By Kim Coghill
Analysts anticipate a strong launch for Viread, a Gilead Sciences Inc. once-daily HIV tablet slated to go before an FDA advisory panel next week.
Viread (tenofovir disoproxil fumarate) is a nucleotide reverse transcriptase inhibitor that can be administered in conjunction with other HIV drugs, and according to Gordon Cohen, an associate with Banc of America Securities in New York, the drug should generate about $400 million in worldwide sales at its peak.
Viread is in the same class as AZT and 3TC, two HIV treatments already on the market. Cohen said Viread will not replace other products, but will provide physicians and patients with another option. ¿Eventually you develop resistance, so the more you have in the arsenal, the better off you are,¿ Cohen told BioWorld Today. ¿It¿s a matter of finding the best combination and sequence of using these drugs to help patients stay healthy longer.¿
On Tuesday, Gilead, of Foster City, Calif., released positive data from a Phase III pivotal study that were set to be presented at the 41st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago. The meeting, however, has been rescheduled to Dec. 16-19 due to the terrorist attacks in Washington and New York.
Back in May, the Phase III data were submitted for regulatory approval to both the FDA and the European Agency for the Evaluation of Medicinal Products.
Although the data are significant, Cohen said the more important information released by Gilead deals with the 5,000 patients who enrolled over the past several months in the expanded access program.
¿Expanded access allows patients to be put on the medication before it is approved by the FDA and the more patients on this program before the launch, the stronger the launch,¿ Cohen said. ¿As soon as the drug is approved, all those patients on the drug become paying patients. Following these trends and comparing it to other HIV drugs, Viread looks pretty strong.¿
Amy Flood, Gilead¿s manager of corporate communications, referred to the expanded access as the compassionate use program under which patients in need of treatment (oftentimes in other countries) are given access to investigational drugs before they win regulatory approval. Not only do such programs provide treatment options for suffering patients, but they also give doctors the chance to gain experience with the drug.
Gilead is scheduled to present its new drug application to the FDA¿s Antiviral Advisory Committee Oct. 3. Banc of America expects FDA approval by early November.
Gilead¿s proposed indication is for HIV-positive adults, but as Flood pointed out, the FDA will make the decision on the label.
Gilead will present data from Study 907 and Study 902. The former study enrolled 552 treatment-experienced patients in North America, Europe and Australia for a period of 48 weeks. The study met its primary endpoint of reduction in viral load, and serious side effects (usually gastrointestinal) were similar in Viread and placebo patients.
Study 902, a Phase II trial of 189 patients, looked at long-term safety. According to the company, the trial demonstrated that treatment with Viread continues to be associated with an adverse event profile similar to that in the placebo group during the first 24 weeks, and sustained reductions in HIV RNA in treatment-experienced patients after nearly two years of treatment.
A final trial, Study 903, was designed for treatment-naove patients and should be complete later this year, with data available sometime in the first quarter of 2002. The 601-patient trial runs 96 weeks and is designed to compare a treatment regimen of Viread, lamivudine (3TC) and efavirenz to a treatment regimen of stavudine (d4T), 3TC and efavirenz in a blinded fashion in patients in the U.S., Europe and South America.
In other business, Gilead last week said it likely will file a new drug application during the first half of 2002 for adefovir dipivoxil, a treatment for chronic hepatitis B. (See BioWorld Today, Sept. 20, 2001.)
Gilead¿s stock (NASDAQ:GILD) closed Tuesday at $52.38, up $3.92, or 8 percent.