Profile: Salix Pharmaceuticals Ltd (SLXP.OQ)
18 Dec 2013
Salix Pharmaceuticals, Ltd., incorporated on December 31, 2001, is a specialty pharmaceutical company dedicated to acquiring, developing and commercializing prescription drugs and medical devices used in the treatment of a variety of gastrointestinal disorders, which are those affecting the digestive tract. As of December 31, 2012, the Company’s products included XIFAXAN, MOVIPREP, APRISO, RELISTOR, OSMOPREP, SOLESTA, DEFLUX, FULYZAQ, GIAZO, METOZOLV ODT, AZASAN, ANUSOL-HC, PROCTOCORT, PEPCID, DIURIL and COLAZAL. As of December 31, 2012, its primary product candidates under development included Rifaximin, Methylnaltrexone bromide oral, Budesonide foam and Rifaximin EIR.
Xifaxan (rifaximin) tablets
Xifaxan is a gastrointestinal-specific oral antibiotic. The Food and Drug Administration ( FDA) approved Xifaxan 200 milligram for the treatment of patients 12 years of age and older with travelers’ diarrhea caused by noninvasive strains of E coli. Xifaxan 550 milligram was approved by the FDA for reduction in risk of overt hepatic encephalopathy (HE), recurrence in patients 18 years of age or older.
It launched Xifaxan 200milligram in the United States and Xifaxan 550 milligram using its own direct sales force. The Company is exploring potential additional indications, formulations, clinical trials and co-promotion arrangements to capitalize on the potential for Xifaxan, including its development program in irritable bowel syndrome.
In October 2012, the USPTO declared an interference action to determine the priority of invention between Cipla’s application related to amorphous rifaximin and Solmag SpA’s application directed to amorphous rifaximin. In February 2012, the FDA posted draft bioequivalence guidance for rifaximin 550 milligram tablets. The draft guidance for rifaximin 550 milligram tablets recommends that in addition to conducting the program outlined in the FDA posted draft guidance document for rifaximin 200 milligram tablets discussed above, a single-dose, three-way crossover in-vivo study of fasting bioequivalence with pharmacokinetic endpoints in both fasting and fed states be performed in the 550 milligram tablets. Additionally, the guidance stipulated that the formulation of the 550 milligram strength should be proportionally similar to that of the 200 milligram strength in order to file an ANDA for approval of a generic rifaximin 550 milligram tablet for the treatment of hepatic encephalopathy.
MoviPrep (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid) oral solution
MoviPrep is a patent-protected, liquid polyethylene glycol-salt, or PEG, bowel cleansing product that the FDA approved. MoviPrep is indicated for bowel cleansing prior to colonoscopy, intestinal surgery and barium enema X-ray examinations.
Apriso (mesalamine) extended-release capsules 0.375 gram
Apriso is a locally-acting aminosalicylate and is the only delayed and extended release mesalamine product approved by the FDA for once-a-day dosing for the maintenance of remission of ulcerative colitis. Apriso is designed to provide for the distribution of the active ingredient beginning in the small bowel and continuing throughout the colon. The product’s prolonged release mechanism might allow them to expand the range of treatment options for ulcerative colitis.
Relistor (methylnaltrexone bromide)
Relistor Subcutaneous Injection is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Relistor is approved for use in over 55 countries worldwide.
OsmoPrep and Visicol (sodium phosphate monobasic monohydrate, USP, sodium phosphate dibasic anhydrous, USP) tablets
Visicol and OsmoPrep tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. Visicol and OsmoPrep are the only, tablet bowel cleansing products approved by the FDA and marketed in the United States. OsmoPrep is a patented, second-generation tablet bowel cleansing product that the FDA approved. OsmoPrep offers potential benefits compared to Visico,l such as its lack of microcrystalline cellulose, smaller tablet size and possible lower dose administration.
