Last $159.83 USD
Change Today -4.40 / -2.68%
Volume 785.9K
As of 8:10 PM 09/22/14 All times are local (Market data is delayed by at least 15 minutes).

salix pharmaceuticals ltd (SLXP) Snapshot

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09/19/14 - $165.32
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salix pharmaceuticals ltd (SLXP) Details

Salix Pharmaceuticals, Ltd. acquires, develops, and commercializes prescription drugs and medical devices to treat various gastrointestinal diseases in the United States. The company provides XIFAXAN tablets to treat overt hepatic encephalopathy, and patients with travelers’ diarrhea; APRISO too maintain remission of ulcerative colitis (UC); MOVIPREP and OSMOPREP for cleansing of the colon as a preparation for colonoscopy in adults; RELISTOR for the treatment of opioid-induced constipation (OIC) in patients with advanced illness; SOLESTA to treat fecal incontinence; and DEFLUX to treat vesicoureteral reflux. It also offers FULYZAQ for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy; GIAZO, COLAZAL, and UCERIS to treat mildly to moderately active UC; and METOZOLV ODT for the treatment of refractory gastroesophageal reflux disease (GERD) that fails to respond to conventional therapy. Its products also comprise AZASAN azathioprine tablets, which are used as adjunct to prevent rejection in renal homotransplantations and to reduce signs and symptoms of severe active rheumatoid arthritis; ANUSOL-HC and PROCTOCORT for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses; and PEPCID for the short-term treatment of GERD, active duodenal ulcer, active benign gastric ulcer, erosive esophagitis due to GERD, and peptic ulcer diseases. In addition, the company provides DIURIL to treat hypertension and also as adjunctive therapy; ZEGERID for the treatment of upper gastrointestinal conditions; GLUMETZA and CYCLOSET to enhance glycemic control in adults with type 2 diabetes mellitus; and FENOGLIDE to treat lipoprotein-cholesterol, total cholesterol, triglycerides, and apolipoprotein B, as well as hypertriglyceridemia. It has strategic collaboration with RedHill Biopharma Ltd. Salix Pharmaceuticals, Ltd. was founded in 1989 and is headquartered in Raleigh, North Carolina.

555 Employees
Last Reported Date: 02/28/14
Founded in 1989

salix pharmaceuticals ltd (SLXP) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $867.5K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $488.9K
Chief Development Officer, Chief Medical Offi...
Total Annual Compensation: $466.4K
Executive Vice President of Business Developm...
Total Annual Compensation: $437.0K
Compensation as of Fiscal Year 2013.

salix pharmaceuticals ltd (SLXP) Key Developments

Salix Pharmaceuticals, Ltd. Announces That the FDA Grants Tentative Approval for UCERIS

Salix Pharmaceuticals Ltd. announced that the FDA has granted tentative approval for UCERIS (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge. The foam is a rectally administered corticosteroid that overcomes treatment limitations associated with currently approved therapies which are often ineffective due to insufficient distribution of active drug to the distal colon. The FDA's tentative approval of this product means that Salix's product meets all of the FDA's manufacturing quality and clinical safety and efficacy standards and will be granted final approval upon the resolution of patent issues. Salix anticipates resolution of patent issues early in the fourth quarter of 2014 and the launch of UCERIS rectal foam during the first quarter of 2015. Two identically designed, randomized, double-blind, placebo-controlled Phase III studies found that a significantly greater percentage of patients receiving UCERIS 2mg rectal foam achieved remission of distal ulcerative colitis at six weeks compared with placebo (41.2% vs 24.0%). Significantly more patients treated with UCERIS rectal foam also achieved key secondary outcome measures compared with placebo at six weeks, including a Modified Mayo Disease Activity Index (MMDAI) endoscopy score of 0 or 1 in 55.6% versus 43.2% in the first trial and 56.0% vs 36.7% in the second trial. A significantly greater percentage of patients treated with UCERIS rectal foam experienced improvement in rectal bleeding within the first two weeks of treatment (twice daily dosing); this percentage increased and was maintained after an additional two and four weeks of treatment once a day. At week six, the percentage of patients achieving MMDAI rectal bleeding score of 0 was 46.6% vs 28.0% in the first trial and 50.0% vs 28.6% in the second trial.

Salix Pharmaceuticals Ltd. Submits Response to XIFAXAN(R) 550mg Complete Response Letter Regarding Repeat Treatment for Irritable Bowel Syndrome with Diarrhea

Salix Pharmaceuticals Ltd. announced that on August 29, 2014, it submitted its response to the March 7, 2011, Food and Drug Administration (FDA) Complete Response Letter (CRL) regarding the Company's supplemental New Drug Application (sNDA) for XIFAXAN(R) 550 mg tablets for the proposed indication of the treatment of irritable bowel syndrome with diarrhea or IBS-D. Upon receipt of Salix's response, the FDA will have six months to issue a response. During its original review of Salix's sNDA, the FDA determined it is important in a chronic condition such as IBS to have information about how a product that is intended for short course administration in order to confer prolonged benefit should be administered beyond the first cycle of use once symptoms reappear. In addition, the FDA determined that patients and their health care providers should have information on the safety and effectiveness of this retreatment. The FDA conveyed this information to Salix in a March 7, 2011, CRL. Over the past three and one-half years, Salix and the FDA worked collaboratively to develop a study protocol (TARGET 3) intended to collect prospective controlled data to support repeat treatment with rifaximin in order to obtain adequate information for product labeling to guide patients and their health care providers on how to safely and most effectively administer repeat treatment of rifaximin in patients with IBS. This collaboration with the FDA also included a publicly held meeting with the Gastrointestinal Drugs Advisory Committee on November 16, 2011.

Pharming Group NV and Salix Pharmaceuticals Ltd. Announces the Initiation of Clinical Study of RUCONEST

Pharming Group NV and Salix Pharmaceuticals Ltd. announced the initiation of a clinical study of RUCONEST(Registered), (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg, for attack prophylaxis in patients with hereditary angioedema (HAE). The phase 2 randomized, double-blind, placebo-controlled, crossover study will evaluate the safety and efficacy of RUCONEST(Registered) when used for the prophylaxis of angioedema attacks in patients with HAE. The study will enroll approximately 30 patients and compare a dosing regimen of RUCONEST(Registered) given either once or twice weekly versus placebo over a total of 12 weeks. The initiation of the study follows the filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA). The study will be conducted at sites in Europe and the United States. Under the terms of the Pharming-Salix license agreement, the companies will equally share the development costs for RUCONEST(Registered) for HAE prophylaxis and Pharming will receive an undisclosed milestone payment from Salix at FDA approval for this additional indication. This randomized-controlled study follows an open-label study with RUCONEST(Registered) given once weekly, which was published in the peer reviewed journal Allergy in November 2012. The 25 patients included in the open-label study had a history of frequent HAE attacks (mean 0.9 attacks/week). During the 8 week RUCONEST(Registered) treatment period, the mean frequency of HAE attacks was reduced by more than 50% to 0.4 attacks/week. The repeated administrations were generally safe and well-tolerated. The results of that open-label study suggest that RUCONEST(Registered) could be effective in providing long term prophylaxis in patients with frequent attacks.


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Price/Earnings 100.0x
Price/Sales 8.3x
Price/Book 14.2x
Price/Cash Flow 54.7x
TEV/Sales 5.7x

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