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) October 19, 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 October 19, 2012, Salix Pharmaceuticals, Ltd. issued a press release announcing that educational activities and numerous presentations describing the investigation of several of the Company’s products will occur during the American College of Gastroenterology (ACG) 2012 Annual Scientific Meeting. A copy of this press release is attached as Exhibit 99.1.
On October 19, 2012, the Company issued a press release announcing the premiere screening of “Wrestling the Monster: Living with Hepatic Encephalopathy” at the 2012 ACG Scientific Meeting. 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 educational activities and presentations at the American College of Gastroenterology 2012 Annual Scientific Meeting dated October 19, 2012. | |
| 99.2 | Press release regarding screening of “Wrestling the Monster: Living with Hepatic Encephalopathy” at the 2012 American College of Gastroenterology Scientific Meeting dated October 19, 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: October 22, 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 |
SALIX PHARMACEUTICALS PREVIEWS AMERICAN COLLEGE
OF GASTROENTEROLOGY 2012
RALEIGH, NC, October 19, 2012 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that educational activities and numerous presentations describing the investigation of several of the Company’s products – including XIFAXAN® 550mg/rifaximin, APRISO®, MOVIPREP® and SOLESTA® - will occur during the American College of Gastroenterology (ACG) 2012 Annual Scientific Meeting. ACG 2012 is being held in Las Vegas, NV, October 19-24, 2012.
XIFAXAN® 550mg/Rifaximin-Related Presentations
Hepatic Encephalopathy
| Poster #926: | Neff et al. “Outcomes in length of hospital stay in cirrhotics admitted for overt hepatic encephalopathy” | |
| Poster #927: | Neff et al. “Long term survival following overt hepatic encephalopathy” | |
| Poster #1348: | Neff et al. “Malnutrition in cirrhotics; daily calorie counts and nutritional deficits uncovered” | |
| Poster #P1349: | Neff et al. “Readmission rates and maintenance of overt hepatic encephalopathy” | |
Other
| Poster #P1571: | Lembo et al. “Responsiveness of a tri-component endpoint in non-constipation irritable bowel syndrome: pooled results from two phase 3 trials, TARGET 1 and TARGET 2” | |
| Poster #P856: | Kim et al. “The effect of rifaximin on staphylococcus species in the stool” | |
| Poster #P1486: | Vizuete et al. “Rifaximin for the treatment of weight loss” | |
APRISO®-Related Presentation
President’s Plenary Session Oral Presentation: Aron et al. “Mesalamine granules 1500 mg once daily for 12 weeks provides adequate relief of IBS symptoms in irritable bowel syndrome with diarrhea: results from a phase 2 trial”
MOVIPREP®-Related Presentation
Plenary Session Oral Presentation: Matro et al. “The incidence of hyponatremia with two commonly prescribed purgatives for colonoscopy – polyethylene glycol 3350 with sports drink (PEG-SD) compared to polyethylene glycol with electrolyte solution (PEG-ELS)”
About XIFAXAN® (rifaximin) 550 mg tablets
Important Safety Information
XIFAXAN 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ³ 18 years of age. In the trials of XIFAXAN for HE, 91 percent of the patients were using lactulose concomitantly. XIFAXAN has not been studied in patients with MELD scores greater than 25, and only 8.6 percent of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C).
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
The most common adverse reactions occurring in greater than eight percent of patients in the clinical study were edema peripheral (15 percent), nausea (14 percent), dizziness (13 percent), fatigue (12 percent), ascites (11 percent), muscle spasms (nine percent), pruritus (nine percent) and abdominal pain (nine percent).
About XIFAXAN® (rifaximin) 200 mg tablets
Rifaximin is a gut-selective antibiotic with negligible systemic absorption and broad-spectrum activity in vitro against both Gram-positive and Gram-negative pathogens. Rifaximin has a similar tolerability profile to that of placebo.
Rifaximin tablets 200 mg, which Salix markets in the U.S. under the trade name XIFAXAN® (rifaximin) tablets 200 mg, currently is approved for the treatment of patients, 12 years of age or older, with travelers’ diarrhea (TD) caused by non–invasive strains of Escherichia coli. XIFAXAN should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli. XIFAXAN should be discontinued if diarrhea symptoms get worse or persist more than 24–48 hours, and alternative antibiotic therapy should be considered. In clinical trials, XIFAXAN was generally well-tolerated. The most common side effects (versus placebo) were flatulence 11.3 percent (versus 19.7 percent), headache 9.7 percent (versus 9.2 percent), abdominal pain 7.2 percent (versus 10.1 percent) and rectal tenesmus 7.2 percent (versus 8.8 percent).
