Apricus Biosciences Inc., of San Diego, said the Spanish Agency for Medicines and Health Products granted national phase approval to Vitaros, a topical on-demand treatment for erectile dysfunction. The company has now received a total of 10 national phase approvals for the alprostadil-containing cream. Partner Recordati SpA, of Milan, Italy, is commercializing Vitaros in Spain.
Athersys Inc., of Cleveland, is working with the Cell Therapy Catapult, of London, on projects to progress the company's Multistem cell therapy product in Europe. Among the projects, Cell Therapy Catapult will undertake a European market access assessment for the Multistem product that considers factors such as data requirements for evidence-based decision-making, payers' value perceptions and pricing benchmarks.
Bioasis Technologies Inc., of Vancouver, British Columbia, said it identified a new family of peptides that conserve the brain shuttling properties of Transcend, the firm's vector designed to shuttle molecules across the blood-brain barrier. In side-by-side comparisons, those new, second-generation peptide vectors are more efficient than the native, full-size Transcend molecule at delivering cargo to the brain.
Biogen Idec Inc., of Cambridge, Mass., and biopharma development and commercial outsourcing firm Quintiles, of Research Triangle Park, N.C., entered a five-year clinical development agreement designed to optimize Biogen's clinical development processes. Under the terms, a team from Quintiles will work with Biogen on the design, planning and execution of its phase II through phase IV studies and select phase I studies. Biogen also will leverage Quintiles' technology and systems across its portfolio. Financial terms were not disclosed.
Endo International plc, of Dublin, said affiliates of the company acquired worldwide rights to Sumavel Dosepro (sumatriptan injection) for subcutaneous use from Zogenix Inc., of San Diego, for an up-front payment of $85 million and rights to additional cash payments based on the achievement of certain commercial milestones. Endo also will assume an existing third-party royalty obligation on net sales of the acute migraine product.
Evotec AG, of Hamburg, Germany, said it achieved a milestone in its biomarker alliance with Roche AG, of Basel, Switzerland, following Roche's decision to use a response prediction marker, identified by Evotec's Proteome Profiling platform, in an extended phase I oncology trial. It marked the first minor milestone achieved under the collaboration and license deal inked in 2011, which is part of the m4 Munich Biotech Cluster Personalized Medicine and Targeted Therapies initiative funded by the German Federal Ministry of Education and Research. Under the initial three-year term, the companies conduct biomarker discovery and validation programs for patient stratification in targeted cancer therapy. Evotec is eligible for further success-based payments upon clinical companion diagnostics development.
Hydra Biosciences Inc., of Cambridge, Mass., and Boehringer Ingelheim GmbH, of Ingelheim, Germany, entered a worldwide collaboration to research and develop small-molecule TRPC4/5 inhibitors for the treatment of central nervous system diseases and disorders. Under the terms, the companies will work together to identify and advance candidate inhibitors. Boehringer will be responsible for global development and commercialization, while Hydra will receive an undisclosed up-front payment and additional research funding and be eligible for milestone payments and tiered royalties on future product sales.
Intelgenx Corp., of Saint Laurent, Quebec, and Redhill Biopharma Ltd., of Tel Aviv, Israel, reported that the FDA acknowledged receipt of the companies' response to the complete response letter (CRL) for the Versafilm oral film product new drug application and has requested further clarifications. The CRL raised questions primarily related to chemistry, manufacturing and controls (CMC), and the FDA has requested additional CMC data, which the firms said they should be able to supply within several weeks based on the available information. The product is an oral thin-film formulation of rizatriptan for the treatment of acute migraines.
Kamada Ltd., of Ness Ziona, Israel, reported a significantly improved infusion rate for Glassia (alpha1-proteinase inhibitor, human), achieved following a postmarketing study conducted by Baxter International Inc., of Deerfield, Ill., which is marketing the product in the U.S. as a chronic augmentation and maintenance therapy in adults with alpha-1 antitrypsin deficiency. The improved infusion rate reduces the overall time from preparation to finish, which Kamada said is key for patients who are using the therapy chronically and should increase the number of patients treated by Glassia in the U.S.
Medivation Inc., of San Francisco, and Oncofusion Therapeutics Inc., of Ann Arbor, Mich., said they entered a research and license agreement for certain compounds targeting bromodomain and extra-terminal, or BET, proteins for potential use in oncology and other disease areas. Medivation will gain exclusive worldwide rights for the development and commercialization of those compounds and will have access to Oncofusion's library of small-molecule BET inhibitors from which Medivation may select compounds to move forward into drug development efforts. Oncofusion is eligible for undisclosed up-front payments and potential future milestone payments subject to defined clinical and commercial achievements. Oncofusion also will be eligible for royalties. Specific financial details were not disclosed.
Sinovac Biotech Ltd., of Beijing, said it received notification that a ¥60 million (US$9.6 million) free government grant was approved by China's Ministry of Finance, National Development and Reform Commission, Ministry of Industry and Information Technology and National Health and Family Planning Commission for construction of the company's production facility for its Enterovirus 71 (EV71) vaccine against hand, foot and mouth disease. The funding criteria are to complete the construction of the production facility, in compliance with China's new GMP guidelines, with an annual capacity of 20 million doses of EV71 vaccine and to commercialize the vaccine in China. The grant will be funded in several tranches, of which ¥20 million will be provided within the year, and the remaining will be provided after the criteria are met.