-----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, TCTxF3xNm2M6eqZI8vCxkMZQtK0br0PcE5JJ3NoB8Nd7AQS/Z+9LctwpHLZCKg5Y T49bw6SE037aZma2GBDCdQ== 0000912057-99-009781.txt : 19991220 0000912057-99-009781.hdr.sgml : 19991220 ACCESSION NUMBER: 0000912057-99-009781 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19991210 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19991217 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: SEC FILE NUMBER: 000-21589 FILM NUMBER: 99776496 BUSINESS ADDRESS: STREET 1: 4 UNIVERSITY PLACE STREET 2: 4611 UNIVERSITY DRIVE CITY: DURHAM STATE: NC ZIP: 27707 BUSINESS PHONE: 9194935980 MAIL ADDRESS: STREET 1: 4 UNIVERSITY PLACE STREET 2: 4611 UNIVERSITY DRIVE CITY: DURHAM STATE: NC ZIP: 27707 8-K 1 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 DECEMBER 10, 1999 (Date of Report - earliest event reported) TRIANGLE PHARMACEUTICALS, INC. (Exact name of registrant as specified in charter) DELAWARE 000-21589 56-1930728 (State of incorporation (Commission (IRS Employer or organization) File Number) Identification No.) 4 University Place, 4611 University Drive, Durham, North Carolina 27707 Registrant's telephone number, including area code: (919)493-5980 NONE -------------------------------------------------------------- (Former name or former address, if changed since last report.) Item 5. OTHER EVENTS. On December 10, 1999, we issued a press release announcing that the Food and Drug Administration, following extensive discussions with us, advised us that we would need to conduct one or possibly two additional Phase III studies in order to prove that regimens containing Coactinon(R) are equivalent or superior to current first line regimens used to treat HIV-infected patients. The press release has been filed as an exhibit to this Current Report on Form 8-K. Item 7. EXHIBITS. 99.1 Press Release dated December 10, 1999. 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. TRIANGLE PHARMACEUTICALS, INC. DATE: December 17, 1999 By: /s/ David W. Barry --------------------------------- Name: David W. Barry, M.D. Title: Chairman and Chief Executive Officer TRIANGLE PHARMACEUTICALS, INC. FORM 8-K EXHIBIT INDEX EXHIBIT NUMBER DOCUMENT DESCRIPTION - ------- -------------------- 99.1 Press Release dated December 10, 1999. EX-99.1 2 EXHIBIT 99.1 EXHIBIT 99.1 CONTACT: Peter A. Arakelian Douglas MacDougall Director of Investor and Public Relations Priscilla Harlan Triangle Pharmaceuticals, Inc. Feinstein Kean Healthcare (919) 493-5980 (617) 577-8110 www.tripharm.com www.fkhealth.com For Immediate Release - --------------------- TRIANGLE PHARMACEUTICALS ANNOUNCES THAT ADDITIONAL PHASE III STUDIES FOR COACTINON(R) (EMIVIRINE) ARE REQUIRED DURHAM, N.C. - DECEMBER 10, 1999 - Triangle Pharmaceuticals, Inc. (Nasdaq: VIRS) today announced that the Food and Drug Administration (FDA), following extensive discussions with the Company, has advised Triangle that it would need to conduct one or possibly two additional Phase III studies in order to prove that regimens containing Coactinon are equivalent or superior to current first line regimens used to treat HIV-infected patients. Over the first half of 2000, Triangle Pharmaceuticals will review the results of an ongoing study, MKC-401, which compares the use of Coactinon in conjunction with stavudine and Coviracil(R) (emtricitabine) with a regimen of abacavir, stavudine and Coviracil. This study will determine whether the profile of Coactinon justifies the initiation of additional studies. David W. Barry, M.D., Chairman and Chief Executive Officer of Triangle, commented, "It is always disappointing to learn that the requirement of additional studies will lead to delay or discontinuation of the development of a drug candidate, but we believe it is a wise decision to allocate our resources to those drug candidates which we believe offer the most significant incremental benefit to patients suffering from HIV or hepatitis B infection. The reallocation of resources will provide greater support for the continuing development of our other drugs, including Coviracil, for which we plan to submit a New Drug Application (NDA) in late 2000." 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, including the acquired immunodeficiency syndrome (AIDS), and hepatitis B virus (HBV). Triangle drug candidates under development for HIV and/or HBV include Coactinon(R) (emivirine), Coviracil(R) (emtricitabine), DAPD, L-FMAU and DMP-450. More information about Triangle's portfolio, management and product development strategy is available on Triangle Pharmaceuticals' website at HTTP://WWW.TRIPHARM.COM. Statements in this press release may constitute forward-looking statements and are subject to numerous risks and uncertainties, including the failure to successfully complete pivotal clinical trials, the Company's future capital needs, the inability to commercialize Coviracil(R) (emtricitabine) and DAPD due to patent rights held by third parties, the Company's ability to obtain additional funding (including contingent contractual milestones), patent protection and required regulatory approvals for its drug candidates, the development of competitive products by others, the cost of coactive therapy and the extent to which coactive therapy achieves market acceptance, the Company's success in identifying new drug candidates, acquiring rights to the candidates on favorable terms and developing any candidates to which the Company acquires any rights, and these and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. The actual results may differ materially from those projected in this press release. The Company disclaims any obligations to update the statements in this press release. -----END PRIVACY-ENHANCED MESSAGE-----