• BAC BV, of Naarden, the Netherlands, entered into a collaboration with Octapharma AG, of Lachen, Switzerland, to discover and develop a custom CaptureSelect ligand for the purification of a recombinant Factor IX product developed by Octapharma for the prophylaxis and treatment of bleeding in hemophilia B. BAC's CaptureSelect ligand technology is based on unique Camelid single chain antibody fragments, which can be selected for desirable chromatographic characteristics and produced at high-titre in a proprietary S. cerevisiae strain, and Octapharma will use the technology in the downstream processing of the protein from mammalian cell lines.
• Juvaris BioTherapeutics Inc., of Burlingame, Calif., said Grant E. Pickering has been appointed CEO. Pickering also will be elected to the company's board of directors. In conjunction with Pickering's appointment, the corporate headquarters now will be located within the company's recently expanded research, development and manufacturing facilities in Burlingame.
• Lev Pharmaceuticals Inc., of New York, said it was advised that the Blood Products Advisory Committee (BPAC) of the FDA will review the biologics license application for Cinryze (C1 inhibitor) for the prophylactic treatment of hereditary angioedema. The BPAC review, set for May 2, followed the firm's complete response to the FDA's Jan. 30 approvable letter requesting information with respect to chemistry, manufacturing and controls, as well as additional analyses of existing efficacy data from the Cinryze trials. (See BioWorld Today, Feb. 1, 2008.)
• NimbleGen Systems Inc., of Madison, Wis., a subsidiary of F. Hoffmann-La Roche Ltd., expanded the terms of the license to a number of patents originally granted to Santa Clara, Calif.-based Affymetrix Inc. in October 2006. The expanded license provides certain diagnostic rights for array-based DNA copy number analysis and array-based resequencing, in addition to covering the manufacture, use and sale of nucleic acid microarrays and related products and services in the research field. Financial details were not disclosed.
• Oncolytics Biotech Inc., of Calgary, Alberta, reported preclinical data showing that its reovirus induced cell death mediated through apoptosis in up to 70 percent of multiple myeloma cell lines tested. Additional data showed that the reovirus in combination with radiation significantly enhanced efficacy compared to either treatment alone in mice implanted with pediatric rhabdomyosarcoma and Ewing's sarcoma tumors. Oncolytics' lead product, Reolysin, is a formulation of the human reovirus and is in Phase I and Phase II testing.
• OncoMethylome Sciences, of Liege, Belgium, said its research collaborators demonstrated that gene methylation is associated significantly with recurrence of early stage non-small-cell lung cancer. Researchers from Johns Hopkins University and Lovelace Respiratory Research Institute successfully identified genes whose methylation is associated with tumor recurrence, independently of cancer stage, histologic characteristics of the tumor and demographic variables such as age, sex, race and smoking history. Those results were published in the March 13, 2008, issue of the New England Journal of Medicine. Under the terms of an existing research collaboration agreement between OncoMethylome and Johns Hopkins, OncoMethylome has an option to license the methylation marker assay.
• Salix Pharmaceuticals Ltd., of Raleigh, N.C., said Dr. Falk Pharma GmbH, of Freiburg, Germany, granted it a U.S. license to a family of budesonide products, including a budesonide rectal foam and a budesonide gastro-resistant capsule. Under the terms, Salix will make up-front and regulatory milestone payments to Dr. Falk, with the majority of the milestones contingent upon achievement of regulatory approval. Salix also will make royalty payments on net sales. Specific financial terms were not disclosed.
• Sciele Pharma Inc., of Atlanta, acquired from Verus Pharmaceuticals Inc., of San Diego, the Twinject epinephrine auto-injector for the treatment of severe allergic reactions and anaphylaxis, as well as certain other related Verus products under development, for $29 million. Verus also may receive additional payments resulting from the achievement of certain development milestones. Twinject, which is composed of two doses of epinephrine in a single, compact device, is FDA-approved.
• Silence Therapeutics plc, of London, said it is collaborating with AstraZeneca plc, also of London, on a range of approaches for delivering siRNA molecules. The deal builds on Silence's work in the functional system delivery of siRNA in vivo using its AtuPLEX technology. Financial terms were not disclosed, but the companies said the latest collaboration is separate from their potential $400 million July 2007 deal, in which they are developing siRNA therapeutics against specific targets exclusive to AstraZeneca. (See BioWorld Today, July 9, 2007.)