• Advancis Pharmaceutical Corp., of Germantown, Md, has received a "refusal to file" letter from the FDA for the company's once-daily Amoxicillin PULSYS new drug application. The FDA said the application did not include a proposed commercial batch record or a detailed commercial process description with process parameters and in-process controls. The company said it plans to meet with the FDA to seek an agreement on what additional information is needed. Amoxicillin is indicated for a range of infections, but is not approved for a once-daily dosing in pharyngitis. Advancis has said it believes it could capture a significant portion of the annual $600 million market with a product that calls for less frequent administration which would improve patient compliance. Its lead product failed in Phase III trials in 2005, which led to a streamlining and the loss of 33 jobs. Matters were complicated when its partner responsible for funding the late-stage trials pulled out of the deal.

• ALSP Inc., of San Diego, has been awarded a $296,000 R21 grant from the National Institute of Aging for development of an Alzheimer's disease. The company also announced it has named Michael D. Pierschbacher as president and CEO, succeeding Steve Richieri, who remains as chairman of the board. The privately held company is working to identify and reduce production of key enzymes in the brain, called neuroproteases, which produce biologically active peptides that are thought to cause Alzheimer's.

• Avista Capital Partners, of New York, a private equity firm, has signed a definitive agreement to acquire BioReliance Corp., of Rockville, Md., for approximately $210 million. The deal is expected to close during the second quarter. BioReliance is a contract service organization providing biological safety testing, toxicology, viral manufacturing and laboratory animal diagnostic services to biotechnology and pharma companies. Charles Harwood, previously president and CEO of Focus Diagnostics, will serve as chairman of BioReliance, and Tim Derrington, general manager of BioReliance, will become president and CEO of the new stand-alone company. BioReliance has been a business unit of Invitrogen Corp. of Carlsbad, Calif.

• BrainStorm Cell Therapeutics, of New York, has initiated a safety trial using an animal model of Parkinson's disease in primates. The study utilizes BrainStorm's proprietary adult stem cell technology, which has shown efficacy in animal models of Parkinson's disease in previous pre-clinical trials. The study is being carried out in collaboration with the Center for Applied Medical Research of the University of Navarra in Pamplona, Spain. In addition to the Parkinson's disease program, BrainStorm also is progressing with pre-clinical trials applying the company's stem cell technology to the treatment of ALS and multiple sclerosis.

• Champions Biotechnology Inc., of Arlington, Va., acquired patent rights encompassing two benzoylphenylurea sulfur analogue compounds that have shown activity against prostate and pancreatic cancer cell lines. The antimitotic inhibitors target microtubule-associated protein tau-deficient tumors. Rights were acquired from the investors at Johns Hopkins University in exchange for 550,000 restricted shares of common stock.

• ChemDiv Inc., of San Diego, said Merck KGaA, of Darmstadt, Germany, renewed and expanded an agreement with the company as a provider of discovery libraries of lead-like small molecules through 2009. The companies signed the original deal three years ago, and this new arrangement roughly doubles the FTE effort at ChemDiv Chemical Diversity Research Institute in Moscow. Under the terms, a steering committee with representatives from both companies will determine projects to be produced by ChemDiv for early stage discovery at Merck. Financial terms were not disclosed.

• Elixir Pharmaceuticals Inc., of Cambridge, Mass., and Siena Biotech SpA, of Siena, Italy, agreed to collaborate on the optimization, validation and evaluation of Elixir's SIRT1 inhibitors in Huntington's disease. SIRT1, a member of the sirtuin class of protein deacetylase enzymes, is the human equivalent of Sir2, a gene identified as playing a key role in the control of lifespan, metabolism, resistance to stress and other cellular regulatory pathways. Under the terms, Elixir will provide its small-molecule SIRT1 inhibitors and related know-how to Siena, which might modify those compounds using its medical chemistry and profiling capabilities. Elixir will own rights to the new compounds for use in all disease areas, excluding neurodegenerative diseases, for which Siena will have the right to an exclusive license. Financial terms were not disclosed.

• Favrille Inc., of San Diego, has entered into an agreement with Berlex, Inc., a U.S. affiliate of Bayer Schering Pharma AG, of Leverkusen, Germany. Terms of the agreement were not disclosed. The focus of the agreement will be on studying the use of Favrille's active immunotherapy, FavId, in conjunction with Berlex's growth factor in patients with B-cell non-Hodgkin's lymphoma. FavId is a patient-specific, active immunotherapy currently in Phase III trials following Rituxan induction therapy for the treatment of follicular B-cell non-Hodgkin's lymphoma. Leukine is a recombinant granulocyte-macrophage colony-stimulating factor used to help fight infections by enhancing immune cell function. Patients enrolled in Favrille's Phase III trial of FavId whose disease remained stable or improved following induction treatment with Rituxan were randomized to receive either FavId with Leukine or placebo with Leukine.

