Salix Pharmaceuticals, Inc. is a specialty pharmaceutical company that focuses on developing, marketing, and licensing prescription pharmaceutical products for the prevention and treatment of gastrointestinal disorders. It sells its products to healthcare professionals through its direct sales force in the United States. The company was founded in 1989 and is based in Raleigh, North Carolina. Salix Pharmaceuticals, Inc. operates as a subsidiary of Salix Pharmaceuticals Ltd.
8510 Colonnade Center Drive
Raleigh, NC 27615
Founded in 1989
Napo Pharmaceuticals, Inc. Files Brief on Appeal in Dispute with Salix Pharmaceuticals, Inc
Feb 3 15
Napo Pharmaceuticals, Inc. announced that it has filed its opening brief in the Appellate Division of the Supreme Court of the State of New York seeking to reverse the December 2013 Order of the Supreme Court of the State of New York that prevented important claims from being tried to verdict by a jury in the Napo vs. Salix Pharmaceuticals, Inc. litigation. Napo filed a lawsuit against the company in New York on May, 2011 seeking to terminate its December 9, 2008 Collaboration Agreement with Salix for the Development, Manufacture and Commercialization of Napo's first-in-class anti-diarrheal drug, crofelemer. Napo's original complaint alleged that the company had materially breached its contract with Napo by its failure to use commercially reasonable efforts to develop crofelemer. Napo's appeal includes a challenge to the lower court decision that the company's decision to withhold investment in commercial manufacturing capacity sufficient to launch crofelemer upon FDA approval was reasonable. The issues on appeal include the lower court's ruling that Salix was entitled to ignore its obligations to commercialize and develop other indications for crofelemer as required by the Collaboration Agreement, including specifically diarrhea predominant irritable bowel syndrome, an indication for which the company has licensed worldwide rights. Other licensed indications include pediatric, acute infectious (including cholera), and chemotherapy-related diarrheas. In December, 2012, the US Food and Drug Administration approved crofelemer for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. The Appeal also cites the company's delay in obtaining FDA approval of FULYZAQ, especially in light of the announcement of positive Phase 3 trial results in November, 2010. Crofelemer had previously received Fast Track designation from the FDA for this indication.
Lupin Ltd Enters into an Exclusive Deal to Market Some Products of Salix Pharmaceuticals Inc
Sep 13 14
Lupin Ltd. announced that it has entered into an exclusive deal to market some products of Salix Pharmaceuticals Inc. in Canada, in a move to expand its footprint in that region. Lupin will get an upfront payment from Salix, and is entitled to additional payments contingent on meeting some sales milestones. Lupin has the option to sell other gastroenterology products in Salix's pipeline after approval by Canadian regulators. The deal includes Salix's Relistor injection for the treatment of opioid-induced constipation, and Zaxine for use in adults to help reduce risk of recurrence of overt hepatic encephalopathy - a disorder that causes worsening of brain function.