• Acambis plc, of Cambridge, UK, said the FDA designated its smallpox vaccine, ACAM2000, a fast-track product. The company has delivered 182.5 million doses of ACAM2000 to the U.S. government's strategic national stockpile. It is close to submitting a biologics license application based on data from more than 2,900 subjects in Phase III trials.
• AtheroGenics Inc., of Atlanta, said it plans to sell about $125 million worth of convertible notes due 2012 to qualified institutional buyers. The company, which is developing products for chronic inflammatory diseases, also expects the terms of the offering to include an option for an additional $25 million of notes. AtheroGenics plans to use proceeds to fund ongoing costs of the ARISE trial of AGI-1067 and other research and development activities, including clinical trials, process development and manufacturing support, as well as for general corporate purposes such as working capital.
• Biopure Corp., of Cambridge, Mass., obtained commitments from institutional and individual investors to purchase about $11.3 million of its common stock for anticipated net proceeds of about $10.4 million. The company said that the latest funding, coupled with cash on hand, would sustain its operations for the next year. Biopure is developing its investigational oxygen therapeutic Hemopure (hemoglobin glutamer - 250 [bovine]) for a potential cardiovascular ischemia indication and for a trauma indication in collaboration with the U.S. Naval Medical Research Center. The company expects to sell 22.2 million shares at 51 cents apiece in the offering, which is expected to close Monday, and they will be issued under an existing shelf registration statement. C.E. Unterberg, Towbin LLC is the offering's agent.
• BioVeris Corp., of Gaithersburg, Md., and the Brooke Army Medical Center, Department of Clinical Investigation, entered a Cooperative Research and Development Agreement to develop BioVeris technology-based tests to detect clinical markers of disease and disease progression or recovery. The work will occur over the next two years, and BioVeris would commercialize tests that are identified.
• Cerus Corp., of Concord, Calif., received $3 million after signing a letter of intent with BioOne Corp., of Tokyo, for Asian commercialization in the Intercept blood system developed by Cerus and subsidiaries of Deerfield, Ill.-based Baxter International Inc. The companies are negotiating a definitive agreement, but Cerus' right to retain the up-front payment is not contingent upon completion of the agreement. In 2004, BioOne reached an agreement with Cerus to commercialize the Intercept system - designed to enhance safety by inactivating viruses, bacteria and other pathogens in donated blood components - for platelets in several Asian countries. The new agreement would allow the sale of plasma products developed from the Intercept system.
• CytoGenix Inc., of Houston, said its researchers have identified and tested an antisense oligonucleotide sequence that will kill Staphylococcus aureus bacteria including vancomycin-resistant and methicillin-resistant strains. The achievement is part of the company's ongoing research and development program for a new generation of antimicrobial compounds.
• DOV Pharmaceuticals Inc., of Hackensack, N.J., announced that the initial purchasers of the company's 2.5 percent convertible debentures due 2025 exercised their option to purchase an additional $15 million aggregate principal amount of the debentures. Upon closing, that would bring the total proceeds of DOV's offering to $80 million. The sale of additional debentures is expected to close today. DOV said net proceeds will be used for general corporate purposes, including working capital, research and development, capital expenditures and potential acquisitions or other strategic investments.
• EntreMed Inc., of Rockville, Md., commenced Phase Ib trials to evaluate the pharmacokinetic properties and safety of Panzem NCD, its next-generation formulation of 2-methoxyestradiol (2ME2). The trials will enroll advanced cancer patients whose disease has failed to respond to existing therapies or in cases in which no approved therapy is available. Panzem NCD, an oral liquid formulation, has been shown in preclinical studies to increase the drug's bioavailability.
• GenData Research Corp., of Salt Lake City, formed a sponsored research and exclusive agreement with Amgen Inc., of Thousand Oaks, Calif., for the discovery, development and commercialization of therapeutics and diagnostics aimed at an undisclosed disorder. Amgen will select genetic targets identified by GenData's population genetics discovery platform. Terms include sponsored research activities, product development milestones and financial consideration associated with therapeutic and diagnostic products that result.
• Genfit SA, of Lille, France, reported a three-year partnership deal with the Pierre Fabre Group, of Paris. The companies have been collaborating since October 2001 on the pharmacological characterization of several products and their mechanisms of action in the field of cardiovascular diseases. The new partnership relates to the development of a new family of compounds for which proof of concept already has been obtained. Financial terms of the agreement were not disclosed. Pierre Fabre will pay Genfit research fees, milestones and royalties. It will be the intellectual property owner and have exclusive rights to the sale of the products.
• Genomatica Inc., of San Diego, entered a license agreement with the biochemicals business unit of Kyowa Hakko Kogyo Co. Ltd., of Tokyo, for Genomatica's model of Escherichia coli and its modeling and simulation platform SimPheny. Kyowa Hakko will use the products in its research on producing fine chemicals, such as amino acids. Financial details were not disclosed, but include license fees and milestone payments.
• Gen-Probe Inc., of San Diego, licensed rights to develop molecular diagnostic tests for about 50 potential genetic markers from Seattle-based Corixa Corp. The company said it will pay Corixa a $1.6 million initial access fee, $3.2 million in two equal access fees in 2006 and 2007, and up to an additional $2 million on a product-by-product basis. Under the agreement, Gen-Probe will have access to Corixa's multiple genetic sequences related to potential markers, including AMACR for prostate and colon cancers, CA125 for ovarian cancer and L5235 for cervical and lung cancers.
• ImClone Systems Inc., of New York, began patient treatment in a Phase I trial of its fully human monoclonal antibody targeting the vascular endothelial growth factor receptor-2, IMC-1121B, in patients with solid tumors. The trial will evaluate the drug administered weekly by intravenous infusion. It is expected to involve 33 patients.
