presented at the American Heart Association Scientific Sessions 2007. Naproxcinod is in Phase III trials for osteoarthritis.

• Pluristem Life Systems Inc., of New York, said it intends to conduct a 200-for-1 reverse stock split in conjunction with its previously announced application to list its shares on the Nasdaq capital market. The stem cell company's shares (OTC BB:PLRS) closed at 3 cents on Thursday, unchanged.

• Qiagen NV, of the Netherlands, said that data showed the FastHPV, a molecular test for cancer-causing types of human papillomavirus (HPV), could reduce the incidence of cervical cancer by as much as 56 percent if given just three times over a woman's life and combined with appropriate treatment. A clinical research study, the firm said, concluded that the FastHPV test produces rapid, accurate results, yet is also simple to run, requires minimal infrastructure and will be affordable for public-health programs. The test is on track to be submitted for its first regulatory approvals in China and India in 2008.

• Sonus Pharmaceuticals Inc., of Bothell, Wash., said that it has received a notice from The Nasdaq Stock Market indicating that the company does not comply with the $1 minimum bid price requirement for continued listing. The firm has 180 days, or until May 5, 2008, to regain compliance.

• Tripos Discovery Research Ltd., of Bude, UK, a wholly owned subsidiary of Commonwealth Biotechnologies Inc., signed a service agreement with Kenilworth, N.J.-based Schering-Plough Corp. to design, synthesize and purify high-quality, drug-like compounds to expand Schering-Plough Research Institute's compound collection. Under the terms, TDR will use its design software ChemSpace to collaborate with SPRI for compound libraries, as well as large-scale, high-throughput synthesis, purification and analysis of those compounds. Financial terms were not disclosed.