¿ Access Pharmaceuticals Inc., of Dallas, said data from its Phase II study of OraRinse for the prevention and treatment of mucositis confirms the mucoadhesive liquid technology could be a platform technology. Access said when the analysis of the data is complete, it will meet with the FDA to determine how to quickly advance its mucositis development program.
¿ AVAX Technologies Inc., of Kansas City, Mo., said its wholly owned subsidiary, Genopoietic SA, has received notification from the European Agency for the Evaluation of Medicinal Products that the application of severe combined immunodeficiency (SCID-X1) for designation as an orphan medicinal product has been granted. SCID-X1 is a primary immune deficiency that occurs in one out of 170,000 male births. Treatment consists of introducing the normal gene into the stem cells of patients through gene therapy. Genopoietic has manufactured the vector for these treatments.
¿ BioErgonomics Inc., of St. Paul, Minn., and Loma Linda University Medical Center entered an agreement granting BioErgonomics an option to acquire an exclusive license to commercialize certain new technology covered under the center¿s patent rights for ¿Iron Regulating Protein¿2 as a Diagnostic for Alzheimer¿s Disease and Other Neurodegenerative Diseases.¿ Financial details were not disclosed. Privately held BioErgonomics is involved in the development and commercialization of multiplexed tests for rare proteins.
¿ BresaGen Ltd., of Thebarton, South Australia, was awarded a grant to research a new treatment for juvenile diabetes by the National Health and Medical Research Council of Australia and the Juvenile Diabetes Research Foundation. BresaGen will receive about A$250,000 (US$128,370) each year for five years to develop cloning technologies that allow the deletion and insertion of genes to overcome rejection of pig tissue transplants. The collaborative program will research the use of pig islet xenotransplantation for juvenile diabetes.
¿ Celera Genomics Group, of Rockville, Md., signed multiyear agreements with the University of Alabama at Birmingham, Case Western Reserve University School of Medicine in Cleveland, the Fred Hutchinson Cancer Research Center in Seattle, University of Oxford in the UK, and Pennington Biomedical Research Center at Louisiana State University in Baton Rouge. The agreement allows the institutions to access Celera¿s database products, using the company¿s Discovery system.
¿ DeCode genetics Inc., of Reykjavik, Iceland, and Applied Biosystems Group, of Foster City, Calif., said they formed a three-year alliance to combine deCode¿s bioinformatics tools for genotypic analysis and Applied Biosystems¿ bioanalytical instruments to build capabilities for DNA research. They intend to adapt deCode¿s genotyping software suite for integration with Applied¿s laboratory management software to provide customizable solutions for the generation, management and analysis of genotyping data. Financial details were not disclosed. DeCode¿s stock (NASDAQ:DCGN) rose 90 cents Thursday, or about 11 percent, to close at $8.90.
¿ DNA Sciences Inc., of Fremont, Calif., said more than 10,000 individuals have registered for the DNA Sciences Gene Trust Project, a consumer-focused, Internet-based research initiative designed to discover links between genetics and common diseases. The project will help DNA Sciences researchers identify the genetic basis of common diseases, it said.
¿ Esperion Therapeutics Inc., of Ann Arbor, Mich., said it plans to open a satellite facility in Kalamazoo, Mich., for its chemistry group, for the discovery of novel therapeutic compounds for the treatment of cardiovascular and metabolic diseases. Once it is completed Esperion will occupy a state-of-the-art research and discovery lab on the campus of Western Michigan University. In the meantime, the company will use an existing campus facility.
¿ Genaissance Pharmaceuticals Inc., of New Haven, Conn., said its enrollment goal of 600 patients was reached for the largest prospective personalized medicine clinical trial ever conducted. The STRENGTH (statin response examined by genetic HAP markers) study is designed to link specific markers of human genetic variation to clinical response so that physicians can decide which cholesterol-lowering drug is best for each person based on the person¿s DNA. The study enrolled 600 patients at 60 centers in the U.S., with 150 patients enrolled in each arm of the study. A full analysis is expected by the first quarter of 2002.
