-----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, D4Im6rEnzRdzReMVMVk35FUKpqZXYzSEJwGvJMVhac/yFCnYGMpvDC+zoEAlsQHz /rQTles2ZhaTNS8Dg4eSnw== 0001193125-03-063878.txt : 20031020 0001193125-03-063878.hdr.sgml : 20031020 20031020104525 ACCESSION NUMBER: 0001193125-03-063878 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20031020 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20031020 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: 03947180 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) October 20, 2003

 


 

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)

 

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

 


 


Item 5. Other Events and Regulation FD Disclosure

 

On October 20, 2003, Salix Pharmaceuticals, Ltd. (the “Registrant”) issued a press release announcing the signing of an agreement with Chong Kun Dang Pharmaceutical Corporation (CKD) of Seoul, Korea to market the Registrant’s drug product, COLAZAL®, for the treatment of mild to moderate ulcerative colitis in the Republic of Korea. A copy of this press release is attached as an exhibit hereto.

 

Item 7. Financial Statements and Exhibits.

 

(c) Exhibits

 

Exhibit No.

  

Description


99.1   

Press release dated October 20, 2003, announcing the signing of an agreement with Chong Kun Dang Pharmaceutical Corporation (CKD) of Seoul, Korea to market the Registrant’s drug product, COLAZAL®, for the treatment of mild to moderate ulcerative colitis in the Republic of Korea.

 


SIGNATURES

 

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 hereunto duly authorized.

 

    SALIX PHARMACEUTICALS, LTD.
     
     
Date: October 20, 2003  

By:     /s/ Adam C. Derbyshire


   

Adam C. Derbyshire

Senior Vice President and Chief Financial Officer

     
     

 

EX-99.1 3 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

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 ANNOUNCES KOREAN STRATEGIC PARTNERSHIP WITH

CHONG KUN DANG (CKD) PHARMACEUTICAL CORPORATION

 

CKD Will Market COLAZAL® in the Republic of Korea

Salix Receives First Right of Negotiation for CKD GI Products in the United States

 

Raleigh, NC, October 20, 2003—Salix Pharmaceuticals, Ltd (Nasdaq:SLXP) today announced the signing of an agreement with Chong Kun Dang Pharmaceutical Corporation (CKD) of Seoul, Korea to market Salix’s drug product, COLAZAL®, for the treatment of mild to moderate ulcerative colitis in the Republic of Korea. Chong Kun Dang is one of South Korea’s leading pharmaceutical companies with 2002 sales of over $300M. CKD markets ethical products in the cardiovascular, anti-infective and gastrointestinal disease therapeutic areas through a sales force of 300 medical representatives. As part of the agreement, Salix also will have a first right of negotiation for all CKD gastrointestinal products available for commercialization in the U.S.

 

The prevalence and incidence of ulcerative colitis in Korea have been increasing in recent years and are expected to continue to increase. The prevalence of ulcerative colitis doubled between 1997 and 2001 and the annual incidence of the disease experienced a six-fold increase over the time period 1985 to 2001. Factors contributing to these increases include trends toward the westernization of diet and lifestyle and improved effectiveness of diagnosis.

 

“We are extremely pleased and excited by our new collaboration with CKD and the opportunities this Agreement presents for both companies,” noted Carolyn Logan, President and CEO of Salix. “The Korean ulcerative colitis market is smaller than that of the United States, but is growing at a compounded annual growth rate of 25%. We are enthusiastic about the possibility of bringing, COLAZAL, the fastest growing 5-ASA product in the United States, to Korean physicians and

 


patients to help meet the growing medical need for treating ulcerative colitis. COLAZAL continues to do well in the US market, achieving a new high in weekly total prescriptions for the first week of October,” added Ms. Logan.

 

In a related announcement, CKD President, Jung-Woo Kim, Ph.D. stated that CKD plans to obtain regulatory and marketing approval for COLAZAL in Korea as soon as possible and intends to launch in the second half of 2005. Dr. Kim also noted that the success of COLAZAL in the Korean marketplace should be aided greatly by the strong international reputation the drug has gained since its launch in the United States and Europe.

 

The collaboration on other CKD GI products also may be advantageous for both parties. The strategic alliance allows for the possible commercialization of CKD’s gastrointestinal products in the North American market while providing Salix access to additional products.

 

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 84-member gastroenterology specialty sales and marketing team. Salix’s first marketed product is COLAZAL®, 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. The Company launched the product in the U.S. through its specialty sales force in January 2001. 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’s next product candidate is Rifaximin, currently in development for the potential treatment of infections of the gastrointestinal tract. The Company submitted an NDA for Rifaximin for the treatment of travelers’ diarrhea to the FDA on December 26, 2001. The Company received an approvable letter from the FDA on October 25, 2002 and is currently working with the FDA to complete the approval process. In July 2002, Salix acquired exclusive U.S. development and

 


marketing rights to a Granulated Mesalamine product. The Company intends to complete the development work required to secure regulatory approval for the product in the U.S. 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.

 

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, risks of regulatory review and clinical trials, 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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