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Last €160.61 EUR
Change Today +2.62 / 1.66%
Volume 0.0
As of 10:50 AM 03/31/15 All times are local (Market data is delayed by at least 15 minutes).
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Company Description

Contact Info

8510 Colonnade Center Drive

Raleigh, NC 27615

United States

Phone: 919-862-1000

Fax: 919-862-1095

Salix Pharmaceuticals, Ltd., a specialty pharmaceutical company, engages in acquiring, developing, and commercializing prescription drugs and medical devices used in the treatment of various gastrointestinal disorders, which are those affecting the digestive tract. Strategy The company’s strategy is to identify and acquire rights to products that have potential for near-term regulatory approval or are already approved; apply its regulatory, product development, manufacturing and sales and marketing expertise to commercialize these products; and market its products through its specialty sales and marketing team by primarily focusing on the following groups of high-prescribing U.S. physicians: gastroenterologists, who are doctors who specialize in gastrointestinal disorders; hepatologists, who are doctors who specialize in liver disease; colorectal surgeons, who are doctors who specialize in disorders of the colon and rectum; endocrinologists, who are doctors who specialize in diagnosing and treating hormone imbalances, such as diabetes mellitus; primary care doctors; doctors who specialize in pain management; allergists, who are doctors who specialize in treating allergies and asthma; immunologists, who are doctors who specialize in immunologic disorders; and doctors who specialize in infectious diseases. Product The company offers approximately 20 marketed products. Xifaxan (rifaximin) tablets Xifaxan, the company’s major product, is a gastrointestinal-specific oral antibiotic. Xifaxan 550 mg is approved by the U.S. Food and Drug Administration (FDA) for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients 18 years of age or older. HE is a chronic worsening of brain function that occurs when the liver is not able to remove toxic substances from the blood. Additionally, the FDA approved Xifaxan 200 mg for the treatment of patients 12 years of age and older with travelers’ diarrhea (TD) caused by noninvasive strains of E coli. The company is exploring potential additional indications, formulations, and clinical trials and co-promotion arrangements to capitalize on the potential for Xifaxan, including its development programs in irritable bowel syndrome (IBS), Crohn’s disease and early decompensated chronic liver disease. Xifaxan 550 mg has orphan drug exclusivity, granted by the FDA, for HE through March 24, 2017. The company has 15 patents potentially providing combined protection on the Xifaxan molecule until 2027 and method of use patent protection for the TD, HE and IBS indications until 2029. The company filed an application in Canada in 2013 to market Xifaxan 550 mg to treat HE and received marketing approval in 2013. Apriso (mesalamine) extended-release capsules Apriso is a locally-acting aminosalicylate that is approved by the FDA. It is the only delayed and extended release mesalamine product that is FDA-approved for the maintenance of remission of ulcerative colitis (UC) in adults. Apriso is designed to provide for the distribution of the active ingredient beginning in the distal small bowel and continuing throughout the colon. Apriso sales, together with sales from Uceris, Giazo and Colazal, three of the company’s other products used to treat UC. Uceris (budesonide) extended release tablets Uceris is a locally acting corticosteroid in a once-daily oral tablet formulation that utilizes proprietary multimatrix system (MMX) colonic delivery technology. The company acquired rights to the product in connection with its acquisition of Santarus, Inc. (Santarus). Uceris is indicated for the induction of remission in patients with active, mild to moderate UC and was approved by the FDA in 2013. Uceris (budesonide) rectal foam The company owns a license from Dr.Falk Pharma GmbH (Dr.Falk Pharma), to a family of budesonide products, including a budesonide rectal foam, in the United States. In 2013, the company announced positive data from two Phase 3 trials that evaluated the effectiveness and safety of budesonide rectal foam for the treatment of mild to moderate ulcerative proctitis or proctosigmoiditis. MoviPrep (PEG 3350, sodium sulfate, sodium chloride

 

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