Under the agreement, Mylan will market and distribute in
Gilead has partnered with Mylan since 2006, granting the company rights to manufacture and sell their own generic versions of licensed Gilead HIV therapies in
Gilead's executive vice president of Corporate and Medical Affairs,
In addition to distributing branded Gilead medicines, Mylan will manage regulatory and pharmacovigilance activity, such as adverse event reporting, as well as broader medical education initiatives.
Mylan and HIV in
Mylan has one of the largest field forces exclusively specializing in HIV/AIDS in
Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) is a complete once-daily single tablet regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naive. (U.S. approval, 2012)
Truvada® (emtricitabine/tenofovir disoproxil fumarate) is a fixed-dose once-daily combination pill containing Viread and Emtriva. It is used in combination with other antiretroviral agents for the treatment of HIV infection in adults and pediatric patients 12 years of age and older (U.S. approval, 2004; EU approval, 2005). Once-daily Truvada is also approved for use in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. (U.S. approval, 2012)
Viread® (tenofovir disoproxil fumarate) is a once-daily oral nucleotide reverse transcriptase inhibitor (NtRTI) for the treatment of HIV infection in patients 2 years of age and older in combination with other antiretroviral agents. (First U.S. approval, 2001; EU approval, 2002.) Viread is also approved as a treatment for chronic hepatitis B in adults and pediatric patients 12 years of age and older. (U.S. and EU approval, 2008)
Viread® is also indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated and decompensated liver disease and pediatric patients 12 years of age and older. (U.S. and EU approval, 2008)
AmBisome® (amphotericin B liposome for injection) is a treatment for life-threatening, systemic fungal infections in adults. (EU approval, 1990; U.S. approval, 1997).
This press release includes statements that constitute "forward-looking statements," including with regard to the settlement of the litigation. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any legal or regulatory challenges to the settlement; strategies by competitors or other third parties to delay or prevent product sales; risks inherent in legal and regulatory processes; and the other risks detailed in the company's periodic filings with the
Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com
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