• Merck KGaA, of Darmstadt, Germany, said its Merck Serono division signed two deals with Osaka, Japan-based Ono Pharmaceutical Co. Ltd. The first grants Merck worldwide, exclusive rights to develop and commercialize ONO-4641, a Phase II-stage sphingosine-1-phosphate receptor agonist in a Phase II multiple sclerosis trial, outside of Japan, Korea and Taiwan. Merck will pay ¥1.5 billion (US$19.5 million) up front, plus undisclosed milestones. The second agreement provides Ono with co-development and co-marketing rights for Stimuvax, a cancer immunotherapy candidate designed to stimulate the body's immune system to target cancer cells expressing MUC-1, in Japan. Stimuvax is in Phase III testing in non-small-cell lung cancer. Under the terms of that deal, Merck will receive an up-front payment of €5 million (US$6.6 million). No additional terms were disclosed.

• Mymetics Corp., of Epalinges, Switzerland regained its intranasal influenza vaccine from Solvay Pharmaceuticals Inc., now part of Abbott, of Abbott Park, Ill. Mymetics had licensed the vaccine to Solvay, which completed a successful Phase I study that found the vaccination was safe and well tolerated, and resulted in antibodies in the blood that exceeded the Committee for Medicinal Products for Human Use criteria for injected influenza vaccines. Solvay suspended development of the product after a change in strategy and reprioritization following the company's sale to Abbott. In addition to reclaiming the vaccine candidate, Mymetics gained the clinical trial data. Terms were not disclosed.

• Somaxon Pharmaceuticals Inc., of San Diego, said the FDA provided clinical and regulatory guidance to move an OTC version of Silenor forward, including the development of an OTC label tailored to Silenor's clinical profile and differentiated from other OTC sleep products that could potentially enable Silenor to become the first prescription insomnia agent converted to an OTC product. Somaxon is developing OTC Silenor, for the treatment of insomnia, with partner Procter & Gamble Co. (P&G), of Cincinnati. Somaxon also amended its co-promotion agreement with P&G, extending P&G's negotiation period on Silenor's OTC rights from 60 to 120 days and discontinuing co-promotion services. P&G will be entitled to a low single-digit royalty on net sales of Silenor for the 2012 fiscal year. Somaxon stock (NASDAQ:SOMX) rose 12 cents, or 15 percent, on Tuesday to close at 92 cents. (See BioWorld Today, Aug. 26, 2010, and Aug. 4, 2011.)

• X-Body Inc., of Waltham, Mass., inked a partnership with Tanabe Research Laboratories U.S.A. Inc. (TRL), an independent subsidiary of Mitsubishi Tanabe Pharma Corp., of Osaka, Japan. Under terms of the agreement, X-Body will screen its antibody libraries against target cells of therapeutic interest to TRL to identify tissue-specific epitopes and human antibody therapeutic candidates in autoimmune disease. TRL will fund the collaboration. Additional terms were not disclosed. TRL has the option to negotiate rights to the antibodies discovered in the collaboration for further preclinical research, clinical development and commercialization.

• Yaupon Therapeutics Inc., of Malvern, Pa., said the FDA accepted the filing of its new drug application (NDA) for a propriety gel formulation of mechlorethamine hydrochloride (mechlorethamine). The NDA submission includes data from a pivotal, multicenter clinical study of topical mechlorethamine gel in patients with early stage mycosis fungoides that met its primary endpoint of assessment of lesion severity. Yaupon is seeking U.S. marketing approval of the water-soluble, greaseless topical mechlorethamine gel formulation to treat stage I-IIA mycosis fungoides, the most common cutaneous T-cell lymphoma. The chemotherapeutic agent already is approved for intravenous treatment of mycosis fungoides. The FDA has granted orphan drug status to mechlorethamine gel.