• 4SC AG, of Martinsried, Germany, and Sanofi-Aventis Group, of Paris, completed a research agreement. The former used its High-Throughput Screening technology to identify and provide small molecules predicted to bind to two targets from Sanofi-Aventis, which is responsible for further development. 4SC could receive milestone payments.

• Active Biotech AB, of Lund, Sweden, began Phase I trials of its candidate drug 57-57 against systemic lupus erythematosus. The trials entail a dose-escalation study of ABR-215757 in parallel groups of healthy volunteers. The study is taking place at the Karolinska Institute hospital in Stockholm and is scheduled for completion during the first half of 2005.

• Affimed Therapeutics AG, of Heidelberg, Germany, signed a partnership to co-develop one of its Tandab antibodies with the biopharmaceutical unit of Syngenta AG, of Basel, Switzerland. Tandabs recruit the body's immune system to fight cancers and other disease. The molecules have been engineered to have four binding sites, two of which are for antigens on the cancer or diseased cell, while the other two are specific for immune system killer cells. The parties will use Affimed's technology platform to identify and develop Tandabs for cancer and other indications through research supported in part by a €1 million grant recently awarded to Affimed by the German government. Financial terms were not disclosed.

• Affitech AS, of Oslo, Norway, and Peregrine Pharmaceuticals Inc., of Tustin, Calif., expanded their antibody collaboration to include the production of fully human monoclonal antibodies against up to six additional targets. They already are collaborating to produce fully human monoclonal antibodies against three targets that will be evaluated for cancer and viral diseases. Financial terms include research fees, milestone payments and royalties on net sales upon commercialization.

• Antisoma plc, of London, released data showing that one of its telomere-targeting agents (TTA) blocks prostate tumor growth in a human xenograft model. The findings increase the number of cancers found to be susceptible to TTAs, and the company said it is close to selecting a lead candidate for clinical trials. Rather than inhibiting telomerase, TTAs bind directly to the telomere itself and destabilize it.

• AstraZeneca plc, of London, presented data demonstrating Iressa's (gefitinib) antitumor activity as a single agent and in combination with chemotherapy in a variety of common solid tumors. Researchers saw encouraging disease control rates of Iressa in combination with chemotherapy in advanced non-small-cell lung cancer (57.7 percent), metastatic colorectal cancer (97.5 percent) and advanced ovarian cancer (61.2-80.9 percent), it said. As a monotherapy in advanced esophageal cancer, the control rate was 33 percent to 37 percent.

• Australian Cancer Technology Ltd., of Sydney, Australia, said its 1-for-10 rights issue closed, raising A$4 million (US$3 million) through subscriptions and a sub-underwritten shortfall placed by Burdett Buckeridge Young Ltd. to its institutional clients. The A$1.9 million placement taken by Bioaccelerate Inc., of New York, also was confirmed following approval by shareholders at the annual general meeting. AustCancer has three drugs, two of which are in Phase II trials.

• Axis-Shield plc, of Dundee, UK, said it reached a settlement with Carolina Liquid Chemistries Corp., of Delaware, over sales of homocysteine tests based on Axis' patents. To settle the lawsuit brought by Axis, CLCC will pay a royalty all previous sales of the test, and be licensed to sell any tests remaining in its inventory.

• Basilea Pharmaceutica AG, of Basel, Switzerland, moved its cephalosporin antibiotic, ceftobiprole (BAL5788), into a Phase III trial in complicated skin and skin-structure infections caused by methicillin-resistant Staphylococcus aureus. The study, which will recruit about 700 patients, will compare the efficacy and safety of ceftobiprole vs. vancomycin. The primary endpoint has been defined as clinical outcome at the test-of-cure visit, which generally occurs within one to two weeks after treatment. Basilea also recently commenced a Phase III trial of alitretinoin (BAL4079) in patients with chronic hand dermatitis. (See BioWorld International, Nov. 3, 2004.)