Solesta is a biocompatible tissue bulking agent, consisting of dextranomer microspheres and stabilized sodium hyaluronate. Solesta is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy, such as diet, fiber therapy and/or anti-motility medications. It is the only injectable gel for this indication to be administered in an outpatient setting without the need for surgery or anesthesia.
Deflux is a medical device indicated for children affected by Grades II-IV vesicoureteral reflux, a malformation of the urinary bladder that can result in severe infections of the kidneys and irreversible kidney damage. Deflux was granted premarket approval application (PMA) approval, and has been on the market in the United States.
Fulyzaq (crofelemer) delayed-release tablets
On December 31, 2012, the FDA granted marketing approval for this product, under the trade name Fulyzaq. Fulyzaq is indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. Fulyzaq should also be eligible for five years of marketing exclusivity from the date of FDA approval, and the product might be entitled to patent term restoration.
Giazo (balsalazide disodium) tablets
February 3, 2012, the FDA granted marketing approval for this product under the trade name Giazo. Giazo is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older. It shipped Giazo to wholesalers in 2012.
Metozolv ODT (metoclopramide hydrochloride) 5 milligrams and 10 milligrams orally disintegrating tablets
METOZOLV ODT is indicated for the relief of symptomatic gastroesophageal reflux or short-term (4-12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy and diabetic gastroparesis or the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis.
Azasan (azathioprine) tablets
Azasan is an FDA-approved drug that suppresses immune system responses and is indicated for preventing rejection of kidney transplants and treatment of severe arthritis. It launched the 75 and 100 milligrams dosage strengths of Azasan in the United States.
Anusol-HC and Proctocort (hydrocortisone) creams and suppositories
The Company acquired the right to sell Anusol-HC 2.5% (hydrocortisone USP) cream, Anusol-HC 25 milligrams (hydrocortisone acetate) rectal suppositories, Proctocort 1% (hydrocortisone USP) cream and Proctocort 30 mg (hydrocortisone acetate) rectal suppositories from King Pharmaceuticals, Inc. The two cream products are topical corticosteroids indicated for relief of the inflammatory and pruritic, or itching, manifestations of corticosteroid-responsive dermatoses. The two suppository products are indicated for use in inflamed hemorrhoids and postirradiation proctitis, as well as an adjunct in the treatment of chronic ulcerative colitis and other inflammatory conditions.
Pepcid (famotidine) for Oral Suspension and Diuril (Chlorothiazide)
Pepcid Oral Suspension is a widely known prescription pharmaceutical product indicated for several gastrointestinal indications, including the treatment of duodenal ulcer, benign gastric ulcer and gastro-esophageal reflux disease. Pepcid Oral Suspension and Diuril Oral Suspension, both liquid formulations of their solid dosage form counterparts, compete in a combined annual United States market concentrated in pediatric and hospitalized patient populations.
Colazal (balsalazide disodium) capsules
The Company launched Colazal to physicians in the United States. FDA approved Colazal for use in pediatric patients between 5 to 17 years of age with ulcerative colitis. The pediatric use of Colazal has been granted orphan drug designation. The Office of Generic Drugs, or OGD, approved three generic balsalazide capsule products.
The Company competes with GlaxoSmithKline plc, Giuliani S.p.A., Axcan Pharma, Inc., Abbott Laboratories, Warner Chilcott plc, Shire Pharmaceuticals Group plc, Pharmacia & Upjohn, Inc., Alaven Pharmaceutical LLC, Ferring Pharmaceuticals, Inc, Takeda Pharmaceutical Company Limited, Cumberland Pharmaceuticals, Inc, Prometheus Laboratories, Inc., Ranbaxy Pharmaceuticals, Ferndale Laboratories, GATE Pharmaceuticals , Nycomed , Medtronic, Inc., and Cubist Pharmaceuticals, Inc.
Salix Pharmaceuticals Ltd
8510 Colonnade Center Drive
RALEIGH NC 27615
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