• Ingenuity Systems, of Redwood City, Calif., entered a multiyear agreement to extend and expand Whitehouse Station, N.J.-based Merck & Co. Inc.'s access to the Ingenuity Pathways Analysis software for biological exploration, interpretation and analysis. Financial terms were not disclosed.

• Lipomics Technologies Inc., of West Sacramento, Calif., has entered into an agreement with Isis Pharmaceuticals Inc., of Carlsbad, Calif., to provide lipid-focused support of preclinical and clinical trial testing for various compounds to treat metabolic disease. Lipomics will retain exclusive rights to develop diagnostic applications based on the data from the studies, while Isis will retain all therapeutic rights.

• The Mayo Clinic, of Scottsdale, Ariz., has partnered with the Biodesign Institute at Arizona State University to create a vaccine to prevent cancer. This project is the first initiative undertaken under an umbrella partnership. In results from animal studies, pre-vaccination with foreign proteins creates an immune response that prevents tumors from forming. Mayo Clinic and ASU have invested seed funds to launch this project and obtain the initial supportive data. Space has been allocated in a new research facility on the Scottsdale campus of Mayo Clinic, and additional faculty and clinicians are being hired to support this phase of the project.

• NitroMed Inc., of Lexington, Mass., received an exclusive worldwide license from Dublin, Ireland-based Elan Corp. plc to patents and technology that will be used to develop an extended-release formulation of BiDil (isosorbide dinitrate/hydralazine hydrochloride). In exchange, NitroMed will pay Elan milestones and royalties on any product sales.

• Royal DSM NV, of Sittard, The Netherlands, and Crucell NV, of Leiden, The Netherlands, Wednesday announced fermentation yields of more than 10 grams per liter for monoclonal antibodies, a breakthrough in the development of their PER.C6 technology platform. That result was achieved by combining DSM's expertise in fermentation science and technology with Crucell's PER.C6 human cell line. The parties believe that in the foreseeable future 20 grams per liter could be realized. Yields in the range of 10-20 grams per liter are an order of magnitude higher than current industry averages. The higher yields allow the use of smaller bioreactors and could lower the cost of goods for biopharmaceuticals.

• Sanofi Pasteur, of Lyon, France, has entered into an agreement with Acambis, of Cambridge, Mass., to license a single dose vaccine, ChimeriVax, for Japanese encephalitis in a deal that could approach nearly $40 million. The agreement grants Sanofi Pasteur marketing, distribution and certain manufacturing rights worldwide, excluding India and the Indian subcontinent, and the U.S., for which Sanofi Pasteur has an option. The company plans to introduce the new vaccine through the Asia Pacific region, focusing on Thailand and China. Acambis will receive up-front and milestone payments totaling €30 million (US$39.3 million) following marketing authorization of ChimeriVax in key countries and in the European Union. Acambis also will receive royalties on sales and payment for the supply of the product. Acambis will supply the vaccine from its manufacturing facility in Canton, Mass. Clinical data from a pivotal Phase III safety trial published last October showed the vaccine requires only one dose for adequate protection, versus two to three doses required for current JE vaccines.

• Telik Inc., of Palo Alto, Calif., has implemented a restructuring to reduce spending, resulting in a work force reduction of about 25 percent. The cutbacks will result in a first quarter charge of about $1.6 million in restructuring and severance costs. The company focuses on discovering, developing and commercializing novel small-molecule drugs. Its most advance candidate is TELCYTA, a tumor-activated small-molecule product for advanced ovarian cancer and non-small-cell lung cancer. Another product, TELINTRA, is in clinical development in myelodysplastic syndrome. The work force reduction leaves the company with 125 employees.

• Tikvah Therapeutics Inc., of Atlanta, signed a licensing agreement with Therapade Technologies LLC, a drug development company founded by researchers at the Emory University School of Medicine and the College of William and Mary, for worldwide rights to develop and commercialize D-cycloserine and related compounds for anxiety-related disorders, including post-traumatic stress disorder, panic disorder, social phobia and obsessive compulsive disorder. Tikvah also will explore additional indications for D-cycloserine through its own research and development efforts. Financial terms of the deal were not disclosed.

• Xencor Inc., of Monrovia, Calif., signed a deal with Ingelheim, Germany-based Boehringer Ingelheim GmbH to use Xencor's XmAb technology platform, including its Fc domains, to maximize the efficacy of BI's antibody drug candidates against selected targets. Xencor's XmAb Fc domains are designed to enhance the therapeutic properties of antibodies, including sustained half-life, increased structural stability and greater potency. Under the terms, Xencor will receive an up-front payment, and is eligible to receive additional license fees, milestones and royalties on any commercialized products. Specific terms were not disclosed.