-----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, DU2DEDSPvhcKnaE6kCr6654ivp5p3N02Ivcsy87xIDbRsWZ0bQwH1zbDQDsyYwN+ 8/bOFr+J0ZaxOAX3V+x6+A== 0001193125-04-171314.txt : 20041014 0001193125-04-171314.hdr.sgml : 20041014 20041014114045 ACCESSION NUMBER: 0001193125-04-171314 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20041014 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041014 DATE AS OF CHANGE: 20041014 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: 041078284 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
   

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 14, 2004

 

 

 

SALIX PHARMACEUTICALS, LTD.
(Exact name of registrant as specified in its charter)

 

 

Delaware   000-23265   94-3267443

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

 

8540 Colonnade Center Drive, Suite 501, Raleigh, North Carolina   27615
(Address of principal executive offices)   (Zip Code)

 

 

Registrant’s telephone number, including area code       (919) 862-1000

 

 

 

 
(Former name or former address, if changed since last report)

 

 

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 (see General Instruction A.2. below):

 

¨ 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 14, 2004, Salix Pharmaceuticals, Ltd. issued a press release reporting on Company-related activities that will take place over the next several days at the 2004 Annual Scientific Assembly of the American Academy of Family Physicians (AAFP) in Orlando, Florida. A copy of this press release is attached.

 

Item 9.01. Financial Statements and Exhibits.

 

  (c) Exhibits

 

Exhibit No.

 

Description


99.1   Press release dated October 14, 2004.


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 14, 2004    
   

/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 ON AMERICAN

ACADEMY OF FAMILY PHYSICIANS ACTIVITIES

 

RALEIGH, NC, October 14, 2004 - Salix Pharmaceuticals, Ltd. (Nasdaq:SLXP) today reported on Company-related activities that will take place over the next several days at the 2004 Annual Scientific Assembly of the American Academy of Family Physicians (AAFP) in Orlando, FL. AAFP 2004 will provide a venue for Salix to introduce XIFAXAN (rifaximin) tablets 200 mg to more than 94,000 primary health care providers.

 

Salix is supporting, by means of an unrestricted educational grant, a continuing educational symposium for general practitioners entitled: “New Perspectives in Managing Infectious Diarrhea in the Traveler: A Focus on Prevention and Post-Infectious Complications.” A faculty of nationally recognized key opinion leaders comprised of Robert E. Rakel, M.D., Herbert L. DuPont, M.D. and Henry Lin, M.D. will address issues related to the epidemiology, diagnosis and current and new management strategies for travelers’ diarrhea.

 

Commenting on the Company’s presence and activities at AAFP, Ms. Carolyn Logan, President and CEO, stated, “Salix looks forward to this first opportunity to meet face-to-face with and introduce XIFAXAN to family physicians. We anticipate that these primary care providers will be very receptive to XIFAXAN, a nonabsorbed, gut-selective antibiotic, as a significant new addition to currently available systemic antibiotic therapy for the treatment of travelers’ diarrhea.”


Salix licensed rifaximin from Alfa Wassermann S.p.A. More than 500 million tablets of rifaximin have been sold/distributed in Italy since its approval in 1987. Currently, rifaximin is approved in 17 countries worldwide.

 

XIFAXAN (rifaximin) tablets 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 tablets and other Salix products, please visit www.salix.com.

 

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”.

 

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 products, our reliance on our first few products including specifically COLAZAL and XIFAXAN, intellectual property risks, management of 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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