• Affymetrix Inc., of Santa Clara, Calif., said the University of Ottawa Heart Institute is using its Genome-Wide Human SNP Array 6.0 for its whole-genome association study on coronary artery disease. Over the next three years, researchers at UOHI will use the array to screen the DNA of more than 12,000 individuals to confirm previous findings, as well as to identify new associations to provide a better understanding of how to develop personalized treatments for the causes of CAD.

• AMAG Pharmaceuticals Inc., of Cambridge, Mass., said its European partner, Guerbet SA, of France, withdrew its European marketing authorization application for Sinerem (Combidex in the U.S.) for the detection and characterization of metastatic lymph nodes in patients with pelvic cancer. Guerbet said that decision was prompted by the Committee for Medicinal Products for Human Use's warning that Phase III does not provide sufficient statistical demonstration. Guerbet said it will evaluate all possible options that would satisfy the EMEA's requirements. Sinerem/Combidex is a molecular imaging agent consisting of superparamagnetic iron oxide nanoparticles for use in conjunction with magnetic resonance imaging. The product was deemed approvable by U.S. regulators in March 2005, and AMAG said it is working to determine whether additional data from Guerbet's Phase III study in Europe, along with additional analyses and new information, will be sufficient to address the FDA's concerns. Based on a preliminary review of that Phase III data, AMAG said it "remains highly uncertain" whether those results will meet the agency's requirements. The company's stock (NASDAQ:AMAG) fell $2.51 Thursday to close at $59.64. (See BioWorld Today, March 25, 2005.)

• Anavex Life Sciences Corp., of Geneva, reported preclinical data showing that ANAVEX 1-41 prevented oxidative stress, which damages and destroys cells and is believed to be a primary cause of Alzheimer's disease, in animal models. The drug also prevented the expression of caspase-3, an enzyme that plays a role in programmed cell death and in the loss of cells in the hippocampus. ANAVEX 1-41 preclinical studies will be completed in the coming weeks, and the company will then file an investigational new drug application to start clinical testing.

• Applied Biosystems, of Foster City, Calif., and Integromics SL, of Grenada, Spain, launched a product that integrates Applied Biosystems' high-throughput, real-time PCR instrument systems with Integromics' Real-Time StatMiner data analysis software. The companies will co-market the product.

• CureVac GmbH, of Tuebingen, Germany, received a €400,000 (US$587,400) grant from the federal state of Baden-Württemberg for development of a vaccine adjuvant based on mRNA. The company also plans to begin Phase I/II trials in 2008 with its mRNA-based cancer vaccines.

• Depomed Inc., of Menlo Park, Calif., said a court granted its motion for summary judgment in its patent infringement lawsuit against IVAX Corp. The court denied IVAX's motions related to the validity and enforceability of the patents, and the lack of willful infringement. Depomed sued IVAX in January 2006 for patent infringement related to extended-release metformin hydrochloride tablets.

• EMD Serono Inc., an affiliate of Merck KGaA, of Darmstadt, Germany, joined forces with the Michael J. Fox Foundation for Parkinson's Research to support a $2 million initiative focused on cognitive defects and mood disorders associated with Parkinson's. The program will accept proposals for basic, translational or clinical research projects until Feb. 13, 2008 and will award grants in July.

• Emerillon Therapeutics Inc., of Montreal, named Lisa McKerracher CEO. McKerracher joined the company with a mandate to refocus Emerillon's multiple technologies toward product development and to move the more advanced products, aimed at infectious diseases, into the clinic.

• Hemispherx Biopharma Inc., of Philadelphia, concluded an agreement with a major Japanese vaccine manufacturer, for the use of Ampligen as an immune enhancer to influenza vaccines. The company's agreement with Biken, the non-profit operational arm of the Foundation of Microbial Disease of Osaka University, is part of a three-party deal to develop an effective flu vaccine for Japan using National Institute of Infectious Diseases of Japan resources. Under the terms of the nonexclusive licensing arrangement, Hemispherx will receive both royalties and income for all Ampligen supplies uses in ongoing experimental work, as well as any subsequent marketing of Ampligen as an immuno-enhancer for flu vaccines delivered intranasally. Specific financial terms were not disclosed.

• Inverness Medical Innovations Inc., of Waltham, Mass., said it finalized the acquisition of Matritech Inc., of Newton, Mass. The deal was structured as an asset purchase under which a newly formed subsidiary of Inverness acquired all the assets of Matritech for aggregate consideration of 616,713 shares of Inverness common stock, valued at about $36 million. Inverness also agreed to pay Matritech up to $2 million of incremental consideration, in cash or stock, upon achievement of certain revenue targets for the upcoming 12-month period.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., received orphan drug designation from the FDA for ISIS 333611 in inherited amyotrophic lateral sclerosis (ALS). ISIS 333611 is a second-generation antisense drug undergoing preclinical studies.

