• 4SC AG, of Martinsried, Germany, entered a research cooperation agreement with Schwarz Pharma AG, of Monheim, Germany. The aim is to identify a pre-development candidate for the prevention or treatment of a urological disorder. As part of the agreement, 4SC will receive research funds and is entitled to milestone payments. The deal also envisages that payments will be made when certain milestones in clinical development are reached, as well as revenue share, if the substance is brought to market successfully. Further details on the agreement were undisclosed.

• 7TM Pharma A/S, of H rsholm, Denmark, entered a joint research project with Procter & Gamble Co., of Cincinnati, to identify development candidates for vascular indications. The collaboration will draw on 7TM's Y peptide platform. P&G will have exclusive worldwide rights to develop, manufacture and commercialize drugs emerging from the program, while 7TM will gain an up-front fee, milestones and royalties on eventual product sales. It also has retained co-promotion rights for the Scandinavian region.

• Arakis Ltd., of Little Chesterford, UK, said its rheumatoid arthritis drug, AD 452, recently completed a Phase IIa trial. Results showed that AD 452, a small-molecule, disease-modifying drug designed to reduce joint inflammation and destruction and pain, as well as preserve mobility, was well tolerated at the three dose levels tested when administered in combination with standard methotrexate treatment. Arakis said it will advance the product to a Phase IIb program to determine efficacy.

• Australian Cancer Technology, of Sydney, Australia, said it will proceed with a pro-rata non-renounceable rights issue to raise A$5.7 million (US$4.4 million) for the company. The rights issue has been fully underwritten by BBY Ltd. Eligible shareholders will be offered one new share for every three shares they hold, as of April 26 at an issue price of 13 cents a share, which the company said is a "significant" discount to the one month volume-weighted average. The company also submitted a drug master file to the FDA for its cancer vaccine adjuvant, GPI-0100. The company's objective in developing GPI-0100 and a related series of compounds is to improve the effectiveness of therapeutic vaccines designed to treat pathogens such as genital herpes and cancers of the breast, prostate, kidney and lung.

• Bavarian Nordic A/S, of Copenhagen, Denmark, said its quality-control laboratory at the Kvistgard site has been granted authorization by the Danish Medicines Agency to perform its own analysis and release on production batches of Imvamune smallpox vaccine and MVA-BN products for use in the company's development programs. Bavarian Nordic also reported that all other activities to prepare for the commercial manufacture at the Kvistgard site are proceeding as planned, and expects to produce 60 million doses of Imvamune vaccine per year beginning in September 2005.

• Biogen Idec Inc., of Cambridge, Mass., and Fumapharm AG, of Lucerne, Switzerland, said a Phase III trial of the oral fumarate BG-12 for psoriasis met its primary endpoint of a statistically significant improvement over placebo. The multicenter, double-blind, placebo-controlled study enrolled 175 patients that received treatment or placebo for 16 weeks. The data will support a filing for market authorization in Germany this year. Additional Phase III studies are required for filings in the U.S. and the rest of Europe. Biogen Idec said a Phase II study of BG-12 in relapsing-remitting multiple sclerosis began last November.

• CellCentric, of Cambridge, UK, received new funding of £250,000 (US$467,379) from the Rainbow Seed Fund. The investment enabled a new commercial relationship with the Babraham Institute, also of Cambridge. CellCentric has exclusive rights to epigenetic-related intellectual property generated at the institute. CellCentric will use its discovery platform to develop a variety of products for cancer based on proteins and small molecules.

• CeNeS Pharmaceuticals plc, of Cambridge, UK, said recent clinical data on its lead morphine-6-glucuronide (M6G) by an academic group at King's College in London further supported the potential of M6G as a treatment for post-operative pain, focusing on its potential for administration under patient-controlled analgesia. Data indicated that M6G has an analgesic potency similar to morphine, but causes lower respiratory depression and reduced nausea, and researchers noted significantly less sedation in the M6G group compared to the morphine group. The results were published in Anesthesiology.

