Company Overview of Salix Pharmaceuticals, Inc.
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
Key Executives for Salix Pharmaceuticals, Inc.
Chairman of the Board and Acting Chief Executive Officer
Acting Chief Financial Officer and Senior Vice President of Finance & Administrative Services
Acting Chief Operating Officer
Chief Development Officer and President of Medical, Research & Development
Compensation as of Fiscal Year 2015.
Salix Pharmaceuticals, Inc. Key Developments
Salix Pharmaceuticals, Inc Receives U.S. Food and Drug Administration Approval for Xifaxan(R) 550 mg for the Treatment of IBS-D (Irritable Bowel Syndrome - With Diarrhea)
May 27 15
Valeant Pharmaceuticals International, Inc. announced that Salix Pharmaceuticals, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Xifaxan(R) 550 mg for the treatment of IBS-D in adults. The FDA approval of Xifaxan 550 mg is based on data from three phase 3 studies, TARGET 1, TARGET 2 and TARGET 3. Xifaxan 550 mg was studied in over 3,000 patients and demonstrated the efficacy and safety of repeat treatment following completion of a two-week course of treatment. A full course of Xifaxan 550 mg for IBS-D is available in a convenient 2 week pack of 42 pills. As many as 35 million adult Americans may experience IBS, and 40% of people with IBS suffer from diarrhea-prominent symptoms that include urgency, loose, watery stools and abdominal pain.i,ii,iii Although millions suffer from the condition, current treatments for IBS-D are limited to products aimed at relieving individual symptoms (e.g., antispasmodics, anti-diarrheal agents, bulking agents, anti-flatulence agents) and fail to address the syndrome complex. The FDA approval was based on data from three clinical studies of more than 3,000 patients. Results of TARGET 1 and 2 showed patients treated with Xifaxan 550 mg achieved relief of the FDA composite endpoint (stool consistency and abdominal pain) versus placebo. TARGET 3 showed that patients who responded to treatment with Xifaxan 550 mg but experienced recurrent symptoms responded to repeat treatment in the FDA composite endpoint versus placebo. Xifaxan 550 mg offers a safety and tolerability profile comparable to placebo when used as directed. Xifaxan is also FDA-approved to manage hepatic encephalopathy (550 mg). Recommended dosing for Xifaxan 550 mg for IBS-D is one 550 mg tablet three times a day for 14 days. Patients can take up to two additional courses if IBS-D symptoms recur in the future. Xifaxan 550 mg is currently available to patients.
Lupin Pharma Canada Ltd Enters Strategic Licensing Agreement with Salix Pharmaceuticals Inc
Apr 20 15
Lupin Ltd. announced that its Lupin Pharma Canada Ltd, has launched its antibiotic drug 'Zaxine' in Canada with its strategic partner Salix Pharmaceuticals Inc. Lupin Pharma Canada Ltd. has launched its first brand product Zaxine under a strategic licensing agreement with the Salix Pharmaceuticals Inc. The agreement grants Lupin exclusive rights to promote, distribute and market Zaxine in the Canada. Further, the company will promote the product to Hepatologists and Gastroenterologists through its own specialty sales force in Canada. Lupin is in the process of establishing its Canadian presence and the launch opens up growth opportunities for the future.
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.
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