• Liponex Inc., of Ottawa, Canada, said it discontinued studies of its new enteric-coated formulation of CRD5 in a mini-pig model after data showed no significant effects of the drug relative to control in that model. The company's board and management said they will assess the next steps for the CRD5 program, which has been in development for dyslipidemia and heart disease, and, in parallel, will continue efforts around strategic options to leverage the company's assets and resources. Liponex's stock (TSX:LPX) fell C3 cents, or 20 percent, Thursday to close at C12 cents.

• Merck & Co. Inc., of Whitehouse Station, N.J., voluntarily recalled 11 lots of its Haemophilus influenzae type B vaccine, PEDVAXHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)], and two lots of its combination Haemophilus influenzae type B/ hepatitis B vaccine, COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate)]. The recall is due to possible sterility issues associated with manufacturing, although no contamination has been found to date.

• MicroIslet Inc., of San Diego, held a pre-investigational new drug application (pre-IND) meeting with the FDA and plans to file an IND in the third quarter of 2008 for MicroIslet-P, a microencapsulated suspension of porcine pancreatic islet cells for type I diabetes. MicroIslet's shares (OTCBB:MIIS) rose 10 cents, or 18.87 percent, to close at 63 cents on Thursday.

• Neurologix Inc., of Fort Lee, N.J., said the FDA granted fast-track designation for its gene transfer procedure in advanced Parkinson's disease. The fast track program aims to facilitate development and expedite the agency's review process. Neurologix's procedure is designed to deliver a gene (glutamic acid decarboxylase) to the subthalamic nucleus of the brain, where it makes the inhibitory neurotransmitter GABA that helps to quiet abnormal brain activity associated with motor deficits in Parkinson's disease patients. The company is gearing up to start a Phase II study in early 2008.

• Odyssey Thera Inc., of San Ramon, Calif., said it achieved two milestones under its ongoing collaboration with Pfizer Inc., triggering undisclosed milestone payments. The companies signed a deal last year in which Odyssey is utilizing its protein fragment complementation assay platform to test Pfizer's compounds. The milestones achieved include the creation of an assay panel and the establishment of a system to quantify the biological activity of drug metabolites in living human cells. (See BioWorld Today, Sept. 6, 2006.)

• Recordati SpA, of Milan, Italy, successfully concluded its acquisition of Orphan Europe, of Paris, for €135 million (US$192 million). Orphan Europe, which develops and markets drugs for rare and orphan indications, had sales of about €40 million in 2006.

• Rosetta Genomics Ltd., of Rehovot, Israel, entered a collaboration with Columbia University Medical Center to develop microRNA-based diagnostic tests for multiple types of non-Hodgkin's lymphoma (NHL).Researchers will also screen for microRNA targets for use in therapeutic NHL applications. Terms of the deal were not disclosed.

• Scynexis Inc., of Research Triangle Park, N.C., said it earned a milestone payment under its drug discovery collaboration with animal health company Merial Ltd. The amount of the payment and details regarding the milestone achieved were not disclosed. The two companies entered a potential $150 million deal in 2005. (See BioWorld Today, Sept. 29, 2005.)

• Sinovac Biotech Ltd., of Beijing, said Healive was one of two inactivated hepatitis A vaccines selected by the Beijing Centers For Diseases Control and Prevention for its hepatitis A vaccination program. Government purchases of the vaccine will take place from 2007 through 2009. Separately, Sinovac continued to defer its 2007 annual stockholders meeting into 2008 due to an inability to form the necessary quorum.

• Sirtris Pharmaceuticals Inc., of Cambridge, Mass., said preclinical data showed that one of its SIRT1 activators lowers plasma glucose and improves insulin sensitivity in a model of Type II diabetes as well as or better than sitagliptin, a DPP-IV inhibitor sold as Januvia by Whitehouse Station, N.J.-based Merck & Co. Inc. In an intraperitoneal glucose tolerance test, Sirtris' SIRT1 activator also demonstrated an ability to control glucose excursion as well as sitagliptin. Those data were presented at the RBC Capital Markets Healthcare conference in New York.

• Stallergenes SA, of Antony, France, signed a partnership agreement with Protein eXpert SA, a Grenoble, France-based contract research organization, for developing and pharmaceutically producing mites recombinant allergens. That deal is part of the company's "Enhanced Allergens" innovation program for a recombinant protein treatment for sublingual desensitization of allergy to mites, and the second-generation treatment is made up of the recombinant allergens Der p 1 and Der p 2 in the form of a fusion protein, combined with an adjuvant and/or mucoadhesive formulation for facilitating recognition of the allergen by the immune system. Terms of the agreement were not disclosed.

• UCB Pharma Inc., of Atlanta, said the FDA accepted for filing its supplemental new drug application for Neupro in moderate-to-severe restless legs syndrome. Neupro (rotigotine), a patch designed to provide continuous drug delivery, was launched in the U.S. earlier this year in Parkinson's disease. The sNDA is based on trials showing that rotigotine produced statistically significant reductions in RLS symptoms and was generally well tolerated.

No Comments