• Bionomics Ltd., of Adelaide Australia, was awarded a A$247,000 (US$187,000) federal government Biotechnology Innovation Fund grant to further work on developing targets for antibody treatments that inhibit blood vessel formation in cancer and other diseases, such as macular degeneration, diabetic retinopathy and rheumatoid arthritis. The company also received a A$20,000 grant from the South Australian government's BioInnovationSA for the same project. Also, Bionomics and Genetic Technologies Ltd., of Fitzroy, Australia, formed an alliance to commercialize new genetic tests for epilepsy. Bionomics granted Genetic Technologies worldwide testing and marketing rights to epilepsy tests developed by Bionomics. Genetic Technologies granted Bionomics a license to its non-coding patents and will pay Bionomics a signing fee, and potential royalties and milestone payments in relation to worldwide revenues. Bionomics will pay Genetic Technologies a license fee.

• Biovitrum AB, of Stockholm, Sweden, is splitting its research and development organization into two units that will focus on basic research and discovery and preclinical and clinical development. The move is intended to increase the company's focus on late-stage development. By 2006, it aims to have six programs in the clinic. Andres Ullman, previously head of global development operations at Bayer Pharmaceuticals Corp., will head the new development unit.

• Borean Pharma A/S, of Aarhus, Denmark, promoted chief operating officer Johanna Holldack to CEO. Holldack, who joined the company a year ago, previously was chief operating officer at MediGene AG, of Munich, Germany, and vice president for global vaccines and therapeutics at Chiron Corp., of Emeryville, Calif.

• Cortical Pty. Ltd., of Melbourne, Australia, was awarded a federal government grant of more than A$3 million (US$2.3 million) to develop drugs against inflammatory diseases such as arthritis, psoriasis, asthma, multiple sclerosis and colitis. The research and development grant will help the company conduct Phase I trials on its small-molecule macrophage migration inhibitory factor antagonist for such inflammatory conditions.

• Cryptome Pharmaceuticals Ltd., of Melbourne, Australia, said Mathew Vadas will be interim CEO, subject to release by the Institute for Medical and Veterinary Science in Adelaide. Vadas is the company's chief scientific adviser and chairman of its scientific advisory board. Cryptome focuses on the discovery and development of protein-derived medicines targeting cancer and cardiovascular disease.

• Cyclacel Group plc, of Dundee, UK, said preclinical data reported at last week's American Society for Nephrology meeting pointed to the activity of its experimental CDK inhibitor drug, seliciclib (CYC202 or R-roscovitine), in two models of kidney disease. Specifically, it significantly improved survival of animals with lupus nephritis and, at the same time, had a protective effect on kidney function. Also, seliciclib attenuated disease in a mouse model of crescentic glomerulonephritis.

• Elan Corp. plc, of Dublin, Ireland, said it expects to provide additional guarantees of the outstanding 7.25 percent senior notes issued by its wholly owned subsidiary, Athena Neurosciences Finance LLC, and guaranteed by Elan. The guarantees will be provided by all subsidiaries of Elan expected to guarantee notes issued pursuant to the recently announced offering. The provision of the note guarantees will be conditioned upon, and is expected to occur concurrently with, the completion of that offering.

• Genapta Ltd., of Cambridge, UK, completed the first stage in the development of an optical screening system for quantifying the transient binding of potential drug compounds to protein targets. The company, a spinout from Cambridge University, has been working with GlaxoSmithKline plc, of London, since March 2003 to prove the system.

• GeneMedix plc, of Newmarket, UK, agreed to a $10 million financing facility with Southridge Capital Management LLC, of Ridgefield, Conn. Southridge also invested £292,000 (US$542,368) in the biogenerics company, in exchange for 2.5 million new shares at 11.7 pence per share, a 10 percent discount. That completes a total investment by Southridge in GeneMedix of £562,000. The agreement gives GeneMedix the ability to place blocks of shares of up to $1 million, at any time, up to $10 million over the next three years.

