Gilead Sciences Announces Third Quarter 2012 Financial Results

Corporate Highlights

In August, Gilead together with Mylan Laboratories, Ranbaxy Laboratories Limited and Strides Arcolab, announced a collaboration agreement to promote access to high-quality, low-cost generic versions of Gilead's HIV medicine emtricitabine in developing countries - including single tablet regimens containing emtricitabine, and fixed-dose combinations of emtricitabine co-formulated with other Gilead HIV medicines.

Product and Pipeline Update

Antiviral Franchise

In July, Gilead announced:

• The U.S. Food and Drug Administration (FDA) approved once-daily oral Truvada, in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk for acquiring HIV. Truvada is the first drug to be approved for HIV prevention in uninfected adults, a strategy called pre-exposure prophylaxis (PrEP).
• 24-week data from a Phase 3 clinical trial, SPIRIT ( Switching boosted PI to Rilpivirine In Combination with Truvada as a Single Tablet Regimen), which evaluated virologically suppressed treatment-experienced HIV patients switching from a multi-pill regimen containing a ritonavir-boosted protease inhibitor to the once-daily single tablet regimen Complera. The study met its 24-week primary endpoint, which found that switching to Complera was non-inferior to remaining on a ritonavir-boosted protease inhibitor regimen. The findings were presented in an oral session at the 19th International AIDS Conference in Washington, D.C.
• Two-year Phase 3 clinical trial results showing that the integrase inhibitor elvitegravir dosed once daily is non-inferior to raltegravir dosed twice daily among treatment-experienced HIV patients. The findings were presented in an oral session at the 19th International AIDS Conference in Washington, D.C.
• Full clinical trial results from a pivotal Phase 3 study evaluating cobicistat, a pharmacoenhancing or “boosting” agent for HIV therapy, compared to ritonavir, currently the only approved agent used to boost certain antiretroviral treatment regimens. The study found that an HIV regimen containing a cobicistat-boosted protease inhibitor was non-inferior to a regimen containing a ritonavir-boosted protease inhibitor at 48 weeks of therapy. The findings were presented in an oral session at the 19th International AIDS Conference in Washington, D.C.

In August, the FDA approved Stribild, a complete once-daily single tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults. Stribild, previously referred to as “Quad” prior to FDA approval, combines four compounds in one daily tablet: elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.

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