August 02, 2004
U.S. FDA Approves Gilead's Truvada, a One-Tablet, Once-a-Day Fixed-Dose Co-Formulation of Viread and Emtriva as Part of HIV Combination Therapy
FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 2, 2004-- Gilead's Third HIV Therapeutic and Fourth Antiviral Approved in Three Years; Truvada Also Available Through Gilead Access Program for Developing World
Gilead Sciences (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Truvada(TM) (emtricitabine and tenofovir disoproxil fumarate) a fixed-dose combination of the company's anti-HIV medications Emtriva(R) (emtricitabine) and Viread(R) (tenofovir disoproxil fumarate). Truvada combines 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate in one tablet, taken once a day in combination with other antiretroviral agents. The detailed indication and important safety information for Truvada are highlighted below. Truvada is Gilead's third once-a-day HIV therapeutic and fourth once-a-day antiviral approved by the FDA in less than three years.
"We're making great strides in the treatment of HIV infection, but improvements are still needed," said Joel Gallant, MD, MPH of Johns Hopkins University School of Medicine. "Making therapy easier is likely to improve patients' ability to adhere to therapy. This fixed-dose product - a once-a-day treatment as part of combination therapy - will make it easier to construct convenient combination regimens."
Gilead also announced that it has received clearance from the FDA for an alternate trade dress for Truvada for use in the developing world. The company plans to include Truvada in the Gilead Access Program, an initiative to increase access to anti-HIV medications in the developing world through sale of the company's antiretrovirals at no-profit pricing. Since 2003, the program has offered Viread at a no-profit price in 68 countries - all countries in Africa and 15 other United Nations-designated "least developed" countries - that represent 70 percent of the global AIDS epidemic. Truvada will be available in the United States as a dark blue capsule-shaped tablet and as a similarly shaped light blue tablet in the developing world. The company also plans to conduct additional stability studies of Truvada in Climatic Zones III and IV, or hot and humid climates.
The parent compound of Viread, tenofovir, was discovered through a collaborative research effort between Dr. Antonin Holy, Institute for Organic Chemistry and Biochemistry, Academy of Sciences of the Czech Republic (IOCB) in Prague and Dr. Erik DeClercq, Rega Institute for Medical Research, Katholic University in Leuven, Belgium. Emtriva was discovered by Dr. Raymond F. Schinazi, Dr. Dennis C. Liotta and Dr. Woo-Baeg Choi and licensed to Gilead by Emory University in 1996. Emory University and the inventors of both Viread and Emtriva, the components in Truvada, have agreed to waive their right to a royalty on sales of Truvada in the 68 Gilead Access Program countries to ensure the product can be offered at a no-profit price in parts of the world where the epidemic has hit the hardest.
Truvada works by blocking reverse transcriptase, an enzyme crucial for viral replication. By interfering with the replication process, Truvada, when combined with other anti-HIV medication, can help lower the amount of HIV, or "viral load" in a patient's body and increase the number of immune system cells (called T cells or CD4 cells). Both of these changes are generally associated with improving a patient's health and decreasing the likelihood of AIDS-related illnesses.
It is important that patients be aware that HIV medications must be taken as part of combination regimens and do not cure HIV infection, nor do they reduce its transmission.
"Truvada represents an important step forward in our company's ongoing commitment to developing therapeutics that advance patient care around the world," said John C. Martin, PhD, President and CEO of Gilead. "We are pleased by the FDA's rapid review and approval of this HIV therapeutic and will work quickly to make it available to patients, including in those resource-limited countries where the HIV epidemic has hit the hardest through the Gilead Access Program."
Truvada is indicated in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults. Safety and efficacy studies using Truvada tablets or using Emtriva and Viread in combination are ongoing.
Both components of Truvada have been studied individually, as part of multi-drug regimens and have been found to be safe and effective. Since Emtriva and lamivudine (3TC) are comparable in their structure, resistance profiles, and efficacy and safety as part of multi-drug regimens, existing data from the use of lamivudine and Viread in combination have been extrapolated to support use of Truvada tablets for the treatment of HIV-1 infection in adults. Therefore, in treatment-naive patients, Truvada should be considered as an alternative to the combination of Viread and lamivudine for those patients who might benefit from a once-daily regimen. In treatment-experienced patients, the use of Truvada should be guided by laboratory testing and treatment history.
There are no study results demonstrating the effect of Truvada on clinical progression of HIV-1, and it is not recommended that Truvada be used as a component of a triple nucleoside regimen.
Important Safety Information
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Truvada is not indicated for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Truvada have not been established in patients co-infected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Emtriva or Viread. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue Truvada and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
No drug interaction studies have been conducted using Truvada. Drug interactions have been observed when didanosine, atazanavir, or lopinavir/ritonavir is co-administered with Viread, a component of Truvada. Detailed prescribing information contains additional information on drug interactions, including dose adjustment guidelines for co-administration of Truvada with didanosine or atazanavir. Truvada should not be used with Viread or Emtriva, or other drugs containing lamivudine, including Combivir(R), Epivir(R), Epivir-HBV(R) or Trizivir(R).
Changes in body fat have been observed in patients taking Viread, Emtriva and other anti-HIV medicines. The cause and long term health effect of these conditions are unknown.
Two-hundred eighty-three patients have received combination therapy with Emtriva and Viread with either a non-nucleoside reverse transcriptase inhibitor or protease inhibitor for 24 to 48 weeks in ongoing clinical studies. Based on these limited data, no new patterns of adverse events were identified and there was no increased frequency of established toxicities.
Adverse events that occurred in more than 5 percent of patients receiving Emtriva with other antiretroviral agents in clinical trials include abdominal pain, asthenia (weakness), headache, diarrhea, nausea, vomiting, dizziness, and rash. Approximately 1 percent of patients discontinued participation because of these events. All adverse events were reported with similar frequency in Emtriva and control treatment groups with the exception of skin discoloration which was reported with higher frequency in the Emtriva treated group. Skin discoloration, manifested by hyperpigmentation on the palms and/or soles was generally mild and asymptomatic. The mechanism and clinical significance are unknown.
Adverse events that occurred in more than 5 percent of patients receiving Viread with other antiretroviral agents in clinical trials include headache, nausea, diarrhea, vomiting, rash and depression. Less than 1 percent of patients discontinued participation because of gastrointestinal events. Renal impairment, including serious cases, has been reported. Renal impairment occurred most often in patients with underlying systemic or renal disease or in patients taking concomitant nephrotoxic agents, though some cases have appeared in patients without identified risk factors. Decreases in bone mineral density (BMD) at the lumbar spine and hip have been seen with the use of Viread. The clinical significance of changes in BMD and biochemical markers is unknown and follow-up is continuing to assess long-term impact.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases worldwide. The company has seven marketed products, and focuses its research and clinical programs on anti-infectives. Headquartered in Foster City, CA, Gilead has operations in North America, Europe and Australia.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that the safety and efficacy data obtained in controlled clinical trials for Viread and Emtriva will not be observed in an uncontrolled clinical setting, and the risk that physicians and regulatory agencies may not see advantages of Truvada over other antiretrovirals and may therefore be reluctant to prescribe or grant regulatory approval for Truvada. These risks and uncertainties could cause actual results to differ materially from those referred to in the forward-looking statements. Risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2003 and in Gilead's Quarterly Reports on Form 10-Q, all of which are on file with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward-looking statements.
For full prescribing information, please visit www.Truvada.com.
Truvada is a trademark and Emtriva and Viread are registered trademarks of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
CONTACT: Gilead Sciences, Inc.
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SOURCE: Gilead Sciences, Inc.