• Ark Therapeutics Group plc, of London, said the FDA has given approval for Trinam, its gene therapy for preventing blood vessels blocking in kidney dialysis patients who have undergone vascular access graft surgery, to enter Phase III. The agency has agreed a single Phase III trial will be acceptable for marketing approval, and offered to assess it under the special protocol assessment. The Phase III study will be a multicenter, randomized, controlled trial of up to 250 patients.

• Arrow Therapeutics Ltd., of London, said a second hepatitis C compound, A-689, has entered full preclinical development. A-689 is the second compound from the company's NS5a target program to enter development.

• Crucell NV, of Leiden, the Netherlands, and technology partner DSM Biologics, a business unit of DSM Pharmaceutical Products, of Parsippany, N.J., signed a PER.C6 research license agreement with the Taiwan-based AbGenomics Corp., which intends to use the cell line for its research, development and early clinical studies of monoclonal antibodies. AbGenomics will make license payments and annual maintenance fees in exchange for certain rights. Financial details were not disclosed.

• Epidauros Biotechnologie AG, of Bernried, Germany, and Osmetech plc, of London, signed a strategic partnership to develop pharmaceutical companion diagnostics and molecular diagnostic products. The deal covers diagnostics for new and existing pharmaceuticals, as well as pharmacogenomic biomarkers. Financial terms were not disclosed.

• Immuno-Biological Laboratories Co. Ltd., of Takasaki, Japan, said New York-based Intellect Neurosciences Inc. purchased rights to manufacture, develop and commercialize two therapeutic, beta-amyloid-specific, humanized monoclonal antibodies for Alzheimer's disease. Under the terms, Intellect agreed to pay IBL milestone payments, as well as a royalty based on sales of any resulting drug product. Intellect also granted IBL an exclusive license with respect to certain of its intellectual property related to the antibodies. Specific financial terms were not disclosed.

• Innogenetics NV, of Ghent, Belgium, said the U.S. District Court entered a permanent injunction enjoining Abbott Park, Ill.-based Abbott Laboratories from any further sales or use of products that infringe on Innogenetics' patented hepatitis C virus genotyping technology. The court's injunction also prohibits Abbott from exporting components of the infringing products to foreign countries. A jury found in September that Abbott willfully infringed on the patent covering a method of genotyping HCV, and awarded Innogenetics $7 million in damages. Earlier this month, a judge overturned the jury's findings that Abbott's infringement had been willful, but affirmed the monetary award in damages.

• MMI plc, of Cambridge, UK, a technology commercialization company, was granted a US patent on its cancer vaccine technology. The patent covers a genetic adjuvant that has been shown to enhance the anti-cancer activity of DNA vaccines. The European patent was granted in June 2006.

• Organon, of Oss, the Netherlands, signed a deal with San Diego-based Huya Bioscience International LLC to develop new drugs in three undisclosed indications. Huya specializes in identifying and licensing Chinese drug candidates for commercialization in Western markets. Financial terms were not disclosed.

• Oxford BioMedica plc, of Oxford, UK, said the Phase III TRIST trial of its cancer immunotherapy, TroVax, in patients with renal cancer, has been adopted by the UK National Cancer Research Network (NCRN). That means that various National Health Service hospitals are able to participate in the study, which should facilitate rapid recruitment of patients in the UK. Since the NCRN was set up in April 2001 and it has more than tripled recruitment into clinical trials. In reaching its decision to adopt the TRIST trial, the Renal Cancer Clinical Studies Group of the NCRN evaluated TroVax and the trial design. There are no financial obligations or loss of commercial rights through NCRN's involvement.

• Proteome Sciences plc of Cobham, UK said it received a notice of allowance of a European patent for its diagnostic assay for stroke, which uses levels of heart fatty acid binding protein and/or brain fatty acid binding protein (FABP's), two of the company's proprietary biomarkers discovered in the blood of stroke patients.

