-----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, C4kopppAwkRKYWgz0OhCv9NE4Nl5EQ2UBSfTcG0xM9ZtdKBnNgbUCxfq3g4F5Cm1 Xczs+ChcjVzG+csjojr1ZA== 0000931763-01-502567.txt : 20020413 0000931763-01-502567.hdr.sgml : 20020413 ACCESSION NUMBER: 0000931763-01-502567 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20011227 ITEM INFORMATION: Other events FILED AS OF DATE: 20011227 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: 1823876 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.txt 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) December 27, 2001 SALIX PHARMACEUTICALS, LTD. -------------------------------------------------------------------- (Exact name of registrant as specified in its charter) British Virgin Islands -------------------------------------------------------------------- (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) (919) 862-1000 - ------------------------------------------------------------------------------ Registrant's telephone number, including area code Item 5. Other Events On December 27, 2001, Salix issued a press release to announce the filing with the U. S. Food and Drug Administration of a new drug application for rifaximin. A copy of this press release is attached as an exhibit. 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: December 27, 2001 /s/ Adam C. Derbyshire ----------------------------------- Adam C. Derbyshire, Vice President and Chief Financial Officer EX-99.1 3 dex991.txt PRESS RELEASE DATED DEC. 27, 2001 Exhibit 99.1 Thursday December 27, 9:01 am Eastern Time Press Release SOURCE: Salix Pharmaceuticals, Ltd. Salix Pharmaceuticals Submits New Drug Application for Rifaximin for the Treatment of Travelers' Diarrhea RALEIGH, N.C.--(BW HealthWire)--Dec. 27, 2001--Salix Pharmaceuticals, Ltd. (Nasdaq:SLXP) today announced its submission of a New Drug Application ---- (NDA) for rifaximin to the U.S. Food and Drug Administration (FDA). The Company is seeking approval to market rifaximin for the treatment of travelers' diarrhea. Rifaximin is a novel, broad-spectrum antibiotic that belongs to the rifamycin class of antibiotics. The drug is chemically structured to deliver high concentrations of antibiotic to the gastrointestinal tract while remaining minimally absorbed outside the gastrointestinal tract. Salix licensed U.S. and Canadian rights to rifaximin from Alfa Wassermann S.p.A. Currently, the product is marketed in Italy by Alfa Wassermann under the trade name Normix(R) and is licensed by Alfa Wassermann in Mexico to GlaxoSmithKline and Schering-Plough under the respective trade names RedActiv(R) and Flonorm(R). 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 proprietary therapeutic drugs which have an existing database of positive, late-stage clinical data; complete the development and regulatory submission of these products; and market them through the Company's gastroenterology specialty sales force. Salix's lead product is COLAZAL(TM), an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis. 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 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.salixpharm.com. ------------------ 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 the risks of regulatory review and clinical trials, the need to acquire additional products, and management of rapid growth. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission. - -------------- Contact: Salix Pharmaceuticals, Ltd., Raleigh Adam C. Derbyshire or Mike Freeman, 919/862-1000 -----END PRIVACY-ENHANCED MESSAGE-----