-----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, NlDa4j0JOfYrGA6Db8eaOFSPGWIAtaVtcsK8GIZBMe0ucyzuxlwHd5zy+8ZRcX6L ghu000AVXruBKtTyQumNAQ== 0001193125-05-110732.txt : 20050518 0001193125-05-110732.hdr.sgml : 20050518 20050518161328 ACCESSION NUMBER: 0001193125-05-110732 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050518 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050518 DATE AS OF CHANGE: 20050518 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: 05841928 BUSINESS ADDRESS: STREET 1: 8540 COLONNADE CENTER DR STREET 2: SUITE 501 CITY: RALEIGH STATE: NC ZIP: 27615 BUSINESS PHONE: 9198621000 MAIL ADDRESS: STREET 1: 8540 COLONNADE CENTER DR STREET 2: SUITE 501 CITY: RALEIGH STATE: NC ZIP: 27615 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 18, 2005

 


 

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 18, 2005, Salix Pharmaceuticals, Ltd. issued a press release announcing reported results of three investigator-initiated trials of XIFAXAN (rifaximin) tablets 200 mg that are being presented at Digestive Disease Week® 2005 (DDW). A copy of this press release is attached hereto and incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

  (c) Exhibits

 

Exhibit No.

 

Description


99.1   Press release dated May 18, 2005.

 

 


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 18, 2005    
   

/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

 

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

 

SALIX PHARMACEUTICALS REPORTS

DIGESTIVE DISEASE WEEK UPDATE

 

XIFAXAN Investigated in Crohn’s Disease and Small Bowel Bacterial Overgrowth

 

RALEIGH, NC, May 18, 2005 - Salix Pharmaceuticals, Ltd. (Nasdaq:SLXP) today reported results of three investigator-initiated trials of XIFAXAN (rifaximin) tablets 200 mg that are being presented at Digestive Disease Week® 2005 (DDW) today. These posters are available for viewing from 8:00 a.m. until 5:00 p.m. today. The investigators have been requested to be present at their respective posters from 12:00 noon until 2:00 p.m.

 

Mild-Moderate Crohn’s Disease

 

Dr. Asher Kornbluth, Associate Clinical Professor of Medicine at Mount Sinai School of Medicine, et al. conducted a trial in 30 Crohn’s patients to assess the efficacy and tolerability of rifaximin in patients with mild-moderate Crohn’s disease who had failed multiple baseline therapies. Rifaximin was dosed 600 mg daily (200mg TID) in 10 patients and 800 mg daily (400 mg BID) in 20 patients. Clinical outcome, assessed using the Present-Korelitz score, was dependent on disease location; 43% of patients with ileitis improved, 67% of patients with ileocolitis improved and 63% of patients with colitis improved. The only adverse event was oral thrush in 1 patient.

 

Severe Crohn’s Disease

 

Dr. Ellen Scherl, Associate Professor of Medicine, Joan and Sanford I. Weill Medical College, Cornell University, and Director, Inflammatory Bowel Disease Center, New York Presbyterian Hospital, et al. investigated the efficacy and tolerability of rifaximin 800 mg daily (400 mg BID) in 8 patients with severe Crohn’s disease refractory to conventional therapy. Rifaximin was


dosed from 10 days to 5 months and the median time to response was 8.9 days. Patients experienced a mean improvement in Harvey Bradshaw index (a clinical index of Crohn’s disease activity) of 63.1%.

 

Small Bowel Bacterial Overgrowth

 

Dr. Leonard Baidoo, Graduate Hospital, Philadelphia, PA, et al. investigated the efficacy and tolerability of rifaximin 800 mg daily (400 mg BID) for 14 days in 14 patients with lactulose breath test-documented small bowel bacterial overgrowth. Patients in the study had underlying diagnoses of Crohn’s disease, scleroderma or mixed connective tissue disorder. In this open label study mean time to onset of response was 4 days and mean time to complete remission was 10 days. Thirteen of the 14 patients responded, and 92% of responding patients had complete remission and 8% reported a greater than 50% response. Mean bowel frequency decreased from 9 daily to 2 daily and all patients reported decreased fecal urgency and complete resolution of abdominal pain. No adverse events were reported.

 

Digestive Disease Week (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 (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 14-19, 2005 in Chicago. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, please visit www.ddw.org.

 

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 100-member gastroenterology specialty sales and marketing team. XIFAXAN (rifaximin) tablets 200 mg are indicated for the treatment of patients (³12 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%).

 

For full prescribing information on Xifaxan, please visit www.salix.com.

 

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

 

For more information please contact the Company at 919-862-1000 or visit our web site at www.salix.com. Information on our web site is not incorporated in our SEC filings.

 

XIFAXAN is licensed from Alfa Wassermann SpA.

 

###

 

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 market acceptance for approved products, management of rapid growth, intellectual property risks, 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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