-----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, CD1TYg893cEpEb9U+3NIMFkho9nKMMoClPWtprMJOR3+JOScmPFnQ1+fRtRCfD6J 3XiE9uPFnRniVsXjImc32Q== 0001193125-05-109953.txt : 20050517 0001193125-05-109953.hdr.sgml : 20050517 20050517170006 ACCESSION NUMBER: 0001193125-05-109953 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050517 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050517 DATE AS OF CHANGE: 20050517 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: 05839416 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 17, 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 17 2005, Salix Pharmaceuticals, Ltd. issued a press release announcing it will report results of an investigator-initiated trial of XIFAXAN (rifaximin) at Digestive Disease Week® 2005 (DDW) today. A copy of this press release is attached as Exhibit 99.1.

 

Additionally on May 17, 2005, Salix Pharmaceuticals, Ltd. issued a press release announcing it will present at UBS Global Pharmaceuticals Conference in New York, NY on Tuesday, May 24 at 3:00 p.m. ET. A copy of this press release is attached as Exhibit 99.2.

 

Item 9.01. Financial Statements and Exhibits.

 

  (c) Exhibits

 

Exhibit No.

  

Description


99.1    Press release dated May 17, 2005.
99.2    Press release dated May 17, 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 17, 2005

   
   

/s/ Adam C. Derbyshire


   

Adam C. Derbyshire

   

Senior Vice President and Chief Financial Officer

EX-99.1 2 dex991.htm PRESS RELEASE DATED MAY 17, 2005 Press release dated May 17, 2005

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

 

Rifaximin Investigated in Small Intestinal Bacterial

Overgrowth in Irritable Bowel Syndrome

 

RALEIGH, NC, May 17, 2005 - Salix Pharmaceuticals, Ltd. (Nasdaq:SLXP) today reported results of an investigator-initiated trial of rifaximin that are being presented at Digestive Disease Week® 2005 (DDW) today. The poster is available for viewing from 8:00 a.m. until 5:00 p.m. today. The investigator has been requested to be present at the poster from 12:00 noon until 2:00 p.m.

 

Small Intestinal Bacterial Overgrowth in Irritable Bowel Syndrome

 

Dr. Cristiano Lauritano, Gemelli Hospital, Catholic University of Rome, et al. conducted a study to investigate the efficacy and tolerability of three doses of rifaximin in 90 irritable bowel syndrome patients affected by small intestinal bacterial overgrowth. The diagnosis of irritable bowel syndrome was based on the Rome II criteria and the presence of small intestinal bacterial overgrowth was based on a glucose breath test. Patients were treated for 7 days with rifaximin dosed at either 600 mg daily, 800 mg daily or 1200 mg daily. Glucose breath test was reassessed one month after the end of therapy. Glucose breath test normalization rate was 60.0% in patients treated with rifaximin 1200 mg daily (p<0.05, compared to other treatment groups), 26.6% in patients treated with 800 mg daily and 16.6% in patients treated with 600 mg daily. No significant differences in patient compliance and incidence of adverse events were reported among the groups.


Schedule information on upcoming poster presentations is provided below:

 

TOPIC


  

LEAD AUTHOR


  

DATE/TIME*


Moderate to Severe Crohn’s Disease

   Dr. Brian Bosworth    May 18

Mild-Moderate Crohn’s Disease

   Dr. Asher Kornbluth    May 18

Small Bowel Bacterial Overgrowth

   Dr. Leonard Baidoo    May 18

* Posters are available for viewing from 8:00 a.m. until 5:00 p.m. on the day listed above. Investigators are requested to be present at their respective poster from 12:00 noon until 2:00 p.m.

 

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.

EX-99.2 3 dex992.htm PRESS RELEASE DATED MAY 17, 2005 Press release dated May 17, 2005

Exhibit 99.2

 

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 TO PRESENT AT

UBS GLOBAL PHARMACEUTICALS CONFERENCE

 

RALEIGH, NC, May 17, 2005 - Salix Pharmaceuticals, Ltd. (Nasdaq:SLXP) today announced that the Company will present at UBS Global Pharmaceuticals Conference in New York, NY on Tuesday, May 24 at 3:00 p.m. ET.

 

Interested parties can access a live audio web cast of the presentation at http://www.salix.com. A replay of the presentation will be available at the same location.

 

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. Salix markets COLAZAL®, XIFAXAN, AZASAN®, ANUSOL-HC® and PROCTOCORT®. A granulated mesalamine product also is under development. 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.

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