-----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, HCbNBIRpmU/GMvBCOEKMmTOuOwQIlSAZ+vbRmivKoCbf+PTzc4GIA1//M/pLV2dU snSnR9ojec0TRcyDx2NyKA== 0000912057-02-040774.txt : 20021104 0000912057-02-040774.hdr.sgml : 20021104 20021104155705 ACCESSION NUMBER: 0000912057-02-040774 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20021104 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20021104 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TRIANGLE PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001022622 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 561930728 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21589 FILM NUMBER: 02808377 BUSINESS ADDRESS: STREET 1: 4611 UNIVERSITY DRIVE CITY: DURHAM STATE: NC ZIP: 27707 BUSINESS PHONE: 9194935980 MAIL ADDRESS: STREET 1: 4611 UNIVERSITY DRIVE CITY: DURHAM STATE: NC ZIP: 27707 8-K 1 a2092660z8-k.txt 8-K 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) November 4, 2002 ---------------------------- TRIANGLE PHARMACEUTICALS, INC. - ------------------------------------------------------------------------------- (Exact name of registrant as specified in its charter) DELAWARE 000-21589 56-1930728 - ----------------------------- ------------------ ------------------------- (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 4 University Place, 4611 University Drive, Durham, North Carolina 27707 - ------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (919) 493-5980 ---------------------------- - ------------------------------------------------------------------------------- (Former name or former address, if changed since last report) Item 5. Other Events On November 4, 2002, Triangle Pharmaceuticals, Inc. issued a press release, a copy of which is attached hereto as Exhibit 99.1, and is incorporated herein by reference. Item 7. Financial Statements and Exhibits. (c) Exhibits. The following document is incorporated by reference to this Report: 99.1 Press release dated November 4, 2002. SIGNATURES Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. Triangle Pharmaceuticals, Inc. --------------------------------------- (Registrant) November 4, 2002 /s/ Daniel G. Welch. - ------------------------------- --------------------------------------- Date (Signature) Name: Daniel G. Welch Title: Chairman and Chief Executive Officer EX-99.1 3 a2092660zex-99_1.txt EXHIBIT 99.1 EXHIBIT 99.1 CONTACT: Mr. Daniel G. Welch Mr. Robert F. Amundsen, Jr. Chairman and Chief Executive Executive Vice President and Chief Officer Financial Officer Triangle Pharmaceuticals, Inc. Triangle Pharmaceuticals, Inc. (919) 493-5980 (919) 493-5980 www.tripharm.com www.tripharm.com FOR IMMEDIATE RELEASE: COVIRACIL(R)NDA FOR THE TREATMENT OF HIV DISEASE ACCEPTED BY THE FOOD AND DRUG ADMINISTRATION DURHAM, N.C., NOVEMBER 4, 2002 -- Triangle Pharmaceuticals, Inc. (Nasdaq: VIRS) announced today that the U.S. Food and Drug Administration (FDA) has notified the Company that its New Drug Application (NDA) for marketing approval of Coviracil for the treatment of HIV disease has been accepted for filing. Filing of the NDA is recognition by the FDA that the application is sufficiently complete for review. "We are very pleased with this notification," commented Daniel G. Welch, Chairman and Chief Executive Officer of Triangle. He continued, "Consistent with our previous guidance when we submitted our NDA, the FDA granted Coviracil a standard review. This means that as early as the third quarter of 2003, we hope to have our first NDA approved. We believe, once approved, Coviracil will offer patients and physicians an important new medicine for the management of HIV disease. We will now turn our efforts to completion of the review process with the FDA to work towards the timely approval of Coviracil." Coviracil is a potent, once-a-day Nucleoside Reverse Transcriptase Inhibitor (NRTI). The NDA includes data from over 2,000 patients and is supported by two pivotal trials, FTC-303 and FTC-301. Triangle expects to file a European Marketing Authorisation Application (MAA) by December 31, 2002. Triangle Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the development of new antiviral drug candidates, with a particular focus on therapies for the human immunodeficiency virus (HIV) and the hepatitis B virus. Triangle's proprietary drug candidates under development for HIV and/or hepatitis B include Coviracil(R) (emtricitabine), amdoxovir (formerly DAPD), and clevudine (formerly L-FMAU). Triangle is also developing immunotherapies for hepatitis B in collaboration with Dynavax Technologies Corporation (Dynavax) utilizing Dynavax' immunostimulatory sequence (ISS) technology. More information about Triangle's portfolio, management and product development strategy is available on Triangle's website. STATEMENTS IN THIS PRESS RELEASE THAT ARE NOT HISTORICAL FACTS ARE FORWARD-LOOKING STATEMENTS AND ARE SUBJECT TO NUMEROUS RISKS AND UNCERTAINTIES, INCLUDING THE RISK THAT WE MAY NOT SUBMIT OUR COVIRACIL MAA AS PLANNED AND OUR COVIRACIL NDA OR MAA MAY NOT RECEIVE REGULATORY APPROVAL, OR IF APPROVED, COVIRACIL MAY NOT ACHIEVE MARKET ACCEPTANCE OR THE MEDICAL RESULTS WE EXPECT. THESE AND OTHER RISKS ARE DISCUSSED IN DETAIL FROM TIME TO TIME IN OUR FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION. AS A RESULT OF THESE AND OTHER RISKS AND UNCERTAINTIES, ACTUAL RESULTS MAY DIFFER MATERIALLY FROM THOSE PREDICTED IN THIS PRESS RELEASE. TRIANGLE DISCLAIMS ANY OBLIGATIONS TO UPDATE ANY FORWARD-LOOKING STATEMENTS IN THIS PRESS RELEASE. -----END PRIVACY-ENHANCED MESSAGE-----