• Advanced Life Sciences Holdings Inc., of Chicago, reported top-line results from a pivotal, nonhuman primate study of once-daily, oral, antibiotic Restanza (cethromycin), which demonstrated statistical significance at a 90 percent survival rate against an inhaled lethal dose of plague. The study tested Restanza's protective efficacy at various doses up to 64 mg/kg, with nine of 10 animals starting a 14-day course of Restanza within 24 hours of exposure surviving, compared to one of 10 animals in the placebo group. Restanza also is being developed for community-acquired pneumonia, and ADLS received a complete response letter in that indication earlier this year. (See BioWorld Today, Aug. 3, 2009.)

• Cleveland BioLabs Inc., of Buffalo, N.Y., was awarded a $5.3 million Grand Opportunities grant from the National Institute Allergy and Infectious Disease, under the American Recovery and Reinvestment Act of 2009, to fund studies of molecular mechanisms by which Protectan CBLB502 mitigates gastrointestinal damage from radiation exposure. Funds will support advancement of Protectan CBLB502 toward completion of a biologic license application in acute radiation syndrome and also further the company's work in radiation-induced GI damage in medical settings.

• MabCure Inc., of Hasselt, Belgium, successfully created monoclonal antibodies against colorectal cancer, which, after further characterization, will be explored in terms of both early diagnoses of the disease, as well as imaging agents for detecting micrometastatic disease during surgery and the detection of cancerous polyps during colonoscopy. MabCure, founded in 2008, is developing MAbs against tumor-specific antigens. (See BioWorld Today, June 4, 2009.)

• Marshall Edwards Inc., of Sydney, Australia, reported data demonstrating that NV-128, a flavonoid small-molecule mTOR inhibitor, had much greater safety than some other mTOR inhibitors in mice bearing human ovarian cancer xenografts. Administered daily, NV-128 resulted in a reduction in tumor volume of 51 percent relative to untreated control animals after 15 days, compared to a 50 percent reduction in mice given rapamycin every other day, though mice treated with NV-128 gained weight, finishing at 6 percent above their starting weight, while mice on rapamycin lost 8 percent of body weight over the same period.

• MediGene AG, of Martinsried, Germany, signed a license and supply deal with Solvay Arzneimittel GmbH, the German affiliate of Brussels, Belgium-based Solvay Pharmaceuticals, for the supply and commercialization of Veregen (formerly Polyphenon E ointment) in Germany, Austria and Switzerland. Upon achievement of specific milestones and sales targets, MediGene is entitled to successive payments totaling up to €3.65 million (US$5.3 million), plus royalties on net sales. Veregen, which is designed to treat genital warts, was acquired by MediGene from Canadian firm Epitome Pharmaceuticals Inc. in 1999.

• Metabolon Inc., of Research Triangle Park, N.C., said a study identified biomarkers for periodontitis and gingivitis using the company's biochemical profiling technology, and suggested that those diseases are mediated by enhanced purine degradation. Details were published in the Journal of Dental Research.

• Nabi Biopharmaceuticals, of Rockville, Md., said the National Institute on Drug Abuse agreed to extend its support for the continued development of NicVAX, the company's vaccine for treating nicotine addiction and preventing smoking relapse. NIDA granted the firm $10 million under the American Recovery and Restoration Act of 2009 to fund part of the first pivotal trial. In conjunction with that grant, Nabi decided to proceed with the first Phase III study, while advancing strategic partnering discussions for further development and commercialization.

• Novelos Therapeutics Inc., of Newton, Mass., in collaboration with the Massachusetts General Hospital, received a $950,371 grant from the National Institutes of Health to study two Novelos compounds - NOV-002 and NOV-205 - for the mitigation and treatment of radiation-induced pulmonary injury. The 17-month grant will fund the assessment of both drug candidates in animal models.

• Palatin Technologies Inc., of Cranbury, N.J., will receive $5 million from London-based AstraZeneca plc relating to an amendment of its ongoing, exclusive research collaboration and license agreement to discover, develop and commercialize compounds targeting melanocortin receptors to treat obesity and related indications. Under the terms, AstraZeneca agreed to make a $2.5 million payment upon signing and, subject to completion of certain tasks, another $2.5 million payment will be made in the first quarter of next year. Terms of the original 2007 deal relating to milestones and royalties were restructured. (See BioWorld Today, Feb. 1, 2007.)

• SIGA Technologies Inc., of New York, received a $1.6 million research project cooperative agreement from the National Institutes of Health, under the American Recovery and Reinvestment Act of 2009, to accelerate development of its broad-spectrum antiviral candidates. Funds will be used to find targets for identified compounds.

• Valeant Pharmaceuticals International Inc., of Aliso Viejo, Calif., said it agreed to buy out income rights associated with out-licensed and pipeline products included in its acquisition of Dow Pharmaceutical Sciences Inc. for a one-time payment of $115 million. In exchange, former stockholders of Dow agreed to release Valeant from up to $235 million in milestone obligations they could have received upon successful commercialization of Dow pipeline compounds. Income rights to the 1 percent clindamycin and 5 percent benzoyl peroxide gel abbreviated new drug application were excluded in the December 2008 acquisition. (See BioWorld Today, Dec. 11, 2008.)

• VIA Pharmaceuticals Inc., of San Francisco, received a deficiency letter from Nasdaq, stating that the firm had failed to regain compliance with the board independence rules and its stock was subject to delisting. VIA said it will present its written views with respect to that deficiency by Sept. 30.

• Vitae Pharmaceuticals Inc., of Fort Washington, Pa., earned an $8 million payment from Boehringer Ingelheim GmbH, of Ingelheim, Germany, for achievement of a performance milestone in the companies' 11beta-hydroxysteroid dehydrogenase-1 diabetes and metabolic disease strategic alliance. Vitae is eligible for up to $300 million in milestones under the terms of the 2007 collaboration. (See BioWorld Today, Oct. 16, 2007.)

• Vivalis, of Nantes, France, said partners GlaxoSmithKline K.K., of Tokyo, GlaxoSmithKline Biologicals (part of GSK, of London) and the Chemo-Sero-Therapeutic Research Institute in Kumamoto, Japan, agreed to co-develop influenza vaccines, including pandemic influenza vaccines, produced using EB66 cell-culture, in-licensed by GSK from Vivalis, in Japan. Specific terms were not disclosed.

Published: September 30, 2009