• AVAX Technologies Inc., of Philadelphia, will receive more than $1 million in research and development funding through an agreement with Cancer Treatment Centers of America (CTCA) focused on AVAX's O-Vax therapeutic for ovarian cancer and CTCA's activated natural killer cell technology for various human cancers. AVAX intends to begin a Phase I/II study for Stage III and IV ovarian cancer patients who have relapsed following chemotherapy, evaluating them for safety and immunological responses. Terms of the collaboration are for a three-year period. CTCA will provide funding to AVAX for the initial production of vaccines, and for AVAX to bring its biological clean-room facility in Philadelphia on line to produce vaccines and activated NK cell preparations.

• BioMimetic Therapeutics Inc., of Franklin, Tenn., said the FDA designated its recombinant human platelet derived growth factor (rhPDGF-BB) an orphan drug for treating osteonecrosis of the jaw. The disease, which typically presents with pain, soft-tissue swelling and infection, loosening of teeth, drainage and exposed bone, is growing more common in patients receiving high doses of bisphosphonates for severe osteoporosis and other diseases. The protein therapeutic makes use of one of the principal wound healing stimulators in the body.

• Genentech Inc., of South San Francisco, said its Cabilly patent, U.S. Patent No. 6,331,415, was rejected by the U.S. Patent and Trademark Office following a reexamination of its claims. The company plans to respond within the next several months and, if necessary, appeal the decision through all appropriate means of review within the patent office and the courts. In the meantime, Genentech said the patent remains valid and enforceable through the appeals process, which could take one to two years or longer. That patent was at the center of a recent Supreme Court ruling that went against Genentech in a suit brought by Medimmune Inc., of Gaithersburg, Md. Separately, the FDA is requesting that the company add a boxed warning to the product label for Xolair (omalizumab) to emphasize that it may cause anaphylaxis. The drug, used to treat patients with asthma related to allergies, has been approved since 2003. (See BioWorld Today, Oct. 11, 2006, and Jan. 10, 2007.)

• Hana Biosciences Inc., of South San Francisco, said FDA approval likely would be delayed on its new drug application for Zensana, an oral spray formulation of the 5-HT3 antagonist ondansetron, for preventing nausea and vomiting as a result of chemotherapy, radiation and surgery. Ongoing, long-term stability studies detected small amounts of precipitated material in scale-up batches of Zensana, which may require an adjustment to the formulation and/or the manufacturing process. Hana said it investigating this issue, which likely will delay approval beyond the existing Prescription Drug User Fee Act action date of April 30. Hana's stock (NASDAQ:HNAB) fell $1.25 Wednesday, or 20 percent, to close at $4.99.

• Integrated Genomics, of Chicago, licensed its ERGO bioinformatics software system to the enzyme developer Genencor International Inc., of Palo Alto, Calif. Optimized for analysis of microorganisms, the software platform integrates biological data from genomics, biochemistry, gene expression studies, genetics and literature. Financial terms were not disclosed.

• Novavax Inc., of Rockville, Md., said preclinical data published in the online edition of Vaccine showed that its seasonal virus-like particle (VLP) influenza vaccine produced more robust and broad immune responses than other flu vaccine types. Specifically, the VLP vaccine produced antibody responses that were between 1.8 times and 7.4 times greater than antibody responses triggered by the comparator vaccines.

• Noven Pharmaceuticals Inc., of Miami, has received from Shire plc, of Basingstoke, UK, the first of three possible $25 million milestone payments related to sales of Daytrana, the transdermal medication for attention deficit hyperactivity disorder. Payment of the first milestone was triggered on Shire's net sales of Daytrana exceeding $25 million in 2006. Under the Daytrana transaction agreement, two additional payments of $25 million each are payable upon Shire's achievement of $50 million and $75 million, respectively, in annual net sales of Daytrana.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., announced that the Satraplatin Expanded Rapid Access protocol (SPERA) has been launched by the company's partner, GPC Biotech, of Munich. Expanded Access Programs are intended to give patients access to investigational drugs to treat serious or life-threatening diseases or conditions for which there are limited treatment options available. Under the SPERA program, satraplatin will be provided to patients free of charge.

• Theravance Inc., of South San Francisco, announced that the FDA has accepted the new drug application for its investigational antibiotic telavancin for complicated skin and skin structure infections caused by Gram-positive organisms, including methicillin-resistant Staphylococcus aureus. The FDA has established a goal of a standard 10-month review of the telavancin NDA. The NDA submission is based on data from two large multinational, double-blind, randomized Phase III studies involving 1,867 patients, 719 of whom were infected with MRSA. In the trials, Telavancin achieved its primary endpoint of non-inferiority to vancomycin. Telavancin compared favorably to standard therapy in clinical cure, microbiological eradication and overall therapeutic response rates. The safety profile of telavancin was compatible with treatment of patients with serious infections due to resistant bacteria. The NDA filing triggers a milestone payment of $31 million from Theravance's partner, Astellas Pharma Inc., of Tokyo.