• Acambis plc, of Cambridge, UK, will pay £12 million (US$20.4 million) to discharge all past and future rights, obligations and claims after settling with BTG International Ltd., of London, concerning payments due under an assignment consideration agreement. Signed in 1997, the agreement relates to a technology license agreement between Acambis and BTG originally established in 1994. The agreement provided for Acambis to pay 2 percent of its reported turnover to BTG potentially until 2024.

• Active Biotech AB, of Lund, Sweden, said ABR-215757 was shown to inhibit systemic lupus erythematosus in mice that spontaneously developed a similar condition. Oral treatment with daily doses of 2 or 12 mg/kg of the candidate resulted in a statistically significant decrease of kidney inflammation, measured as protein level and blood in the urine, compared to the control group.

• Beijing Pason Pharmaceuticals Inc. in China entered a license agreement with Vion Pharmaceuticals Inc., of New Haven, Conn., for the exclusive rights to develop, manufacture and market Triapine for cancer and antiviral uses in China, Taiwan, Hong Kong and Macao. The agreement needs final approval from various Chinese government agencies. Terms of the agreement include an initial payment of $500,000 to Vion upon receipt of required approvals, $4.75 million in potential milestone payments, and royalty payments of 11 percent on Triapine revenues. Pason will fund the preclinical and clinical development.

• Benitec Ltd., of Queensland, Australia, said it simultaneously disabled multiple genes through RNA interference as a result of its continuing research and development efforts in DNA directed RNAi (ddRNAi) technology to extend its patent portfolio in RNA interference. The company said the finding could play a role in combating resistance to existing drugs, noting that the greater the number of genes that can be targeted, the lower the possibility that any one cell or virus could develop resistance to the treatment. Benitec said ddRNAi provides the ability to control the silencing effect so that it either knocks down or completely silences the target gene.

• Codon AG, of Berlin, said at its annual meeting it had liquidity for about the next year of operations and that it intends to have additional investors by May. Last week, the company simultaneously released reports for 2002 and the first six months of 2003, with most recent sales numbers showing a 30 percent drop compared with the same period last year. An association for the protection of small shareholders also has announced that it will call for the resignation of the company's supervisory board. Codon was founded in 1993 and specializes in cell-based biomedical products for the regeneration of cartilage, bone and intervertebral discs.

• Crucell NV, of Leiden, the Netherlands, said its vaccine candidate against malaria will undergo testing and collaborative development in two programs involving three research organizations. The first program is with the Department of Medical and Molecular Parasitology at New York University, where Crucell's vaccine will be tested in NYU's Plasmodium yoelii mouse malaria model. The second program is with the Walter Reed Army Institute of Research and GlaxoSmithKline Biologicals, a unit of GlaxoSmithKline plc, of London. The two parties, together with Crucell, entered a Cooperative Research and Development Agreement to evaluate Crucell's vaccine against the human malaria parasite Plasmodium falciparum. Crucell's candidate will be tested as a stand alone or in combination with GSK's malaria vaccine candidate, RTS,S, and formulated in a GSK adjuvant, AS01B. All of Crucell's vaccines are being developed using the company's PER.C6 cell line production technology.

• Evotec OAI AG, of Hamburg, Germany, and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, expanded their partnership through a medicinal chemistry collaboration to identify and develop a clinical lead candidate for one of Roche's cancer targets. The companies have worked together on the production of chemical libraries since 2001, with Evotec supplying chemical compound libraries to Roche for use in drug discovery screening programs. Financial terms were not disclosed.

• Genmab A/S, of Copenhagen, Denmark, and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, reported that Genmab achieved a second milestone in their collaboration, having reached the proof-of-concept stage with a human antibody generated by Genmab. It is the second antibody program in the alliance to reach that stage. The companies entered the collaboration in May 2001. If all goals are reached, the value of the collaboration to Genmab could be $100 million, plus royalties. The agreement was expanded in June 2002.

• IsoTis SA, of Lausanne, Switzerland, completed its merger with GenSci OrthoBiologics Inc., a part of GenSci Regeneration Sciences Inc., of Toronto. IsoTis' management, which said full-year sales from combined operations would slightly exceed 2002 combined sales of $23 million, expects IsoTis OrthoBiologics to become profitable during 2005. Prior to completion, IsoTis had issued about 27.5 million new shares to pay for shares of GenSci OrthoBiologics and certain related assets that IsoTis acquired. At the same time, GenSci President and CEO Douglass Watson resigned. In separate news, IsoTis transferred its orthobiology research group to the University of Twente in the Netherlands. The group will become part of the school's Biomedical Technology Institute, with two of the company's scientific founders heading the new group, which will focus on the biology and repair of musculoskeletal tissues. In return for providing financial support, IsoTis will own resulting technology or products to secure the inflow of new technology into its product pipeline. Financial terms were not disclosed.

