• Acusphere Inc., of Watertown, Mass., pushed back its planned new drug application filing date for Imagify (perflubutane polymer microspheres) injectable suspension from late 2007 to early 2008. The company said its manufacturing clean rooms have been certified and it has completed a Chemistry Manufacturing and Controls meeting with the FDA, but it still needs to confirm that its manufacturing process is sterile. Imagify is designed to improve the detection of coronary artery disease, and Acusphere said last month that the compound is the subject of partnership discussions.

• Albany Molecular Research Inc. (AMRI), of Albany, N.Y., and the Cystic Fibrosis Foundation Therapeutics Inc. signed a four-year research collaboration, worth up to $23.7 million, aimed at identifying treatments that address the core defect in CF. The deal calls for AMRI to screen its natural products-based libraries to find compounds that improve the function of the defective protein in CF, known as the cystic fibrosis transmembrane conductance regulator. AMRI also will conduct an integrated drug discovery program, including chemistry and in vitro biology, on compounds that might emerge from the screening program. For any compounds advanced into preclinical and clinical testing, AMRI has the options to provide chemical development and GMP manufacturing services to CFFT.

• Bioject Medical Technologies Inc., of Portland, Ore., said Trimeris Inc., of Morrisville, N.C., and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, have elected not to pursue FDA approval for a Biojector 2000 formulation of their approved HIV fusion inhibitor Fuzeon (enfuvirtide). The Biojector 2000 device provides needle-free injection by pushing a high-pressure stream of liquid medication through the skin. The approach is being studied by other partners, but Bioject shares (NASDAQ:BJCT) fell 36 cents, or 25 percent, to close at $1.05 on Thursday due to the Fuzeon setback.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., has completed validation studies of LibiGel for the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder. The data will be presented at the annual meeting of the North American Menopause Society in Dallas, Texas. The Phase III efficacy trials of LibiGel in the treatment of FSD, one of which has been initiated, are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial.

• HemoBioTech Inc., of Dallas, said results from an ex vivo human study of HemoTech showed that the product reduced platelet aggregation, one of the major complications associated with percutaneous coronary intervention procedures. It also demonstrated the potential for preventing restenosis. HemoTech, a human blood substitute technology licensed exclusively from Texas Tech University Health Sciences Center, is composed of bovine hemoglobin that is chemically modified with adenosine triphosphate, adenosine and glutathione and is designed to carry oxygen through the bloodstream and to induce erythropoiesis. It is in development to reduce or eliminate the danger resulting from acute blood loss in trauma, surgery and other conditions.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, presented preclinical data demonstrating that HE3235 significantly inhibited tumor growth compared to control (p=0.038) in a model of hormone-independent prostate cancer. HE3235 also lowered the expression of BCL2 and induced apoptosis in LNCaP cells independently of endogenous hormone levels, suggesting the drug kills tumor cells. The data were presented at the Fourth International Conference on Tumor Progression and Therapeutic Resistance. HE3235 has previously shown positive preclinical results in breast cancer models, and Hollis-Eden plans to file an investigational new drug application in the first quarter of 2008. Shares of Hollis-Eden gained 50 cents, or 25 percent, to close at $2.54 on Thursday.

• Lipid Sciences Inc., of Pleasanton, Calif., said initial results of studies assessing the ability of the company's HDL mimetic peptide, LSI518P, to mimic the principal functional characteristics of HDL showed that that drug significantly raised HDL in a mouse model following a single dose of the peptide and was effective in removing cholesterol from cholesterol-filled cells by the ABCA1 transporter. Results also showed that LSI518P decreased CD11B adhesion molecules, thereby reducing the potential inflammation in the vessel wall associated with atherosclerosis. Data were presented at the lipid drug symposium in New York.

• Phosphagenics Ltd., of Melbourne, Australia, and Nestle Nutrition, of Vevey, Switzerland, said they will jointly start a Phase II trial in Australia shortly to establish the efficacy of Phosphagenics' Phospha E in the management of metabolic syndrome. Nestle will fund the trials and will be granted a worldwide exclusive license for the use of Phospha E in medical foods, while Phosphagenics will manufacture and supply the compound to Nestle. Final commercial arrangements are expected to be completed by the end of this year. Phospha E is a patented derivative of vitamin E, said to have superior properties compared to its parent molecule.

• PolyMedix Inc., of Radnor, Penn., has received a $100,000 Phase I SBIR grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health . The grant will be used to support the development of biomimetic compounds as anticoagulant antagonists. The grant will be used in the development of new compounds as antagonists to the anticoagulant drugs heparin and Low Molecular Weight Heparin.

• Salix Pharmaceuticals Ltd., of Raleigh, NC, said Mayoly-Spindler SAS, of Chatou, France, has licensed exclusive rights to market Osmoprep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) tablets in France. Salix may receive up to $1 million in milestone payments as well as royalties. Mayoly will assist Freiberg, Germany-based Dr. Falk Pharma GmbH, which previously licensed rights to the drug in 28 European territories, in obtaining marketing authorization in Europe. Osmoprep is approved for bowel-cleansing in the U.S. and U.K., and European approval is expected by 2009.

• Sigma-Aldrich, of St. Louis, has entered into a collaboration with the Institute for Research in Immunology and Cancer (IRIC) of the Université de Montréal and Génome Québec to expand the IRIC's large-scale RNA interference (RNAi) functional genomics platform. The investment in the project totals $8.1 millions over three years. It will allow IRIC to add the human and mouse genomes to the sets of genes that can be targeted using its high-throughput RNAi screening facility. Sigma-Aldrich will provide IRIC with its entire human and mouse Mission TRC DNA-based libraries and IRIC will generate arrayed libraries of lentiviral particles expressing RNAi molecules against 15,000 genes from each species.

• SRI International, of Menlo Park, Calif., has been awarded a $9.5 million contract by the Defense Threat Reduction Agency, part of the U.S. Department of Defense. SRI will lead a drug discovery and development program to identify approved drugs that could also be effective against biological threats. The goal of the program is to repurpose drugs that are currently approved and marketed but have not been previously evaluated against diseases caused by biological weapons.

• Targeted Genetics Corp., of Seattle, has received an undisclosed milestone payment from Amsterdam Molecular Therapeutics BV (AMT), of Amsterdam, the Netherlands, under a licensing agreement that provides AMT with non-exclusive rights to patents covering Adeno-Associated Virus type 1. That is a serotype of AAV with potential application in the development and commercialization of products treating lipoprotein lipase deficiency. AMT recently reported the initiation of a pre-registration clinical trial in Canada for AMT-011, an AAV1-based therapy for LPL deficiency. A commercial roll-out of the product is anticipated in 2009. The amount of the milestone payment is not disclosed.

• VIA Pharmaceuticals Inc., of San Francisco, said the non-profit research organization Genome Quebec will fund a pharmacogenomics sub-analysis within the company's ongoing Phase II trial of VIA-2291 in Acute Coronary Syndrome (ACS). VIA will contribute approximately $2.6 million in funding to the study, with about $200,000 of that earmarked for the pharmacogenomics sub-analysis, while Genome Quebec and its affiliates will contribute about $2.4 million. The sub-analysis will seek to develop a 5-lipoxygenase genotyping panel for VIA-2291, an ADME/Tox panel, and additional genotyping panels. VIA-2291, a reversible inhibitor of 5-lipoxygenase, is also in a Phase II carotid endarterectomy trial.