Business Wire - Wednesday March 3, 1999
"Based on these data and ongoing feedback from the Food and Drug Administration (FDA), we plan to complete the submission of a New Drug Application (NDA) for the 60 mg dose of PREVEON in the second quarter of this year," said John C. Martin, President and Chief Executive Officer of Gilead Sciences. "We also will amend the PREVEON Expanded Access protocol so that all patients currently in the program who have been randomized to the 120 mg dose will have their dose reduced to 60 mg and all patients entering the program will initiate treatment with 60 mg."
In November 1998, the FDA granted Fast Track designation to PREVEON for the treatment of HIV-infected patients. Gilead intends to file an NDA for the accelerated approval of PREVEON for the treatment of HIV-infected patients with clinical, immunologic and/or virologic progression despite prior reverse transcriptase inhibitor therapy. In January 1999, Gilead initiated a rolling submission by filing the Chemistry Manufacturing and Controls section of the NDA. In addition to ongoing Phase III trials of PREVEON, additional Phase IV studies will be initiated during 1999 to confirm the long-term efficacy and safety of PREVEON at the 60 mg dose.
Preliminary Study Findings
Study 420. This four-week, randomized, double-blind, placebo-controlled trial was conducted at four U.S. centers. Forty-seven HIV-infected patients with HIV RNA greater than 5,000 copies/mL and a CD4 cell count greater than or equal to 150 cells/mm3 were enrolled. The primary objective of this study was to determine the anti-HIV activity of PREVEON 60 mg monotherapy compared to placebo over four weeks in treatment-naive patients. Results demonstrated that treatment with a 60 mg dose of PREVEON monotherapy is associated with statistically significant anti-HIV activity compared to placebo. This activity was similar in magnitude to the anti-HIV activity of PREVEON 120 mg monotherapy demonstrated in previous studies.
Study 417. Two hundred and fourteen patients were enrolled in this double-blind, dose-comparison trial, which was conducted at 22 centers in the U.S. Patients were required to have HIV RNA greater than 5,000 copies/mL and a CD4 cell count greater than or equal to 100 cells/mm3 upon enrollment into the trial. Patients had not previously received protease inhibitors, but had received extensive prior treatment with nucleoside reverse transcriptase inhibitors. Patients in this study were randomly assigned to receive either PREVEON 60 mg or 120 mg along with a combination of either nelfinavir and saquinavir or of a nucleoside reverse transcriptase inhibitor (AZT, 3TC or d4T) plus nelfinavir or saquinavir.
Twenty-week interim data demonstrate that triple drug regimens containing PREVEON 60 mg were as effective as triple drug regimens containing 120 mg with regard to the proportion of patients whose HIV RNA was below the limit of quantification (less than or equal to 400 copies/mL) at week 20 (the primary endpoint of the study). In addition, both doses of PREVEON were equally effective in decreasing HIV RNA and increasing CD4 cell counts over the study period. Patients who received the 60 mg dose of PREVEON also had a significant reduction in the incidence of nephrotoxicity compared to those who received the 120 mg dose.
Background on PREVEON
PREVEON is an investigational, once-daily, orally administered, reverse transcriptase inhibitor under development for the potential treatment of HIV. To date, more than 8,500 patients have been enrolled in clinical studies of PREVEON, including more than 7,000 in the Expanded Access Program, at one of two dose levels (60 mg or 120 mg once daily). In all studies, PREVEON is co-administered with L-carnitine, a nutritional supplement.
During clinical testing, the most common side effects reported with PREVEON have been dose-related gastrointestinal effects, including nausea and loss of appetite. Nephrotoxicity, including changes in serum creatinine and phosphate, is the most important drug-related toxicity. These changes are generally gradual in onset, asymptomatic, detectable by routine monitoring and resolvable upon dose reduction or withdrawal. Some patients have experienced elevations in liver transaminases.
Gilead Sciences
Gilead Sciences is an independent biopharmaceutical company that seeks to provide accelerated treatment solutions for patients and the people who care for them. The company discovers, develops and commercializes proprietary therapeutics for important viral diseases, including a currently marketed product, VISTIDE« (cidofovir injection), for the treatment of CMV retinitis, a sight-threatening viral infection in patients with AIDS. In addition, the company is developing products to treat diseases caused by HIV, hepatitis B virus and influenza virus.
This press release contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, concerning the timing and nature of potential registration filings for PREVEON and presentation of clinical data at scientific conferences. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective as human therapeutics. Actual results could differ materially from those projected in this release. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 1997 on file with the U.S. Securities and Exchange Commission, copies of which are available from Gilead. Note to Editors: PREVEON and VISTIDE are registered trademarks of Gilead Sciences, Inc.
To receive more information, please visit the Gilead Web site at www.gilead.com or call Corporate Communications at 1-800-GILEAD-5 (1-800-445-3235)
Contact: Gilead Sciences Susan Hubbard, 650/522-5715 (Investors) Sheryl Meredith, 650/522-5505 (Media)
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