• Anadys Pharmaceuticals Inc., of San Diego, reported preliminary data from two studies of ANA598, a non-nucleoside inhibitor of the hepatitis C virus NS5B polymerase, in a primate model of chronic HCV infection. Data from two animals infected with HCV genotype-1b that received once-daily oral doses of the drug for four days showed that both had a rapid viral load decline. At 48 hours, viral load declines were 2.2 log10 and 2.6 log10 in the individual animals. In one animal, the viral load reduction was sustained throughout the remaining dosing period, while in the second animal a modest rise in viral load was seen over days three and four, though that rise was within baseline variability seen in that animal prior to dosing. Anadys intends to submit an investigational new drug application for ANA589 in the second quarter.

• BioMarin Pharmaceutical Inc., of Novato, Calif., and Genzyme Corp., of Cambridge, Mass., restructured their joint venture regarding Aldurazyme (laronidase) for mucopolysaccharidosis I. The revised structure calls for BioMarin to receive a tiered royalty ranging from about 39.5 percent to 50 percent of worldwide net sales, instead of the two firms sharing all costs and profits equally through the 50/50 joint venture. Operational responsibilities for both companies will not change significantly, with Genzyme continuing to globally market and sell the drug and BioMarin handling the manufacturing.

• Genmab A/S, of Copenhagen, Denmark, started a new preclinical antibody program, HuMax-CD32b, a fully human IgG1, k antibody aimed at targeting the CD32b receptor found on immune cells and hematological tumors. The company said HuMax-CD32b might have therapeutic potential in B-cell chronic lymphocytic leukemia, small lymphocytic lymphoma, Burkitt's lymphoma, follicular lymphoma and diffuse large B-cell lymphoma.

• Illumina Inc., of San Diego, said it reorganized its operating structure, creating a Life Sciences Business Unit to include all products and services related to the BeadArray, BeadXpress and Sequencing product lines for the research market. The company also created a Diagnostics Business Unit to focus on molecular diagnostics and to develop diagnostic content for the BeadXpress system and, ultimately, for Illumina's Sequencing products.

• The Michael J. Fox Foundation, of New York, committed up to $3.8 million for the development of a gene silencing therapeutic to treat Parkinson's disease by reducing expression of the protein alpha-synuclein. A team of researchers led by Matt Farrer, of the Mayo Clinic in Jacksonville, Fla., with collaborators at Cambridge, Mass.-based Alnylam Pharmaceuticals Inc. and the Parkinson's Institute and Clinical Center, will work to optimize a small interfering RNA-based therapeutic designed to slow or stop the progression of Parkinson's disease. That work is being funded under the foundation's LEAPS (Linked Efforts to Accelerate Parkinson's Solutions) 2007 initiative.

• Ovation Pharmaceuticals Inc., of Deerfield, Ill., said the FDA granted orphan drug designation for clobazam as an adjunctive treatment of Lennox-Gastaut syndrome, a severe form of childhood epilepsy that frequently persists into adulthood. Orphan status provides regulatory assistance and guarantees the drug seven years of marketing exclusivity upon approval.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said the European Medicines Agency agreed with the company's overall clinical development plan, including design and endpoints in pivotal Phase III trials, for EOquin in non-invasive bladder cancer, and said that those studies should be sufficient for a regulatory decision regarding European registration. The EMEA also indicated that, pending a review of the study outcomes, no additional safety data would be required. The two Phase III EOquin (apaziquone for intravesical instillation) trials are testing the drug against placebo in patients with low-risk non-invasive bladder cancer, with a primary endpoint defined as the difference in the rate of tumor recurrence between the two groups by year two.

• Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, submitted a new drug application for alogliptin, an oral, once-daily selective dipeptidyl peptidase-4 (DPP-4) inhibitor for Type II diabetes. The submission includes data from six Phase III studies demonstrating the compound's safety and efficacy as a once-daily monotherapy adjunct to diet and exercise and as an add-on therapy to other antidiabetic medications, including sulfonylureas, metformin, thiazolidinediones and insulin.

• TAP Pharmaceutical Products Inc., of Lake Forest, Ill., submitted a new drug application for TAK-390MR in acid-related diseases and treatment and maintenance of patients with erosive esophagitis and nonerosive reflux disease. TAK-390MR is a proton pump inhibitor that uses a novel delivery system. TAP is a joint venture between Abbott Park, Ill.-based Abbott and Osaka, Japan-based Takeda Pharmaceutical Co. Ltd.

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