• Andromeda Biotech Ltd., of Yavne, Israel, said the FDA granted orphan drug designation for DiaPep277 in Type I diabetes patients with residual beta cell function. The synthetic peptide, derived from the major T-cell epitope of heat-shock protein, is in multiple Phase III studies. A first study conducted in Europe, South Africa and Israel met its primary endpoint based on initial results, and a global confirmatory Phase III study is being conducted in more than 120 medical centers.

• BioAlliance Pharma SA, of Paris, said the FDA accepted for review its new drug application for Sitavig (acyclovir Lauriad) for recurrent orofacial herpes. The application was based on results from a Phase III study showing that a single application of the drug, marketed in Europe as Sitavir, significantly reduced the occurrence of vesicular lesions and crusts, their time to healing and the severity of symptoms.

• CytRx Corp., of Los Angeles, published research in the May 22, 2012, online issue of Clinical Cancer Research showing that its tumor-targeting doxorubicin conjugate, INNO-206, showed activity against multiple myeloma and enhanced the antitumor effects of Velcade (bortezomib, Millennium/Takeda). Prior research showed that INNO-206 delivered doxorubicin at higher doses than conventional doxorubicin to myelmoa cancers grown in immune-deficient mice. Complete results of its Phase Ib/II trial of INNO-206 will be presented at the upcoming American Society of Clinical Oncology conference in Chicago.

• Ensemble Therapeutics Inc., of Cambridge, Mass., said it will begin a drug discovery collaboration with South San Francisco-based Genentech Inc., a member of the Roche Group, for macrocyclic drug targets using its Ensemblin collection of more than 5 million macrocycles. Genentech will have the right to develop and commercialize resulting lead molecules, and Ensemble will receive an undisclosed up-front payment, milestone payments and royalties on future sales.

• Nuvo Research Inc., of Mississauga, Ontario, inked a license and supply agreement giving Paladin Labs Inc., of Montreal, exclusive Canadian rights to market and sell the topical patch Synera upon regulatory approval. Synera combines lidocaine, tetracaine and heat, using Nuvo's controlled heat-assisted drug delivery technology. The agreement calls for Nuvo to receive a double-digit royalty on net sales of Synera in Canada and to supply Synera to Paladin. In addition, Paladin agreed to loan Nuvo C$8 million (US$7.8 million) in two equal tranches of C$4 million each. The first tranche was advanced on closing, and the second tranche can be drawn by Nuvo, at its option, upon the achievement of undisclosed milestones. The loan, which bears interest at a rate of 15 percent annually and matures on May 25, 2016, is secured by a charge over the assets of Nuvo's pain group.

• Pro Bono Bio Group plc and PolyTherics Ltd., both of London, extended their hematology alliance with an exclusive global licensing agreement to develop and commercialize TheraPEG Factor VIIa. The extension is based on promising preclinical results from their lead program for a long-acting TheraPEG Factor IX. Under the agreements, PolyTherics is eligible for development and regulatory milestones, as well as worldwide royalties, for Factor IX and Factor VIIa. Clinical development of both products is expected to begin within the next 18 to 24 months. The companies also signed an exclusive option agreement to develop a pegylated form of Factor VIII under a feasibility program that includes an exclusive global license.

• Raptor Pharmaceutical Corp., of Novato, Calif., acquired exclusive rights to intellectual property related to cysteamine and related compounds in the potential treatment of parasitic diseases, including malaria, from McGill University in Montreal. The McGill patent covers the use of the compounds in combination with artemisinin, the current standard of care for malaria. Researchers at McGill reported that, in mouse models of malaria, the combination significantly reduced parasite levels in red blood cells and improved survival compared to artemisinin alone. Last year, a Phase III study of Raptor's RP103, a delayed-release version of cysteamine, hit its primary endpoint in nephropathic cystinosis, and the company subsequently filed a marketing authorization application for the drug in the European Union. (See BioWorld Today, July 26, 2011.)