Amaxa GmbH, of Cologne, Germany, entered into an open-ended strategic partnership with Wako Pure Chemical Industries, of Osaka, Japan, under which Wako will exclusively distribute Amaxa's technology in Japan. Founded in 1998, Amaxa focuses on the development, production and commercialization of gene transfer products, particularly nonviral gene transfer into the nucleus of primary cells and cell lines, for industrial applications and gene-based medicine. Wako, an R&D-oriented company that develops chemicals and diagnostic reagents for research, industrial and medical applications, will use Amaxa's technology in its internal research and development and also make it available to Wako's strategic customers. Takeda Chemical Industries, Wako's holding company and Japan's largest pharmaceutical entity, has started using Amaxa's technology for its internal research and development. Financial terms of the alliance were not disclosed.
Berna Biotech Ltd., of Berne, Switzerland, said it received orphan status in the U.S. for its Aerugen vaccine against Pseudomonas aeruginosa infection. It attained the same designation for the product, which targets up to 95 percent of P. aeruginosa infections, in Europe in December. Phase III trials in 46 centers in four European countries are under way. The company said it expects to launch the product in the U.S. in 2005.
GeneScan Europe AG, of Freiburg, Germany, introduced to the market a service for pharmacogenetic profiling test subjects and patients taking part in clinical trials. The genotyping is based on a proprietary biochip technology that identifies 39 of the relevant polymorphisms with currently known functions coding for key enzymes of drug metabolism and transport. The company reports a two- to three-day turnaround on testing services. GeneScan said that targeted recruitment of study participants on the basis of their pharmacogenetic profile can yield more statistically significant results with a lower number of test subjects and patients, achieving cost savings of up to 45 percent.
MorphoSys AG, of Martinsried, Germany, extended its antibody development agreement with ProChon Biotech Ltd., of Rehovot, Israel. MorphoSys obtained exclusive rights to a portfolio of anticancer antibodies from ProChon for development and commercialization in therapeutic applications in oncology. The agreement expands a relationship that began in May 2000 and has seen licensing in both directions of antibodies directed against a human growth factor receptor, fibroblast growth factors receptor 3 (FGFR 3), which is implicated in skeletal disorders such as dwarfism and some forms of cancer. The new agreement extends the companies' relationship by reserving for ProChon the rights to develop the antibodies against FGFR 3 in all non-cancer indications and by starting a three-year collaboration to develop new antibodies against targets related to FGFR 3. No financial details of the agreement were disclosed. Separately, ProChon and Savyon Diagnostics Ltd., of Ashdod, Israel, entered into a collaboration to develop and manufacture an early diagnostic kit for bladder cancer based on an FGF receptor mutation. Under the agreement, Savyon will produce the prototype kit while ProChon will undertake testing and clinical development, retaining worldwide exclusive rights for commercialization of the kit.
NST-NeuroSurvival Technologies Ltd., of Petach Tikva, Israel, approved Eli Hurwitz as its company chairman. Hurwitz, the former chairman of Teva Pharmaceuticals Ltd., will focus on defining the business strategy for NST, which is developing therapies for detecting and modulating apoptosis as it occurs in neurodegenerative disorders, cancer and cardiovascular disease.
Pharmexa A/S, of Horsholm, Denmark, said it planned to undertake U.S. clinical trials of its AutoVacHER-2 Protein pharmaccine for breast cancer, following pre-investigation new drug consultations with the FDA. The company expects to initiate the first study early next year. "As a result of the discussions with the FDA, Pharmexa has reasons to believe that progression to Phase II will be faster than originally anticipated," the company said. The drug candidate is designed to combat breast cancers in which the HER-2 growth factor is overexpressed by inducing the production of antibodies that bind the protein and block its oncogenic action. The company is also developing a DNA-based pharmaccine for the same target, which is designed to induce a cellular immune response. It is in Phase I/II clinical trials.
SkyePharma plc, of London, announced it is stepping up its collaboration with Kowa Company Ltd., of Japan, for the formulation and manufacture of NK-104, Kowa's lipid-lowering drug, which is currently in Phase III trials. Kowa will invest £25.3 million in SkyePharma, and has signed a letter of intent to potentially take a 50 percent stake in SkyePharma's manufacturing facility in Lyon, France. The partners also are collaborating on an undisclosed project using SkyePharma's enhanced solubilization technology, and said they have identified other areas in which they intend to collaborate.
Teva Pharmaceutical Industries Ltd., of Jerusalem, said that the multiple sclerosis drug Copaxone (glatiramer acetate injection) Pre-Filled Syringe has received notice of compliance from Health Canada, clearing it for distribution.
Vernalis Group plc, of Winnersh, UK, said it has agreed to a third research agreement with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, to discover and develop drugs for the treatment of anxiety and depression. Roche is making a loan of £7 million to Vernalis as part of the deal, and has the option to license worldwide rights to compounds arising from Vernalis' R&D. The companies have an existing collaboration around VR 1065, an anti-obesity treatment in Phase I, and in February Roche took certain rights to Vernalis' diabetes program, which is expected to produce candidates in the second half of 2003.