• Alkermes Inc., of Cambridge, Mass., closed with institutional investors a private placement of 7 percent secured notes due 2018, with a face amount of $170 million. The transaction resulted in proceeds of about $145 million, after allowing for the discounted offering price and transaction cost, which will go toward advancing product candidates, including the company's alcohol-dependence drug Vivitrex. Payments of principal and interest on the notes will come from manufacturing and royalty revenues from the sale of Risperdal Consta (risperidone), a long-acting injection for schizophrenia.

• Bioject Medical Technologies Inc., of Bedminster, N.J., entered a supply agreement with Chronimed Inc., of Minneapolis, calling for the sale of Biojector 2000 needle-free systems and related accessories to Chronimed for distribution to eligible patients who are using Fuzeon, an AIDS drug developed by Trimeris Inc. in collaboration with Roche. Financial terms of the agreement were not disclosed.

• Biolex Inc., of Pittsboro, N.C., signed a new agreement with Medarex Inc., of Princeton, N.J., to create a commercial line for an undisclosed Medarex monoclonal antibody using the Biolex LEX System. Financial terms were not disclosed. At Medarex' option, Biolex may scale-up and manufacture the antibody following the commercial line creation phase.

• Cardiome Pharma Corp., of Vancouver, British Columbia, and its co-development partner, Fujisawa Healthcare Inc., of Deerfield, Ill., reported additional Phase III results showing that for recent onset atrial arrhythmia patients dosed with intravenous RSD1235 who converted to normal heart rhythm, the median time to conversion was 11 minutes. Only one out of 75 patients that converted to normal heart rhythm within 90 minutes of dosing relapsed within 24 hours. RSD1235 appears to be ineffective in converting atrial flutter patients to normal heart rhythm. Top-line results for the 416-patient study, known as ACT 1, that showed the drug converted 52 percent of recent onset patients to normal heart rhythm were announced in December. (See BioWorld Today, Dec. 21, 2004.)

• Nanobac Life Sciences Inc., of Tampa, Fla., signed a collaborative agreement with the University of South Florida to work with the Department of Civil and Environmental Engineering to conduct research relating to the prevalence and implications of nanobacteria in environmental samples. The two parties will evaluate the role of nanobacteria in water distribution systems and develop possible treatment methods. Nanobac's research is establishing the pathogenic role of Nanobacterium sanguineum in calcification, particularly in coronary artery heart disease and vascular disease.

• NitroMed Inc., of Lexington, Mass., said the FDA accepted its resubmitted new drug application for BiDil, a heart failure treatment that was tested on African-American patients and showed a 43 percent survival benefit in a late-stage study. The company said acceptance of the Class 2 resubmission means the FDA is expected to complete its review within six months under the Prescription Drug User Fee Act. The PFUFA date is June 23.

• Novavax Inc., of Malvern, Pa., received a three-year contract from the National Institutes of Health to develop a severe acute respiratory syndrome vaccine using its virus-like particle (VLP) technology. The $1.1 million grant will assist Novavax in its development of a VLP vaccine for proof-of-concept studies in preparation for human trials. The company's technology uses recombinant protein technology to imitate the structure of a virus to provide protection without the risk of infection or disease.

• OxiGENE Inc., of Waltham, Mass., said a preclinical study using local administration of Combretastin A4P (CA4P) in the treatment of a murine model of retinoblastoma showed positive results. The study, published in the January issue of Investigative Ophthalmology & Visual Science, showed that a subconjunctival delivery of CA4P, a vascular targeting agent, induced a dose-dependent reduction in blood vessel count leading to tumor reduction, with no evidence of corneal, lenticular, choroidal or retinal toxicity.

• PrecisionMed Inc., of San Diego, and Phenomenome Discoveries Inc., of Saskatoon, Alberta, are undertaking a collaboration to develop noninvasive diagnostics for Alzheimer's disease and bipolar disorder using PrecisionMed's clinical samples and information, and Phenomenome's diagnostics discovery and testing platform. Terms were not disclosed.

• Pressure BioSciences Inc., of West Bridgewater, Mass., extended the expiration date of its tender offer to purchase 5.5 million shares of its common stock at a purchase price of $3.50 per share from 10:00 a.m. EST on Feb. 4, until 10:00 a.m. EST on Feb. 11, unless further extended. The company is focused on the developing a technology called Pressure Cycling Technology, which uses cycles of hydrostatic pressure between ambient and ultra-high levels to control biomolecular interactions.

Sanofi-Aventis Group, of Paris, received marketing approval from the FDA for a new aqueous solution formulation of Eloxatin (oxaliplatin injection). The formulation is a clear, preservative-free, colorless solution, which does not require reconstitution prior to dilution and administration. Debiopharm SA, of Lausanne, Switzerland, and Sanofi-Aventis share development costs for improvements to the available formulations of Eloxatin, new indications and new methods of use for Eloxatin.

• Valeant Pharmaceuticals Inc., of Costa Mesa, Calif., priced its public offering of 7.2 million shares of common stock at $24 per share, totaling about $174 million. The company granted the underwriter a 30-day option to purchase up to about 1.1 million additional shares to cover overallotments. Valeant expects to use the net proceeds to help pay for the acquisition of San Diego-based Xcel Pharmaceuticals Inc. The deal, expected to close in the next few weeks, includes the retirement of $44 million of Xcel debt, with Valeant paying about $280 million to complete the acquisition. (See BioWorld Today, Feb. 4, 2005.)

• Viragen Inc., of Plantation, Fla., and its majority-owned subsidiary, Viragen International Inc., said a marketing application for Multiferon was filed in Sweden. The companies are seeking approval of the product to include the first-line adjuvant treatment of high-risk malignant melanoma, following dacarbazine after surgical removal of tumors. Viragen intends to request a meeting with the FDA to review its Phase II/III melanoma clinical trial being conducted in Germany and to discuss an outline for clinical work needed to bring Multiferon to the U.S. market.

• Viventia Biotech Inc., of Toronto, said its lead drug, Proxinium, was granted orphan drug designation from the FDA for the treatment of advanced, recurrent head and neck cancer. Head and neck cancer includes cancers of the larynx, tongue, mouth, oral cavity and pharynx. There are more than 50,000 new cases diagnosed each year in the U.S. Proxinium consists of a proprietary antibody fragment conjugated with a cancer-killing payload.

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