By Lisa Seachrist
Gilead Sciences Inc. said Monday that it had filed a new drug application (NDA) for Forvade, a gel formulation of cidofovir, for the treatment of refractory herpes simplex virus in AIDS patients.
The company is applying for an indication in AIDS patients whose herpes infections are either resistant or no longer respond well to the standard herpes therapy, acyclovir.
“This is exciting; it is now our second new drug application. And it shows the strength of our nucleotide development plan,“ said Lana Lauher, manager of corporate communications at Gilead, in Foster City, Calif.
Cidofovir, a nucleotide analog, already won approval last June as Vistide, an infusion for treating cytomegalovirus in AIDS patients. The new topical formulation is considered an entirely different drug entity, but the company said it hopes the FDA will consider it for expedited review since it has an AIDS indication and is a drug for an unmet medical need.
Gilead included in its NDA for Forvade the results of a double-blind, placebo-controlled clinical trial which involved 30 AIDS patients with refractory herpes lesions. The patients applied either Forvade or a placebo gel once a day for five days. After five days, 50 percent of the patients receiving Forvade had good responses or complete resolution of lesions compared to zero percent of the placebo group. And, none of the patients using Forvade reported major side effects.
“Not many patients actually develop refractory herpes, maybe a couple thousand every year,“ Lauher said. “But for those who do, the condition can be debilitating with lesions several inches across that won’t heal.“
Gilead has made Forvade available under an expanded access program while it is under review.
The company also is testing Forvade as a treatment for genital warts, and Lauher said that there were European trials testing it as a treatment for cervical lesions. In addition, the company has its AIDS drug GS840, a nucleotide analog active against reverse transcriptase, in Phase II/III clinical trials.
“We just signed an agreement with the National Institutes of Health for an NIH-sponsored trial of GS840 in combination with other AIDS drugs,“ Lauher said. “So, it will be in another large-scale, late-stage trial soon.
“This filing is another milestone for the company,“ said Tom Dietz, managing director of Pacific Growth Equities, in San Francisco. “It’s not a very big indication and probably only has a $10 million market. But, it shows clearly that they are able to move compounds through clinical trials and the FDA approval process.“
Dietz also noted that the company only conducted a Phase I/II trial and that the FDA accepted the data as strong enough to warrant a filing. In addition to the Forvade filing, Dietz said that he wouldn’t be surprised if the company also filed its AIDS drug GS840 by the end of the year.
Gilead’s stock (NASDAQ:GILD) closed at $27.00 up $2.25.