3 /PRNewswire/ -- Analysts Michael King of BancBoston Robertson Stephens and Franklin Berger of JP Morgan will discuss Tuesday's FDA advisory-panel vote against approving Gilead Science's (Nasdaq: GILD) HIV drug, Preveon
, on InformedInvestors.
While we view the market potential for Preveon
as being limited, we believe that the approval and launch of the drug, will be an important first step for the company.
Note to Editors: PREVEON
and VISTIDE are registered trademarks of Gilead Sciences, Inc.
During HIV clinical testing, the most common side effects reported with PREVEON
have been dose-related gastrointestinal effects, including nausea and loss of appetite.
As a result, the agency articulated a strong vision for Preveon
, one which reflected the goals and objectives of Gilead.
Results indicate that treatment with 60 mg monotherapy provides significant anti-HIV activity compared to placebo in treatment-naive patients, and that combination regimens comparing 60 mg and 120 mg doses of PREVEON
show similar antiviral effects in treatment-experienced patients.
Gilead will have a busy first half of 1999 due to the coming NDA filings on both PREVEON
and the influenza drug GS 4104, as well as a marketing and development deal for adefovir for the treatment of the hepatitis B virus infection," said King.
Results from recently unblinded studies indicate that treatment with 60 mg monotherapy provides statistically significant anti-HIV activity compared to placebo in treatment-naive patients, and that combination regimens including 60 mg or 120 mg doses of PREVEON
have similar efficacy in treatment-experienced patients.
Two development-stage products, Gilead's PREVEON
for the potential treatment of HIV and GS 4104 for the potential treatment of viral influenza, will be submitted in 1999 to the U.
These studies (GS 411, GS 417 and GS 420 and CPCRA 039, respectively) were designed to assess the safety and efficacy of 120 mg and 60 mg doses of PREVEON
, an experimental, once-a-day oral medication for the treatment of HIV.
Gilead Sciences Provides Update On PREVEON
Clinical Program for the Treatment of HIV; PREVEON
Profile to be Highlighted in Five Oral (BW0023 07:29)
is being tested in a variety of Phase II/III clinical trials in North America, Europe and Australia and is available in the United States through an Expanded Access Program for patients with limited treatment options.