• Celator Pharmaceuticals Inc., of Princeton, N.J., entered into a research agreement with Cephalon Inc., of Frazer, Pa., to explore Celator's proprietary technology in liposomal and nonparticle encapsulation to an ongoing drug development and life-cycle management program at Cephalon. Terms and conditions were not disclosed.

• China Sky One Medical Inc., of Harbin, China, said it has signed an agreement with Taiwan Golden Biotechnology Corp., of China, to develop Antroquinonol, an anticancer compound extracted from antrodia cinnamomea chang and chou, a rare medicinal fungus that grows naturally inside the Cinnamomum kanehirae tree trunk, a native tree species of Taiwan. The firms are developing the drug to treat liver and lung cancers.

• Cleveland BioLabs Inc., of Buffalo, N.Y., signed a term sheet with Bioprocess Capital Ventures, a Russian venture capital fund, to enter into a Russia-based joint venture to develop the company's Curaxin compounds for cancer applications. Under the terms, CBLI would transfer rights to its pipeline of Curaxin anticancer molecules to the new joint venture, and Bioprocess Capital Ventures would contribute about $15 million over three payments to support development of the compounds. The first payment would be due upon signing of the final agreement, and the ensuing payments would be based upon achievement of predetermined development milestones. CBLI would own slightly more than 50 percent of the joint venture, and Bioprocess Capital Ventures would own less than 50 percent of the joint venture. The term sheet is not binding, and conclusion of the deal is subject to completion of a final approval process by the investment committee of the Russian fund.

• Emisphere Technologies Inc., of Cedar Knolls, N.J., received a $500,000 milestone payment from MannKind Corp., of Valencia, Calif., in connection with MannKind's filing and the FDA's acceptance of MannKind's new drug application for Afresa, an ultra rapid-acting insulin. In February 2008, Emisphere sold to MannKind certain Emisphere patents and a patent application relating to diketopiperazine technology for a total purchase price of $2.5 million. An initial payment of $1.5 million was received at the time, and another $500,000, recently received, was to be paid no later than July 5. The remaining $500,000 is due to be paid to Emisphere no later than Oct. 5, 2010.

• Genzyme Corp., of Cambridge, Mass., submitted the final documentation to address all items in the FDA's complete response letter for Lumizyme (alglucosidase alfa), produced at the 2,000 L bioreactor scale. The submission included clinical data requested by the FDA from Genzyme's Pompe Registry, which the FDA said can fulfill the requirements for a verification study to demonstrate clinical benefit. Also included in the submission were the risk evaluation and mitigation strategy and the final label for the product. Genzyme said it expects the filing will be designated as a class 2 resubmission with a six-month PDUFA goal. However, the company said it expects that the FDA will expedite the review process. The company said it and the FDA are also in discussions regarding the submission of a supplemental biologics license application for the 4,000 L-scale manufacturing process.

• Hemispherx Biopharma Inc., of Philadelphia, said Japan's Council for Science & Technology Policy awarded funds to the nation's National Institute of Biomedical Innovation to advance research with influenza vaccines using the firm's Ampligen as a adjuvant. The research is aimed at developing high-value-added vaccines for various infections such as pandemic influenza, malaria and HIV/AIDS. The FDA currently is reviewing the new drug application for Ampligen as a therapy to treat chronic fatigue syndrome. The agency is expected to make a decision on the application by May 25.

• Human Genome Sciences Inc., of Rockville, Md., submitted a biologics license application to the FDA for its human monoclonal antibody drug ABthrax (raxibacumab) for the treatment of inhalation anthrax. The BLA submission includes the results of two randomized placebo-controlled studies conducted in rabbits and monkeys to evaluate the efficacy of raxibacumab, showing a survival benefit in two relevant animal species, which is the requirement for establishing the efficacy of new drugs used to counter bioterrorism. The submission also includes the results of safety studies of raxibacumab conducted in healthy human volunteers.

• Keryx Biopharmaceuticals Inc., of New York, said Ron Bentsur has been appointed CEO and also is expected to join the firm's board in June. Most recently, Bentsur served as CEO of XTL Biopharmaceuticals Ltd., of Valley Cottage, N.Y, where he also served as chief financial officer. Bentsur earlier had served as director of technology investment banking at Tel Aviv, Israel-based Leumi Partners Underwriters Ltd.

• NeurogesX Inc., of San Mateo, Calif., said the European Commission has formally granted marketing authorization of Qutenza 179 mg cutaneous patch (formerly NGX-4010) for the treatment of peripheral neuropathic pain in nondiabetic adults, either alone or in combination with other medicinal products for pain. Qutenza can only be obtained with a prescription. The centralized marketing authorization allows Qutenza to be marketed in all 27 countries of the European Union.

• Otsuka Pharmaceutical Co. Ltd., of Toyko, and its subsidiary, Otsuka Pharmaceutical Development and Commercialization Inc., of Princeton, N.J., said that the FDA approved Samsca (tolvaptan) for patients with clinically significant hypervolemic and euvolemic hyponatremia. It is a selective antagonist of the vasopressin V2 receptor, which is located predominantly in the kidney and plays a role in the regulation of fluid retention in the body.

• Vical Inc., of San Diego, said the company has completed development of a prototype H1 vaccine, produced an initial supply of research-grade material and initiated immunogenicity testing in animals in response to the global H1N1 swine-origin influenza A outbreak. If its testing is successful and a commitment for program-specific external funding has been secured, the company said it was ready to advance directly to large-scale cGMP manufacturing of vaccine for human clinical trials. Vical has entered into a cooperative research and development agreement with the U.S. Naval Medical Research Center to advance its Vaxfectin-formulated H1 DNA vaccine into clinical testing. Vical and the NMRC are actively pursuing funding to support the program. The company last year successfully completed a Phase I trial of a vaccine against the H5N1 influenza strain.