¿ Actelion Ltd., of Allschwil, Switzerland, said the European Commission granted orphan medicinal product designation to bosentan (Tracleer) for treatment of pulmonary arterial hypertension. The FDA has granted the company similar status for bosentan, an oral dual endothelin receptor antagonist.
¿ Advanced Tissue Sciences Inc., of La Jolla, Calif., said the FDA informed the company that the initial review of ATS' premarket approval application for Dermagraft for treatment of diabetic foot ulcers is complete. However, the FDA requires additional information from ATS. Company officials declined comment about what information the FDA requires, citing ongoing discussions with the regulatory agency. The company applied for FDA approval in August after Dermagraft was deemed unapprovable in 1998. (See BioWorld Today, August 28, 2000.)
¿ Alfacell Corp., of Bloomfield, N.J., said its anticancer agent Onconase received orphan medicinal product designation in Europe. Onconase is designed for treatment of malignant mesothelioma.
¿ Anadys Pharmaceuticals Inc., of San Diego, established operations in Heidelberg, Germany. Anadys Pharmaceuticals Europe GmbH, or Anadys Europe, will operate as a wholly owned subsidiary to complement its high-throughput screening and medicinal chemistry capabilities in antiviral drug discovery.
¿ Aurora Biosciences Corp., of San Diego, said Merck and Co. Inc., of Whitehouse Station, N.J., purchased several VIPR II voltage ion probe readers for ion channel drug discovery. Financial details were undisclosed.
¿ Avant Immunotherapeutics Inc., of Needham, Mass., said preliminary results from a double-blind, placebo-controlled extension of its completed Phase I trial of its CETP vaccine indicated the vaccine produced an antibody response as early as a week after administration and for as long as 10 weeks in patients subjected to the highest dose level of 250 micrograms. The extension was designed to evaluate the safety, immunogenicity and dose-response relationship of the vaccine, intended for use in management of patients with low levels of high-density lipoprotein cholesterol.
¿ Bavarian Nordic Research Institute SA, of Copenhagen, Denmark, received approval to initiate a Phase I study of MVA-BN, an orthopox vaccine, in Germany. The study will enroll 90 healthy volunteers and is designed to evaluate the vaccine's safety and immunogenicity. The vaccine's ability to induce an immune response also will be evaluated through measurement of antibody, T-cell and other immune reactions.
¿ Biomira Inc., of Edmonton, Alberta, said it has recruited 928 patients so far in its Phase III trial of the Theratope vaccine for metastatic breast cancer. The company plans to enroll 950 patients and keep the study open until the end of the first quarter
¿ Bio-Technology General Corp., of Rehovot, Israel, will invest $45 million in a new Israeli plant. The company, which has developed products for growth hormone deficiency and weight gain promotion, expects the plant to be operational by the end of 2002.
¿ Chiesi Farmaceutici S.p.A., of Parma, Italy, and Biomedical Frontiers Inc., of Minneapolis, executed an option agreement giving Chiesi the right to enter an exclusive license agreement for BMF's patented iron-binding drug, 40SD02, for treatment of chronic iron overload disorders and iron poisoning. The license agreement would grant Chiesi the right to manufacture, use and sell BMF's drug product in all territories outside North America, and provide BMF with milestone payments and royalties on sales.
¿ Compugen Ltd., of Tel Aviv, Israel, entered an agreement with Scimagix Inc., of Redwood Shores, Calif., to resell Compugen's Z3 automated system for rapid analysis of 2-D electrophoresis gels. Scimagix will sell the Z3 system with its SIMS image data management system and ProteinMine 2D-gel analysis and mining application. Financial details were undisclosed.
¿ Diversa Corp., of San Diego, and Celera Genomics Inc., of Rockville, Md., completed the sequencing of the entire Streptomyces diversa genome. The companies entered a collaboration to do so in December. S. diversa belongs to a group of microorganisms, actinomycetes, which produces the majority of antibiotics used in human and veterinary medicine. Diversa said it will use S. diversa for the production of novel compounds of pharmaceutical interest.
¿ EntreMed Inc., of Rockville, Md., discovered and published in the Feb. 1, 2001, issue of Cancer Research news of a new angiogenesis inhibitor and antitumor agent, Metastatin, an endogenous complex isolated from bovine cartilage. The company has three anticancer agents - Endostatin, Panzem, and Angiostatin - in a total of 10 clinical trials.
¿ ETEX Corp., of Cambridge, Mass., said it will reorganize, splitting the company into two divisions, one focused on commercialization of ETEX's current Osteobiologic product line and one that will expand the company's base calcium phosphate technology into drug discovery with an initial focus on oncology and vaccines. The company said the reorganization is aimed at positioning the company to better focus on current commercialization efforts.
