• Abraxis BioScience Inc., of Los Angeles, said it plans to separate its hospital-based product business, Abraxis Pharmaceutical Products, from its proprietary-product business, Abraxis Oncology and Abraxis Research (the new Abraxis BioScience). The deal, subject to confirmation that the transaction would be tax-free, would result in two independent public companies. Each current shareholder would get one share of Abraxis Pharmaceutical Products, which is expected to be known as APP Inc., and one share of the new Abraxis BioScience, for each share previously held. Abraxis has received commitments for $1.45 billion of senior credit facilities comprised of a funded $1.3 billion term loan and an unfunded $150 million revolving credit facility. APP would be responsible for servicing the debt following the separation. The deal is expected to be completed in the fourth quarter.

• Affymetrix Inc., of Santa Clara, Calif., said the Genetic Association Information Network will use the recently launched Genome-Wide Human SNP Array 6.0 for a series of studies designed to identify the genetic causes of common, complex diseases such as schizophrenia and bipolar disorder. Launched in February 2006, GAIN is a partnership between the Foundation for the National Institutes of Health, the National Institutes of Health and Pfizer Global Research and Development.

• Albany Molecular Research Inc., of Albany, N.Y., has completed its acquisition of two pharmaceutical manufacturing sites, along with additional land for expansion, in Aurangabad and Navi Mumbai, India for approximately $11 million in cash. AMRI has acquired from the Runwal Group the assets of Ariane Orgachem Pvt. Ltd., of Aurangabad, and Ferico Laboratories Ltd., of Navi Mumbai. The existing facilities currently manufacture a range of pharmaceutical intermediates and bulk active ingredients, including treatments for diabetes, heart disease and asthma. AMRI also has obtained additional land in Aurangabad and plans to invest approximately $15 million to expand and upgrade manufacturing capabilities over the next three years.

• Aldagen Inc., of Durham, N.C., has established a Class 10,000 clean room for Good Manufacturing Practice-certified manufacture of its cellular products. The facility is approximately 1,000 square feet and is fully validated and supported by environmental monitoring and quality control activities. Aldagen's proprietary stem cell isolation technology has been incorporated into the manufacturing process and the products produced at the facility will be used for three ongoing clinical studies.

• Algeta ASA, of Oslo, Norway, established a research collaboration with an undisclosed partner to discover radio-immunotherapeutic approaches to cancer treatment. The collaboration is aimed at utilizing Algeta's TH-1 technology to link alpha-emitting thorium-227 to tumor-selective antibodies developed by the partner. The two parties will jointly manage a feasibility study. Further terms were not disclosed.

• Beike Biotechnology Co. Ltd., of Shenzhen, China, said a research team at its collaborating hospital in Shenyang completed a study assessing clinical efficacy, safety and feasibility of transplantation of peripheral blood stem cells for patients with peripheral vascular disease of the lower extremities. Results from the 152-patient study showed that, at 12 weeks, primary symptoms, including lower limb pain and coldness, were improved significantly in 137 (90.1 percent) of those treated. Limb ulcers improved or healed in 46 (86.6 percent) of the 53 patients, while 25 of the 48 patients (47.9 percent) with limb gangrene remained steady or improved. The patients had no severe adverse effects or complications related to cell transplantation. Data were published in the Journal of Geriatric Cardiology.

• BioCurex Inc., of Richmond, British Columbia, said it agreed to transfer the license agreement covering its RECAF cancer marker technology from Abbott, of Abbott Park, Ill., to General Electric, of Norwalk, Conn. Abbott earlier this year said it planned to transfer its core diagnostics and point-of-care business to GE. Abbott and BioCurex entered a deal on the RECAF, or receptor for alpha fetoprotein, technology in March 2005. GE will be assigned the semi-exclusive license and assume all rights and obligations under that agreement. (See BioWorld Today, March 30, 2005.)