• Novuspharma SpA, of Milan, Italy, and Cell Therapeutics Inc., of Seattle, said they received shareholder approval for their $236 million merger, which they expect to close late this quarter or early in the first quarter of next year. Also, Novuspharma began a Phase II trial of Pixantrone (BBR 2778) as part of the new BSHAP regimen (Pixantrone Administered in Combination with Cytarabine, Methylprednisolone and Cisplatin) in patients with aggressive non-Hodgkin's lymphoma who are experiencing their first relapse. The U.S.-based trial, which is expected to recruit about 75 patients, is designed to evaluate BSHAP's efficacy as a salvage therapy and assess its safety and use as an induction regimen before bone marrow transplant.

• Paradigm Therapeutics Ltd., of Cambridge, UK, in collaboration with the reproductive endocrine unit of Massachusetts General Hospital in Boston, said findings published in the Oct. 23, 2003, issue of the New England Journal of Medicine point to their identification and validation of a cell-surface receptor, GPR54, required for regulation of sex hormone secretion. Gene mutations that disrupt the normal function of the receptor cause a lack of production of hormones from the pituitary gland, and have been shown to result in failure to reach sexual maturation in both mice and humans.

• PhenoMed, of Kuala Lumpur, Malaysia, partnered with GenoMed Inc., of St. Louis, to expand the latter's medical therapeutics services into the Asia-Pacific region. The medical genomics company said PhenoMed provides a research base for conducting clinical trials against severe acute respiratory syndrome, and would aid in GenoMed's efforts to deliver its disease management services for hypertension, diabetes and emphysema in that region. Financial terms were not disclosed.

• ProSkelia SAS, of Paris, and High Throughput Genomics Inc., of Tucson, Ariz., reported that ProSkelia will incorporate HTG's ArrayPlate high-throughput screening technology into one of its drug discovery programs. HTG's ArrayPlate contains a generic Universal Array in each well of a standard 96-well microplate. Each array can be programmed using reagents, either by HTG or by the customer, for the measurement of any set of up to 100 DNA, RNA or protein molecules.

• Rentschler Biotechnologie GmbH & Co. KG, of Laupheim, Germany, entered a collaboration with Neose Technologies Inc., of Horsham, Pa. Neose will use its technologies to develop a therapeutic protein using material supplied by Rentschler. Rentschler would have the right to collaborate further with Neose as a co-developer or supplier of the protein, if Neose decides to proceed with commercialization.

• SkyePharma plc, of London, said the FDA issued an approvable letter for Foradil Certihaler (formoterol fumarate inhalation powder), which was co-developed with Novartis Pharma AG, of Basel, Switzerland. Formoterol, the product's active ingredient, is a long-acting beta-agonist bronchodilator that combines a rapid onset of action with a long-lasting bronchodilation of 12 hours to benefit patients with obstructive lung diseases. The companies did not disclose the outstanding issues detailed in the letter that need to be resolved before final approval.

• TaiGen Biotechnology Co. Ltd. and TTY Biopharm Co. Ltd., both of Taipei, Taiwan, signed an agreement to jointly develop and market a novel topoisomerase-I inhibitor, DB67, for cancer. DB67 was discovered and patented by researchers at the University of Pittsburgh. National Health Research Institutes of Taiwan licensed the Asian rights of DB67, assigning them to TTY for development and commercialization. TaiGen will conduct studies in the areas of animal disease models, pharmacokinetics, drug metabolism and toxicology. TTY will handle formulation, GMP production of dosage forms and organization of clinical trials. The companies plan to market the drug jointly in Asia. Separately, TaiGen signed an agreement with the Executive Yuan of the People's Republic of China for the discovery and development of drugs against the coronavirus that causes severe acute respiratory syndrome. TaiGen will receive funding of NT$29.5 million (US$890,000) to support 50 percent of the total cost that TaiGen budgeted for the first year of research. Future funding of the six-year proposal will depend on the progress made, it said.

• Teva Medical Ltd., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd., of Jerusalem, entered an agreement with Ortec International Inc., of New York, in which Teva Medical obtained a license to promote and sell Ortec's tissue-engineered wound-healing product, OrCel, in Israel for chronic wounds and other dermatological applications. The agreement, which has an initial term of 10 years, provides for marketing and sales commitments on behalf of OrCel and requires Teva to seek regulatory approval and reimbursement of OrCel in Israel. Financial terms were not disclosed.

• Xenova Group plc, of Slough, UK, began a randomized, placebo-controlled, Phase IIb trial of TA-CD for cocaine addiction. Up to 132 methadone-dependent cocaine addicts will be recruited in the study, which is being supported by the U.S. National Institute for Drug Abuse in Baltimore. Subjects will be monitored three times a week to assess cocaine usage, including testing for cocaine metabolites in urine, for 20 weeks. Patients also will undergo medical examinations and blood tests for anti-cocaine antibodies to assess the dosing schedule's immunogenicity. Previous clinical trials have shown the compound to be safe and well tolerated, with vaccination generating a dose-related immune response, and preclinical studies have demonstrated that vaccination produces a reduced self-administered consumption of cocaine.

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