• Bioenvision Inc., of New York, filed an application with the European Medicines Agency to expand the label of Evoltra (clofarabine), a purine nucleoside analog. Evoltra is approved in Europe to treat pediatric relapsed or refractory acute lymphoblastic leukemia (ALL), and Bioenvision is seeking approval in certain adult acute myeloid leukemia (AML) patients. The filing is based on data from a Phase II trial in which 44 percent of elderly patients treated with Evoltra achieved a complete response. In the U.S., Genzyme Corp., of Cambridge, Mass., markets clorfarabine as Clolar for pediatric ALL and is conducting a Phase III trial in adult AML.

• Cougar Biotechnology Inc., of Los Angeles, announced its shares have been accepted for quotation on the OTC Bulletin Board. The company expects the shares to begin trading this week under the symbol CGRB.OB. Cougar in-licenses and develops clinical-stage cancer drugs. In December, the company initiated a Phase II trial of lead candidate CB7630 (abiraterone acetate), an oral inhibitor of the steroidal enzyme 17-alpha hydroxylase/c17,20 lyase, for advanced prostate cancer.

• Devgen NV, of Ghent, Belgium, entered a five-year research and development agreement with Monsanto Co., of St. Louis, in addition to a technology exchange agreement of the same length. The R&D arrangement commits additional funding from Monsanto for Devgen's research and is coupled with an agreement to broaden their relationship so that both companies can explore technology applications in their crop areas of interest. Devgen will leverage Monsanto's work in rice and small cereal grains, especially in Asia, and Monsanto initially intends to leverage Devgen's gene regulation technologies to protect against crop damage in its core crops of interest such as corn, cotton and soybeans.

• Inex Pharmaceuticals Corp., of Vancouver, British Columbia, is free to close its previously announced spinout of Tekmira Pharmaceuticals Corp. after a court decision dismissing an appeal brought forward by Protiva Biotherapeutics Inc., also of Vancouver. Protiva had challenged a prior court ruling that approved Inex's plan of arrangement to transfer all of its transferable assets and liabilities to Tekmira. On Wednesday, Inex's stock (TSX:IEX) gained C12 cents (US9 cents), or 7.1 percent, to close at C$1.80.

• Pro-Pharmaceuticals Inc., of Newton, Mass., began filing Davanet's new drug application with the FDA as a treatment in combination with 5-fluorouracil (5-FU) for cancer. The submission is based on an analysis of Phase l and Phase ll testing that demonstrated Davanet's potential to improve the pharmacokinetic profile of 5-FU, as well as other FDA-approved anticancer drugs, without increasing toxicity markers as would be expected with increased 5-FU exposure. For example, the combination allowed 5-FU to remain in the bloodstream up to 10 times longer than usual, without increasing its toxicity. The company is conducting two international Phase ll trials in colorectal and biliary cancers, administering Davanet with 5-FU.

• Replidyne Inc., of Louisville, Colo., and Forest Laboratories Inc., of New York, have ended a year-old collaboration to commercialize faropenem medoxomil (faropenem), a novel community antibiotic in late-stage clinical development. The end of the partnership means Replidyne regains all U.S. adult and pediatric rights previously granted to Forest. Last October, the FDA issued a non-approvable letter for faropenem for four adult indications: acute bacterial sinusitis (ABS), community-acquired pneumonia (CAP), acute exacerbation of chronic bronchitis (AECB) and uncomplicated skin and skin structure infections (SSSI). In the non-approvable letter, the FDA recommended further clinical studies for all indications including studies using a superiority design for the indications of ABS and AECB, more extensive microbiologic confirmation, and consideration of alternate dosing regimens. The FDA did not raise any safety concerns or chemistry, manufacturing or controls (CMC) issues related to the product.

• S*BIO Pte. Ltd., of Singapore, entered a research collaboration with the Agency for Science, Technology and Research's (A*STAR) Institute of Molecular and Cell Biology for the discovery and development of multiple oncology compounds. S*BIO will provide expertise in high-throughput screening, medicinal chemistry and the identification and optimization of lead compounds, while A*STAR will use its targets and assays to screen for chemical starting points. The two parties will jointly develop resulting compounds. Last month S*BIO entered a cancer research collaboration with the Department of Tumorbiology and Microbiology at the Karolinska Institute in Sweden.

• Vivalis, of Nantes, France, has granted Sanofi Pasteur SA, of Lyon, France, additional rights to its chicken and duck embryonic stem cell-derived EBx cell lines to test, produce and market vaccine candidates. The companies signed a licensing agreement in 2003 for the use of the cell line platforms for HIV and cancer recombinant vaccines. The new license is worldwide and nonexclusive. The agreement entails up-front payments, milestone payments and royalties for Vivalis.