• Abiogen Pharma SpA, of Pisa, Italy, said the Italian Ministry of Health authorized studies of Abiogen's osteogenic growth peptide. OGP 10-14 L is an active sequence of the natural 14-mer peptide, named Osteogenic Growth Peptide, which shows mitogenic and differentiating activities on stromal and staminal bone marrow cells. The ministry approved a Phase I trial in myelofibrosis.

• Adolor Corp., of Exton, Pa., said it completed enrollment in the first of three Phase III trials for alvimopan, designed to manage postoperative ileus. The company expects to complete the analysis of the trial and report top-line results in the first quarter of 2003. It expects enrollment in the other two Phase III trials to complete in 2003's first half.

• Amgen Inc., of Thousand Oaks, Calif., said a study assessing 50 mg of Enbrel (etanercept) administered once weekly demonstrated similar efficacy, tolerability and pharmacokinetics to that of 25 mg of Enbrel administered twice weekly. The company said the study shows the product can be given to patients in a more flexible schedule. Enbrel, a fully human anti-TNF therapy, is approved for use to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis, and to reduce the signs and symptoms and inhibit the structural damage in patients with moderately to severely active rheumatoid arthritis. Expanded results from the trial will be presented at a future scientific meeting, the company said.

• Atrium Medical Corp., of Hudson, N.H., said a federal court jury in Wilmington, Del., unanimously vindicated Atrium in a patent infringement suit brought against it by Genzyme Corp., of Cambridge, Mass., and its unit, Genzyme Biosurgery. The jury found that Atrium did not infringe on any of the five patents in the Genzyme claim. The suit centered on chest drains.

• AVI BioPharma Inc., of Portland, Ore., reported preclinical results from targeting single-stranded RNA viruses with its Neugene antisense drugs. The viral program has focused primarily on one family of viruses that includes West Nile virus, hepatitis C virus and calicivirus. The company said it plans to initiate clinical trials against hepatitis C in 2003.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said it licensed three patents encompassing combinations of hormone therapies from Wake Forest University School of Medicine in Winston-Salem, N.C. The license also includes an option to use triple hormones in contraceptives. Financial details were not disclosed.

• BioTransplant Inc., of Charlestown, Mass., agreed with Gambro BCT, a wholly owned subsidiary of Gambro AB, of Stockholm, Sweden, to terminate the companies' distribution agreement for the Eligix HDM Separation Systems. The termination was mutually agreed upon by both parties. As part of the termination agreement, BioTransplant will pay Gambro an undisclosed amount to purchase unused inventory and Gambro agreed to provide customer support through Jan. 15, 2003.

• Cardiome Pharma Corp., of Vancouver, British Columbia, reported that a proof of concept oral dosing study in humans demonstrated that its antiarrhythmic drug, RSD1235, has oral bioavailability. Phase II efficacy data reported in September demonstrated that intravenous RSD1235 converts atrial fibrillation to normal heart rhythm in an acute-use, in-hospital setting. Blood levels of orally administered RSD1235 reached concentrations equivalent to the doses seen in the Phase II study.

• Centagenetix Inc., of Cambridge, Mass., entered an agreement with Boston University and Boston Medical Center to conduct research into the diseases of aging. Each party will share access to its collection of genetic samples collected from centenarians around the world to help speed the process of finding correlations. Centagenix will gain exclusive commercial rights to resulting intellectual property and to the development and commercialization of any medical products that may result from the research. Boston University and Boston Medical Center retain access to any discoveries and intellectual property to advance their own academic research and would receive royalties from Centagenix.

• Dharmacon Inc., of Lafayette, Colo., expanded its oligonucleotide synthesis capabilities to include large-scale synthesis services. Dharmacon's 5-silyl-2-ACE synthesis chemistry system is designed to be used to generate large quantities of RNA, DNA or RNA analogues.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., said it reached a milestone in its pharmacogenomics-based alliance with Johnson & Johnson Pharmaceutical Research & Development, a division of Janssen Pharmaceutica NV, of Beerse, Belgium. Genaissance will grant certain rights to the Janssen unit and the unit will make an undisclosed payment to Genaissance in recognition of those rights. The milestone "demonstrates that our HAP Technology can be used to identify meaningful associations between genetic variation and clinical observations," the company said. The multiyear agreement between the companies was formed in November 2000.

• Illumina Inc., of San Diego, notified Applera Corp.'s Applied Biosystems Group, of Foster City, Calif., that it is in breach of the parties' 1999 joint development agreement to commercialize a genotyping system. The notification follows a patent infringement suit filed by Applied Biosystems against Illumina in the Federal District Court in Northern California concerning several patents related to Applied Biosystems' oligo ligation assay and a notification from Applied Biosystems alleging that Illumina breached the agreement. Illumina reported in July that Applied Biosystems would be unable to meet the planned mid-year product launch of the collaboration system.

