• 4SC AG, of Martinsried, Germany, completed its fourth round of financing, raising €6.5 million (US$7.9 million). The KfW Mittelstandsbank and Bayern Kapital participated in the second closing in June. The first closing occurred in December with investments from Deutsche Venture Capital Gesellschaft, 3i, BioM and Mulligan BioCapital. Proceeds will be used for a Phase IIa study in rheumatoid arthritis, as well as further development of its projects in the fields of cancer and inflammatory diseases.

• Abingworth Management, of London, announced the initial $53 million closing of the Abingworth Bioequities Fund, its seventh life sciences fund and the first solely for investments in quoted stocks. The firm said funds will be invested in under-appreciated quoted stocks that have the potential to produce high returns over a two- to four-year holding period. A second offering of shares is planned for late this year.

• Acambis plc, of Cambridge, UK, began a Phase II trial of its MVA smallpox vaccine, MVA3000. Acambis is co-developing MVA3000 with its process development and manufacturing partner, Baxter Healthcare SA. MVA3000 is being developed for use in people for whom the traditional smallpox vaccine is contraindicated, such as patients with disorders of the immune system or skin conditions such as eczema. The randomized, double-blind, placebo-controlled study will involve 700 healthy adults, half of whom have been previously vaccinated against smallpox.

• Active Biotech AB, of Stockholm, Sweden, completed its Phase I study in 30 healthy volunteers of its candidate 57-57 for the treatment of systemic lupus erythematosus, and the drug was well tolerated in all of the studied dose levels, both as a single and repeated dose. Results also showed 57-57 is suitable as an oral, daily treatment. A Phase I patient trial is expected to begin before the end of the year.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., granted Eurogentec SA, of Liege, Belgium, a nonexclusive license to provide research products and services in RNA interference under the Kreutzer-Limmer patent family owned by Alnylam. The patent family covers short interfering RNAs and their use to mediate RNAi in mammalian cells.

• Amarillo Biosciences Inc., of Amarillo, Texas, resolved all clinical and safety issues with the FDA and is ready to initiate a study with a Turkish pharmaceutical company, Nobel Ilac San. Ve Ticaret AS, Amarillo said. The study is expected to begin in October and to be completed within a year. ABI's oral low-dose interferon-alpha will be tested as a treatment for Behcet's disease in 90 Turkish patients.

• Ambion Inc., of Austin, Texas, and Ambion Ltd., of Huntingdon, UK, formed an agreement with the MitoCheck consortium to provide a genome-wide siRNA library targeting every human gene. MitoCheck is a European Union-funded multinational research consortium that will use a genome-wide human siRNA library in experiments designed to answer questions about how cell division is regulated. The consortium will search for human genes that have a role in mitosis.

• Arpida Ltd., of Basel, Switzerland, said the FDA granted an investigational new drug application for the oral formulation of iclaprim, the company's second development program for the antibiotic product. Arpida will begin a Phase I trial to evaluate safety as well as the pharmacokinetics of the capsule formulation. The injectable formulation is in Phase III studies for the treatment of complicated skin and skin-structure infections in hospitals.

• Cellectis SA, of Paris, signed a license agreement granting Ozgene Pty. Ltd., of Perth, Australia, a worldwide nonexclusive commercial license covering its patented process for the specific replacement or insertion of a gene in a eukaryotic genome. Ozgene will use Cellectis' technology for creating, developing and selling genetically modified mice as part of its knock-in activities. Financial terms were not disclosed.

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, and Menlo Park, Calif., reported its accelerated development plan for its lead cancer therapeutic, Ceflatonin (homoharringtonine, HHT). The initiation of the first of two registration-directed Phase II/III trials is scheduled for the third quarter. The first trial will target chronic myeloid leukemia (CML) accelerated-phase patients who are resistant to high-dose Gleevec. A second single-agent Phase II/III trial to treat CML patients with a specific gene mutation that makes them resistant to tyrosine kinase inhibitors such as Gleevec is planned to begin in the first quarter of 2006.

• Crucell NV, of Leiden, the Netherlands, and its contract manufacturer DSM Biologics, of Groningen, the Netherlands, signed a PER.C6 research license agreement with Symphogen A/S, of Copenhagen, Denmark. The agreement allows Symphogen to evaluate and use the PER.C6 cell line for production of its recombinant polyclonal antibodies, known as symphobodies. Symphogen will pay a signing fee and annual maintenance fees. Also, Crucell plans to begin clinical development of its combination of two human monoclonal antibodies against rabies, discovered last year using the company's MAbstract technology. Crucell's discovery offers the potential for a replacement for the serum products that are in use to treat rabies. Each year about 55,000 people die of rabies because of insufficient care or lack of appropriate treatment. Crucell's rabies antibody product is highlighted in the July 2005 Journal of Virology.

