• Abraxis BioScience Inc., of Los Angeles, granted an exclusive license for Green Cross Corp., of Osaka, Japan, to commercialize Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in Korea. Under the agreement, Green Cross will pay Abraxis an up-front fee and milestone payments, as well as royalties, following Korean regulatory and pricing approval of the drug. In addition, Green Cross granted an exclusive license to Abraxis for the future commercialization of several biosimilars in the U.S. and Canada: erythropoietin, pegylated G-CSF (granulocyte-colony stimulating factor), interferon-alpha, recombinant Factor VIII and etanercept (Enbrel, Amgen Inc.). Abraxis will be responsible for clinical development and regulatory approval of those products, and will pay Green Cross a milestone upon each product approval, plus royalties on net sales.

• Adolor Corp., of Exton, Pa., and GlaxoSmithKline plc, of London, said the FDA's Gastrointestinal Drugs Advisory Committee will review the new drug application for Entereg (alvimopan) Jan. 23, for the proposed indication of acceleration of time to upper- and lower-gastrointestinal recovery following partial large- or small-bowel resection surgery with primary anastomosis. Entereg was deemed approvable in postoperative ileus a year ago, and the FDA accepted the companies complete response to the approvable letter in August. (See BioWorld Today, Aug. 29, 2007.)

• Anavex Life Sciences Corp., of Geneva, said preclinical studies of ANAVEX 1-41, its lead drug candidate for Alzheimer's disease, showed the compound prevented oxidative stress, which damages and destroys cells and is believed to be a primary cause of Alzheimer's disease. It also prevented the expression of caspase-3, an enzyme that plays a key role in programmed cell death and in the loss of cells in the hippocampus, the part of the brain that regulates learning, emotion and memory. Testing was conducted in a nontransgenic mouse model of Alzheimer's disease. The preclinical studies will be completed in the coming weeks, and the company plans an investigational new drug application filing so that human trials can begin.

• CardioVascular BioTherapeutics Inc., of Las Vegas, engaged the Bruckner Group to help find a joint commercialization partner for CVBT-141H, a drug candidate containing fibrolast growth factor-1 that is in Phase II for severe coronary heart disease.

• DOR BioPharma Inc., of Ewing, N.J., has entered into a letter of intent with Orphan Australia Pty Ltd., of Melbourne, Australia, under which Orphan Australia will act as DOR's sponsor for administration of a Named Patient Access Program (NPAP) for orBec to gastrointestinal graft-vs.-host disease patients in Australia, New Zealand and South Africa. The NPAP is a compassionate use drug supply program administered by the Therapeutic Goods Administration, which allows medical practitioners to legally supply investigational drugs to patients who qualify. OrBec is being investigated for use in bone marrow/stem cell transplantation patients.

• Immunosyn Corp., of La Jolla, Calif., said Biozyme Laboratories Ltd., of Blaenavon, South Wales, has received approval from the UK's Medicines and Healthcare products Regulatory Agency to import base material and manufacture SF-1019 for human use in clinical trials. SF-1019 is a biopharmaceutical for which Immunosyn holds the exclusive license for worldwide marketing rights.

• MediGene AG, of Martinsried, Germany, and Celltrion Inc., of Munich, Germany, signed a binding memorandum of understanding for co-development and commercialization of an anti-L1 monoclonal antibody for the treatment of cancer in humans covering major cancer indications. The companies will share responsibilities for development and commercialization. Celltrion will conduct process development and manufacturing and will have exclusive responsibility for development and commercialization of the L1 MAb in Asia, including Japan. Celltrion also will have an option for global manufacturing rights to supply Phase III and commercial material. MediGene retains the rights for the development and commercialization of the product in Europe, the U.S. and the remaining areas. MediGene will have the right to exercise an option to acquire an exclusive worldwide license on the application of the anti-L1 monoclonal antibody in antitumor therapy.

• OxiGene Inc., of Waltham, Mass., reported that its lead product candidate, Zybrestat (combretastatin A4 phosphate/CA4P), demonstrated anti-leukemic effects in preclinical studies. Results, as published in Blood, showed that low and nontoxic doses of CA4P inhibited leukemic cell proliferation in vitro and induced mitotic arrest and cell death. In mouse models of human leukemia, the drug prolonged survival without inducing hematological toxicity, likely by inhibiting proliferation and circulation of leukemic cells, and also diminished the extent of perivascular leukemic cell infiltrates. Zybrestat, a vascular disrupting agent, currently is in pivotal testing in anaplastic thyroid cancer.

• S*BIO Pte Ltd., of Singapore, said it expanded its pipeline with a third development candidate, SB1317, an oral, small molecule for acute leukemias. SB1317, which is designed to selectively inhibit major signaling pathways involving FLT3 and CDK, is positioned to treat relapsed and refractory acute leukemias. The product has entered preclinical development.

• Synthetic Blood International Inc., of Costa Mesa, Calif., said the Virginia Commonwealth University Reanimation Engineering Shock Center (VCURES) has received $1.3 million under a previously awarded U.S. Office of Naval Research grant for the treatment and prevention of decompression sickness with Oxycyte, the company's perfluorocarbon therapeutic oxygen carrier and blood substitute. Synthetic Blood has begun the process of manufacturing and shipping Oxycyte to VCURES for use in the studies. The company, in conjunction with VCURES, is planning a 100-150 patient, double-blind, multicenter, placebo-controlled Phase IIb study to compare Oxycyte with present-day advanced therapies in traumatic brain injury.

• Zogenix Inc., of San Diego, has licensed exclusive U.S. rights from an affiliate of Elan Corp. plc, of Dublin, Ireland, to develop and commercialize a late-stage, controlled-release opioid for the treatment of pain. The unnamed product demonstrated in a Phase II clinical trial a clinically acceptable safety profile and a reduction in pain intensity for chronic moderate to severe osteoarthritis pain patients across multiple dosage strengths. Under the agreement, Elan will receive from Zogenix an undisclosed up-front payment and future payments upon the achievement of clinical and regulatory milestones. Elan also will receive royalty payments based on sales of the product upon commercialization. Zogenix will assume responsibility for the clinical development and commercialization in the U.S., and Elan will manufacture the product for Zogenix.