• Igeneon AG, of Vienna, Austria, said Phase II survival data reported at the International Society for the Biological Treatment of Cancer meeting in San Francisco showed that use of its IGN101 cancer vaccine produced a statistically significant survival prolongation in a subgroup of patients with metastatic rectal cancer. While no difference in overall survival was seen for the whole intent-to-treat population of 239 patients, in 53 patients one-year survival doubled from 23.8 percent for placebo to 59.4 percent for IGN101 (p=0.009). In that indication, median survival was 407 days for the IGN101 group, compared to 253 days for placebo (p=0.021).

• Immuno-Designed Molecules SA, of Paris, and the Walter Reed Army Institute of Research in Silver Spring, Md., entered a three-year research and development deal to develop a cancer vaccine incorporating the KSA antigen. IDM owns worldwide exclusive rights to the KSA antigen, which is expressed in most carcinomas. The agreement covers the GMP production of the vaccine and the conduct of Phase II trials in prostate cancer. The institute will produce the vaccine, collect and analyze preclinical data and validate the product for clinical use. The results of a Phase I trial of the KSA cancer vaccine were published earlier this year, showing that eight of 11 patients suffering from metastasized colorectal cancer developed a specific immune response with anti-KSA antibodies.

• Imugene Ltd., of Sydney, Australia, received a A$250,000 (US$189,337) Commonwealth government Biotechnology Innovation Fund grant for work on developing an avian influenza vaccine. The candidates use Imugene's platform Adenoviral Delivery Vector technology to deliver a protective gene from the avian influenza virus. The vaccine aims to stimulate a bird's immune response and prevent the disease.

• IT.Omics, of Lille, France, agreed to grant Galderma SA, of Lausanne, Switzerland, access to the LSGraph technology for dermatology-related marker and target discovery. The technology is used to mine functional relationships between known genes, proteins and compounds; the graph includes more than 50,000 biological entities and more than a million relationships. Financial terms were not disclosed.

• Microscience Ltd., of Wokingham, UK, reported results from a Phase I trial of its spi-VECTM oral immunotherapeutic vaccine designed for the treatment of chronic hepatitis B infection. The trial met its primary objectives and demonstrated safety and immunogenicity. The immunological data demonstrated that all subjects mounted a T-cell-proliferative response to both the HBcAg and to groups of peptides representing the whole sequence of HBcAg.

• Nonlinear Dynamics Ltd., of Newcastle upon Tyne, UK, and GenoLogics Life Sciences Software Inc., of Victoria, British Columbia, entered a global partnership to work toward a fully integrated protein informatics solution. The deal brings together Nonlinear's image analysis and data mining expertise with GenoLogics' LIMS technology. Financial terms were not disclosed.

• Novozymes A/S, of Bagsvaerd, Denmark, entered a collaboration with Solvay Pharmaceuticals BV, of Brussels, Belgium, to develop products for enzyme-replacement therapy for patients suffering from pancreatic exocrine insufficiency. They expect to develop a mixture of digestive enzymes with efficacy close to that of human pancreatic enzymes. Financial terms were not disclosed.

• NsGene A/S, of Copenhagen, Denmark, reported that Biogen Idec Inc., of Cambridge, Mass., moved Neublastin, NsGene's protein, from research into development in neuropathic pain. NsGene and Biogen Idec entered a license and collaboration agreement in June 2000 granting Biogen Idec exclusive rights to use Neublastin for indications outside the central nervous system. NsGene will receive fees and milestone payments, in addition to royalties, if a product is developed and commercialized by Biogen Idec. Further details were not disclosed.

• Nucleonics Inc., of Horsham, Pa., filed with Australian authorities a request for re-examination of Benitec Ltd., of Queensland, Australia, and Commonwealth Scientific and Industrial Research Organization's Australian Innovation Patent No. 2001100608, called "Control of Gene Expression." The request submits prior art documents showing that the patent claims are invalid. Nucleonics believes the claims are ambiguous. The company previously filed a request for re-examination for another of Benitec and CSIRO's Australian patents and for a U.S. patent. The patents prevent Nucleonics from advancing its expressed interfering RNA technology.