• BioDelivery Sciences International Inc., of Morrisville, N.C., said its June 28 pre-new drug application meeting with the FDA regarding the company's Phase III BEMA Fentanyl product went according to plan, and the firm continues to project an NDA submission for its breakthrough cancer pain product, BEMA Fentanyl, during the third quarter of 2007. The meeting was held to review the company's questions regarding the format and content of the proposed NDA and the FDA's responses in an effort to avoid any potential delays to the NDA submission and the FDA review process.

• Ceragenix Pharmaceuticals Inc., of Denver, said researchers at the University of Pennsylvania in collaboration with Brigham Young University have demonstrated in a series of in vitro experiments that an investigational drug compound known as CSA-13 shows promise as a potential therapy to treat multidrug-resistant Pseudomonas aeruginosa infections. The research appears ahead of print in an advanced online publication of the Journal of Antimicrobial Chemotherapy.

• DeCode Genetics Inc., of Reykjavik, Iceland, published a paper in Nature with several academic collaborators regarding the discovery of two single nucleotide polymorphisms linked to a 70 percent and 40 percent increase in the risk of atrial fibrillation. The variants are located on chromosome 4q25 near the PITX2 gene, which plays a role in the development of the heart. DeCode also launched a reference laboratory test for the variants, dubbed deCODE AF.

• DOR BioPharma Inc., of Miami, said first results from testing of a multivalent form of its botulinum toxin vaccine, BT-VACC, have been published in the journal Infection and Immunity. Those results in mice are the first that describe the protective immunity elicited by a multivalent vaccine that is active by the mucosal route. The vaccine consists of a combination of three non-toxic subunits of botulinum toxin that induced protection against the corresponding versions of the natural toxins. Results showed that non-toxic subunits (protein components of the natural toxin) of three of the serotypes of botulinum toxin that cause almost all instances of human disease - serotypes A, B, and E - can be combined and delivered via nasal administration.

• Galapagos NV, of Mechelen, Belgium, said it is expanding its multiyear alliance in osteoarthritis with GlaxoSmithKline plc, of London. As part of the deal, GSK is purchasing 513,281 Galapagos shares for €4.4 million (US$6 million). GSK will bring a drug discovery program against a selected GSK target into the alliance. Within that additional program, Galapagos will progress a disease-modifying drug toward completion of Phase IIa trials, at which point GSK would be responsible for the late-stage development, production and marketing. GSK also may add a second osteoarthritis drug discovery program against a selected GSK target into the alliance. Galapagos could receive up to €186 million in total milestones if the expanded collaboration yields two marketed products. It also would get royalties on worldwide sales by GSK. Galapagos already has received €7.6 million in access fees and milestone payments from GSK since the start of the program in June 2006. (See BioWorld Today, June 8, 2006.)

• Genzyme Corp., of Cambridge, Mass., is waiving the condition to its tender offer for Bioenvision Inc., of New York, that it acquire at least 50 percent of the outstanding shares of common stock and is extending the tender offer for all outstanding shares of common and preferred stock of Bioenvision until 12:01 a.m. As of the start of Monday, Genzyme has received approximately 26 percent of the outstanding shares, including all shares of preferred stock. Genzyme agreed on May 29 to acquire Bioenvision in an all-cash transaction valued at $5.60 per outstanding common share and $11.20 per outstanding preferred share (plus accrued but unpaid dividends), or approximately $345 million. (See BioWorld Today, May 30, 2007.)

• Karo Bio AB, of Huddinge, Sweden, extended its atherosclerosis collaboration with Madison, N.J.-based Wyeth for an additional year until Aug. 31, 2008. The companies began collaborating in 2001 and extended the agreement for a year in August 2005 and again in August 2006. The goal of the collaboration is to characterize backup compounds and evaluate additional clinical possibilities of targeting LXR, a hormone receptor that regulates cholesterol metabolism. Wyeth began Phase I trials with a lead LXR compound in August 2006.