• The Centre for Human Genetics, at the University of Bremen in Germany, reported in a recent issue of American Journal of Pathology their findings on a signaling molecule called "High Mobility Group Protein B1," which appeared to be a signal sent by tumor cells that induce the sprouting of blood vessels that supply tumors with oxygen. The study concluded that the molecule might be a promising target for therapeutics aimed at blocking the angiogenetic signal to reduce tumor cell growth.

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, launched a multicenter Phase II study of Ceflatonin (homoharringtonine) in combination with Gleevec (imatinib mesylate, Novartis AG) in patients with chronic myelogenous leukemia who have developed resistance to Gleevec. About 20 percent of patients have primary resistance to Gleevec and another 20 percent develop resistance after 14 months. Agents with synergistic mechanisms of action, such as Ceflatonin, are needed for use in combination with tyrosine kinase inhibitors to limit resistance and increase the chances of a cure, ChemGenex said.

• Cryptome Pharmaceuticals Ltd., of Melbourne, Australia, signed an agreement with Boston's Northeastern University for it to use technology that identifies and isolates low abundance human proteins. Also, the company signed an agreement with Murdoch Childrens Research Institute to provide Cryptome with two proteins to mine for drug candidates. Cryptome uses a high-throughput screening process, called Cryptomics, to identify, segregate and test fragments of natural proteins not previously recognized as potential therapeutic drugs. Cryptome will retain all intellectual property and commercialization for new entities emerging from the work.

• CureTech Ltd., of Yavne, Israel, completed its Phase I trial of CT-011, a humanized monoclonal antibody directed against a B7 family-associated protein, in patients with advanced hematological malignancies. The purpose of the study was to evaluate the safety and determine the maximum tolerated dose of CT-011 single intravenous administration in cancer patients. Despite the advanced stage of their disease, clinical responses have been observed in five patients. One patient has exhibited a partial response for more than eight months and two additional patients have had no disease progression for more than seven months. Minimal response to treatment has been observed in two additional patients. Four other patients, with an average of three months of follow up, are alive with active disease.

• Enzo Biochem Inc., of Farmingdale, N.Y., said the U.S. Patent and Trademark Office has declared an interference between a patent application for the interferon protein, interleukin-6, owned by the company's subsidiary, Enzo Therapeutics Inc., and four U.S. patents owned by Israel's Yeda Research & Development Co. Ltd. The purpose of the interference is to determine which was the first to make the invention. IL-6 is a cytokine that plays roles in host defense, acute phase reactions, immune response and hematopoiesis.

• Gilead Sciences Inc., of Foster City, Calif., received early termination of the required waiting period with respect to the licensing agreement announced on March 22 granting Gilead exclusive rights to develop and commercialize Tokyo-based Japan Tobacco Inc.'s HIV integrase inhibitor, JTK-303. The agreement calls for Gilead to pay Japan Tobacco $15 million up front and up to $90 million in milestone payments, plus future royalties.

• Icon Genetics AG, of Munich, Germany, received undisclosed funding from the Bavarian Research Foundation to fund a three-year research collaboration between Icon Genetics, Research Center Freising, and the University of Munich. The project aims to develop switches for controlling the expression of transgenes in plant chloroplasts, which would be applied in creating transgenic plants to prevent undesired spread of foreign genetic information through pollen flow.

• IntegraGen, of Bonn, Germany, appointed Gerald Wagner nonexecutive director. Wagner has held a number of senior roles at Agfa Corp. and Bayer Corp. IntegraGen is developing informative and predictive genetic tests for several common diseases.

• Isolagen Inc., of Houston, acquired a two-building corporate campus in Neuchatel, Switzerland, for $10 million. The facility will serve continental Europe, the Middle East, Africa and the Pacific Rim, and will be operational by the end of 2006. The total estimated cost of acquisition and renovation is $25 million, which will be funded through a $14 million loan and government grants. The facility is expected to use the automated cellular expansion processes being developed by Isolagen.

