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Press release from Business Wire

Gilead Receives European Marketing Authorization for Eviplera®, a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naïve Adults

Monday, November 28, 2011

Gilead Receives European Marketing Authorization for Eviplera®, a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naïve Adults13:00 EST Monday, November 28, 2011 FOSTER CITY, Calif. (Business Wire) -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for Eviplera® (emtricitabine/rilpivirine/tenofovir disoproxil), a complete once-daily single-tablet regimen for the treatment of HIV-1 infection in antiretroviral treatment-naïve adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/mL. Today's authorization allows for the commercialization of Eviplera in all 27 countries of the European Union (EU). “As people with HIV are living and remaining on treatment longer, the availability of new simplified therapeutic options has become even more critical,” said Dr. Mark Nelson, Service Director for the HIV Directorate, Chelsea and Westminster Hospital, London, United Kingdom. “Eviplera has the potential to be an important new treatment option for patients starting HIV therapy because it streamlines an effective HIV treatment regimen into a single daily tablet.” Eviplera combines Gilead's Truvada®, a fixed-dose combination of the two nucleoside reverse transcriptase inhibitors emtricitabine 200 mg and tenofovir disoproxil 245 mg, and Tibotec Pharmaceuticals' rilpivirine 25 mg, marketed by Janssen-Cilag International N.V. as Edurant®. “Gilead continues to lead the development of single-tablet regimens because we and our partners recognize the ongoing need to simplify HIV therapy,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “With Eviplera, we are pleased to expand the therapeutic options for European patients, and are now working with national authorities to ensure the regimen is made available across the EU as quickly as possible.” Eviplera is the second single-tablet HIV regimen to be authorized in the EU. The first, Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil 245 mg), became available in 2007 and is also marketed by Gilead, in partnership with Bristol-Myers Squibb and Merck & Co. The authorization of Eviplera was 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 in treatment-naïve HIV-infected adults. Both studies included a background regimen of two nucleosides/nucleotides, which for the majority of patients was 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 administered separately. The single-tablet regimen received regulatory authorization from the U.S. Food and Drug Administration under the trade name Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) in August 2011. Gilead first entered into a license and collaboration agreement with Tibotec for the development and commercialization of this single-tablet regimen in July 2009. Under the terms of the agreement, Gilead will assume the lead role in the manufacturing, registration, distribution and commercialization of the product in the United States, Canada, Brazil, the European Union, Australia and New Zealand. Tibotec will be responsible for the commercialization of rilpivirine as a single agent and will hold rights to co-detail the single-tablet regimen in these territories. The companies also have finalized an agreement for the development and commercialization of this single-tablet regimen for the rest of world, including resource-limited settings. 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. EU IMPORTANT PRODUCT INFORMATION ABOUT EVIPLERA Lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues, including emtricitabine and tenofovir disoproxil fumarate. Lactic acidosis has a high mortality and patients at increased risk should be followed closely. Eviplera should not be taken with any of the following as significant decreases in the plasma concentrations of rilpivirine may occur which may cause loss of therapeutic effect of Eviplera:-the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin-the antimycobacterials rifabutin, rifampicin, rifapentine-proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole-the systemic glucocorticoid dexamethasone, except as a single dose treatment-St John's wort (Hypericum perforatum). In the pooled analysis from the two Phase 3 clinical studies (ECHO and THRIVE), patients treated with the Eviplera combination with a baseline viral load > 100,000 HIV-1 RNA copies/mL had a greater risk of virologic failure than patients with a baseline viral load ≤ 100,000 HIV-1 RNA copies/mL. Patients with a baseline viral load > 100,000 HIV-1 RNA copies/mL who experienced virologic failure exhibited a higher rate of treatment emergent resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class. More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine-associated resistance. Eviplera has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy. As with other antiretrovirals, resistance testing should guide the use of Eviplera. As a fixed combination, Eviplera should not be co-administered with other medicines containing emtricitabine, rilpivirine hydrochloride or tenofovir disoproxil fumarate. Due to similarities between emtricitabine and lamivudine, Eviplera should not be administered with medicines containing lamivudine. Eviplera should not be co-administered with adefovir dipivoxil. Rilpivirine at supratherapeutic doses (75 mg and 300 mg once daily) has been associated with prolongation of the QTc interval of the electrocardiogram (ECG). Eviplera should be used with caution when co-administered with medicinal products with a known risk of Torsade de Pointes. Rare events of renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil fumarate. It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with Eviplera and renal function (creatinine clearance and serum phosphate) is also monitored every four weeks during the first year and then every three months. In patients at risk for renal impairment, more frequent monitoring should be considered. Use of Eviplera should be avoided with concurrent or recent use of nephrotoxic medications. If concomitant use of Eviplera and nephrotoxic agents is unavoidable, renal function must be monitored weekly. Eviplera is not recommended for patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min) as the appropriate dose interval adjustment of emtricitabine and tenofovir disoproxil fumarate cannot be achieved with the combination tablet. Bone abnormalities (infrequently leading to fractures) may be associated with proximal renal tubulopathy and appropriate consultation should be obtained if suspected. Eviplera has not been studied in patients with severe hepatic impairment (CPT Score C) and is therefore not recommended in these patients. If Eviplera is discontinued in patients co infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis. In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post treatment exacerbation of hepatitis may lead to hepatic decompensation. Immune reconstitution syndrome has been reported in patients treated with combination therapy, including the components of Eviplera. Redistribution and/or accumulation of body fat have been observed in patients taking anti-HIV medicines. The cause and long-term health effect of these conditions are unknown. This does not include all data contained in the Eviplera Summary of Product Characteristics (SmPC). Please see the complete SmPC for further details. 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. Forward-Looking Statement 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 Eviplera over other therapies and may therefore be reluctant to prescribe the product. 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 September 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. EU Summaries of Product Characteristics for Eviplera, Truvada and Atripla are available at www.ema.europa.eu.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.U.S. full prescribing information for Complera is available at www.Complera.com.Eviplera, Truvada and Complera are registered trademarks of Gilead Sciences, Inc. or its related companies.Atripla is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.Edurant is a registered trademark of Tibotec, 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. Gilead Sciences, Inc.Susan Hubbard, 650-522-5715 (Investors)James Read, +44-208-587-2323 (Media - EU)Erin Rau, 650-522-5635 (Media - US)