Rifaximin has been used in Italy for 25 years and is approved in 33 countries. Salix acquired rights to market rifaximin in North America from Alfa Wassermann S.p.A. in Bologna, Italy. Alfa Wassermann markets rifaximin in Italy under the trade name Normix®.
About APRISO®
APRISO™ is a locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older. APRISO is contraindicated in patients with hypersensitivity to salicylates, aminosalicylates, or to any of the components of APRISO capsules. The recommended dose of APRISO is four 0.375 g capsules once daily in the morning (1.5 g/day) with or without food. Because dissolution of the coating of APRISO granules depends on pH, APRISO should not be coadministered with antacids. Patients with phenylketonuria should be aware that APRISO contains aspartame, equivalent to 0.56 mg of phenylalanine. In two well-controlled clinical trials, the most common treatment-related adverse events occurring in greater than 3% of adult patients taking 1.5 g/day of APRISO (versus placebo) were headache (11% vs. 8%), diarrhea (8% vs. 7%), upper abdominal pain (5% vs 3%), nausea (4% vs 3%), nasopharyngitis (4% vs 3%), influenza and influenza-like illness (4% vs 4%) and sinusitis (3% vs 3%).
About MOVIPREP® (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution)
Important Safety Information
MOVIPREP® (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. MOVIPREP is
contraindicated in patients with gastrointestinal (GI) obstruction, bowel perforation, gastric retention, ileus, toxic colitis or toxic megacolon, and patients who have had a severe hypersensitivity reaction to any of its components. MOVIPREP should be used with caution in patients at risk of or with fluid and electrolyte abnormalities, hyponatremia, arrhythmias, seizures, in patients with impaired renal function or patients taking concomitant medications that affect renal function, patients with known or suspected inflammatory bowel disease, patients with suspected GI obstruction or perforation, patients at risk for aspiration, and patients with glucose-6-phosphate dehydrogenase deficiency. Most common adverse reactions for split dosing (incidence ³ 5%) are malaise, nausea, abdominal pain, vomiting, and upper abdominal pain. The most common adverse reactions for evening only dosing (incidence ³ 5%) are abdominal distension, anal discomfort, thirst, nausea, abdominal pain, sleep disorder, rigors, hunger, malaise, vomiting, and dizziness. MOVIPREP contains 233 mg of phenylalanine per treatment. Advise patients to hydrate adequately before, during, and after the use of MOVIPREP.
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) 550 mg and 200 mg tablets, 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:
| 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 |
New Documentary, “Wrestling the Monster: Living with Hepatic Encephalopathy,”
Premieres at American College of Gastroenterology 2012 Scientific Meeting
Documentary by Academy Award®-winning director explores the devastating effects on patients
and families of often- untreated liver disease
Raleigh, N.C. – October 19, 2012 – Today Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) announced the premiere screening of “Wrestling the Monster: Living with Hepatic Encephalopathy” at the 2012 American College of Gastroenterology (ACG) Scientific Meeting. The first documentary to focus on hepatic encephalopathy (HE), the film portrays the condition’s disruptive effect on four patients and their families.
“The release of this documentary is a landmark event for HE patients everywhere,” said Carolyn J. Logan, President and Chief Executive Officer, Salix Pharmaceuticals, which sponsored the project in partnership with the American Liver Foundation. “Raising awareness of the condition is more important now than ever before. The number of people with liver disease and cirrhosis continues to increase, and it is critical that we provide the right support for the patients and families living with these conditions. This documentary gives us a rare glimpse into their lives, allowing us to see the disease through the eyes of the patient.”
HE occurs when a damaged liver cannot filter toxins as a healthy liver normally would, allowing these toxins to reach the brain and cause symptoms such as altered personality and loss of cognition and motor skills.1
“Patients with cirrhosis and their caregivers should all be aware of the signs and symptoms of HE,” said Dr. Guy Neff, Chief of Hepatology for Tampa General Medical Group. “HE will not get better without treatment. However, once diagnosed, overt recurrences of HE can be managed and even prevented with the right medication.”
“Wrestling the Monster: Living with Hepatic Encephalopathy” will be shown at a special premiere screening during ACG, Sunday, October 21 at 6:30 pm and 8:00 pm at the TAO Bistro Las Vegas in the Venetian Hotel. Seats are available to ACG attendees and can be reserved by visiting www.HEsBack.com. Following the showing, a panel discussion will take place featuring Donna Cryer, the Chief Executive Officer of the American Liver Foundation.
| 1 | Caruana, Peter and Shah, Neeral. Hepatic encephalopathy: Are NH4 levels and protein restriction obsolete? Practical Gastroenterology. 2011; May 2011:6.http://www.practicalgastro.com/pdf/May11/CaruanaArticle.pdf. |
Cryer will speak from the patient advocacy perspective about HE, liver disease, and the importance of awareness. She will be joined by Dr. Neff.
