• Advanced Life Sciences Holdings Inc., of Chicago, said Nasdaq has informed the company that the market value of its listed securities was below $50 million for 10 consecutive days, which is the requirement for continued listing on the Nasdaq Global Market. Nasdaq also informed the company that it is not in compliance with a rule which requires total assets and total revenue of $50 million each for the most recently completed fiscal year or two of the last three most recently completed fiscal years. Advanced Life Sciences has 30 calendar days, or until Sept. 12, to regain compliance.

• Adventrx Pharmaceuticals Inc., of San Diego, said the FDA has granted fast track designation for ANX-510 (CoFactor injection), which is being investigated in a pivotal Phase III study, with 5-fluorouracil (5-FU) and bevacizumab for the initial treatment of metastatic colorectal cancer. CoFactor is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-FU. Adventrx is conducting a 1,200-patient, Phase III study across the U.S. and in Europe. Patients are randomized to two arms containing either CoFactor or leucovorin, each in combination with the widely used cancer chemotherapy regimen of 5-FU and bevacizumab (Avastin). The primary endpoint is progression-free survival.

• Ardea Biosciences Inc., of Carlsbad, Calif., received its first milestone payment of $500,000 from Valeant Pharmaceuticals International Inc., of Aliso Viejo, Calif., under a neuropharmacology deal the two companies signed in late 2006. The milestone was triggered by Valeant's selection of several pre-IND candidates from a family of potassium-channel openers that Ardea had been optimizing. Under the deal, Ardea receives $3.5 million in fees annually and may receive another $500,000 in milestones. Ardea also licensed its HIV, cancer and inflammatory disease pipeline from Valeant. (See BioWorld Today, Dec. 27, 2006.)

• Baxter International Inc., of Deerfield, Ill., said its European subsidiary in the UK has entered into an advanced supply agreement with the UK Department of Health that contains an option to purchase pandemic influenza vaccine in the event the World Health Organization declares a pandemic. Baxter will manufacture its vaccine in a serum-free, vero cell-based system. The use of vero cell culture, rather than conventional egg-based technology, allows the culture process to be initiated more rapidly, and vaccines produced using this process can be released within approximately 12 weeks. Financial details were not disclosed.

• Bioenvision Inc., of New York, said its marketing authorization application to the European Medicines Evaluation Agency now includes a new indication for Evoltra (clofarabine), for the treatment of acute myeloid leukemia (AML) in elderly patients who have one or more of the following: adverse cytogenetics, secondary AML, greater than or equal to 70 years old or significant co-morbidities and are therefore not considered suitable for intensive chemotherapy. Evoltra is currently approved in Europe for the treatment of acute lymphoblastic leukemia in pediatric patients who have relapsed or are refractory to at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. In May an EMEA panel asked for more information, which the company plans to submit by Nov. 16.

• Cangene Corp., of Winnipeg, Manitoba, said its contract with the U.S. Centers for Disease Control and Prevention for the supply of Vaccinia Immune Globulin Intravenous was extended for five years. The original five-year contract was signed in August 2002, and under that contract Cangene developed and delivered VIG product to the U.S. Strategic National Stockpile. Although a supply of product already is maintained within the SNS, the extended contract supports licensing requirements, ongoing stability studies, further clinical testing and development projects, and could provide for future orders. VIG is a hyperimmune product used to treat and prevent certain types of complications that may be associated with smallpox vaccination.

• Cepheid, of Sunnyvale, Calif., has entered into a five-year master purchase order with Northrop Grumman for up to $200 million in Bacillus anthracis (anthrax) test cartridges and associated materials. The anthrax test is currently used in biohazard detection systems installed at U.S. Postal Service mail processing centers nationwide. The agreement covers the USPS fiscal years of 2007 through 2011. Cepheid began supplying USPS with GeneXpert modules and anthrax test cartridges in 2003. Under the agreement, the purchase quantity of anthrax tests will be determined on an annual basis. Cepheid has received notice that expected test purchases for fiscal 2008 will be approximately two million cartridges.

