¿ Ariad Pharmaceuticals Inc., of Cambridge, Mass., and NsGene A/S, of Copenhagen, Denmark, established a collaboration to evaluate novel small-molecule regulated gene and cell therapy products for central nervous system diseases. The collaboration will combine Ariad's Regulated Gene Expression Technology and NsGene's neurotrophic factors and technologies to culture and engineer neural cells for delivery to the central nervous system.
¿ Baxter International Inc., of London, gained a 20 percent stake in Peptide Therapeutics Group plc, of Cambridge, UK, in a deal in which Baxter will buy #27.8 million (US$39.2 million) of Peptide shares over the next three years. The investment deal for Peptide was in lieu of its planned merger with Cantab Pharmaceuticals plc, also of Cambridge. Cantab confirmed the termination of talks to acquire Peptide in a news release Wednesday.
¿ Cellegy Pharmaceuticals Inc., of South San Francisco, said it successfully completed a Phase I/II clinical trial of its transdermal testosterone gel product, Tostrelle, for treatment of low testosterone levels in menopausal women, a frequent cause of diminished libido or low sex drive. Results of the trial indicated that Tostrelle is well tolerated and causes no adverse effects. Cellegy plans to begin an expanded Phase I/II trial to determine dosing based on the results of the trial.
¿ Targeted Genetics Corp., of Seattle, said it completed its planned acquisition of Genovo Inc., of Sharon Hill, Pa., in a stock-swap deal worth about $67 million. Targeted Genetics issued 6.63 million shares of common stock, about 15 percent of the company's post-transaction shares outstanding, to Genovo shareholders. Genovo focuses on AAV-based product development programs in hyperlipidemia and atherosclerosis. (See BioWorld Today, Aug. 10, 2000, p. 1.)
¿ Cephalon Inc., of West Chester, Pa., said it launched mondafinil, its wake-promoting drug for treatment of excessive daytime sleepiness associated with narcolepsy, in Switzerland. In the U.S., UK, Ireland and Italy, the drug, marketed in Switzerland under the trade name Mondasomil, is marketed under the brand name Provigil.
¿ Gliatech Inc., of Cleveland, said the European Economic Area regulatory agency has granted approval for commercial distribution of Adcon-L manufactured in Gliatech's Solon, Ohio, facility. Gliatech has commenced distribution of the product designed to inhibit postsurgical scarring and adhesions. In separate news, Gliatech is the focus of a class action suit brought by Berman, DeValerio & Pease LLP alleging the company withheld adverse news about clinical trials on Adcon-L. The suit was filed in U.S. District Court for the Northern District of Ohio, and is on behalf of stock buyers in the period between April 9, 1998, and Aug. 29, 2000.
¿ Hemosol Inc., of Toronto, said it began construction on a new production facility and headquarters in Mississauga, Ontario. The $60 million, 120,000-square-feet facility is expected to be operational in early 2002, and production of Hemosol's hemoglobin replacement therapy, Hemolink, is expected to meet design estimates of 300,000 units annually there.
¿ Isis Pharmaceuticals Inc., of Carlsbad, Calif., said it licensed its third-generation antisense chemistry, Peptide Nucleic Acid, to Pantheco A/S, of Copenhagen, Denmark, to treat diabetes and cardiovascular disease. Isis will receive a $1.1 million licensing fee in the transaction, payable in Pantheco shares at the completion of a Pantheco financing, in addition to royalties and milestone payments on products developed from the technology. Following the financing, Isis will be a 21 percent shareholder in the Danish biotech company.
¿ Magainin Pharmaceuticals Inc., of Plymouth Meeting, Pa., said two recently published journal articles presenting preclinical data related to interleukin-9's role in controlling human eosinophils, inflammatory cells involved in the asthmatic response, provide further evidence for the role of IL-9 in regulating airway immune responses and demonstrate that IL-9 potentiates eosinophil function by perpetuating the cells' survival. The articles were published in the September issue of the Journal of Allergy and Clinical Immunology and Blood, respectively. Magainin said the findings validate its proprietary gene, interleukin-9, as a critical mediator of asthma.
¿ OraVax Inc., of Cambridge, Mass., a wholly owned subsidiary of Peptide Therapeutics Group plc, of Cambridge, U.K., was awarded a 20-year contract from the Centers for Disease Control and Prevention for the development and maintenance of a national stockpile of smallpox vaccine worth $343 million. The stockpile is designed to counter the threat of bioterrorism. The contract calls for an initial production of 40 million doses.
¿ Ortec International Inc., of New York, said it successfully completed an FDA-mandated preapproval inspection of its manufacturing facilities for its Composite Cultured Skin (CCS) for treatment of epidermolysis bullosa in connection with the humanitarian device exemption approval process. Remaining in the FDA review process for CCS is completion of the FDA's review of safety and probable benefit data.
¿ PPL Therapeutics plc, of Blacksburg, Va., said it achieved positive results from a year-long study of alpha-1-antitrypsin (AAT) in cystic fibrosis patients. The safety study, designed to gain further, long-term safety data on the use of transgenic AAT, observed no drug-related serious adverse events in patients.
¿ Techne Corp., of Minneapolis, is taking on biotech giant Amgen Inc., of Thousand Oaks, Calif., according to Reuters. At issue in the suit brought by Techne in U.S. District Court in Minnesota is a $31.9 million invoice for biological materials, specifically, an inventory supply of erythropoietin, delivered in 1991. Amgen reportedly sent Techne a bill for the erythropoietin, saying it mistakenly failed to bill the Minnesota company. Techne claims it owes Amgen nothing.
¿ The American Corn Growers Association, of Washington, said increased demand for genetically modified (GMO) corn could require segregation from traditional supplies. It said that action is likely to rise from news that an unapproved GMO corn variety, Cry9C, was detected in taco shells marketed by Taco Bell. Cry9C is marketed by Aventis Pharmaceuticals, of Parsippany, N.J., and is approved for animal consumption. The Environmental Protection Agency did not approve the variety for human consumption because it exhibited some characteristics of known allergens.
¿ Transgene, of Strasbourg, France, said parent company bioMerieux Group, of Paris, and the Pierre Fabre Group, also of Paris, will merge in a deal expected to take effect Jan. 1. The new group, bioMerieux-Pierre Fabre, is expected to generate sales of FrF10.7 billion (U.S.$1.4 billion). The merger will create a company equally owned by the two merging parties, run by a supervisory board chaired by Fabre and a management board chaired by Alain Merieux and led by a pair of CEOs. The deal shouldn't affect Transgene, it said.
¿ VaxGen Inc., of Brisbane, Calif., said the same principal at work in the creation of the first HIV/AIDS vaccine was used to create the first herpes vaccine, data for which efficacy was revealed this week. Both vaccines were created by cloning surface, or viral, envelope proteins, promoting an immune system response in vitro. Studies show the vaccine was more than 70 percent effective in preventing genital herpes.