•Amgen Inc., of Thousand Oaks, Calif., filed a complaint in the U.S. District Court for the District of Columbia against the Centers for Medicare & Medicaid Services and the Department of Health and Human Services. The complaint seeks an injunction prohibiting the implementation of certain provisions of a new rule that changes the hospital outpatient prospective payment system. Specifically, Amgen is disputing the legality of provisions that would result in a significant reduction in the reimbursement rate for Aranesp (darbepoetin alfa) for Medicare patients in the hospital outpatient setting, effective Jan. 1. (See BioWorld Today, Nov. 4, 2002.)

•CeNeS plc, of Cambridge, UK, sold to Acorda Therapeutics Inc., of Hawthorne, N.Y., an exclusive worldwide license to its neuregulin products, glial growth factor 2 (GGF2) and neuregulin 2 (NRG2), a class of therapeutic agents that promoted remyelination in animal studies. Financial terms were not disclosed, but Acorda said it plans to immediately advance preclinical development on GGF2 in preparation for clinical trials in multiple sclerosis. The earlier-stage product, NRG2, has potential applications in multiple sclerosis, spinal cord injury, Parkinson's disease and chronic heart failure. Separately, CeNeS reported positive results from its recent Phase II trial comparing the analgesic efficacy of morphine-6-glucuronide with morphine. The study, carried out under a June 2001 joint venture agreement with Elan Corp. plc, of Dublin, Ireland, showed that patients undergoing hip replacement surgery obtained equivalent post-operative pain relief with M6G as with a standard regimen of morphine.

•Microbix Biosystems Inc., of Toronto, entered an agreement to distribute Helper-Dependent Adenovirus Vector technology for Merck & Co., of Whitehouse Station, N.J. In that system, only the cis-acting elements (required for viral DNA replication and packaging) are derived from adenovirus type 5. The rest of the adenovector is composed of nonviral and nonexpressing DNA sequences. The recombinant adenovectors produced using the system can allow for a longer duration of transgene expression compared to traditional adenovirus vectors. Financial terms were not disclosed.

• Milkhaus Laboratory Inc., of Providence, R.I., said it would spin out its veterinary products subsidiary called Milkhaus Veterinary Products Inc. The move includes a licensing agreement whereby each has access to discoveries made by the other in their respective therapeutic domains. Milkhaus, which will retain an equity position in the spinout, named Thomas Hatch the new corporate entity's president and CEO.

• Photogen Technologies Inc., of New Hope, Pa., said it closed a transaction to split off its therapeutic business, sold $9 million of common stock and instituted a one-for-four reverse split of its common stock. The spin-off of its photodynamic therapy and laser device business to five founding shareholders was in exchange for all their common stock holdings in Photogen, which represented 52.9 percent of its outstanding shares. The institutional investment was led by Mi3 LP, of Wellesley, Mass., which gained a seat on Photogen's board, and included Oxford Biosciences, of Boston, and Tannebaum LLC, of Chicago. They purchased the shares for 27 cents apiece, on a pre-reverse-split basis. In conjunction with the sale, all outstanding debt and Series B Preferred Stock were converted into common stock. Following the reverse split, Photogen's outstanding common stock will total about 13.5 million shares.

• ProMetic Life Sciences Inc., of Montreal, said its wholly owned subsidiary, ProMetic BioSciences Inc., successfully scaled up the GMP-grade synthesis process for PBI-1402, its investigational oncology product scheduled to enter clinical trials in early 2003. CEO Pierre Laurin said the company had successfully translated its manufacturing expertise from its established Mimetic Ligand business to the development of value-added products.

• The Scripps Research Institute, of La Jolla, Calif., said its researchers designed a vaccine that might be used to protect against the consequences of severe sepsis. Although the vaccine has not been applied in clinical trials, it has worked well in preclinical studies, the results of which were reported in the latest issue of Angewandte Chemie.

• St. Jude Children's Research Hospital in Memphis, Tenn., said its research demonstrated that it may be possible to improve treatment of autoimmune diseases such as multiple sclerosis, as well as prevent rejection of transplanted organs and tissues. The research involves using cells carrying a genetically engineered protein "bait" to lure specific types of rogue immune system cells to their deaths. Transgenic T cells injected into the mice significantly reduced brain damage by destroying the rogue immune cells that caused experimental allergic encephalomyelitis.

• Xcellsyz Ltd., of London, completed a $1.9 million equity investment by Northern Enterprises Ltd., of Newcastle, UK, and ITX Corp., of Tokyo. The equity raised is in addition to regional development funding, and together the money will allow Xcellsyz to move into new facilities. It then plans to expand its portfolio of human conditionally immortalized cell lines and develop high-throughput cell-based assay systems.