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|U.S. Food and Drug Administration Approves Gilead Sciences' Complera(TM), a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naïve Adults|
- Approval Marks Gilead's Second Successful Collaboration to Develop a Complete Single-Tablet Regimen for HIV/AIDS -
FOSTER CITY, Calif., Aug 10, 2011 (BUSINESS WIRE) -- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Complera(TM) (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults. Complera combines three antiretroviral medications in one daily tablet - Gilead's Truvada(R), which is a fixed-dose combination of the two nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir disoproxil fumarate, and Tibotec Pharmaceuticals' non-nucleoside reverse transcriptase inhibitor, rilpivirine (marketed as Edurant(TM) in the United States by Janssen Therapeutics, Division of Janssen Products, LP). Truvada and rilpivirine were approved by the FDA in August 2004 and May 2011, respectively, for use as part of HIV combination therapy.
"In the 30 years since the first AIDS cases were reported, we've made incredible strides in the treatment of this disease," said Tony Mills, MD, Director of Medical Research, Anthony Mills MD, Inc. and a participating investigator in ongoing Complera studies. "The concept of a single-tablet regimen has become a goal in HIV drug development, and the standard of care in medical practice in the United States. However, no one therapy is appropriate for all patients. Given its efficacy, safety and convenience, the availability of Complera represents an exciting milestone in addressing the individual needs of patients new to HIV therapy."
The approval of Complera is supported by 48-week data from two Phase 3 double-blind, active controlled, randomized studies (ECHO and THRIVE) conducted by Tibotec that evaluated the safety and efficacy of rilpivirine compared to efavirenz among treatment-naïve HIV-1 infected adults. Both arms of the study were administered with a background regimen, in which the majority of patients in the rilpivirine arm received Truvada. A bioequivalence study, conducted by Gilead, demonstrated that the co-formulated single-tablet regimen achieved the same levels of medication in the blood as emtricitabine plus rilpivirine plus tenofovir disoproxil fumarate.
"Complera is the second complete single-tablet regimen that Gilead has introduced, and it represents a collaboration between two organizations that share a vision of simplifying HIV therapy for patients," said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. "Tremendous progress has been made in the field of HIV, but we recognize new therapies are still needed, and we continue to work to advance options that address the needs of patients."
Complera is the second complete antiretroviral treatment regimen for HIV-1 available to treatment-naïve patients in a single once-daily pill. The first, Atripla(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), is marketed by Gilead and Bristol-Myers Squibb. Complera does not cure HIV-1 infection or help prevent the transmission of HIV to others. Complera has Boxed Warnings including lactic acidosis/severe hepatomegaly with steatosis and post treatment acute exacerbation of hepatitis B; see below for additional important safety information. The following points should be considered when initiating therapy with Complera:
Gilead first entered into a license and collaboration agreement with Tibotec for the development and commercialization of Complera in July 2009. Under the terms of the agreement, Gilead will assume the lead role in the manufacturing, registration, distribution and commercialization of Complera in the United States, Canada, Brazil, the European Union, Australia and New Zealand. Tibotec will be responsible for the commercialization of rilpivirine as a stand-alone product and will hold rights to co-detail Complera in these territories. A marketing application for the emtricitabine/rilpivirine/tenofovir disoproxil fumarate single-tablet regimen is currently pending in the European Union.
The companies also have finalized an agreement for the development and commercialization of the single-tablet regimen for the rest of world, including the developing world. Gilead will be responsible for the registration, distribution and commercialization of the single-tablet regimen in certain European countries, Latin America and the Caribbean. Tibotec will be responsible for all countries outside of the Gilead territories, the most significant of which include Asia Pacific, including Japan, the Middle East, Eastern Europe and all of Africa.
Important Product Safety Information About Complera, Including Boxed Warnings
BOXED WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of Complera, in combination with other antiretrovirals.
Complera is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Complera have not been established in patients coinfected with HBV and HIV-1.Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Emtriva or Viread, which are components of Complera.Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Complera.If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Complera should not be co-administered with the following drugs, as significant decreases in rilpivirine plasma concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance to Complera or to the class of NNRTIs:
WARNINGS AND PRECAUTIONS
The most common adverse drug reactions to rilpivirine (incidence greater than or equal to 2%, Grades 2-4) were insomnia and headache.
The most common adverse drug reactions to emtricitabine and tenofovir disoproxil fumarate (incidence greater-than or equal to 10%) were diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.
DOSAGE AND ADMINISTRATION
Adults: The recommended dose of Complera is one tablet taken orally once daily with a meal.
Renal Impairment: Because Complera is a fixed-dose combination, it should not be prescribed for patients requiring dose adjustment such as those with moderate or severe renal impairment (creatinine clearance below 50 mL per minute).
Important Safety Product Information About Truvada, Including Boxed Warnings
Truvada, a combination of Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate [DF]), 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.
The following points should be considered when initiating therapy with Truvada for the treatment of HIV-1 infection:
WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including Viread, a component of Truvada, in combination with other antiretrovirals.
Truvada is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of Truvada have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Truvada. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Truvada. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
WARNINGS AND PRECAUTIONS
New Onset or Worsening Renal Impairment
Coadministration With Other Products
Bone Mineral Density
Early Virologic Failure
DOSAGE AND ADMINISTRATION
Please see full Prescribing Information for Complera and Truvada (including BOXED WARNINGS).
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
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 physicians may not see advantages of Complera over other therapies and may therefore be reluctant to prescribe the product, and payers may be reluctant to approve or provide reimbursement for the product. In addition, pending marketing applications such as those in the European Union may not be approved or approval may be delayed, and marketing approval, if granted, may have significant limitations on its use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, as filed 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.
U.S. full prescribing information for Complera is available at www.Gilead.com.
U.S. full prescribing information for Truvada is available at www.Truvada.com.
U.S. full prescribing information for Atripla is available at www.Atripla.com.
Complera, Truvada, Viread, Emtriva and Hepsera are trademarks or registered trademarks of Gilead Sciences, Inc. or its related companies.
Edurant is a trademark of Tibotec Pharmaceuticals.
Atripla is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.
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.
SOURCE: Gilead Sciences, Inc.
Gilead Sciences, Inc.
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