• Abraxis BioScience Inc., of Los Angeles, has entered into an agreement with the Buck Institute for Age Research that provides Abraxis with the exclusive worldwide intellectual property rights for technologies generating novel therapeutics and identifying new drug discovery targets. Included in the licensed technologies are a novel immunotherapeutic/anticancer compound (T9) and cell-based assay systems for the discovery of additional immune-modulating drugs. T9 is a bi-functional molecule with the ability to kill cancer cells and activate the immune response to recognize cancer cells in a manner analogous to childhood vaccination. The agreement also includes a proprietary discovery platform designed to discover new chemical entities that remediate the signaling activities of the tumor suppressor p53 in p53-dysfunctional cancer cells. Financial terms were not disclosed.

• Avanir Pharmaceuticals, of Aliso Viejo, Calif., has completed the sale of currently marketed antipsychotic drug FazaClo (clozapine, USP) to Azur Pharma, of Dublin, Ireland. Avanir received an up-front payment of $42 million, plus an additional $1.9 million in working capital adjustments. Under the terms of the agreement, Avanir could receive up to an additional $10 million in payments in 2009 contingent upon certain regulatory conditions, and up to $2 million in royalties, based on 3 percent of annualized net product revenues in excess of $17 million. (See BioWorld Today, July 5, 2007) Avanir has allocated $11 million in payments to pay down a portion of its outstanding debt, which will be reflected on the balance sheet for the year ending Sept. 30, 2007. The company said the net payments from the sale of FazaClo, plus the cash, cash equivalents and unrestricted investments in securities at June 30, will finance operating expenses through the end of the next fiscal year. That includes the initiation of the planned confirmatory Phase III clinical trial of Zenvia in patients with involuntary emotional expression disorder, otherwise known as pseudobulbar affect

• BioServe, of Laurel, Md., and Phenomenome Discoveries Inc., of Saskatoon, Canada, developed a serum-based diagnostic test for the identification of colorectal cancer and precancerous states conducive to the development of CRC. The test has been validated in four independent studies, across which the sensitivity of detection for positive cases had an average of 75 percent, and the specificity had an average of 90 percent. Trials are planned for late 2007 in Canada and Japan to evaluate the test's utility as part of a broad-based population screening regimen. Both companies anticipate that the test will be available in the U.S. in the fourth quarter.

• Critical Diagnostics, of New York, said a research paper has been published in the Journal of the College of Cardiology demonstrating the strength of ST2 as a biomarker for risk stratification and prediction of mortality in patients who present to the emergency department with shortness of breath and suspected acute decompensated heart failure. ST2 is a mechanically-induced cardiomyocyte protein, and serum levels of ST2 have been shown to predict outcome in patients with acute myocardial infarction or heart failure. The research illustrates that ST2 is a powerful biomarker for prediction of near-term mortality in dyspneic as well as acute decompensated heart failure patients, the company said.

• Entelos Inc., of Foster City, Calif., entered a Cooperative Research and Development Agreement with the FDA's Center for Drug Evaluation and Research. Under the two-year deal, Entelos will work with the FDA to develop a computer model of drug-induced liver injury. The goal is to use the platform to guide the development of clinical biomarkers and preclinical assays to identify patient types and drug combinations that increase the risk of developing liver injury. Entelos focuses on building predictive computer models and "virtual patients" for drug discovery and development.

• Ichor Medical Systems Inc., of San Diego, received a two-year contract valued at more than $2.3 million from the Defense Threat Reduction Agency to assist the Biological Defense Research Directorate of the Naval Medical Research Center in Rockville, Md., in the development of a DNA vaccine for anthrax and plague. Terms call for Ichor to use its TriGrid Delivery System to assess a collection of vaccine candidates developed by the Navy. The contract builds on the firm's ongoing collaboration with the Department of Defense to explore the potential of electroporation-based delivery to increase the effectiveness of a number of biodefense-related DNA vaccine candidates.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said the FDA approved Sanctura XR (trospium chloride extended-release capsules) for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. The product is a once-daily formulation of the Indevus' approved product Sanctura, a quaternary ammonium compound belonging to a class of anticholinergic agents known as muscarinic receptor antagonists. The compounds relax smooth muscle tissue found in the bladder, thus decreasing bladder contractions.