The film’s director, Cynthia Wade, is an Academy Award®-winning documentary director. Her 2007 film “Freeheld” won the Oscar® for Best Documentary (Short Subject), as well as the Special Jury Grand Prize at the Sundance Film Festival® and 16 other film festival awards worldwide.
“Many HE patients are not receiving the treatment and support they need,” said Wade. “This film was created to capture the stories of patients who often do not have the comprehensive support they desperately need.”
Following the ACG premiere, “Wrestling the Monster: Living with Hepatic Encephalopathy” also will be screened at the American Association for the Study of Liver Diseases November Liver Meeting® in Boston.
About the Documentary Cast
Deborah, age 50, Carlstadt, N.J.
Deborah worked as an accountant, during which time she met her loving and devoted husband, Anthony, and had their daughter, Zoe. But after a cirrhosis diagnosis, she suffered episodes of hepatic encephalopathy, ascites, several hepatic comas, and eventually, liver cancer. A transplant saved her life, but now she and Anthony must try to hold things together through post-transplant complications ranging from persistent ascites to insurance issues and crushing debt from the procedure that saved her life but also changed the family forever.
Jennie, age 65, Sacramento, Calif.
A matriarch and a proud military veteran, Jennie is part of a family of 4 generations of strong women living in close proximity in Sacramento. Over the years, she raised a son and 2 daughters and completed a successful military career. Several years ago she began to suffer debilitating and confusing episodes of hepatic encephalopathy. Her daughters, Elena and Monica, must now juggle caregiver duties while managing their own full-time careers and caring for Elena’s 3 daughters. All the while, Jennie is frustrated with her inability to be the person she used to be—one who took care of others instead of requiring their care.
Mike, age 48, Woodward, Okla.
After years of hard living and struggles with addiction, Mike’s health spiraled out of control when he was diagnosed with cirrhosis, hepatitis C, diabetes, and kidney stones. His recent hepatic coma was a wake-up call. Now he’s trying to get on the transplant list before it’s too late so that he will be around for his son, Joey. But Mike’s angry and sometimes bizarre HE-related outbursts are alienating his wife and caregiver, Sandy, as well as Joey. With Joey’s future and Mike’s life on the line, the stakes have never been higher for this family.
Lynette, age 48, Plant City, Fla.
Lynette’s mind was always going a mile a minute during her career as an executive and HR assistant and payroll manager. She also raised a son and always found time to write—her creative passion. Five years ago, she began to experience memory problems and serious health issues, and eventually she was diagnosed with cirrhosis. Her liver disease has progressed to the point that she needs a transplant and is stricken by episodes of hepatic encephalopathy that change her into someone her friends and loved ones barely even recognize. After years of isolating herself with the disease, she’s finally letting her supportive sister, Monica, get involved. With Monica’s help, Lynette is trying to keep herself in the best possible shape for a transplant—and hold on to the sharp mind that’s always made her who she is.
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.
About the American Liver Foundation
The American Liver Foundation is the nation’s largest non-profit organization focused solely on promoting liver health and disease prevention. The American Liver Foundation achieves its mission in the fight against liver disease by funding scientific research, education for medical professionals, advocacy, information and support programs for patients and their families as well as public awareness campaigns about liver wellness and disease prevention. The mission of the American Liver Foundation is to facilitate, advocate and promote education, support and research for the prevention, treatment and cure of liver disease. Additional information can be found at www.liverfoundation.org or by calling 1 800 GO LIVER (800-465-4837).
®Academy Award and ®Oscar are registered trademarks of the Academy of Motion Picture Arts and Sciences.
®Sundance Film Festival is a registered trademark used for Entertainment Services, Namely, Planning, Managing, and Conducting an International Film Festival and owned by Sundance Enterprises, Inc.
The Liver Meeting® and AASLD are registered trademarks of the American Association for the Study of Liver Diseases.
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. In addition, Salix did not create “Wrestling the Monster: Living with Hepatic Encephalopathy” and does not necessarily endorse or support any statement made in the film.
Please Note: This press release might contain or imply forward–looking statements regarding future events. Actual results might differ materially from those contained in these forward-looking statements for a number of reasons, including: risks of market acceptance of Company 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; 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.