¿ Genetic Vectors Inc., of Miami, signed a research and technology transfer agreement with The Cleveland Clinic Foundation, of Cleveland, to discover and define genes and nucleic acid sequences related to diseases, therapeutic response and patient management. The companies will collaborate to discover genes involved in cardiovascular diseases. They will use Genetic Vector's proprietary high-throughput genotyping system to screen blood samples provided by the clinic and compare the genetic data to health records to determine correlative links between certain mutations in genes and disease susceptibility to drug efficacy.
¿ Genome Therapeutics Corp., of Waltham, Mass., and Schering-Plough Corp., of Kenilworth, N.J., said they discovered a novel asthma gene, marking the first identification of a susceptibility gene for asthma using a positional cloning platform for a large patient population. The research collaboration was initiated and sponsored by Schering-Plough.
¿ Human Genome Sciences Inc., of Rockville, Md., completed construction of a manufacturing facility for human antibody drugs for clinical trials. The facility also can produce human therapeutic proteins for clinical trials using mammalian cell cultures.
¿ LION bioscience AG, of Heidelberg, Germany, will acquire 16.1 percent of the shares of the Gesellschaft f|r Medizinische Datenverarbeitung (GMD), worth about EUR8.7 million (US$8 million). GMD will use the investment for the further development and commercialization of e-health.solutions, its web-based data management system for the health care industry. In a joint project, the companies will develop software modules to discover the causes of diseases through clinical trials and to further explore opportunities for individualized diagnostics and therapy. Depending on the results of the pilot project, LION retains the right to acquire an additional 9 percent of GMD's shares via a call option limited until June 30, 2002, and then to enter into a strategic alliance with GMD in the future.
¿ MediChem Life Sciences Inc., of Chicago, renewed and expanded its collaboration with AstraZeneca plc, of London. Under the terms, MediChem's medicinal chemistry and parallel synthesis teams provide AstraZeneca with synthetic libraries and novel method development discoveries to advance its drug discovery programs.
¿ Millennium Pharmaceuticals Inc., of Cambridge, Mass., and Ilex Partners LP, a joint venture between Millennium and Ilex Oncology Inc., of San Antonio, said the FDA issued a Class 1 complete response letter concerning the biologics license application the companies filed for Campath, a humanized monoclonal antibody for treatment of chronic lymphocytic leukemia. The companies expected to get the letter requesting additional information. The action extends the accelerated approval time frame by 60 days. The companies expect to complete package labeling and design of a post-marketing confirmatory study during this time. (See BioWorld Today, Feb. 15, 2001.)
¿ Neurocrine Biosciences Inc., of San Diego, said the expansion of its Phase I/II clinical program of NBI-6024, an altered peptide ligand, for Type I diabetes is under way in the United States in newly diagnosed adolescent and adult patients. Neurocrine will be initiating pivotal Phase IIb multicenter, multinational safety and efficacy trials in approximately 600 adult, adolescent and pediatric patients during the third quarter.
¿ NexMed Inc., of Robbinsville, N.J., entered into an agreement with a U.S. financial institution for a $5 million line of credit for the purchase of equipment for its new East Windsor, N.J., manufacturing facility and for its expanded corporate and laboratory facilities in Robbinsville. The East Windsor facility is expected to cost about $10 million and be fully operational by the end of 2001.
¿ Telik Inc., of South San Francisco, completed a Phase I trial of TLK286 in advanced cancer patients whose disease had failed to respond to multiple prior treatments. It plans to initiate multiple Phase II trials of the product, initially in colorectal, ovarian and non-small-cell lung cancer. TLK286 is a small-molecule candidate developed through the application of Telik's proprietary TRAP chemogenomics technology.
¿ UroGenesys Inc., of Laguna Niguel, Calif., said its portfolio of anticancer product candidates has grown to include antigens expressed in major solid tumors beyond urological cancers, the company's focus. The company also said it plans to develop therapeutic antibodies for targets in its growing portfolio, and that it plans to gain access to a medium-scale GMP manufacturing facility later this year, enabling it to produce future antibody products for clinical trials.
¿ Variagenics Inc., of Cambridge, Mass., said the Amsterdam Genomics Center at the University of Amsterdam ordered a NuCleave genotyping and haplotyping system. It will be used for population studies that are designed to identify susceptibility factors and for pharmacogenomic studies.
¿ Xenogen Corp., of Alameda, Calif., postponed its initial public offering. It filed in late September, set its price range of $10 to $12 per share and number of shares to 7 million in late December, and decreased its range to $9 in January.
¿ Zygogen LLC, of Atlanta, said it will provide Curis Inc., of Cambridge, Mass., with limited access to its proprietary transgenic zebrafish technology for Curis to accelerate its drug discovery program. Using its proprietary technology, Z-Tag, Zygogen designs transgenic zebrafish with labeled organs and specific cell lineages.