¿ Genome Canada, of Ottawa, Ontario, said it is beginning a second national competition to fund several large-scale genomics research projects and their related science and technology platforms in the health, forestry, agriculture, environment and fisheries sector. Last year¿s competition totaled investments of C$270 million (US$175.2 million), C$135 of which came from Genome Canada. Genome Canada said it might invest as much as C$165 million in this year¿s competition.
¿ Genomic Solutions Inc., of Ann Arbor, Mich., a supplier of automated solutions for genomic and proteomic research, formed a collaborative agreement with the Life Sciences division of NuTec Sciences Inc., of Atlanta, to expand and enhance the bioinformatics technology capabilities of Genomic Solution¿s GeneTAC Biochip system. NuTec will work with Genomic Solutions to design and develop the new software, which is expected to be released in the fourth quarter. NuTec¿s Life Sciences division provides the technology platform to accelerate medical and academic research in disease management, treatment and drug discovery.
¿ Genzyme Transgenics Corp., of Framingham, Mass., appointed Geoffrey Cox as chairman and CEO. Cox most recently served as chairman and CEO of Aronex Pharmaceuticals Inc., of The Woodlands, Texas. Using milk from specially bred animals, Genzyme Transgenics develops monoclonal antibodies and immunoglobulin fusion proteins or other therapeutic proteins for conditions such as rheumatoid arthritis, HIV/AIDS and cancer.
¿ GPC Biotech AG, of Martinsried, Germany, and MorphoSys AG, of Munich, Germany, said they achieved a preclinical milestone in GPC¿s antibody program for the treatment of specific blood cancers, the MHC class II positive B-cell lymphomas. GPC showed the human antibody, generated and optimized by MorphoSys from its HuCAL library, has in vivo efficacy in rodent xenograft tumor models. The milestone triggers an undisclosed payment from GPC to MorphoSys.
¿ ICN Pharmaceuticals Inc., of New York, said it initiated full redemption of its outstanding 9< percent senior notes, due 2005. The approximate $189 million aggregate principal amount of the notes will be redeemed on Aug. 17 at a redemption price of about 104.6 percent of the principal amount thereof, plus accrued and unpaid interest to Aug. 17.
¿ Lilly ICOS LLC, a joint venture of ICOS Corp., of Bothell, Wash., and Eli Lilly and Co., of Indianapolis, said that the Opposition Division of the European Patent Office declared Pfizer Inc.¿s ¿method of use¿ patent for PDE inhibitors, including sildenafil, invalid. The decision means that Pfizer is not entitled to exclusivity in the field of erectile dysfunction (ED), but that does not affect Pfizer¿s compound patent, which covers sildenafil. Lilly IOCS recently submitted applications with the FDA and the European Agency for the Evaluation of Medicinal Products (EMEA) requesting market approval of Cialis for the treatment of ED.
¿ LION bioscience AG, of Heidelberg, Germany, and MDL Information Systems Inc., of San Leandro, Calif., entered a software licensing and reselling agreement. LION will license a range of MDL¿s informatics applications and databases in order to develop and commercialize software applications to interface with MDL¿s products. MDL will be the exclusive reseller for LION¿s iDEA product line for the prediction and analysis of ADME (absorption, distribution, metabolism, excretion). Financial details were not disclosed.
¿ Morphochem AG, of Munich, Germany, raised EUR15 million (US$13 million) in its fourth private funding round. Life Sciences Partners, of Amsterdam, the Netherlands, led the round with a EUR9 million investment. This round follows one of EUR40 million last year, and will allow Morphochem to strengthen its technology platform and develop its product pipeline though 2003, the company said. The company¿s total equity funding since its launch in 1998 is EUR77 million.
¿ New York University Medical Center, of New York, said researchers have initiated a trial to study the efficacy of an OGT-918 (Vevesca) for Type 1 Gaucher disease. The study is being conducted in the Gaucher clinic at NYU and will involve 14 patients who have not received previous treatment with enzyme replacement therapy, or who stopped therapy for more than three months prior to enrollment. OGT-918 was developed by Oxford GlycoSciences plc, of Oxford, UK, and has been studied in a total of 80 patients, both in combination with enzyme replacement therapy and as monotherapy.
