Less than a month after Gilead Sciences Inc. presenteddata from a pivotal study of Vistide (cidofovirintravenous) which showed the drug delayed progressiontime to retinitis in AIDS patients with relapsingcytomegalovirus (CMV), the Foster City, Calif.-basedcompany filed a new drug application (NDA).

Gilead announced at the Interscience Conference onAntimicrobial Agents and Chemotherapy (ICAAC) inSeptember that the nucleoside analogue drug delayed thetime to progression to CMV, an AIDS-relatedopportunistic infection. (See BioWorld Today, Sept. 19,1995, p. 1.)

"While it's difficult to predict how long the FDA willtake to review our application, other drugs that are AIDS-related or have similar indications were reviewed in a six-month time frame," said Lana Lauher, director ofcommunications for Gilead.

The NDA filed with the FDA on Thursday includes safetyand efficacy data from the pivotal study unveiled atICAAC. Gilead currently makes Vistide available free ofcharge under a treatment investigational new drugexpanded access program for patients with relapsingCMV retinitis which has progressed despite treatmentwith one of two approved intravenous therapies.

CMV affects about 95 percent of AIDS patients. Gilead,which owns all rights to Vistide, also had underdevelopment candidate products for viral disease causedby HIV, human papillomavirus, herpes simplex virus andhepatitis B virus infection.

Gilead's stock (NASDAQ:GILD) closed down 75 centson Tuesday to $20.75. _ Michele L. Robinson

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