Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
PRNewswire - April 7, 2000
The FDA is awaiting the outcome of discussions between Triangle and the South African Medicines Control Council concerning the appropriate future management of the patients in the trial. The FDA indicated that as a result of the factors considered in issuing the clinical hold, study FTC-302 may not provide adequate support as part of an NDA submission. The planned submission of a U.S. NDA for Coviracil« (emtricitabine) may be delayed until at least the second half of 2001, and the Company will continue discussions with the FDA concerning what additional data may be required for an NDA.
Study FTC-302 began in August of 1999. A total of 470 patients have been enrolled and the trial is ongoing. The design of the trial is a comparison of Coviracil and lamivudine, both drugs being used in combination with d4T and nevirapine. Patients with high viral loads (>100,000 copies/mL) are receiving efavirenz instead of nevirapine.
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 Coviracil(r) (emtricitabine), Coactinon(r) (emivirine), 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 that are not historical facts, including the statement that the planned submission of a U.S. NDA may be delayed into at least the second half of 2001, are forward-looking statements and are subject to numerous risks and uncertainties, including the risk that the Company could fail to successfully complete pivotal clinical trials or that such trials could be halted by regulatory authorities, including study FTC-302, whether data collected from study FTC-302 may be utilized in connection with an NDA submission, whether the planned submission of a U.S. NDA will be delayed and for how long, the Company's future capital needs, the inability to commercialize Coviracil« (emtricitabine) and DAPD due to patent rights held by third parties, the Company's ability to obtain additional funding (including contingent contractual milestone payments), 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. As a result of these and other risks and uncertainties, actual results may differ materially from those predicted in this press release. The Company disclaims any obligations to update any forward-looking statements in this press release.
SOURCE: Triangle Pharmaceuticals, Inc.
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