¿ Oxxon Pharmaceuticals Inc., of Oxford, UK, licensed intellectual property on adenovirus vaccine technology from Isis Innovation, the technology transfer company at the University of Oxford. The license covers the worldwide exclusive use of adenovirus vaccine to boost an immune response to an antigen for therapeutic and prophylactic applications in the fields of infectious disease and cancer.
¿ Pieris Proteolab AG, of Weihenstephan, Germany, named Martin Poehlchen CEO. Poehlchen previously served as vice president, business development, at MediGene AG, of Martinsried, Germany.
¿ Pyrosequencing AB, of Uppsala, Sweden, completed the worldwide distribution network for its DNA sequencing and analysis systems to include major markets in Asia Pacific. In addition to six already-established distributorships, the company has signed four new agreements with distributors of life science research products: Millennium Science Pty. Ltd., for Australia, New Zealand, Singapore and Malaysia; Bio-Medical Science Co. Ltd. for Korea; Biowell Technology Inc. for Taiwan; and Gene Company Ltd. for China and Hong Kong. The company said these agreements will complement its existing distribution arrangement with Sumitomo in Japan.
¿ Scios Inc., of Sunnyvale, Calif., reported that the FDA said the preapproval inspection for Natrecor was completed. The FDA¿s San Francisco district office informed the company that it would recommend approval of the Natrecor new drug application to the Center for Drug Evaluation and Research (CDER). Scios developed Natrecor as an intravenous treatment for patients with acutely decompensated congestive heart failure. The only item yet to be completed before the CDER issues the final action letter of the Natrecor NDA is the finalization of labeling, Scios said, and discussions with the FDA on that are ongoing
¿ Tibotec-Vicro, of Mechelen, Belgium, appointed Philippe Ballero as CEO, effective Sept. 1. Ballero currently is president and COO of Yamanouchi Pharma Europe BV, of Leiderdorp, the Netherlands. He will assume responsible for day-to-day operations, including drug development and diagnostics.
¿ Ventana Medical Systems Inc., of Tucson, Ariz., said GlaxoSmithKline plc, of London, selected Ventana¿s Discovery high-throughput in situ hybridization and immunochemistry (ISH) system as its primary technology for ISH analysis associated with target and compound discovery. The companies also signed a co-development agreement to investigate improvements in their discovery efforts, specifically targeted at tissue gene expression profiling studies.
¿ Vertex Pharmaceuticals Inc., of Cambridge, Mass., completed the acquisition of Aurora Biosciences Corp., of San Diego. The merger is a tax-free stock-for-stock deal worth $592 million. Aurora shareholders will receive 0.62 shares of Vertex common stock for each share of Aurora stock. Cash will be provided for fractional shares. Aurora will delist its stock from Nasdaq, and will become a wholly owned subsidiary of Vertex. The merger combines Aurora¿s assay development, screening and cell biology capabilities with Vertex¿s drug discovery expertise to accelerate drug candidate output in target-rich gene families. (See BioWorld Today, May 1, 2001.)
¿ ViroLogic Inc., of South San Francisco, received a $600,000 research grant from the National Institutes of Health to aid in the development of new technology to measure HIV replication capacity. The grant will be paid over two years. This is the second NIH Advanced Technology grant awarded to the company this year, with the combined grants totaling $1.2 million.
¿ XTL Biopharmaceuticals Ltd., of Rehovot, Israel, and Dong-Wha Pharmaceutical Industrial Co. Ltd., of Seoul, South Korea, signed a collaborative agreement to evaluate small-molecule compounds for the treatment of hepatitis C. Dong-Wha will provide XTL access to its library of small-molecule drug candidates, which already have been screened for efficacy using in vitro models of hepatitis C. XTL will further evaluate the efficacy of these candidates using its human tissue-based in vivo disease model. Dong-Wha will retain development and marketing rights to any resulting products in Korea, and XTL has the option to acquire an exclusive development and commercialization license for the rest of the world.
¿ ZymoGenetics Inc., of Seattle, named George Rathmann chairman of its board. Rathmann, a co-founder of Amgen Inc., of Thousand Oaks, Calif., also is chairman of Hyseq Inc., of Sunnyvale, Calif.