• DiagnoCure Inc., of Quebec City, Quebec, said it acquired Catalyst Oncology Inc., of Worcester, Mass., for an initial payment of $3 million in cash and stock. Catalyst Oncology also is eligible to receive milestone payments. Catalyst Oncology is developing prognostic tests for breast, colon and potentially other cancers. DiagnoCure intends to complete the development of the tests and conduct additional validating clinical studies. DiagnoCure said the tests have been validated in multiple clinical studies involving patients with five tumor types.

• EvoGenix Ltd.., of Sydney, Australia, began a second project with GlaxoSmithKline plc, of London, under a 2005 research and collaboration agreement. The first project, which involved optimizing a GSK protein using EvoGene protein engineering technology, was completed in March. The second project will be similar to the first. EvoGenix receives research funding, milestone payments and potential royalties on each project.

• Interleukin Genetics Inc., of Waltham, Mass., initiated a study on the genetics of osteoarthritis in collaboration with the Hospital for Joint Diseases of New York University Medical Center. Interleukin Genetics is investigating whether there is an association between candidate gene variations, either individually or in composite patterns, and poly-articular manifestations of osteoarthritis, defined in the study as the prevalence of knee and hand OA. The study also will evaluate the association between certain genetic patterns and the peripheral blood mononuclear cell expression of interleukin-1 beta in OA patients.

• Samaritan Pharmaceuticals Inc., of Las Vegas, said it exclusively licensed a patent application titled "Structure Based Drug Design of Steroid Inhibitors'' from Georgetown University. University scientists developed a method to virtually screen databases consisting of 15 million small molecules, without any biological input. It identified compounds with antitumor potential.

• Santhera Pharmaceuticals, of Liestal, Switzerland, and Takeda Pharmaceutical Co., of Osaka, Japan, said the European Medicines Agency (EMEA) has accepted the filing of the marketing authorization application for Santhera's lead compound SNT-MC17 (INN: idebenone, originally developed by Takeda) for the treatment of Friedreich's Ataxia. The compound, which has been granted orphan drug designation in the European Union, could become the first approved product for the treatment of FRDA and will be marketed in Europe by Takeda. SNT-MC17 has shown clinical efficacy in FRDA patients on neurological as well as cardiac endpoints in several clinical studies and proved to be well tolerated in all studies so far. The application acceptance triggers a milestone payment of €3 million to Santhera from Takeda.

• SRI International, of Menlo Park, Calif., has been awarded a $4.6 million contract from the National Institute of Allergy and Infectious Diseases to research, develop and manufacture dosage formulations for new and existing anti-HIV or AIDS-related anti-infectives and microbicides. In addition to dosage development, SRI will provide analytical chemistry evaluation of drug substances intended for pharmacology studies and clinical trials. The evaluations will help ensure that materials used in drug studies conform to FDA regulations and are of a defined quality.

• TapImmune Inc., of Vancouver, British Columbia, entered an agreement with AppTec Laboratory Services Inc., of St. Paul, Minn., for the preclinical testing of its lead product. TapImmune's immunotherapy vaccine is designed to treat a variety of cancers. Terms of the deal were not disclosed.

• TheraGenetics, of London, has named Heiner Dreismann chairman of the board, and Robert Forrester as director. Dreismann most recently was president and CEO of Roche Molecular Systems Inc., the division of Hoffmann-La Roche Ltd. that pioneered clinical molecular diagnostics. Forrester serves as executive vice president and CFO of CombinatoRx Inc., and formerly was senior vice president of finance and corporate development at Coley Pharmaceutical Group.

• VGX Pharmaceuticals, of Blue Bell, Pa., has initiated investigational new drug-enabling preclinical toxicology studies for three of its DNA plasmid-based product candidates. The candidates include vaccines for human papilloma virus for the treatment of cervical cancer (VGX-3100) and avian influenza (VGX-3400), and a therapeutic based on human growth hormone releasing hormone (VGX-3200) for cancer related cachexia. VGX is conducting the studies in combination with its patented Cellectra electroporation device and the studies will provide pre-clinical safety data for both the product candidates as well as the device in a GLP environment.

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