• Living Cell Technologies Ltd., of Adelaide, Australia, reported the long-term survival of encapsulated pig islets in a man with Type I diabetes. The cells were retrieved after being in the patient's abdomen for almost nine years. A 40-year-old man with Type I diabetes received a transplant of an early prototype of LCT's DiaBCell in 1996, as part of an approved clinical trial. The pig islet transplants were intended to release insulin and restore control of blood glucose levels. The pig islets were prepared in an alginate capsule to protect them from immune rejection and no immune-suppressive drugs were needed for the transplant. Also, the company said DiaBCell (encapsulated living islet cell) was well tolerated and caused no adverse reactions in treated monkeys during a six-month trial. Designed for Type I diabetes, DiaBCell is intended to supply insulin and control blood sugar when transplanted into diabetics. Monkeys in the trial received two doses, one at the start of the study and the second dose three months later, and LCT reported that monkeys receiving DiaBCell reduced their insulin requirements, while those given blank capsules needed more insulin than before the transplants.

• Mologen AG, of Berlin, received an order to set up a cell and gene therapy center in Riyadh, Saudi Arabia. The contract covers equipment, materials, operating procedures and employee training. The agreement also includes provisions for two more centers within the next two years. The total volume of the order is about €9 million (US$11.6 million).

• Mutabilis SA, of Paris, and Chiron Vaccines, a unit of Emeryville, Calif.-based Chiron Corp., announced a license agreement to use Mutabilis' research to develop a new prophylactic vaccine. Terms of the agreement provide for the payment of license fees, milestone fees and royalties to Mutabilis. Further financial details and the exact vaccine target were not disclosed.

• Neuro3d, of Mulhouse, France, reported positive results from a Phase II trial of its atypical antipsychotic agent, ocaperidone, in schizophrenia. It said the drug demonstrated "robust antipsychotic activity" that was "comparable to an approved atypical antipsychotic agent." In particular, the subjects experienced significantly less weight gain than with the reference compound. CEO Charles Woler said the data would form the basis for Phase III trials.

• PharmaMar SA, of Madrid, Spain, said its marine-derived cancer drug, Yondelis (trabectedin), was granted orphan drug designation by the FDA in ovarian cancer. The drug is partnered with Johnson & Johnson Pharmaceutical Research & Development LLC, a division of Johnson & Johnson, of New Brunswick, N.J. The European Commission granted orphan drug status to Yondelis in the same indication in Europe in 2003.

• pSivida Ltd., of Perth, Australia, initiated full development of its BrachySil product in a second cancer indication, pancreatic cancer. A clinical program should begin before the end of this year. BrachySil, a micron-sized particle in which the isotope 32-phosphorus is immobilized, is in another clinical program for primary liver cancer.

• Regenera Ltd., of Perth, Australia, granted an exclusive global license to Alcon Manufacturing Ltd., an affiliate of Alcon Inc., of Fort Worth, Texas. The license involves a product that is used to assist in visualization of the vitreous fluid during a surgical procedure of the eye known as vitrectomy. The terms require a series of payments by Alcon, including an up-front license fee, milestone and royalty payments of double-digit royalties in the U.S. and single-digit royalties elsewhere. The duration of the license corresponds to the life of the subject patent rights.

• Syngenta AG, of Basel, Switzerland, agreed to a settlement with the U.S. Department of Agriculture for its unintended release of a limited amount of Bt10 corn. Investigations by the Environmental Protection Agency and the USDA have concluded that there is no human or animal health or environmental concerns with Bt10 corn. The USDA issued a $375,000 fine and a requirement that Syngenta sponsor a compliance training conference. Genetically modified corn, Bt10 mistakenly was supplied as Bt11 corn between 2001 and 2004.

• UK Gene Therapy Advisory Committee (GTAC) published its 11th annual report, showing that in 2004 it considered applications to conduct 12 gene therapy trials, granting approval to 11. It also approved more than 60 amendments to existing trials. Since its formation in 1993, GTC has approved 96 gene therapy trials, which had enrolled a total of 894 patients by the end of 2004. In the foreword of the report, the chairman of GTAC, Norman Nevin, said current skepticism about gene therapy is not justified, comparing it to the pace of monoclonal antibodies or recombinant proteins. He also pointed to successful UK trials, for example, in cancer immunotherapy.