• Intellect Neurosciences Inc., of New York, and Medical Research Council Technology, of London, entered an agreement under which MRCT will humanize Intellect's beta-amyloid-specific monoclonal antibodies for the treatment of Alzheimer's disease. The antibodies are intended as a form of passive immunization to promote clearance from the brain of the endogenous soluble Alzheimer's toxin, beta-amyloid. MRCT, the commercialization business for the UK Medical Research Council, is entitled to potential milestone and royalty payments in the deal.

• Melior Discovery Inc., of Exton, Pa., entered a deal with Johnson & Johnson Pharmaceutical Research & Development LLC, of New Brunswick, N.J., to apply its theraTRACE discovery platform to identify possible new indications for multiple J&J drug candidates. Terms of the deal were not disclosed. The theraTRACE platform is a multiplexed set of integrated in vivo models designed to identify previously unknown applications for pharmaceutical compounds.

• MitoPharm Corp., of Seattle, has entered into an exclusive, worldwide licensing agreement with Hong Kong University of Science and Technology for the use and commercialization of its new process for the extraction of (-) Schisandrin B and Schisandrin B. The terms of the agreement were not disclosed. The new process incorporates hybrid chromatography-crystallization technology widely used in the fine chemical and pharmaceutical industries for the recovery of high-purity products. The new extraction process will extend MitoPharm's reach with its own branded products to pharmaceuticals, dietary supplements, functional beverages and commercial-grade raw material applications.

• Monogram Biosciences Inc., of South San Francisco, launched Trofile co-receptor tropism assay, its HIV diagnostic, following the FDA's approval of New York-based Pfizer Inc.'s Selzentry (maraviroc) tablets for HIV. Selzentry, a viral entry inhibitor, was approved for the combination antiretroviral treatment of adults infected with only CCR5-tropic HIV-1 who have evidence of viral replication and have HIV-1 strains resistant to multiple antiviral agents. Trofile was the pivotal test used for patient selection for Selzentry's clinical development program, and the FDA label for the drug requires that tropism testing guide treatment. Selzentry is expected to be available in the U.S. by mid-September, and the two companies are collaborating to make the assay available for patient use.

• Senetek plc, of Napa, Calif., has entered a marketing collaboration for its second-generation cytokinin with Triax Aesthetics LLC, of Cranford, N.J. under which Senetek will provide $4.5 million in the first-year sales and marketing payments. Senetek has granted Triax an exclusive license in the ethical market channel in the U.S. and its territories, Canada and select Middle East countries. All product packaging will be labeled Senetek/Triax. In return for the payments, Senetek will receive all net product revenues in the first year of the agreement, with a guaranteed minimum of $10.8 million in 2008. The agreement calls for increased minimum sales annually after the first year. After the first year, the companies will share net revenues on a 50/50 basis. Triax will be responsible for all sales, marketing and order fulfillment during the life of the agreement.

• SkyePharma plc, of London, said the FDA has raised questions about the design of a Phase III trial for flutiform, a combined asthma treatment. The concerns may require collection of new clinical work, which would cost between £3 million to £5 million (US$6.1 million to US$10.2 million) and push back the filing date from the end of this year to the second half of 2008. The concerns about the trial design arose during a discussion of a new drug application, which otherwise went well, the company said. It also noted that the FDA reservations are not based on any review of the safety or efficacy data, which have not yet been submitted. The European filing for flutiform is due by the end of 2008 and will not be affected by the FDA's position.

• XOMA Ltd., of Berkeley, Calif., named Steven Engle president, CEO and a director. He succeeds Jack Castello, who announced his retirement plans earlier this year and will remain as nonexecutive chairman of the antibody-focused company during a transitional period, expected to run through October. Engle was the longtime chairman and CEO of La Jolla Pharmaceutical Co., of San Diego, before leaving last year.