• Oxis International Inc., of Foster City, Calif., said the University of Cologne, in Cologne, Germany, found evidence supporting the use of l-ergothioneine as a nutritional/dietary supplement to treat chronic inflammatory diseases. Oxis recently launched a human and veterinary sales and marketing campaign for ERGO and scientific validation from the University of Cologne is expected to enhance the company's efforts. ERGO is a unique, naturally occurring anti-oxidant/anti-inflammatory agent that is abundant in most plants and animals.

• ProEthic Pharmaceuticals Inc., of Montgomery, Ala., submitted a new drug application for PRO-513 for treating migraines. PRO-513 uses the company's Dynamic Buffering Technology to enhance the absorption of the active ingredient diclofenac potassium. The NDA was based on data from Phase III trials showing that PRO-513 met all its co-primary endpoints, including pain relief and the symptoms associated with migraine, such as photophobia, phonophobia and nausea. In addition, results showed that the drug began to relieve pain within 30 minutes and that its benefits persisted up to 24 hours.

• SCOLR Pharma Inc., of Bellevue, Wash., received a notification of noncompliance from the American Stock Exchange due to the company's insufficient number of independent directors on its board. That is due to the unexpected death of independent board member Michael Sorell earlier this year and the recent decision of independent board member Hans Mueller not to stand for re-election. SCOLR notified the Amex that it intends to fill the vacancy on the board with an independent director as soon as possible, and Amex has agreed to give the company until Sept. 28 to regain compliance.

• Shire plc, of Basingstoke, UK, submitted a supplemental new drug application to the FDA, seeking approval of Vyvanse (lisdexamfetamine dimesylate) for treating attention deficit hyperactivity disorder in adults. The application is subject to a 10-month FDA review period. The FDA approved the product in February in children ages 6 to 12. Shire developed the amphetamine-based product with the now-acquired New River Pharmaceuticals Inc. (See BioWorld Today, Feb. 27, 2007.)

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., completed the filing of an amendment to the new drug application for ISO-Vorin (levofolinic acid, LFA), the pure active isomer of calcium leucovorin, in osteogenic sarcoma. That amendment addresses questions raised by the FDA regarding the chemistry manufacturing and control section of the filing, following the Oncology Drug Advisory Committee's recommendation for product approval. The company acquired rights to ISO-Vorin from Princeton, N.J.-based Targent Inc. in 2006, and expects to file a supplemental NDA for the additional indication of colorectal cancer. Spectrum also plans to file an oral formulation of ISO-Vorin with the FDA.

• Tecan Switzerland AG., of Mannedorf, Switzerland, and the Monash Antibody Technologies Facility at Monash University in Australia, have partnered to create a monoclonal antibody production system, which will be based around multiple integrated liquid handling workstations and will fully automate all the stages of the production process. The system will be partially funded by the Victorian State Government and Monash University, National Collaborative Research Infrastructure Strategy and the Australian Stem Cell Centre. Tecan will be the system at the company's headquarters in Mannedorf, ready for installation in April 2008.

• The Medicines Co., of Parsippany, N.J., reacquired from Nycomed A/S, of Roskilde, Denmark, all European development and commercial rights to Angiox (bivalirudin). Angiox is an anticoagulant used in patients undergoing percutaneous coronary interventions. The direct thrombin inhibitor is approved in 26 European markets. The Medicines Co. sells the product as Angiomax in the U.S. The company plans to sell the product itself in Europe, where the patent extends through mid-2015. Nycomed gets $20 million up front and $20 million next year, and would get another $5 million if European regulators approve an expanded Angiox label to include findings from the ACUITY trial. The Medicines Co. expects full-year international sales of Angiomax/Angiox in 2008 to be in the range of $15 million to $20 million, increasing by 2011 to $90 million to $110 million.

• Viragen Inc., of Plantation, Fla., said it and the board of directors for its majority-owned subsidiary, Viragen International Inc., approved a 1-for-40 reverse stock split that will reduce Viragen International's outstanding shares from approximately 77.7 million shares to approximately 1.94 million shares. The transaction is part of a plan to optimize Viragen International's capital structure. Shares of Viragen International (OTCBB:VGNI) fell 16.7 percent, or 1 cent, to close at 3 cents on Monday.