PRNewswire - October 26, 1999

The data will be presented by Triangle on October 26, 1999 at the 7th European Conference on Clinical Aspects and Treatments of HIV Infection being held in Lisbon. This is one of the pivotal Phase II/III trials Triangle is conducting with Coactinon and the first of several studies utilizing PI- sparing regimens. These data will be used to support the NDA filing for Coactinon.

"In this pivotal trial, Coactinon, in combination with d4T and 3TC, demonstrated good anti-HIV activity at doses of 750 mg twice-a-day," said Franck S. Rousseau, M.D., Executive Vice President, Medical Affairs and Chief Medical Officer of Triangle Pharmaceuticals. "Of patients receiving Coactinon at 24 weeks, 83% had undetectable levels of virus."

The randomized, double blind 24-week study was designed to examine the antiviral activity, safety and tolerability of Coactinon in a first-line, protease inhibitor-sparing regimen. One hundred sixty-two HIV-infected volunteers, 45% female and 55% male, were randomized to receive 750 mg of Coactinon twice-a-day (BID) or placebo in combination with 40 mg of d4T BID and 150 mg of 3TC BID. The patients were treatment-naive with median baseline HIV-1 RNA levels of 4.3 log 10 copies/ml and median baseline CD4+ counts of 418 cells/mm(3).

Coactinon was generally well tolerated in all groups with mild to moderate adverse events, which occurred early in treatment. The most frequent adverse events included nausea, headache, dizziness, diarrhea, and rash. Dr. Rousseau commented, "Most of these adverse effects are consistent with our earlier findings. These results, along with our knowledge of the pharmacology of Coactinon, suggest that the tolerability of Coactinon in first-line regimens may be enhanced by the use of lead-in dose escalation strategies."

"In addition, we were pleased to have a significant number of women participate in the study, as they unfortunately represent an increasingly large proportion of all HIV infected patients," explained Dr. Rousseau.

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), 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, 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.

SOURCE Triangle Pharmaceuticals, Inc.
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PR991041

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