• Arbor Pharmaceuticals Inc., of Atlanta, said the FDA approved its new drug application for Nymalize (nimodipine) oral solution. The drug has orphan status for use in improving neurological outcome in adults with subarachnoid hemorrhage. Prior to the approval of Nymalize, nimodipine was available only in gel capsule form. Arbor said it will launch the drug in the next few months.

• Cempra Inc., of Chapel Hill, N.C., signed an exclusive license and development agreement for oral solithromycin (CEM-101) with Toyama Chemical Co. Ltd., a subsidiary of Japan's Fujifilm Holdings Corp. Under the terms of the license and development agreement, Toyama will have exclusive rights to develop and commercialize solithromycin in Japan. Cempra will receive an up-front payment of $10 million and up to $60 million in payments based on the achievement of undisclosed milestones, plus tiered sales royalties following launch of solithromycin in Japan. In December 2012, Cempra initiated its global Phase III trial of the first-in-class fluoroketolide antibiotic candidate in patients with community-acquired bacterial pneumonia. The company expects to complete the trial in the first half of 2014. (See BioWorld Today, Dec. 20, 2012.)

• CMC Biologics Inc., of Seattle, executed an agreement with RuiYi Inc., of Shanghai, China, to develop a cell line for RYI-008, an anti-IL-6 monoclonal antibody, using CMC's CHEF1 high-productivity expression plasmid. Financial terms were not disclosed.

• Derma Sciences Inc., of Princeton, N.J., engaged strategic advisor Plexus Ventures to explore options for topical drug candidate DSC127 outside the U.S. The process is expected to take nine to 15 months and to culminate with one or more agreements covering specific geographies or countries in Europe, Asia and emerging markets. The company is considering partnering, licensing or an asset sale. DSC127 is in two U.S. Phase III trials in diabetic foot ulcers, and Derma Sciences plans to submit a new drug application to the FDA following their completion. (See BioWorld Today, Feb. 7, 2013.)

• Inovio Pharmaceuticals Inc., of Blue Bell, Pa., said its SynCon DNA vaccine against Ebola and Marburg filoviruses induced strong and broad immune responses and demonstrated 100 percent protection against death following a challenge with multiple variants of the pathogens in two animal models. The filoviruses are considered "Category A" bioterrorism agents by the U.S. government. Inovio researchers developed a polyvalent DNA vaccine consisting of three consensus plasmids to broadly target variant virus strains within three distinct families of Ebola and Marburg viruses. Following two vaccinations, all vaccinated guinea pigs were protected from death following a virus challenge. The researchers observed significant increases in neutralizing antibody titers and strong and broad levels of vaccine-induced T cells, including killer T cells, and subsequently conducted a test in mice using only one vaccination, which also fully protected the animals from death following a virus challenge. The preclinical data were published in Molecular Therapy.

• Neumedicines Inc., of Pasadena, Calif., said it was notified that the Biomedical Advanced Research and Development Authority (BARDA) plans to exercise its option for continued development of HemaMax (recombinant human interleukin 12, or rHuIL-12) to treat hematopoietic syndrome of acute radiation sickness (HSARS). The goal of the option is to conduct animal studies comparing the effectiveness of HemaMax with granulocyte colony-stimulating factor (G-CSF) and to assess the effectiveness of combining HemaMax and G-CSF to treat HSARS. The study also will advance HemaMax toward a biologics license application submission by fulfilling the FDA requirement for a bridging study to evaluate efficacy of HemaMax with Level 1 supportive care. Neumedicines said it expects BARDA to disclose the amount of the award in the coming months. Earlier this year, Congress reauthorized BARDA and Project BioShield. (See BioWorld Today, Jan. 24, 2013, and March 4, 2013.)

• Seattle Genetics Inc., of Bothell, Wash., said the FDA accepted for filing its supplemental biologics license application supporting the use of Adcetris (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large-cell lymphoma (sALCL). The FDA is expected to take action by Sept. 14. Adcetris, an antibody-drug conjugate directed to CD30, gained accelerated approval in 2011 for relapsed HL and relapsed sALCL. (See BioWorld Today, Aug. 22, 2011.)

• Sorrento Therapeutics Inc., of San Diego, and Igdrasol Inc., of Irvine, Calif., said they acquired exclusive distribution rights from Samyang Biopharmaceuticals, a South Korean firm, to Cynviloq (marketed as Genexol-PM in South Korea) in the 27 countries of the European Union. Igdrasol previously obtained exclusive U.S. distribution rights to the drug, a next-generation micellar diblock co-polymeric paclitaxel formulation, from Samyang. Financial terms were not disclosed. Sorrento has the rights to acquire Igdrasol pursuant to an option agreement inked in March.