SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) February 7, 2012
SALIX PHARMACEUTICALS, LTD.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
|8510 Colonnade Center Drive, Raleigh, North Carolina 27615|
|(Address of principal executive offices) (Zip Code)|
Registrants telephone number, including area code (919) 862-1000
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|¨||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|¨||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|¨||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|¨||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
|Item 8.01.||Other Events.|
On February 7, 2012, Salix issued a press release announcing that the U.S. Food and Drug Administration granted a priority review classification with a Prescription Drug User Fee Act (PDUFA) date of June 5, 2012 for the Companys New Drug Application for Crofelemer for the proposed treatment of HIV-associated diarrhea. A copy of this press release is attached as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
|99.1||Press release dated February 7, 2012.|
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.
|SALIX PHARMACEUTICALS, LTD.|
|Date: February 10, 2012|
|Adam C. Derbyshire|
|Executive Vice President and Chief Financial Officer|
FOR IMMEDIATE RELEASE
|Contact:||Adam C. Derbyshire||G. Michael Freeman|
|Executive Vice President||Associate Vice President, Investor Relations|
|and Chief Financial Officer||and Corporate Communications|
SALIX PHARMACEUTICALS ANNOUNCES FDA GRANTING OF
PRIORITY REVIEW DESIGNATION FOR THE CROFELEMER
NDA FOR TREATMENT OF DIARRHEA IN PATIENTS WITH
HIV/AIDS ON ANTI-RETROVIRAL THERAPY
PDUFA Action Date Designated as June 5, 2012
RALEIGH, NC, February 7, 2012 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the Companys New Drug Application (NDA) for crofelemer 125 mg tablets for the proposed indication for the control and symptomatic relief of diarrhea in patients with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy (ART).
The FDA grants a Priority Review designation to drugs offering major advances in treatment, or providing a treatment where no adequate therapy exists. Based on this review classification, the FDA has issued an action date for the NDA of June 5, 2012 under the Prescription Drug User Fee Act (PDUFA).
We are pleased with the FDAs acceptance of the NDA for crofelemer and their decision to grant Priority Review for our application, stated Bill Forbes, Pharm.D., Executive Vice President, Medical, Research and Development, and Chief Development Officer, Salix. This review classification signals that the FDA believes that crofelemer has the potential to provide a significant advance in the treatment of HIV/AIDS-associated diarrhea for patients on ART. We believe the availability of crofelemer has the potential to change the treatment paradigm for HIV/AIDS patients suffering from diarrhea.
Crofelemer is a first-in-class, gastrointestinal agent of botanical origin. Crofelemer is a gut-targeted, orally administered, anti-secretory, anti-diarrheal agent that has minimal absorption. Crofelemer is a locally-acting product that is believed to possess dual novel mechanisms of action that might be effective in treating both acute infectious diarrhea and chronic diarrhea. Investigational studies support the use of crofelemer as an anti-secretory anti-diarrheal agent that may provide relief to patients through the inhibition of chloride secretion by both gut CFTR (Cystic Fibrosis Transmembrane Conductance Regulator Protein) as well as gut CaCC (calcium-activated chloride channel). Inhibiting CFTR and CaCC prevents the secretion of chloride and other ions, along with the water that passively follows chloride, out of the body into the intestinal lumen. This secretion leads to diarrhea, with the associated symptoms of dehydration, electrolyte imbalance, abdominal cramping, urgency and increased frequency. Additionally, crofelemer, unlike other anti-diarrheal agents, does not affect gut motility. In trials to date, crofelemer is well tolerated, and demonstrates a safety profile comparable to placebo. Crofelemer, if approved, would be a first-in-class CFTR inhibitor as well as a first-in-class CaCC inhibitor that would work as an anti-secretory anti-diarrheal drug.
About HIV/AIDS-Associated Diarrhea
Approximately 50% of the 1 million people in the United States living with HIV/AIDS are currently taking an anti-retroviral therapy (ART), and approximately 30% of HIV/AIDS patients on ART (approximately 150,000 patients) experience episodic or chronic diarrhea. Diarrhea in this patient population can result in weight loss, reduced quality of life, poor compliance with ART and increased healthcare costs.
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription l products for the treatment of gastrointestinal diseases. Salixs strategy is to in-license late-stage or marketed proprietary products, complete any required development and regulatory submission of these products, and market them through the Companys gastroenterology specialty sales and marketing team.
Salix markets XIFAXAN® (rifaximin) tablets 200 mg and 550 mg, MOVIPREP® (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution), OSMOPREP® (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO (mesalamine) extendedrelease capsules 0.375 g,), RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection, SOLESTA®, DEFLUX®, METOZOLV® ODT (metoclopramide HCl, PEPCID® (famotidine) for Oral Suspension, Oral Suspension DIURIL® (Chlorothiazide), AZASAN® (Azathioprine) Tablets, USP, 75/100 mg, ANUSOLHC® 2.5% (Hydrocortisone Cream, USP), ANUSOLHC® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT® Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. Budesonide foam, RELISTOR®, Lumacan® and rifaximin for additional indications are under development.
For full prescribing information on Salix products, including BOXED WARNINGS for VISICOL, OSMOPREP and METOZOLV please visit www.salix.com or contact the Company at 919 862-1000.
Salix trades on the NASDAQ Global Select Market under the ticker symbol SLXP.
For more information please visit our web site at www.salix.com. Information on our web site is not incorporated in our SEC filings.
Please Note: The materials provided herein contain projections and other forward-looking statements regarding future events. Such statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the unpredictable nature of the duration and results of regulatory review of new drug applications; market acceptance for approved products; generic and other competition; the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; and the need to acquire new products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.