• 4SC AG, of Martinsried, Germany, and the Institute of Molecular Virology at the University of Munster in Germany said their collaboration, signed in April 2006, reached some achievements in researching an active agent for fighting the H5N1 virus. Work demonstrated that one of the substances developed by 4SC in the course of its NFkB project effectively inhibits the reproduction of the virus. 4SC now is focused on formulating an inhalable compound based on that substance.

• Imugene Ltd., of Sydney, Australia, has been offered an Australian government Commercial Ready Grant to produce and test vaccines to protect chickens from the H5N1 avian influenza virus. Imugene already has disclosed its work on vaccine candidates, which will undergo live testing in a high-security facility operated by Benchmark Biolabs in Lincoln, Neb. The trials will begin later this month and are scheduled to finish in January.

• MorphoSys AG, of Munich, Germany, said its partner, Boehringer Ingelheim GmbH, of Ingelheim, Germany, exercised its option for optimizing a therapeutic HuCAL antibody and acquired an exclusive license. Under the terms, MorphoSys will optimize the antibody, which is directed against a cancer disease-related target molecule, in accordance with its partners' requirements and will receive additional research payments. Specific terms were not disclosed. The companies have been collaborating since 2003, starting with two therapeutic antibody projects against inflammatory and cardiovascular diseases.

• NicOx SA, of Sophia Antipolis, France, said FDA feedback on long-term safety data needed for the company's new drug application for naproxcinod stated that, based on the information available, a large clinical cardiovascular outcomes study would not be required at the time of NDA submission. Naproxcinod, a COX-inhibiting nitric oxide-donating compound, is in Phase III trials for the signs and symptoms of osteoarthritis.

• Orphan Europe Sarl, of Paris, and Peptimmune Inc., of Cambridge, Mass., signed a collaboration and license agreement to develop a peptide immunotherapy for pemphigus vulgaris, a rare, life-threatening, autoimmune skin disease. The therapy is designed to selectively suppress the production of anti-desmoglein 3 autoantibodies, the pathogenic agent in pemphigus vulgaris, which could reduce or eliminate the need for high-dose steroids and immunosuppressants. Peptimmune has conducted a Phase I trial establishing the safety of the product, which has orphan drug designation in the U.S. Orphan Europe will continue its development and conduct clinical trials to get European marketing authorization and then market it in Europe, the Middle East and Africa. Financial terms were not disclosed.

• Protherics plc, of London, said it withdrew the biologics license application submitted last month for Voraxaze as a adjunctive therapy for cancer patients experiencing, or at risk of, toxicity from methotrexate, after the FDA requested additional manufacturing data. The company said it plans to seek further guidance from the agency on what additional data are needed, and anticipates resubmitting the BLA in 2007. Assuming that the agency grants priority review, Protherics said it could receive approval in the second half of 2008, rather than the second half of 2007 as originally expected.

• PSivida Ltd., of Perth, Australia, said it is negotiating a non-binding memorandum of understanding for an A$5.2 million (US$4 million) convertible preferred equity investment and an A$28.5 million (US$22 million) investment over time in a special purpose vehicle (SPV) to fund the company's portion of costs associated with Medidur, its lead ophthalmic product for diabetic macular edema. At closing, it is expected that pSivida will receive a total of A$6.5 million, consisting of the equity investment plus an A$1.3 million payment by the SPV. Medidur, which is in Phase III trials, is being co-funded by pSivida and its partner, Atlanta-based Alimera Sciences Inc.

• SR Pharma plc, of London, raised £3.8 million (US$7.2 million) in a placing of 20 million shares at 19 pence per share. The company announced also that it successfully completed toxicology studies for Atu047, a systemically-delivered RNAi product, clearing the way for the first clinical trial in Germany in 2007.

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