-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Bdoz9AMs7Mxqem03MI9KcCiYKNJjwSXMoDRdmosoYsuzUVLWV2IVBdMZx3IoH2/D kTD5dJj3LX3ptC94P+OAYQ== 0001193125-06-117253.txt : 20060522 0001193125-06-117253.hdr.sgml : 20060522 20060522163511 ACCESSION NUMBER: 0001193125-06-117253 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060522 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060522 DATE AS OF CHANGE: 20060522 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SALIX PHARMACEUTICALS LTD CENTRAL INDEX KEY: 0001009356 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943267443 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23265 FILM NUMBER: 06858912 BUSINESS ADDRESS: STREET 1: 1700 PERIMETER PARK DRIVE CITY: MORRISVILLE STATE: NC ZIP: 27560 BUSINESS PHONE: (919) 862-1000 MAIL ADDRESS: STREET 1: 1700 PERIMETER PARK DRIVE CITY: MORRISVILLE STATE: NC ZIP: 27560 FORMER COMPANY: FORMER CONFORMED NAME: SALIX HOLDINGS LTD DATE OF NAME CHANGE: 19970807 8-K 1 d8k.htm FORM 8-K Form 8-K

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) May 22, 2006

 


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)

1700 Perimeter Park Drive, Morrisville, North Carolina 27560

(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 May 22, 2006, Salix Pharmaceuticals, Ltd. issued a press release announcing the results of one investigator-initiated trial of XIFAXAN® (rifaximin) tablets 200 mg and one investigator-initiated trial of COLAZAL® (balsalazide disodium) Capsules 750 mg that were presented Sunday, May 21, at Digestive Disease Week® 2006.

On May 22, 2006, Salix Pharmaceuticals, Ltd. issued a press release announcing the results of two investigator-initiated trials of XIFAXAN® (rifaximin) tablets 200 mg that were presented today at Digestive Disease Week® 2006.

Copies of these press releases are attached as exhibits.

Item 9.01. Financial Statements and Exhibits.

 

  (c) Exhibits

 

    

Exhibit No.

  

Description

  

99.1

   Press release dated May 22, 2006.
  

99.2

   Press release dated May 22, 2006.


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: May 22, 2006    
   

/s/ Adam C. Derbyshire

    Adam C. Derbyshire
    Senior Vice President and Chief Financial Officer
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

FOR IMMEDIATE RELEASE

 

Contact:    Adam C. Derbyshire    Mike Freeman
   Senior Vice President and    Executive Director, Investor Relations and
   Chief Financial Officer    Corporate Communications
   919-862-1000    919-862-1000

SALIX PHARMACEUTICALS REPORTS DIGESTIVE DISEASE WEEK 2006 UPDATE

Sunday, May 21 – XIFAXAN® Oral Presentation and COLAZAL® Poster

RALEIGH, NC, May 22, 2006 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced results of one investigator-initiated trial of XIFAXAN® (rifaximin) tablets 200 mg and one investigator-initiated trial of COLAZAL® (balsalazide disodium) Capsules 750 mg that were presented Sunday, May 21 at Digestive Disease Week® 2006.

“Salix and our products are well represented at Digestive Disease Week 2006,” stated Bill Forbes, Pharm. D., Vice President, Research and Development, and Chief Development Officer.

“Results from important studies conducted by two leading independent investigators were presented yesterday. In an oral presentation, Mark Pimentel, M.D., discussed results that suggest XIFAXAN provides durable improvement in symptom relief for IBS patients. This durability of improvement which follows the completion of a 10-day course of XIFAXAN is a marked differentiating factor between XIFAXAN therapy and current therapies which require continuous and chronic treatment. Our hope and expectation is that our current Phase 2b trial will help us replicate much of the work that Dr. Pimentel and his colleagues have done with XIFAXAN in IBS.

“Asher Kornbluth, M.D., reported results of a study comparing the ability of COLAZAL and Asacol® to deliver 5-ASA and Nac-5-ASA to the muscosal lining of the distal colon. The striking difference in mucosal concentrations underscores COLAZAL’s ability to deliver 99% of its active ingredient, 5-ASA, to the colon.”


