-----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, TpFdfF+Ynx7802J8j5gIjTp3mMVkKYMf1Da85/P0g9bkMaZWcKGF+mxpR0h5T7Qt iI+yC3O9LF9bbSIbd3Go9Q== 0001193125-06-118757.txt : 20060524 0001193125-06-118757.hdr.sgml : 20060524 20060524155703 ACCESSION NUMBER: 0001193125-06-118757 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060524 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060524 DATE AS OF CHANGE: 20060524 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: 06864305 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 24, 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 24, 2006, Salix Pharmaceuticals, Ltd. issued a press release announcing results of one investigator-initiated trial of XIFAXAN® (rifaximin) tablets 200 mg presented today at Digestive Disease Week® 2006. A copy of this press release is attached as an exhibit.

Item 9.01. Financial Statements and Exhibits.

 

  (c) Exhibits

 

Exhibit No.  

Description

99.1   Press release dated May 24, 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 24, 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

Wednesday, May 24 – One XIFAXAN® Poster

RALEIGH, NC, May 24 2006 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced results of one investigator-initiated trial of XIFAXAN® (rifaximin) tablets 200 mg presented today at Digestive Disease Week® 2006.

Pouchitis

Blair Lewis, M. D., Mount Sinai Medical Center, New York, NY et al. evaluated the efficacy and tolerability of rifaximin in the treatment of patients with refractory pouchitis. A total of 16 patients participated in the study. Patients who had a diagnosis of pouchitis, confirmed by means of pouchoscopy with severity defined as moderate-severe using the Pouchitis Disease Activity Index, participated in the study. All patients were refractory to all therapies including metronidazole, ciprofloxacin and probitoic therapy with VSL-3, Lactobacillus or Saccaromyces boullardi, including six patients who had also failed treatment with budesonide. A total of 11 patients were treated with rifaximin 400 mg BID and five patients were treated with rifaximin 200 mg TID. Significant improvement was demonstrated in 82% of patients treated with 400 mg BID and in 80% of patients treated with 200 mg TID. All patients with clinical response improved within 3 weeks and there were no adverse effects reported as a result of treatment. All patients with previously medically refractory pouchitis who responded to rifaximin continued maintenance therapy with a mean dose of 400 mg per day and sustained clinical improvement during a mean follow-up period of 16 weeks.

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%).

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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