By Kim Coghill

Washington Editor

A likely delay in its new drug application for Coviracil, Triangle Pharmaceuticals Inc.¿s lead product for HIV, has forced the company to cut its work force by 35 percent and look for other ways to tighten its belt.

Following release of its second-quarter numbers, the company issued a statement saying it intends to reduce its monthly spending from $8 million to $5 million through next year and will cut jobs and consolidate responsibilities to do so. The decision came after conversations with the FDA indicated that data from the FTC-302 Phase III trial of Coviracil most likely will not be enough to secure drug approval.

Coviracil is a nucleoside reverse transcriptase inhibitor licensed from Emory University in Atlanta. Triangle had intended to submit the Coviracil NDA based on FTC-302 and another Phase III study, FTC-303, during the first quarter 2001.

Durham, N.C.-based Triangle officials could not be reached for comment. However, David Barry, company chairman and CEO, released a prepared statement saying: ¿While we are disappointed in the probable delay in filing an NDA for Coviracil in the United States, we continue to be impressed with the therapeutic profile of the drug and expect that it will be approved with the additional data from FTC-301. In addition, we are continuing preparation for the submission for Coviracil to file in Europe in the first half of next year.¿

On Monday, Triangle reported a second-quarter net loss of $21.16 million, or 45 cents per share, compared to a net loss of $26.76 million, or 70 cents per share, in the second quarter of 2000. For the six months ended June 30, the company reported revenues of about $3.5 million and a net loss of $44 million compared to revenue of $3.8 million and a net loss of $58 million for the same period last year. It had $73.2 million in cash on June 30.

Triangle, an employer of 170 people, will cut 54 full-time jobs as well as 31 part-time positions and independent contractors.

Despite the news, Triangle said it will use the remaining staff to march forward with other research, including Phase III trials of Coviracil in HIV and hepatitis B; Phase III studies of Coactinon for HIV; Phase II studies on amdoxovir (formerly DAPD) for HIV; Phase I and II studies of clevudine (formerly L-FMAU) for hepatitis B; and Phase I studies with an ImmunoStimulatory Sequence drug candidate for hepatitis B licensed from Dynavax Technologies Corp.

Enrollment of the 500-patient, 100-site FTC-301 Phase III study is expected to be complete in October. The study compares a regimen of Coviracil, ddi and Sustiva to d4T, ddi and Sustiva.

This is not the first time Triangle has had a problem with Coviracil. A year ago, the South African Medicine Council recommended that Triangle stop the FTC-302 trial because of concerns with liver toxicity. The company didn¿t, but instead forged ahead without increasing enrollment. The 468 patients who already were enrolled continued receiving the drug. (See BioWorld Today, April 7, 2000.)

The FTC-302 trial compared Coviracil and the market-leading lamivudine (3TC) when used in combination with Zerit (d4T) and nevirapine.

In February, Triangle raised $46.2 million through a private placement of 7.7 million shares of common stock at $6 per share and added $12 million to the financing round through the sale of 200,000 Series B preferred shares to an undisclosed group of investors. (See BioWorld Today, Feb. 1, 2001.)

Triangle¿s stock (NASDAQ:VIRS) closed Tuesday at $2.96, down 4 cents.

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