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Heron Therapeutics is a specialty pharmaceutical company developing products using its proprietary Biochronomer™ polymer-based drug delivery platform. This drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals by extending the duration of action. The Company's lead product, SUSTOL™ (formerly APF530), is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting. Heron Therapeutics received a Complete Response Letter to its SUSTOL New Drug Application (NDA) and is targeting a resubmission of the NDA to the U.S. Food and Drug Administration during the fourth quarter of 2014. Heron Therapeutics' core Biochronomer technology, on which SUSTOL and its other products are based, consists of bioerodible polymers designed to release drugs over a defined period of time. The Company has completed over 100 in vivo and in vitro studies demonstrating that its Biochronomer technology is potentially applicable to a range of therapeutic areas, including prevention of nausea and vomiting, pain management, control of inflammation and treatment of ophthalmic diseases. Heron Therapeutics has also completed comprehensive animal and human toxicology studies that have established that its Biochronomer polymers are generally well tolerated. Furthermore, the Company's Biochronomer technology can be designed to deliver drugs over periods varying from days to several months. In addition to its lead drug candidate SUSTOL, Heron Therapeutics has a pipeline of other product candidates that use the Biochronomer technology.
Neponset Controls Inc is a Foxboro, MA-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
Momenta is a biotechnology company with a product pipeline of both complex mixture generic and novel drugs. Our complex mixture generics and follow-on biologics effort is focused on building a thorough understanding of the structure-process-activity of complex mixture drugs to develop generic versions of marketed products. While we use a similar analytical and development approach across all of our product candidates, we tailor that approach for each specific product candidate. Our first objective is to apply our core analytical technology to thoroughly characterize the structure of the marketed product. By defining the chemical composition of multiple batches of a marketed product, we are able to develop an equivalence window which captures the inherent variability of the innovator`s manufacturing process. Using this information, we then build an extensive understanding of the structure-process relationship to design and control our manufacturing process to manufacture reproducibly an equivalent version of the marketed product. Where necessary, and as required by the U.S. Food and Drug Administration, or FDA, we will supplement an application with additional supportive structure-activity data (e.g., immunogenicity, pharmacodynamics). Our goal is to obtain FDA approval for and commercialize generic or follow-on versions of complex mixture products, thereby providing high quality, safe and affordable medicines to patients in need.