¿ American Biogenetic Sciences Inc., of Copiague, N.Y., said it is ¿actively working¿ to provide Nasdaq with information the exchange requested concerning ABS¿s news release Monday. The release detailed a 10-year agreement between ABS and the Ministry of Health of the Russian Federation for human vaccines for anthrax, smallpox, botulism and other diseases, as well as news concerning livestock vaccines. Nasdaq halted American¿s stock Monday morning and requested additional information. The company¿s stock had risen 38 cents, or about 109 percent, on the news. The company said it is working to ¿resolve any issues as expeditiously as possible.¿
¿ AxCell Biosciences Corp., a subsidiary of Cytogen Corp., of Princeton, N.J., and its distribution partner, InforMax Inc., of Bethesda, Md., said that Pluvita Corp., also of Bethesda, entered into a three-year, nonexclusive agreement to use AxCell¿s ProChart database in a range of drug discovery initiatives. Financial terms were not disclosed. ProChart is an expanding resource for signal transduction pathway information in the human proteome. The database includes the map of the known WW protein domain family and also includes protein pathway information from several other domain families, such as PDZ, SH2 and SH3.
¿ Biotechnology Industry Organization, of Washington, said Sharon Cohen was named vice president for government relations, replacing Lee Rawls, who has been asked to become counselor to FBI Director Robert Mueller. Also, Michael Werner will now be BIO¿s vice president of bioethics. He had been a director of federal government relations and bioethics counsel. Brent Erickson also was promoted to vice president. He was director of BIO¿s industrial and environmental section. BIO said the moves were made to make its advocacy efforts more effective on Capitol Hill.
¿ Cel-Sci Corp., of Vienna, Va., said it raised more than $2.2 million in both straight equity and debt financings since its last quarterly filings on June 30. All officers of the company participated in the equity financing. Cel-Sci¿s leading product is an immunotherapy product called Multikine. Multikine¿s lead indications are head and neck cancer and HPV-induced cervical dysplasia in HIV-infected patients.
¿ Collgard Biopharmaceuticals Ltd., of Newton, Mass., and the European Organization for Research and Treatment of Cancer announced that the first patient enrolled in a Phase I/II trial of Halofuginone tablets in patients with advanced-stage cancer. The study is being conducted in collaboration with the EORTC to develop Halofuginone and will be performed at two centers in Europe. It will be an open-label, dose-escalation study with once-a-day oral administration.
¿ Discovery Partners International Inc., of San Diego, established its European headquarters in Basel, Switzerland. This operation will be part of Discovery Partners International AG, the Swiss legal entity that also encompasses Discovery Partners¿ high-throughput screening and biology operations formerly known as Discovery Technology. Discovery Partners International AG will provide customers in Europe with a single point of contact for access to all its products and services. Separately, Discovery Partners announced the expansion of an existing agreement with Takeda Chemical Industries Ltd., of Osaka, Japan, to include a drug discovery research collaboration. Discovery Partners intends to use its integrated lead discovery and optimization framework to discover and optimize new compounds for a proprietary Takeda target. Financial terms were not disclosed, but include both fees and milestone payments.
¿ EntreMed Inc., of Rockville, Md., began a Phase II trial of Endostatin for the treatment of neuroendocrine tumors. Boston¿s Dana-Farber/Partners CancerCare will coordinate the 32-patient study, designed to measure tumor response to Endostatin. Patients will self-administer Endostatin using prefilled syringes. Endostatin received orphan drug status for neuroendocrine tumors in August.
¿ Genaera Corp., of Plymouth Meeting, Pa., began a Phase IIb trial designed to test squalamine, an angiogenesis inhibitor, for the treatment of patients with non-small-cell lung cancer. This multicenter, randomized study will evaluate up to 90 patients receiving weekly dosing of squalamine, combined with weekly chemotherapy of carboplatin and paclitaxel, in patients with Stage IIIB or Stage IV advanced disease. Half of the patients will receive a squalamine dose of 100 mg/m2, and the other half will receive a dose of 200 mg/m2. The optimization in dosing regimen has the potential to yield an improved safety and efficacy profile for the combination of squalamine and the chemotherapy agents.
¿ Gilead Sciences Inc., of Foster City, Calif., began the first Phase I trial of GS7904L, an investigational liposomal thymidylate synthase inhibitor for the potential treatment of cancer, in Germany. Additional Phase I trials of GS7904L are planned to begin in other countries in the coming months. This trial is designed to evaluate the safety, tolerability and toxicity of GS7904L in up to 40 patients at two sites. It will enroll patients with a variety of solid tumors refractory to standard therapy or for whom no curative therapy exists. In this first trial, the dose of GS7904L will be escalated in successive cohorts of patients to determine the maximum tolerated and recommended Phase II doses.
¿ Immunex Corp., of Seattle, broke ground for the BioNext Project, a new manufacturing plant in West Greenwich, R.I., dedicated to the production of Enbrel (etanercept) and ultimately new products in development. The new facility will expand supply capacity for Enbrel. The facility is planned at 500,000 square feet and must be approved by the FDA, with a decision expected in 2005. It is expected to be the fourth plant to manufacture Enbrel.