• pSivida Limited, of Perth, Australia, has entered into a licensing agreement with Faber Research, of Boston, to develop pSivida's Durasert, Zanisert and Co-Drug drug delivery technologies for infectious diseases and diseases of the ear. Faber will make payments totaling $990,000 to pSivida for the right to exclusively negotiate a licensing agreement with the company for a period of three months and to fund the cost of a preclinical study. The commencement of licensing negotiations follows a 12-month evaluation of pSivida's technologies by the large global pharmaceutical company. Faber receives exclusive rights to pSivida's technologies for diseases of the ear and for five specific infectious diseases, namely malaria, HIV/AIDS, influenza, tuberculosis and osteomyelitis. Faber and its operating company Auritec Pharmaceuticals Inc. will pay all development costs, and pSivida will receive unspecified royalties and milestone payments. In addition, Faber received co-exclusive rights to the Durasert, Zanisert and Co-Drug drug delivery technologies for other infectious diseases. The companies also can convert their co-exclusive rights to exclusive rights for specific infectious disease indications.

• ReNeuron Group plc, of Guildford, UK, said it held a telephone conference call with the FDA to discuss why its IND application to stage a Phase I trial of ReN001, a stem cell treatment for stroke, was put on hold. No substantial issues were raised that had not been covered in previous dialogue with the FDA. Michael Hunt, CEO said, "On this basis, we are confident that approval to commence human clinical studies with ReN001 will be granted."

• S*BIO Pte. Ltd., of Singapore, entered a research collaboration with the Department of Tumorbiology and Microbiology at the Karolinska Institute in Sweden to evaluate the role of the company's histone deacetylase (HDAC) inhibitors in colorectal cancer and to investigate the underlying mechanisms of the development of gastrointestinal polyps and tumors. Terms of the collaboration were not disclosed.

• Shire plc, of Basingstoke, UK, received marketing authorization from the European Commission for the use of ELAPRASE for the long-term treatment of patients with Hunter syndrome. ELAPRASE is a purified form of the lysosomal enzyme iduronate-2-sulfatase, and is produced by recombinant DNA technology in a human cell line. ELAPRASE, delivered by weekly infusions, replaces the deficient or missing enzyme that Hunter syndrome patients fail to produce in sufficient quantities. ELAPRASE is the first and only enzyme replacement therapy for people suffering from Hunter syndrome. It was launched in the U.S. in July 2006. Pricing and reimbursement procedures are underway for ELAPRASE in many European countries. The drug will be launched across the majority of European countries in 2007.

• Solvay Pharmaceuticals BV, of Brussels, Belgium, and Wyeth Pharmaceuticals, of Madison, N.J., have entered into a new neuroscience discovery, co-development and co-commercialization agreement. Under the new agreement, the parties will collaborate in a joint discovery effort targeting the identification of small molecules as potential antipsychotic medications. Any compounds discovered as part of the research collaboration will be jointly co-owned and patented by Wyeth and Solvay, as well as co-developed and co-commercialized by the two companies. Each party initially is contributing several compounds to the collaboration for use in the joint discovery program, and thereafter the parties will contribute equal resources to the discovery effort. There were no signing fees or milestone payments associated with the agreement.

• Speedel Holding AG, of Basel, Switzerland, initiated a Phase I trial of SPP1148, a renin inhibitor for hypertension and end-organ disease. The study will evaluate the oral compound's safety in healthy volunteers, with first results expected in the fourth quarter. SPP1148 is one of several renin inhibitors invented by Speedel Experimenta, the company's late-stage research unit.

• Stallergenes SA, of Antony, France, has entered into a development, promotion and distribution agreement , in Canada with Paladin Labs, of Montreal, for Oralair, Stallergenes' allergen extract immunotherapy sublingual tablets. Stallergenes and Paladin plan to submit the first product under this agreement, Oralair Grasses, for Canadian regulatory approval this year. Paladin will assume responsibility for Canadian clinical trials, registration, marketing, sales and distribution of Stallergenes' sublingual tablets, which include Oralair Grasses, Oralair recombinant Bet V 1 (birch) and Oralair Mites. Terms of the agreement were not disclosed.