UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) September 5, 2012
SALIX PHARMACEUTICALS, LTD.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
| 000-23265 | 94-3267443 | |
| (Commission File Number) |
(IRS Employer ID Number) |
8510 Colonnade Center Drive, Raleigh, North Carolina 27615
(Address of principal executive offices) (Zip Code)
Registrant’s 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 September 5, 2012, Salix Pharmaceuticals, Ltd. issued a press release announcing that the Food and Drug Administration advised the Company that its New Drug Application for crofelemer 125 mg tablets is still under review and that a final action will not be taken by the scheduled Prescription Drug User Fee Act goal date of September 5, 2012. A copy of this press release is attached as Exhibit 99.1.
On September 5, 2012, the Company issued a press release announcing that five presentations will occur during The National Conference on Pain for Frontline Practitioners. A copy of this press release is attached as Exhibit 99.2.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit |
Description | |
| 99.1 | Press release regarding the Food and Drug Administration review of crofelemer dated September 5, 2012. | |
| 99.2 | Press release regarding The National Conference on Pain for Frontline Practitioners dated September 5, 2012. | |
SIGNATURE
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: September 7, 2012 | ||
| /s/ Adam C. Derbyshire | ||
| Adam C. Derbyshire | ||
| Executive Vice President and Chief Financial Officer | ||
Exhibit 99.1
FOR IMMEDIATE RELEASE
| Contact: | Adam C. Derbyshire | G. Michael Freeman | ||||
| Executive Vice President and Chief Financial Officer |
Associate Vice President, Investor Relations and Corporate Communications |
|||||
| 919-862-1000 | 919-862-1000 |
FDA CONTINUES REVIEW OF CROFELEMER NEW DRUG
APPLICATION BEYOND PDUFA GOAL DATE OF SEPTEMBER 5, 2012
FDA Action on Crofelemer NDA Anticipated by End of 1Q2013
RALEIGH, NC, September 5, 2012 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Food and Drug Administration has advised the Company that its New Drug Application (NDA) for crofelemer 125 mg tablets, for the proposed indication of symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy, is still under review and that a final action will not be taken by the scheduled Prescription Drug User Fee Act (PDUFA) goal date of September 5, 2012.
Bill Forbes, Pharm. D., Executive Vice President, Medical, Research and Development, and Chief Development Officer, Salix, stated, “The FDA continues to work collaboratively with Salix to progress this important product through its full review. By taking no action at this time, the FDA has allowed for the currently ongoing dialogue between Salix and the FDA to continue.
“The continuing dialogue should allow further collaboration between us and the Agency, a collaboration that has resulted in substantial progress in handling topics important to crofelemer as well as to botanical products in general. The primary topic is the production and control of the crofelemer active pharmaceutical ingredient, a complex mixture that is the first botanical product to be reviewed by the Agency for oral use. This focus is needed to ensure compliance with the manufacturing and product quality requirements of the Food, Drug & Cosmetic Act. Both Salix and the FDA are committed to a robust level of cooperation and data exchange with the goal of providing crofelemer to patients suffering from the very important unmet need of the
indication for which we are seeking approval. Our efforts to date have advanced both the chemical and the regulatory science methods available to ensure the quality and clinical usefulness of crofelemer and, potentially, other botanical products.
“We look forward to this continuing collaboration, and at this time anticipate an action by the FDA on our NDA by the end of the first quarter of 2013.”
About Crofelemer
Crofelemer is a first-in-class anti-diarrheal botanical drug substance. Crofelemer has minimal absorption and no effect on gut motility. Crofelemer’s mechanism of action is through inhibition of both the cystic fibrosis transmembrane conductance regulator protein (CFTR) chloride ion channel and the calcium-activated chloride ion channels (CaCC). Crofelemer acts by blocking chloride ion channel secretion and accompanying high volume water loss in diarrhea, normalizing the flow of chloride ions and water in the GI tract.
About Diarrhea in HIV/AIDS Patients
Diarrhea remains a common problem for patients with HIV/AIDS that often negatively impacts their quality of life and can lead to discontinuation or premature switching of anti-retroviral therapy (ART) regimens. Approximately 1.2 million people in the United States are living with HIV/AIDS and ~40% of those patients suffer from either episodic or chronic diarrhea. This condition can not only significantly reduce quality of life, but also result in weight loss, depression, reduced social interaction, and often increase direct and indirect healthcare costs.
About Salix Pharmaceuticals
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription products for the prevention and treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic products, complete any required development and regulatory submission and market them through the Company’s 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) extended-release capsules 0.375 g, METOZOLV® ODT (metoclopramide HCl), RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection, SOLESTA®, DEFLUX®, PEPCID® (famotidine) for Oral Suspension, Oral Suspension DIURIL® (Chlorothiazide), AZASAN® (Azathioprine) Tablets, USP, 75/100 mg, ANUSOL-HC® 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT® Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. Crofelemer, budesonide foam, RELISTOR® , Lumacan® and rifaximin for additional indications are under development.
For full prescribing information and important safety information on Salix products, including BOXED WARNINGS for OSMOPREP, AZASAN and METOZOLV, please visit www.salix.com where the Company promptly posts press releases, SEC filings and other important information 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 Website at www.salix.com or contact the Company at 919-862-1000. Follow us on Twitter (@SalixPharma) and Facebook (www.facebook.com/SalixPharma). Information on our web site, Twitter feed and Facebook page 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 unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; the cost, timing and results of clinical trials and other development activities involving pharmaceutical products; post-marketing approval regulation; litigation and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties in an increasingly global industry; the cost, timing and results of clinical trials and other development activities involving pharmaceutical products; post-marketing approval regulation; market acceptance for approved products; and generic and other competition in an increasingly global industry. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.
