• Abraxis BioScience Inc., of Los Angeles, is licensing rights to develop a biosimilar version of G-CSF (granulocyte-colony stimulating factor) in North America and the European Union from Biocon Ltd., of Bangalore, India. Under the terms, Biocon will receive an up-front licensing fee and, following approval in the licensed territories, will get royalties on any product sales. Detailed financial terms were not disclosed. G-CSF, a hematopoietic growth factor, primarily is used to treat neutropenia. Biocon recently gained regulatory approval of the product in India to treat neutropenia in cancer patients.

• Alseres Pharmaceuticals Inc., of Hopkinton, Mass., and QSV Biologics Ltd., of Edmonton, Alberta, signed a contract for the process development and cGMP manufacturing of Cethrin for spinal cord injury. QSV will be responsible for technology transfer, process development and manufacturing for Phase IIb/III trial material. Cethrin, a Rho inhibitor designed to stimulate axon regeneration, was licensed by Alseres from Montreal-based BioAxone Therapeutics Inc. Financial terms were not disclosed.

• Alteon Inc., of Montvale, N.J., said its shareholders voted to change the company's name to Synvista Therapeutics Inc. They also approved a reverse stock split determined by the company's board at a ratio of 1-to-50, with the anticipated effective date of July 25, 2007. The company will begin trading July 25 on the American Stock Exchange under its new ticker "SYI."

• Carrington Laboratories Inc., of Irving, Texas, said its subsidiary, DelSite Biotechnologies Inc., extended a joint development agreement with Brookwood Pharmaceuticals Inc., of Birmingham, Ala., to continue an expanded evaluation of the GelSite drug delivery technology as a matrix for injectable applications and for selected classes of drugs. Building upon promising results over the past year, the extension aims at continuing the development program. To date, the joint scientific team has made progress in expanding GelSite applications for parenteral delivery of proteins and peptides.

• Galapagos NV, of Mechelen, Belgium, said its BioFocus DPI service division received an undisclosed milestone payment in the autoimmune discovery research collaboration with Ingelheim, Germany-based Boehringer Ingelheim GmbH. The three-year collaboration, signed in January 2006, involves an expansion of BioFocus DPI's SilenceSelect sh-RNA-based gene collection with an additional gene set, the development of a dedicated cellular assay in the field of autoimmune diseases and its application in a target discovery screen for BI's autoimmune discovery research. Galapagos obtained up-front fees and will continue to get research and development funding, plus additional milestone fees when certain drug discovery criteria are met. Should all criteria be achieved, payments to Galapagos could exceed €2 million (US$2.8 million).

• Genta Inc., of Berkeley Heights, N.J., said the requested re-examination by the European Committee for Medicinal Products for Human Use reaffirmed a negative opinion for approval of Genasense (oblimersen) in advanced melanoma patients. The reviewers indicated that positive findings observed in the Phase III study should be confirmed in an additional study. Genta previously said it intended to conduct an additional Phase III trial, known as AGENDA, which the company said is expected to begin in the near future. Genasense also previously was rejected by the FDA's Oncologic Drugs Advisory Committee.

• GlycoMimetics Inc., of Gaithersburg, Md., said in vivo results showed that intravenous administration of its lead compound, GMI-1070, in a mouse model of sickle-cell vaso-occlusive crisis restored blood flow to normal rates and virtually eliminated adhesion of sickle red blood cells to leukocytes. GMI-1070 is designed to inhibit E-, P- and L-selectins. Data were presented at the International Symposium of Glycoconjugates in Cairns, Australia.

• Humanetics Corp., of Minneapolis, said the FDA granted orphan drug designation to its BIO 300 investigational drug for the prevention of acute radiation syndrome. The product is under development as a medical countermeasure for ionizing radiation resulting from a nuclear or radiological attack, act of terrorism or accident. Orphan drug status would provide seven years of market exclusivity upon approval, and provides tax credits for product development, reduced fees for market applications and assistance from the agency to move the drug through the approval process. BIO 300, a small, single molecular agent, is being studied under a cooperative research and development agreement with the Armed Forces Radiobiology Research Institute of the Department of Defense.

• ImaRx Therapeutics Inc., of Tucson, Ariz., lowered the expected price for its anticipated initial public offering from $6.50 to $7.50 per share to $5 per share. The company, which withdrew its initial IPO filing in October due to marketing conditions, refiled in May to raise funds to support development of therapies for vascular disorders associated with blood clots. Maxim Group LLC is acting as underwriter and book-running manager.

• Nucryst Pharmaceuticals Corp., of Wakefield, Mass., said the FDA granted 510(k) clearance for a topical cream containing NPI 32101, the company's nanocrystalline silver, as a broad-spectrum antimicrobial barrier. In vitro studies demonstrated that NPI 32101 cream serves as a barrier to organisms including Pseudomonas aeruginosa and Staphylococcus aureus, including strains resistant to methicillin.

• Nuon Therapeutics Inc., of San Francisco, completed a $5 million Series A financing with GBS Venture Partners, of Australia. Proceeds will enable to the company to advance its lead compound, tranilast, an oral product approved in Japan and South Korea for asthma, in several new indications. Nuon focuses on developing therapeutics for autoimmune and chronic inflammatory diseases, such as multiple sclerosis and rheumatoid arthritis, and the company holds an exclusive license to technology developed by Imperial College London and Stanford University. The firm also named Rodney Pearlman as CEO.

• Pfizer Inc., of New York, said the European Committee for Medicinal Products for Human Use issued a positive opinion recommending marketing authorization of Celsentri (maraviroc), a CCR5 antagonist, for use in combination with other antiretroviral agents in treatment-experienced adult HIV patients where only CCR5-tropic virus is detectable. The CHMP's opinion will be reviewed by the European Commission, and Pfizer anticipates a final decision in the coming months. Maraviroc, which is designed to work extracellularly by blocking viral entry to human cells via the CCR5 co-receptor, recently received an approvable letter in the U.S.

• Qiagen NV, of Venlo, the Netherlands, entered an agreement with the Joint Center for Structural Genomics to provide protein crystallographers with a new set of crystallization screens that have been assembled from analysis of hundreds of thousands of crystallization experiments. Financial terms were not disclosed.

• Santarus Inc., achieved a $5 million milestone in its collaboration with Schering-Plough Healthcare Products Inc., a division of Schering-Plough Corp., of Kenilworth, N.J., relating to clinical development progress on the companies' over-the-counter license agreement for proton pump inhibitor products using Santarus' PPI technology. Under the terms, Schering-Plough is responsible for the development, manufacturing and commercialization of OTC products using the PPI technology with the lower dosage strength of 20 mg of omeprazol for heartburn-related indications in the U.S. and Canada. In addition to the $15 million up-front license fee received in 2006, and the $5 million milestone to be paid, Santarus could receive up to an additional $60 million upon the achievement of certain regulatory and sales milestones. The company also would be entitled to a low, double-digit royalty on product sales. (See BioWorld Today, Oct. 23, 2006.)

• Vastox plc, of Oxford, UK, changed its name to Summit Corp. plc to reflect the growth and development of its drug pipeline and its core technology capabilities. The name change was approved by shareholders last week.