• Peplin Ltd., of Brisbane, Australia, reported plans to raise A$10.2 million (US$7.7 million) through the issuance of about 24.3 million shares at a discounted price of A42 cents each. The company plans to use the funds for Phase II trials of its skin cancer product, PEP005 Topical. It expects to begin the studies in Australia early next year, with initial results due in the third quarter. In parallel with the studies, Peplin plans to hold discussions with potential partners.

• PharmaMar SA, of Madrid, Spain, presented new data on Yondelis and Aplidin at the 29th European Society for Medical Oncology meeting held in Vienna, Austria. Data showed that the combination of Yondelis with Doxil was safe and feasible, forming the basis for development of Yondelis in ovarian cancer and other tumors. New data from a Phase II study of Aplidin demonstrated evidence of the compound's activity in patients with advanced or metastatic melanoma. Yondelis is a marine-derived antitumor agent isolated from the colonial tunicate Ecteinascidia turbinate, while Aplidin is a marine-derived peptide originally from Aplidium albicans.

• ProBioGen AG, of Berlin, entered a cell line development program with Millennium Pharmaceuticals Inc., of Cambridge, Mass. ProBioGen will use its position-mediated expression-enhancement strategy to develop cell lines for the company's antibodies and for the manufacture of preclinical trial materials.

• Proteom Ltd., of Cambridge, UK, an in silico drug design company, agreed to a partnership with 14TM Ltd., also of Cambridge, to design novel ligands for a range of G protein-coupled receptor (GPCR) targets. 14TM will supply proprietary models of active and inactive GPCR structures that Proteom will feed into its design and screening systems to generate new ligands.

• Selectchemie AG, of Zurich, Switzerland, and Chiral Quest Inc., a subsidiary of VioQuest Pharmaceuticals Inc., of Monmouth Junction, N.J., entered a distribution agreement for Eastern Europe. Selectchemie will distribute Chiral Quest's catalysts and ligands to generic pharmaceutical and fine chemical manufacturers, as well as drug discovery and development groups. Certain unnamed fine chemical companies will distribute Chiral Quest's products in Western Europe.

• Serono SA, of Geneva, said new product features designed to make Rebif (interferon beta-1a) therapy easier and more comfortable to administer are available for patients with multiple sclerosis. The Rebiject II autoinjection device was designed to provide greater comfort, convenience and safety, and the new 29-gauge needle was developed to reduce injection pain and injection-site reactions. Rebif is taken by injection to delay the progression of disability associated with relapsing forms of MS.

• Tripep AB, of Huddinge, Sweden, named Jan Nilsson CEO. Nilsson, currently CEO of the Swedish subsidiary of Schering-Plough Corp., of Kenilworth, N.J., will take up his new post on Dec. 1. He succeeds interim CEO Anders Vahlne, who remains head of research at Tripep.

• UK BioIndustry Association (BIA) welcomed the initiation of a government-sponsored consultation process that will investigate the BIA's claims that shareholders' pre-emption rights prevent companies from responding quickly to funding windows, making it difficult and more expensive to raise money. The findings of the consultation will be submitted to the government early in 2005.

• ZGene A/S, of Lyngby, Denmark, acquired a patent covering "a new medical use of a novel gene and vector encoding a multi-substrate deoxyribonucleosidase" from Akademikliniken AB, of Stockholm, Sweden. Terms were not disclosed. The patent, which recently was granted by the U.S. Patent and Trademark Office, covers the use of a Drosophila melanogaster deoxyribonucleoside kinase, which exhibits rapid activation of several cancer drugs. The research underlying the patent originally was carried out by the Department of Virology at the Karolinska Institute in Stockholm.