Exhibit 99.2
FOR IMMEDIATE RELEASE
| Contact: | Salix Pharmaceuticals: | |||||
| Adam C. Derbyshire | G. Michael Freeman | |||||
| Executive Vice President | Associate Vice President, Investor Relations | |||||
| and Chief Financial Officer | and Corporate Communications | |||||
| 919-862-1000 | 919-862-1000 | |||||
SALIX PHARMACEUTICALS OUTLINES DATA PRESENTATIONS AT PAINWeek
RALEIGH, NC, September 5, 2012 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that five presentations describing the investigation of methylnaltrexone bromide as a potential treatment for opioid-induced constipation in adult patients with chronic, non-cancer pain will occur during The National Conference on Pain for Frontline Practitioners, or “PAINWeek”. PAINWeek is being held in Las Vegas, NV, Wednesday, Sept. 5 – Saturday, Sept. 8.
RELISTOR® (methylnaltrexone bromide) injection for subcutaneous use
Rauck et al. “Cardiac Safety of Subcutaneous Methylnaltrexone: Results from a Pooled Safety Analysis and a Case-Controlled Analysis in Noncancer Pain Patients with Opioid-Induced Constipation”
Methylnaltrexone bromide for oral use
Pepin et al. “Efficacy and Safety of Daily and As Needed Dosing of Oral Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Patients with Chronic Noncancer Pain”
Rauck et al. “Cardiac Safety of Oral Methylnaltrexone in Healthy Subjects and Noncancer Pain Patients with Opioid-Induced Constipation”
Rauck et al. “Oral Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Patients with Noncancer Pain”
Slatkin et al. “Safety and Tolerability of Oral Methylnaltrexone in Chronic Noncancer Pain Patients with Opioid-Induced Constipation”
About RELISTOR (methylnaltrexone bromide), Opioids and Constipation
Opioid analgesics are frequently prescribed for patients with chronic pain. Constipation, a common side effect, occurs in patients receiving opioid therapy. RELISTOR is the first approved medication that specifically targets the underlying cause of opioid-induced constipation in advanced illness patients when laxatives are insufficient. Opioids relieve pain by specifically interacting with mu–opioid receptors within the brain and spinal cord. However, opioids also interact with mu–opioid receptors found outside the central nervous system, such as those within the gastrointestinal tract, resulting in constipation that can be debilitating. RELISTOR is a peripherally acting mu–opioid receptor antagonist that does not cross the blood-brain barrier and was specifically designed to block mu-opioid receptors in the GI tract, therefore decreasing the constipating effects of opioid pain medications without affecting their ability to relieve pain.
RELISTOR Subcutaneous Injection was approved in the United States in 2008 for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. The use of RELISTOR beyond four months has not been studied. The drug is also approved for use in 58 countries worldwide, including the European Union, Canada and Australia. In the 27 member states of the E.U., as well as Iceland, Norway and Liechtenstein, RELISTOR is approved for the treatment of opioid–induced constipation in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient. In Canada, the drug is approved for the treatment of opioid–induced constipation in patients with advanced illness, receiving palliative
care. When response to laxatives has been insufficient, RELISTOR should be used as an adjunct therapy to induce a prompt bowel movement. Applications in additional countries are pending. RELISTOR is under exclusive license to Salix Pharmaceuticals worldwide except Japan, and to Ono Pharmaceutical in Japan only, from Progenics Pharmaceuticals. Salix is developing both subcutaneous injection and oral formulations of methylnaltrexone bromide for the potential treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain.
For more information about RELISTOR, please visit www.RELISTOR.com
Important Safety Information for RELISTOR
RELISTOR is indicated for the treatment of opioid–induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied.
RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician. Use of RELISTOR has not been studied in patients with peritoneal catheters.
Safety and efficacy of RELISTOR have not been established in pediatric patients.
Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie’s syndrome). Perforations have involved varying regions of the GI tract (e.g., stomach, duodenum, colon).
Use RELISTOR with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms.
The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5% vs 9.8%), flatulence (13.3% vs 5.7%), nausea (11.5% vs 4.9%), dizziness (7.3% vs 2.4%), diarrhea (5.5% vs 2.4%), and hyperhidrosis (6.7% vs 6.5%).
RELISTOR full Prescribing Information for the U.S. is available at www.RELISTOR.com
About Salix Pharmaceuticals
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription products for the prevention and treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic products, complete any required development and regulatory submission and market them through the Company’s 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) extended-release capsules 0.375 g, METOZOLV® ODT (metoclopramide HCl), RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection, SOLESTA®, DEFLUX®, PEPCID® (famotidine) for Oral Suspension, Oral Suspension DIURIL® (Chlorothiazide), AZASAN® (Azathioprine) Tablets, USP, 75/100 mg, ANUSOL-HC® 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT® Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. Crofelemer, budesonide foam, RELISTOR® , Lumacan® and rifaximin for additional indications are under development.
For full prescribing information and important safety information on Salix products, including BOXED WARNINGS for OSMOPREP, AZASAN and METOZOLV, please visit www.salix.com where the Company promptly posts press releases, SEC filings and other important information 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 Website at www.salix.com or contact the Company at 919-862-1000. Follow us on Twitter (@SalixPharma) and Facebook (www.facebook.com/SalixPharma). Information on our web site, Twitter feed and Facebook page 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 unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; the cost, timing and results of clinical trials and other development activities involving pharmaceutical products; post-marketing approval regulation; litigation and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties in an increasingly global industry; the cost, timing and results of clinical trials and other development activities involving pharmaceutical products; post-marketing approval regulation; market acceptance for approved products; and generic and other competition in an increasingly global industry. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.