• Active Biotech AB, of Lund, Sweden, presented plans for its new strategic focus, which includes the objective to focus on the company's projects in the clinical phase. The key capabilities required to support clinical and late preclinical development projects will be reinforced. The company said a number of mature discovery projects will be retained in the portfolio, with a possibility to be pursued at a later stage. All discovery activities will be discontinued. Since the start-up in connection with Pharmacia's spin-out of Lund Research Center in 1998, Active Biotech has been operated as an integrated research and development organization with projects in both discovery and development.

• Altana AG, of Bad Homburg, Germany, said that the Australian Health Agency granted marketing approval for Alvesco, an inhaled corticosteroid for the treatment of asthma in adults and adolescents 12 years of age and older.

• Auxilium Pharmaceuticals Inc., of Norristown, Pa., said that men with low testosterone, or hypogonadism, who were treated for more than 12 months with the company's Testim showed significant improvements in sexual function, mood, body composition and bone mineral density in a recent study that involved 290 men. The findings were presented during the 4th World Congress on the Aging Male in Prague, Czech Republic.

• Baxter Healthcare Corp., of Deerfield, Ill., and its development partner, Arriva Pharmaceuticals Inc., of Alameda, Calif., completed a Phase I trial for a recombinant human alpha 1-antitrypsin (recombinant AAT or rAAT) molecule administered by nebulization. Recombinant AAT is under investigation for an inherited form of emphysema caused by alpha 1-antitrypsin deficiency. Results of the trial show that all doses were well tolerated, including the maximum amount administered.

• Biotech Holdings Ltd., of Vancouver, British Columbia, said the company closed a $159,639 private placement reported Jan. 27, bringing total funds received to $425,639. The funds will be used to complete improvements and machinery requirements at its facility for its diabetes drug, Sucanon. The drug is approved in Mexico and Peru for Type II diabetes.

• DUSA Pharmaceuticals Inc., of Wilmington, Mass., raised $24.75 million in gross proceeds after entering definitive agreements with new and existing institutional and other accredited investors for the private placement of 2.25 million common shares at $11 apiece. The company also granted the investors a 30-day option to purchase up to an additional 337,500 shares at the same price. DUSA said it would use the proceeds to expand its sales force, for possible product acquisitions and for general working capital purposes, including research and development opportunities. Separately, the company said it began commercial production of the Levulan Kerastick at its Wilmington manufacturing facility. Although DUSA said it had adequate inventory to meet short-term demand, the start of production is intended to ensure it would have adequate supply to meet market demand this year and beyond.

• GTC Biotherapeutics Inc., of Framingham, Mass., reported that the European Medicines Evaluation Agency accepted for review GTC's market authorization application submission of ATryn. GTC recently completed a multinational safety and efficacy study of ATryn in the prophylactic treatment of hereditary antithrombin deficiency during high-risk situations such as surgery and childbirth. The MAA submission includes data from that trial. Separately, GTC said it presented data from the trial at the German Society of Thrombosis and Hemostasis Research meeting in Hamburg, Germany.

• Igeneon AG, of Vienna, Austria, raised 126.7 million in venture capital in a Series C financing round that closed Feb. 19. The round was co-led by Burrill & Co. Proceeds will be used to advance the development of Igeneon's three clinical lead products: cancer vaccines IGN101 and IGN30 and humanized monoclonal antibody IGN311.

• Isotechnika Inc., of Edmonton, Alberta, received regulatory approval in China for the Helikit, a noninvasive, nonradioactive breath test kit used in the diagnosis of H. pylori. The company now holds two licenses for the importation of the Helikit into China, with additional licenses in Canada, Hong Kong, Korea, Mexico and Taiwan. Isotechnika also secured Taiwan-based Success Vision Biotek to act as a distributor to service Taiwan, China and Hong Kong. As part of the agreement, Success Vision Biotek will purchase a minimum of 180,000 kits over a three-year period.