• ImmunoGen Inc., of Cambridge, Mass., said that British Biotech plc, of Oxford, UK, started the Phase II portion of the Phase I/II study being conducted with huN901-DM1, a monoclonal antibody-based chemotherapy agent designed for the treatment of small-cell lung cancer. HuN901-DM1 is a conjugate of the cytotoxic maytansinoid drug, DM1, with the humanized monoclonal antibody huN901.

• Invitrogen Corp., of San Diego, completed the cash tender offer by Babcock Inc., a wholly owned subsidiary of Invitrogen, for all outstanding shares of common stock of InforMax Inc., of Bethesda, Md. The tender offer's subsequent offering period expired at 5 p.m. on Dec. 4. Invitrogen, through Babcock, has accepted for purchase all shares validly tendered in the initial offering period and the subsequent offering period at $1.36 per share in cash. Babcock acquired about 27.7 million shares of InforMax stock, or about 91 percent of the outstanding shares. Invitrogen reported in October that it would acquire InforMax in an all-cash $47 million deal. (See BioWorld Today, Oct. 16, 2002.)

• Iomed Inc., of Salt Lake City, said Robert Lollini was named president and CEO and also was named to its board. Lollini has been the company's chief financial officer for the past nine years and has been chief operating officer since November 2001. Iomed manufactures and sells active drug transport systems.

• Nabi Biopharmaceuticals, of Boca Raton, Fla., said the FDA granted its product, Civacir, orphan drug status for the prevention of hepatitis C infection in liver transplant recipients. The antibody-based product is in a Phase I/II trial sponsored by the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md.

• NeoTherapeutics Inc., of Irvine, Calif., presented research at the 32nd annual meeting of the Society for Neuroscience. The research helped identify two lead compounds, NEO-376 and NEO-392, from its antipsychotic drug program. The compounds showed similar efficacy to clozapine in reversal of PCP-induced disruption of pre-pulse inhibition, a model for evaluating antipsychotic treatments. In preliminary studies, both compounds had improved safety profiles compared to clozapine and risperidone. Particularly, the data showed that NEO-376 did not impair conditioned-avoidance responding, a measure of cognitive function.

• NexMed Inc., of Robbinsville, N.J., said Phase II results for Alprox-TD were published in the December 2002 issue (Vol. 60, No. 6) of Urology. The article evaluates the dose response relationship to the safety and efficacy of Alprox-TD in 300 men with mild to moderate severe erectile dysfunction. Data indicated that up to 83 percent of patients reported satisfaction with their treatment.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., filed an application with the FDA's Office of Orphan Products Development requesting that its drug, Thymosin Beta 4 (TB4), be designated an orphan drug for the treatment of epidermolysis bullosa. RegeneRx holds a license for TB4, a naturally occurring peptide, from the National Institutes of Health in Bethesda, Md., for wound healing.

• SuperGen Inc., of Dublin, Calif., said its Partaject-delivered busulfan received orphan drug designation from the FDA for the preparative therapy of pediatric patients undergoing bone marrow transplantation. SuperGen's Partaject delivery system allows compounds that are insoluble or poorly soluble in water to be delivered intravenously (or by other routes) without the need for organic solvents, the company said.

• Targeted Genetics Corp., of Seattle, reported the publication of data from its preclinical program in arthritis. Data showed that adeno-associated virus vector delivery of DNA encoding a tumor necrosis factor: immunoglobulin Fc fusion gene resulted in a suppression of chronic inflammatory arthritis in an animal model. While both systemic and local delivery of the product candidate yielded positive results, local delivery to one joint led to suppressed arthritis in other affected joints, suggesting that gene delivery with AAV vector provides an approach for local delivery of anti-arthritic therapies, the company said. The data were published in the December issue of Molecular Therapy.

• Vasogen Inc., of Toronto, reported preliminary results from a pilot study in patients with chronic lymphocytic leukemia. The study evaluated the effects of Vasogen's technology using three treatment regimens. Two-thirds of patients who received the optimal treatment regimen had a clinical response that reached the primary endpoint of the study. A total of 18 patients were recruited into the study. The primary endpoint was a greater than 25 percent reduction in total tumor burden as assessed by a decrease in circulating tumor cells, or greater than 25 percent reduction in lymph node size as measured by physical examination and radiologic studies, compared to pretreatment baseline measurement.