• Cytheris, of Paris, launched two more Phase I trials of its lead compound, a recombinant interleukin-7, this time in HIV-infected patients. rIL-7 is a growth factor that helps rebuild the immune system and enhances the global and specific immune response. A recently completed Phase I trial in cancer showed that the product triggered a rapid and significant increase in patients' T lymphocytes, including CD4 T cells, which protect people from infection but are invaded and destroyed by HIV. One trial of rIL-7 in HIV already has started in the U.S. in collaboration with the National Institutes of Health Aids Clinical Trials Group, while the second will take place at five centers in the Paris area starting in September.

• DNAPrint Genomics Inc., of Sarasota, Fla., said it acquired an 18 percent stake in Biofrontera AG, of Leverkusen, Germany, for €1.5 million (US$1.8 million). Two DNAPrint executives, Richard Gabriel and Hector Gomez, remain on the Biofrontera board. Biofrontera is in Phase II trials with its BF-Derml product, a compound for chronic itching and welts caused by the exposure to cold or other allergens.

• GeneMedix plc, of Newmarket, UK, raised £281,000 (US$500,000) through a placing of about 4.3 million new shares. It is the second placing of $500,000 out of a total funding of $10 million that is available to the biogenerics company over a three-year period from October 2004 from funds advised by Southridge Management LLP. The new money will be used to meet GeneMedix's short-term funding requirements.

• Gentium SpA, of Villa Guardia, Italy, said the FDA agreed that Gentium's chemistry, manufacturing and controls submission provided the adequate characterization of defibrotide for the company's planned Phase III trial for the treatment of hepatic veno-occlusive disease with multi-organ failure.

• Innate Pharma SAS, of Marseille, France, appointed Agustin de la Calle director of business development. His particular responsibilities will include initiating and maintaining partnerships with pharmaceutical companies and expanding Innate's international presence. De la Calle previously was business development director of Micromet AG, of Munich, Germany.

• IntegraGen SA, of Paris, said its scientists have shown that variations in the gene for protein kinase C beta 1, a protein with a role in brain function, are strongly associated with autism. The finding might lead to a mechanistic explanation for some of the characteristics of the condition. Results are published in Molecular Psychiatry.

• Meditech Research Ltd., of Melbourne, Australia, said that preclinical research describing the identification of a new breast cancer target protein has been published in the latest edition of Cancer Research, a publication of the American Association for Cancer Research Inc. The potential new therapeutic target is a protein (HAS2) involved in the biosynthesis of hyaluronic acid.

• Merck KGaA, of Darmstadt, Germany, will acquire most of the global rights for the cancer treatment UFT (tegafur-uracil), used in colorectal cancer, from Taiho Pharmaceutical Co. Ltd., of Japan. Taiho will supply the capsules to Merck for its territories and will retain rights in Japan, South Korea, Taiwan, Malaysia and Singapore. Financial details were not disclosed.

• Nautilus Biotech, of Paris, completed animal studies on a number of IFN-beta variants, engineered to have a substantially improved pharmacological profile. The variants have significantly increased half-life in serum as well as improved bioavailability. Nautilus now plans to move its improved IFN-beta into preclinical development and should file an investigational new drug application by late 2006. Nautilus' IFN-beta has been designed to be resistant to blood, intestinal, pulmonary and nasal proteases.

• Prima Biomed, of Melbourne, Australia, said Biomira Inc., of Edmonton, Alberta, exercised its option to take up equity in Prima, resulting in Biomira holding about a 1.6 percent stake. Under the investment, Biomira will convert its equity in CancerVac Pty. Ltd. into Prima ordinary shares. As a result, Prima will own 86.5 percent of the CancerVac subsidiary. Prima and Biomira are collaborating to develop an immunotherapy for cancer.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., said it closed the sale of its global biologics manufacturing business to subsidiaries of Ferring Holding SA, of Lausanne, Switzerland, for $80 million. Savient will receive the payment in three installments: $55 million at closing, $15 million at the first anniversary of closing and $10 million at the second anniversary. Net proceeds from this transaction are expected to be about $70 million over the next two years.

• Transkaryotic Therapies Inc., of Cambridge, Mass., confirmed that its board unanimously recommended that stockholders vote in favor of the proposed acquisition by Shire Pharmaceutical Group plc, of Basingstoke, UK. The meeting of stockholders is scheduled for July 27. TKT and Shire entered an agreement in April in which Shire will pay $37 in cash for each share of TKT common stock, or about $1.6 billion total.

• U3 Pharma AG, of Martinsried, Germany, appointed Joanna Horobin CEO. Horobin joins U3 Pharma from MPM Capital, of San Francisco, where she was entrepreneur-in-residence. Prior to MPM Capital, she was chief operating officer at CombinatoRx, of Boston.

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