¿ La Jolla Pharmaceutical Co., of San Diego, said that the European Commission granted orphan medicinal product designation in the European Union for its drug candidate for lupus kidney disease, LJP 394, on the recommendation of the Committee on Orphan Medical Products. That enables the company to receive significant fee reductions for scientific advice, marketing authorization and inspections, and provides 10 years of market exclusivity in the EU. LJP 394 is designed to reduce the production of disease-causing antibodies responsible for lupus kidney disease, a leading cause of morbidity and mortality in lupus patients. The company received orphan drug designation for LJP 394 in the U.S. in September 2000.
¿ LION bioscience AG, of Heidelberg, Germany, and IBM Corp., of Armonk, N.Y., said they will work together to tackle the problem of harnessing the avalanche of data pouring in from human genome studies so that it can be used for more effective and faster drug discovery and development. IBM and LION will jointly market enterprise-wide drug discovery solutions, which will combine their technologies to address research and development requirements for information and knowledge management.
¿ MorphoSys AG, of Martinsried, Germany, announced the development and release of a new antibody library, HuCAL Gold. The company said initial results showed the new library and related screening system lead to faster and more efficient antibody generation, as well as enabling the achievement of higher average affinity antibodies and more diverse fully human antibodies.
¿ Nastech Pharmaceutical Company Inc., of Hauppauge, N.Y., began a Phase I U.S. trial to evaluate the nasal administration of interferon beta. The clinical program will explore the tolerance, safety and absorption of interferon beta in 12 healthy male subjects and ultimately aims to validate this technology in the treatment of multiple sclerosis. The continuous administration of interferon beta to MS patients allows the use of a lower dose and may significantly reduce the incidence of drug-related side effects. Interferon beta is indicated for the treatment of relapsing forms of MS administered by injection only.
¿ Nexell Therapeutics Inc., of Irvine, Calif., said the FDA granted orphan drug status to its lead therapeutic stem cell product for the treatment of chronic granulomatous disease, an inherited blood disorder. Nexell is sponsoring a Phase III trial for this product, which is being investigated at the National Institutes of Health. CGD is caused by a group of gene mutations that prevent white blood cells from producing oxygen compounds, their main weapon against bacteria or fungi. Nexell¿s stock (NASDAQ:NEXL) gained $1.65 Wednesday, or 220 percent, to close at $2.40.
¿ Orchid BioSciences Inc., of Princeton, N.J., and Invitrogen Corp., of San Diego, entered into an agreement under which Invitrogen acquired exclusive worldwide rights to offer genotyping products to the research market using Orchid¿s single nucleotide polymorphism scoring technology in a 96-well format. Invitrogen can develop, manufacture and market genotyping kits using Orchid¿s SNP scoring technology and offer customers access to Orchid¿s SNP primer design algorithms. Invitrogen will pay Orchid a royalty on kit sales.
¿ Procter & Gamble Pharmaceuticals Inc., of Cincinnati, said it is selling 3 million shares it owns of Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., for $20 per share to institutional investors, for $60 million. After the sale, P&G will own about 2.66 million common Regeneron shares, or 6.5 percent of the company.
¿ Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., initiated a Phase I trial designed to assess the safety and tolerability of its Vascular Endothelial Growth Factor (VEGF) Trap, an angiogenesis inhibitor, in patients with solid tumor malignancies and patients with non-Hodgkin¿s lymphoma. The trial is an open-label study in patients with advanced tumors and will evaluate VEGF Trap in increasing dose levels. The study is being conducted at a clinical site in New York City.
¿ Rigel Pharmaceuticals Inc., of South San Francisco, said Pfizer Inc., of New York, accepted a validated drug target for allergies and asthma from Rigel, resulting in a milestone payment. The companies originally entered into an agreement in January 1999 to use Rigel¿s peptide libraries to identify intracellular drug targets that control production of IgE, a key mediator in allergic reactions and asthma.
¿ Valentis Inc., of Burlingame, Calif., and Genetronics Biomedical Corp., of San Diego, said Valentis obtained a nonexclusive license to in vivo electroporation technology from Genetronics for use in the development of certain Genemedicine products. Electroporation enhances the ability of cells to take up large molecules such as DNA. When combined with Valentis¿ GeneSwitch gene regulation system, electroporation allows researchers to control the level and duration of gene expression. Financial terms were not disclosed.
¿ Versicor Inc., of New York, is planning to develop its investigational antibiotic, dalbavancin, as the first once-weekly treatment for Staphylococcal and other serious Gram-positive hospital infections based on positive clinical data to be presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy next month. Results of a Phase I study demonstrated that both daily and weekly dosing with dalbavancin are well tolerated. Phase II study patients are being enrolled to evaluate the efficacy and safety of dalbavancin given once a week for the treatment of skin and soft-tissue infections caused by Gram-positive bacteria, usually Staph. Additional Phase II studies evaluating the use of once-weekly dalbavancin in other Gram-positive infections are planned over the next six months.
¿ Viragen Inc., of Plantation, Fla., said that Viragen (Europe) Ltd., Viragen¿s 87 percent owned subsidiary, has been renamed Viragen International Inc. The company¿s wholly owned Swedish subsidiary, BioNative AB, will be renamed ViraNative AB. Also, the company¿s natural human leukocyte-derived alpha interferon will be renamed Multiferon at such time as the Swedish regulatory authorities approve the name change.