• Immunomedics Inc., of Morris Plains, N.J., said the FDA granted fast-track product designation for epratuzumab, a monoclonal antibody-based product designed to treat moderate to severe systemic lupus erythematosus. The company submitted an application to the FDA after reporting positive results of its Phase II study at the annual American College of Rheumatology meeting. Immunomedics said Phase III trials will begin in the first half of 2005.
• MacroMed Inc., of Sandy, Utah, granted exclusive rights to Diatos SA, of Paris, to develop and commercialize OncoGel (injectable paclitaxel formulation for local, intra-tumoral administration) worldwide except for North America and Korea. Diatos also received rights to sub-license OncoGel and to develop and commercialize second-generation OncoGel products. Both privately held companies will collaborate on the product's clinical development, sharing data from trials conducted in their respective territories. They intend to develop OncoGel for treatment of several types of solid tumors. OncoGel already is in Phase II trials in the U.S. for esophageal cancer. Terms of the agreement call for Diatos to pay MacroMed a license fee, milestone payments and royalties on product sales. In addition, MacroMed retained the right to provide the majority of clinical and commercial supplies of OncoGel to Diatos.
• Manhattan Pharmaceuticals Inc., of New York, signed a letter of intent to merge with Tarpan Therapeutics Inc., also of New York. Upon completion of the all-stock transaction, Tarpan shareholders will own about 20 percent of Manhattan's shares on a fully diluted basis. Tarpan has PTH, a peptide believed to regulate epidermal cell growth and differentiation, under development for psoriasis. Manhattan Pharma's lead product, Oleoyl estrone, is in development for obesity and is expected to begin Phase I trials this quarter.
• Metabasis Therapeutics Inc., of San Diego, and Sankyo Co. Ltd., of Tokyo, said a Phase IIb trial of CS-917 in Type II diabetics is under way. The study is designed to evaluate the product's effectiveness in lowering blood glucose levels in such patients; efficacy will be evaluated by measuring levels of hemogloblin A1c. Results will be used to select an appropriate dosage of CS-917 for use in Phase III. Sankyo licensed the compound from Metabasis and is responsible for global development.
• PolyMedix Inc., of Philadelphia, closed a $6 million Series B equity financing, raising $4 million in a second closing. The company said funds will be used to complete preclinical development of its antibiotic compound. It plans to file an investigational new drug application to begin clinical trials this year.
• ProMetic Life Sciences Inc., of Montreal, signed a C$1.4 million (US$1.1 million) development agreement with Octapharma AG, of Lachen, Switzerland. The agreement provides Octapharma with access to ProMetic's Mimetic Ligand affinity technology to manufacture high-purity protein drugs. ProMetic said it anticipates additional revenues based on completion of the development program, as Octapharma's protein product moves through clinical trials.
• Sangamo BioSciences Inc., of Richmond, Calif., entered a collaboration with New York-based Pfizer Inc. in enhanced protein production. Pfizer will fund research at Sangamo, which will provide its zinc finger DNA-binding protein technology to Pfizer to assess its feasibility for use in mammalian cell-based protein pharmaceutical production. Sangamo will generate cell lines and vector systems for enhanced protein production, as well as technology for the creation of new production cell lines. Separately, Sangamo said its collaboration with LifeScan Inc. has been expanded to include additional gene targets important in diabetes. LifeScan, a unit of Johnson & Johnson, of New Brunswick, N.J., is a manufacturer of blood glucose meters. The agreement provides LifeScan with additional access to Sangamo's zinc finger DNA-binding proteins to develop therapeutic cell lines against diabetes. Financial terms were not disclosed.
• Senetek plc, of Napa, Calif., reported positive results from its initial multi-faceted study of the effects of its patented adenine derivative, Zeatin, and two other compounds representing new cytokinin classifications, AK801 and PRK124. The study was conducted over a three-week period at the Department of Dermatology, University of California at Irvine using the hairless mouse model.
• Serono SA, of Geneva, completed patient enrollment in a multinational trial comparing Rebif (interferon beta-1a) to Copaxone (glatiramer acetate, Teva Pharmaceutical Industries Ltd.) in relapsing or remitting multiple sclerosis. More than 700 patients who previously were untreated with disease-modifying therapies have been enrolled in the trial. Rebif was approved in Europe in 1998 and in the U.S. in 2002.
• Symphony Capital LLC in New York announced the final closings of its initial private equity funds, Symphony Capital Partners LP and Symphony Strategic Partners LLC, for an aggregate amount of $315 million. Each of Symphony Capital's portfolio companies will be established to fund and manage clinical-stage programs acquired from biopharmaceutical companies.
• TargeGen Inc., of San Diego, initiated a 100-patient Phase I/II trial of TG100-115, a selective PI3-kinase inhibitor that has demonstrated an ability to suppress edema and reduce infarct size in preclinical models of acute myocardial infarction. When administered intravenously, TG100-115 is designed to block vascular leakage and inflammation following an ischemic event, preserving muscle tissue.
• Tripos Inc., of St. Louis, acquired privately held Optive Research Inc., of Austin, Texas, and its cheminformatics products, including Benchware and EA-Inventor, for $4.75 million in cash and 599,521 in Tripos' shares. The cash was funded through a $4 million investment by Horizon Technology Finance LLC and Sand Hill Capital through the issuance of $3.5 million of subordinated debt, 111,606 shares of common stock and warrants to purchase 156,250 shares of common stock. Tripos expects the acquisition to contribute to its operating income in 2005 and become accretive to net income by 2006.
