• Amira Pharmaceuticals Inc., of San Diego, received its first milestone payment from a January inflammatory disease deal with Basel, Switzerland-based F. Hoffmann-La Roche Ltd. after identifying a series of drug candidates against a mutually agreed target. The collaboration, which focuses on developing products against three targets, could bring a total of $287 million to Amira in total event payments. (See BioWorld Today, Jan. 12, 2006.)

• BioMarin Pharmaceutical Inc., of Novato, Calif., said Japan's Ministry of Health, Labor, and Welfare granted marketing authorization for Aldurazyme (laronidase), the first specific treatment approved in Japan for patients with the genetic disease mucopolysaccharidosis I. Aldurazyme was approved in Japan as an orphan drug. In the U.S., the drug is approved for patients with Hurler and Hurler-Scheie forms of MPS I and for patients with the Scheie form who have moderate to severe symptoms.

• Cerexa Inc., of Alameda, Calif., expanded its anti-infective portfolio through an in-licensing agreement with Tokyo-based Meiji Seika Kaisha Ltd., gaining exclusive rights to develop and commercialize ME1036, a broad-spectrum parenteral carbapenem that has shown preclinical activity against both aerobic and anaerobic Gram-positive and Gram-negative bacteria. Financial terms of the deal were not disclosed. Cerexa's development of ME1036 will focus on addressing the challenge of increasing resistance among bacterial pathogens that cause severe hospital-acquired infections, such as pneumonia, complicated skin and skin-structure infections, complicated intra-abdominal infections, complicated urinary tract infections and bacteremia. The company expects to begin Phase I testing in the first half of 2007.

• Clinuvel Pharmaceuticals Ltd., of Melbourne, Australia, raised A$35.2 million (US$27.3 million) through a A$30.5 million rights issue and a A$4.7 million private placement. Funds will be used to progress CUV1647, its lead candidate, toward Phase III development. CUV1647, a photo-protective agent, is being tested for a range of UV-related skin disorders. The company is preparing to start Phase II/III studies in Australia, Europe, South Africa and the U.S., and remains on target to complete these in 2009.

• EnBioTec Laboratories Co. Ltd., of Tokyo, and Tripos Discovery Research, of Bude, UK, agreed to co-develop nuclear receptor-based lead compounds for drug discovery. EnBioTec has the Receptor Cofactor Assay System to evaluate interactions between nuclear hormone receptors and cofactors in the presence of compounds, and Tripos will provide a targeted set of compounds for testing. Financial terms were not disclosed.

• EpiCept Corp., of Englewood Cliffs, N.J., announced the validation of the marketing application for Ceplene (histamine dihydrochloride) by the European Medicines Agency for the Evaluation of Medicinal Products. Ceplene is EpiCept's lead oncology product candidate that, administered in conjunction with low dose interleukin-2, will be indicated for use in the maintenance of first remission in patients with acute myeloid leukemia.

• Galapagos NV, of Mechelen, Belgium, said its services division, BioFocus DPI, will collaborate with Ballerup, Denmark-based LEO Pharma A/S to use a subset of BioFocus' natural compound collection for high-throughput screening, hit verification and profiling of selected compounds for LEO's antibacterial research program. In return, Galapagos stands to receive up to €400,000 (US$510,732) and up to €3 million in milestone payments, plus royalties.

• MediciNova Inc., of San Diego, acquired two novel, preclinical, small-molecule cardiovascular agents from Meiji Seika Kaisha Ltd., of Tokyo. MN-447 and MN-462 are anti-clotting agents, the company said, and are expected to treat a variety of thrombotic disorders.

• Memory Pharmaceuticals Corp., of Montvale, N.J., said Basel, Switzerland-based F. Hoffmann-La Roche Ltd. elected to maintain its option to gain an exclusive license for MEM 3454, the lead compound from the companies' alliance on nicotinic alpha-7 receptor agonists in neurological and psychiatric disorders. That decision was triggered by Memory's Phase I work on the product, which satisfied a set of pre-defined criteria, and will result in a $2 million milestone payment to Memory. Under the terms of the collaboration, Memory is responsible for the development of MEM 3454 through Phase IIa trials, and Roche retains the right to license the compound through the development process by making three payments to Memory. To date, Roche has paid two milestones.

• Stratagene Corp., of La Jolla, Calif., said a federal judge awarded Invitrogen Corp., of Carlsbad, Calif., $16.2 million in damages plus pre-judgment interest and ruled that Stratagene must pay Invitrogen's attorney's fees. The award stems from a jury's July 2006 determination that Invitrogen's 4,981,797 patent is valid and that Stratagene infringed that patent by making and selling its E. coli cell products. The jury awarded Invitrogen a 15 percent royalty rate on sales between 1997 and 2004 (for a total of $7.9 million) and found that Stratagene willfully infringed on the patent between the years 1997 and 2001 only. Stratagene said it intends to appeal the decisions of both the jury and the judge.

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