aaiPharma Inc., of Wilmington, N.C., entered a drug development joint venture agreement with Tanabe Holding America Inc., a subsidiary of Japan-based Tanabe Seiyaku Co. Ltd., through which the companies will develop, manufacture, sell and potentially license pharmaceutical products for the Americas, Europe and other select territories. The agreement is pending approval by both companies' boards. Tanabe will provide compounds from its R&D discovery pipeline to the joint venture with a focus on U.S. development. aaiPharma will contribute its expertise in research and development and clinical trials management.
Actelion Ltd., of Allschwil, Switzerland, said it jointed Interpharma, a Basel-based association of Swiss pharmaceutical research companies. It joined F. Hoffmann-La Roche Ltd., Serono SA and Novartis AG.
Atrix Laboratories Inc., of Fort Collins, Colo., said its board amended the company's stock repurchase plan to provide for the purchase of up to $15 million of Atrix stock. The purchase is authorized through Dec. 31.
BioTrove Inc., of Cambridge, Mass., completed a study demonstrating the Living Chip technology for ultra-high-throughput screening of a genetic diversity. The technology is a tool that allows about 25,000 nanoliter-volume reactions to be initiated and monitored simultaneously, the company said. In the study, a mutagenized Bacillus library was screened by processing more than 40 pairs of nanoplates for discovery of mutant strains with high-protease expression.
Cubist Pharmaceuticals Inc., of Lexington, Mass., received a Phase I Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health in Bethesda, Md. The grant of $250,000 is to cover six months of research to identify broad-spectrum inhibitors of a bacterial target, Upps (Undecaprenyl Diphosphate Synthase). The goal is to identify drug candidates with efficacy against anthrax, but also against Gram-positive and Gram-negative bacteria.
Curis Inc., of Cambridge, Mass., said a recently published paper that will appear in the Aug. 9, 2002, issue of Cell demonstrates that Curis' hedgehog product can induce stem cells to differentiate into motor neurons, a finding that could have implications in neurodegenerative diseases. The paper describes a method for efficiently directing the differentiation of mouse embryonic stem cells into a fully differentiated type of neuron. The work was done with collaborators at Columbia University College of Physicians and Surgeons.
Epoch Biosciences Inc., of Bothell, Wash., and Amersham Biosciences, the life sciences division of Amersham plc, of London, said Amersham Biosciences will become the exclusive worldwide sales and marketing partner of Epoch's MGB Eclipse Probe Systems for the research field.
Exhale Therapeutics Inc., of Belmont, Calif., licensed intellectual property from Brigham and Women's Hospital related to the use of hyaluronic acid to prevent group A streptococcal pharyngitis. Financial terms were not disclosed. Exhale focuses on inflammatory lung diseases.
Genicon Sciences Corp., of San Diego, launched an ultra-sensitive signal generation and detection system for microarrays and other assays, called the One-Color Microarray Toolkit. The product is nano-based and designed to allow researchers to derive more data from smaller amounts of biological material and detect genes that are expressed at low levels.
Guilford Pharmaceuticals Inc., of Baltimore, said it is implementing a restructuring plan intended to focus resources on its most advanced product development programs and reduce expenses. Guilford will reduce its headcount by about 20 percent to 25 percent. All employees affected by the work force reduction will receive severance and outplacement support, which will result in a third-quarter restructuring charge of up to $1.5 million, Guilford said. The restructuring is expected to result in estimated savings of $10 million to $12 million annually, beginning in 2003. Guilford will report its second-quarter earnings on Aug. 8. In March, Guilford received a nonapprovable letter on a supplemental new drug application for use of Guilford's Gliadel Wafer in patients with newly diagnosed malignant glioma. The product was approved in 1996 for use as an adjunct to surgery in patients with recurrent glioblastoma multiforme. (See BioWorld Today, March 21, 2002.)
Immune Network Ltd., of Vancouver, British Columbia, said it will enter a collaborative agreement with AbNovo Inc., a recently incorporated Canadian company, to develop Immune Network's monoclonal antibody portfolio. AbNovo will be dedicated to developing antibody treatments for viral infections. AbNovo's CEO, Joyce Groote, said that the company will have a "unique opportunity to develop new treatments for AIDS, particularly as drug-resistant strains of HIV are threatening the utility of many of the drugs currently available." AbNovo will focus its initial efforts on the development of hNM01, the most advanced monoclonal antibody from the Immune Network pipeline.
Incara Pharmaceuticals Inc., of Research Triangle Park, N.C., said the FDA approved Incara's investigational new drug application to begin Phase I trials of cryopreserved human liver cells for the treatment of cirrhosis and end-stage liver disease. The company said that assuming adequate resources, it intends to start trials this fall. Patients would be those who would be candidates for placement on a whole-liver transplant list. Those with limited options would be tested initially. Separately, Incara said it received notice from Nasdaq that it fails to comply with the minimum $1 minimum bid price for continued listing. Incara has requested a hearing before a Nasdaq panel.
Lynx Therapeutics Inc., of Hayward, Calif., signed a service agreement with Cue Therapeutics, of Salt Lake City, to study stem cell gene expression. Lynx will receive payments for genomics services it performs on the human stem cell samples it is provided. Data from the work should serve as groundwork for a database of stem cell gene expression, Lynx said. Financial terms were not disclosed.
Peregrine Pharmaceuticals Inc., of Tustin, Calif., said it will submit an extension to file its annual report to the SEC and will postpone its conference call until after the filing, which will be no later than Aug. 12. The company said it is negotiating the terms of a new financing agreement and would like to close the financing in seven to 10 days. Peregrine focuses on the development, commercialization and in-licensing of technologies for cancer.
Regeneron Pharmaceuticals Ltd., of Tarrytown, N.Y., said it submitted an investigational new drug application to the FDA to begin a clinical trial development program for the Interleukin-4 and Interleukin-13 Dual Cytokine Trap in patients with asthma. The proposed Phase I study is designed to evaluate safety and tolerability of increasing doses of the product in adults with mild to moderate asthma. Lab experiments showed the product binds both IL-4 and IL-13 with high affinity, it said.
SuperGen Inc., of Dublin, Calif., said its European affiliate, AeroGen Pharmaceuticals Ltd., filed a mutual recognition application with the Medicines Control Agency of the UK seeking approval to market mitomycin in the UK and certain other European countries. The product, already marketed in the U.S., is designed to treat several cancers. Assuming acceptance of the application, a response would be expected in 210 days.
Variagenics Inc., of Cambridge, Mass., granted a worldwide license for its RNA targeting patent to Renegade Therapeutics, of Cambridge, Mass. Variagenics granted Renegade worldwide exclusive rights to all non-allele-specific applications for the research, development and commercialization of small-molecule drugs that target RNA. Variagenics will receive up-front fees, potential milestone payments, reimbursement for patent-related expenses, and royalties. Other financial terms were not disclosed.
Vernalis Group plc, of Cambridge, UK, said after review of data it decided, along with partner F. Hoffmann-La Roche Ltd., not to continue with additional Phase I trials of VR1065, a 5-HT2c receptor agonist being developed for obesity. The companies will concentrate on progressing other compounds in that class from the collaboration. They extended the obesity collaboration for two years in February.
Viragen Inc., of Plantation, Fla., and the University of Miami's Office of Technology Transfer entered an agreement to develop anticancer technology. The project is designed to develop a form of an immune-enhancing drug that has shown promise by inhibiting tumor growth in cancers. Also, Viragen receives an option to acquire an exclusive worldwide license in order to commercialize the technology. Financial terms were not disclosed.