• MycoLogics Inc., of Denver, Colo., reported the award of a Phase I Small Business Innovation Research grant by the Department of Health and Human Services to isolate a new class of compounds to treat human fungal disease by disrupting beta (1,6)-glucan synthesis. The beta (1,6)-glucan polymer is an essential component for fungal growth, although it is not found in fungi in humans.

• Nautilus Biotech, of Evry, France, developed enhanced IFNbeta molecules, engineered to have a substantially increased half-life. The molecules, developed using Nautilus' technology for prostate evolution, show higher levels of stability in vitro compared to natural IFNbeta, including higher thermal stability, as well as higher resistance to biological clearance.

• Oncolytics Biotech Inc., of Calgary, Alberta, said final findings from a study evaluating Reolysin's efficacy and safety for T2 prostate cancer showed that the trial met its histopathological objective, demonstrating that the drug selectively infects and kills tumor cells in humans without damaging adjacent healthy tissue. The company added that its clinical program going forward would focus on beginning a systemic delivery trial, a collaborative program with the National Cancer Institute in Bethesda, Md., and other local delivery studies. Along those lines, Oncolytics said it received regulatory approval to begin a UK-based Phase I study to investigate the systemic delivery of Reolysin for patients with advanced or metastatic solid tumors. The open-label, dose-escalation study's primary objective is to determine the product's maximum tolerated dose, dose-limiting toxicity and safety profile.

• Pharmacopeia Inc., of Princeton, N.J., said that as of Friday, its common stock is trading on the Nasdaq National Market under the ticker symbol "ACCL." Pharmacopeia said the decision to change its symbol was made in anticipation of its plan to separate its drug discovery and software businesses into two publicly traded companies through the spin-off to its stockholders of the drug discovery unit, Pharmacopeia Drug Discovery Inc. The separation is expected to occur by the end of the first quarter. Pharmacopeia will continue to run its Accelrys software business and will request that shareholder approve a name change to Accelrys Inc.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said it plans to begin a Phase IIb study of its Interleukin-1 (IL-1) Trap for rheumatoid arthritis in the second half of the year. At the same time, the company said Novartis Pharma AG, of Basel, Switzerland, decided to forgo its rights under the parties' collaboration to jointly develop and commercialize the IL-1 Trap product. Last fall, Regeneron disclosed that an initial Phase II study of IL-1 Trap missed its primary endpoint, but the company last week said the trial might not have tested the product's maximally efficacious dose. The new trial will be conducted in a larger patient population and test higher doses for a longer period of time. Following the missed endpoint results, Novartis sought to amend the terms of the agreement, which Regeneron declined to accept. But since the collaboration began about a year ago, Novartis has paid $102 million to Regeneron in up-front payments, equity investments and development expenses. Of that, $13.7 million consists of a loan that is forgivable upon near-term milestones. Novartis also remains obligated to fund development expenses during the nine-month notice period following its decision. Both parties retain rights under the agreement to elect to collaborate on the development and commercialization of other IL-1 antagonists being developed independently by the other party that are in earlier stages of development. (See BioWorld Today, March 31, 2003, and Oct. 8, 2003.)

• The State of New Jersey could become the first in the nation to invest its own funds for the creation of a stem cell research institution, if its legislature heeds its governor's call to invest state funds to create the New Jersey Institute for Stem Cell Research. In January, New Jersey became the second state to legalize stem cell research. The governor's budget calls for $6.5 million in initial funding, to be leveraged with additional private research funding.

• Tm Bioscience Corp., of Toronto, received conditional approval to list its common shares on the Toronto Stock Exchange. The approval is subject to the satisfaction of certain customary conditions on or prior to May 26. The company also reported that it expects to apply for approval to effect a share consolidation at a ratio of one post-consolidation common share for each five pre-consolidation common shares. The consolidation also will be submitted for shareholder approval at the company's next annual and special meeting of shareholders, scheduled for June 2.