Irritable Bowel Syndrome

Mark Pimentel, M.D., Director, GI Motility Program, Cedars-Sinai Medical Center, Los Angeles, CA, et al. presented a subanalysis of a study designed to investigate the efficacy of XIFAXAN in improving the global symptoms of subjects with irritable bowel syndrome (IBS) meeting the Rome I criteria. This subanalysis evaluates the duration of treatment effect and individual symptom improvement. In this randomized, double-blind, two-center study, subjects underwent a one-week run-in and then completed a symptom questionnaire to score improvement in diarrhea, constipation, bloating and abdominal pain. The 87 subjects were randomized to receive either XIFAXAN 1200 mg daily (400 mg TID) or placebo for 10 days. One week after completion of treatment, and for nine weeks thereafter, subjects repeated the weekly symptom questionnaire. The number of subjects with clinical response (greater than 50% improvement) in each of the symptom categories was determined over the 10-week period. Two endpoints were examined: 1) one week following completion of treatment; and 2) the overall 10-week period. At one week after completing treatment, diarrhea and bloating were statistically improved and constipation and abdominal pain were not statistically improved. For the entire 10-week period, all four symptoms were statistically improved including bloating (p<0.0000001), diarrhea (p<0.00001), abdominal pain (p<0.01) and constipation (p<0.05).

Ulcerative Colitis

Asher Kornbluth, M.D., Associate Clinical Professor of Medicine, Mount Sinai Medical Center and School of Medicine, Mount Sinai IBD Center, New York, NY, et al. investigated ulcerative colitis patients undergoing sigmoidoscopy or colonoscopy to determine distal colonic muscosal concentrations of 5-ASA and Nac-5-ASA following treatment with either balsalazide or pH-dependent mesalamine. Patients underwent routine four quadrant biopsies for assessment of histologic activity and measurements of 5-ASA and Nac-5-ASA concentrations by HPLC. These biopsies were performed by a pathologist, blinded to the patient’s drug treatment, at 5, 15 and 25 cm from the anal verge. Dr. Kornbluth compared 13 patients treated with a mean dose of 6.75 mg/day balsalazide (containing 2.4 gm of 5-ASA) with 17 patients treated with a mean dose of 3.74 gm/day of pH-dependent mesalamine. Mean mucosal 5-ASA concentrations were 102% greater with balsalazide than pH-dependent mesalamine at 5 cm, 84% greater at 15 cm and 102% greater at 25 cm, respectively. Similar differences were seen for mucosal Nac-5-ASA concentrations at each site. Interpatient variability was high in both treatment groups.


Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the Company’s 150-member gastroenterology specialty sales and marketing team.

XIFAXAN® (rifaximin) tablets 200 mg is indicated for the treatment of patients (³ 12 years of age) with travelers’ diarrhea caused by noninvasive 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 (vs. placebo) were flatulence 11.3% (vs. 19.7%), headache 9.7% (vs. 9.2%), abdominal pain 7.2% (vs. 10.1 %) and rectal tenesmus 7.2% (vs. 8.8%).

COLAZAL® (balsalazide disodium) Capsules 750 mg, is an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis. Safety and effectiveness of COLAZAL beyond 12 weeks has not been established. COLAZAL was well tolerated in clinical studies. In clinical trials, patients reported the following adverse events most frequently: headache (8%); abdominal pain (6%); diarrhea (5%); nausea (5%); vomiting (4%); respiratory infection (4%); and arthralgia (4%). Withdrawal from therapy due to adverse events was comparable to placebo.

Salix also markets VISICOL® Tablets, OSMOPREP™ Tablets, AZASAN®, Anusol-HC® Cream 2.5%, Anusol-HC® 25 mg Suppository, Proctocort® Cream 1% and Proctocort® Suppositories. MOVIPREP® and granulated mesalamine are under development.

Salix trades on the NASDAQ National Market under the ticker symbol “SLXP”.


For more information on Salix please call 919-862-1000 or visit www.salix.com. Information on the web site is not incorporated in Salix’s SEC filings.

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 20-25, 2006, at the Los Angeles Convention Center. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

Please Note: This press release contains forward-looking statements regarding future events. These 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 risks of regulatory review and clinical trials, intellectual property risks, rapid growth and the need to acquire additional products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.

EX-99.2 3 dex992.htm PRESS RELEASE Press Release

Exhibit 99.2

FOR IMMEDIATE RELEASE

 

Contact:   

Adam C. Derbyshire

Senior Vice President and

Chief Financial Officer

919-862-1000

  

Mike Freeman

Executive Director, Investor Relations and

Corporate Communications

919-862-1000

  

SALIX PHARMACEUTICALS REPORTS DIGESTIVE

DISEASE WEEK 2006 UPDATE

Monday, May 22 – Two XIFAXAN® Posters

RALEIGH, NC, MAY 22, 2006—Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced results of two investigator-initiated trials of XIFAXAN® (rifaximin) tablets 200 mg that were presented today at Digestive Disease Week® 2006.

Travelers’ Diarrhea

Herbert L. DuPont, M.D., School of Public Health, University of Texas-Houston and School of Medicine, University of Texas-Houston, Houston, TX, et al. compared the efficacy of the combination of the antibiotic rifaximin and the antimotility agent loperamide with that of each agent administered alone. A total of 319 U.S. subjects, studying in Mexico, with acute diarrhea were randomized in a double-blind study to receive one of three drug regimens: (R) rifaximin 200 mg TID; (L) loperamide four mg initially followed by two mg after each unformed stool; or (R/L) both drugs in the same dosage schedule for three days. Subjects completed a diary each day for five days. Over the five-day period, the median time from first dose of drug until passage of last unformed stool (TLUS) was shorter for both rifaximin-containing regimens: R=23 hours, R/L=19.5 hours and L=41.5 hours (p=0.01). The incidence of treatment failure was lower with the rifaximin-containing regimens: R=7.5%, R/L=6.5% and L=16.3% (p=0.032). The median/mean numbers of unformed stools passed for the duration of illness were lower with R/L 2.5/3.99 than with either treatment alone R 4/6.23 and L 4/6.72 (p=0.002/0.004). In the first 10 hours after dosing, results for TLUS favored loperamide; however, after the first 10 hours, results favored rifaximin-containing regimens. An initial loperamide response was also observed for median number of stools during the first 24 hours: R=2, L=1, R/L=1 (p=0.002). A total of 48 subjects had a TLUS of zero hours: R=10, L=15 and R/L=23 (p=0.049). The study author


summarized that while the loperamide effect was transient with a high rate of continuing diarrhea, rifaximin treatment resulted in clinical cure.

Hepatic Encephalopathy

Melissa Palmer, M.D., Plainview, NY, investigated the efficacy and tolerability of rifaximin for the treatment of stage 1 hepatic encephalopathy (HE) in patients with cirrhosis due to hepatitis C virus. A total of 37 outpatients were treated with rifaximin 400 mg TID for 14 days. Patients were assessed 24 hours prior to the start of therapy and 14 days after completion of therapy for multiple parameters, including ability to perform mental tasks, asterixis and a quality of life composite score. Twenty-three patients were receiving pegylated interferon plus ribavirin for chronic HCV and 17 of these patients also were receiving a selective serotonin reuptake inhibitor for mild IFN-induced depression. Type 2 diabetes mellitus was reported in 12 patients. Rifaximin treatment lowered serum ammonia to normal levels in all patients, and overall, HE symptoms improved. Rifaximin was well tolerated, with a low incidence of adverse events, and all patients completed treatment.

Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the Company’s 150-member gastroenterology specialty sales and marketing team.

XIFAXAN® (rifaximin) tablets 200 mg is indicated for the treatment of patients (> 12 years of age) with travelers’ diarrhea caused by noninvasive 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 (vs. placebo) were flatulence 11.3% (vs. 19.7%), headache 9.7% (vs. 9.2%), abdominal pain 7.2% (vs. 10.1 %) and rectal tenesmus 7.2% (vs. 8.8%).


Salix also markets COLAZAL® Capsules 750 mg, VISICOL® Tablets, OSMOPREP™ Tablets, AZASAN®, Anusol-HC® Cream 2.5%, Anusol-HC® 25 mg Suppository, Proctocort® Cream 1% and Proctocort® Suppositories. MOVIPREP® and granulated mesalamine are under development.

Salix trades on the NASDAQ National Market under the ticker symbol “SLXP”.

For more information on Salix please call 919-862-1000 or visit www.salix.com. Information on the web site is not incorporated in Salix’s SEC filings.

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 20-25, 2006, at the Los Angeles Convention Center. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

Please Note: This press release contains forward-looking statements regarding future events. These 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 risks of regulatory review and clinical trials, intellectual property risks, rapid growth and the need to acquire additional products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.

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