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Mylan And Zyomyx Enter Into Exclusive Distribution Agreement For Innovative Point-of-Care CD4 Diagnostic Test, Enhancing Mylan's Leadership Position In HIV Care

PITTSBURGH and FREMONT, Calif., June 30, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has entered into an exclusive agreement with Zyomyx, Inc. for the rights to distribute Zyomyx's proprietary point-of-care (POC) CD4 T-cell count test in the developing world. CD4 count testing is a critical diagnostic component in treating HIV/AIDS, as medical professionals refer to a patient's CD4 count to determine when to begin and/or alter HIV treatment. As part of the agreement, Mylan also has made a strategic equity investment in Zyomyx.   

The Zyomyx POC CD4 test is currently in final stages of development and expected to launch in the near-term, pending applicable regulatory approvals. Mylan expects to distribute the portable, easy-to-use, low-cost test in the developing world alongside its broad portfolio of high quality, affordable generic antiretroviral (ARV) drugs in order to improve access to and guide HIV/AIDS treatment in resource-limited settings. 

To complement the exclusive agreement with Zyomyx, Mylan also announced that it has signed a Global Access Commitment with the Bill & Melinda Gates Foundation, an investor in Zyomyx. Mylan has committed to ensuring that the Zyomyx POC CD4 technology can be made available and accessible at a reasonable price in high burden HIV countries.  Increasing access to affordable and effective health interventions for those in need is a priority for the foundation.

Mylan CEO Heather Bresch commented, "Mylan's mission is to set new standards in health care and provide the world's 7 billion people access to high quality medicine. We expect that this distribution agreement with Zyomyx and our collaboration with the Bill & Melinda Gates Foundation will be a true game changer in improving access to treatment of HIV in the developing world by enabling rapid, low-cost testing of patients in any location, however remote, thereby ensuring immediate enrollment on treatment. Further, this distribution agreement and investment represents Mylan's entry into diagnostics as we strive to meet the evolving needs of our customers and patients. It will transform Mylan from a leading provider of HIV treatments to a leading provider of HIV health care solutions, which will continue to differentiate Mylan in this important area."

Rajiv Malik, Mylan's president, added, "Zyomyx's CD4 test is a revolutionary technology that couldn't come at a better time. The World Health Organization's revised antiretroviral treatment guidelines increase the number of people living with HIV and eligible for treatment to close to 26 million, and pregnant women are now advised to start treatment as soon as they test positive. The more quickly patients can receive CD4 testing, the more quickly they can access life-saving medicine. Mylan's investment in Zyomyx is just one step in our efforts to support the goal of universal access to HIV/AIDS treatment."

Trevor Mundel, president of Global Health at the Bill & Melinda Gates Foundation, said, "HIV patients in the developing world have long faced considerable challenges accessing CD4 testing due to the poor availability of testing in rural areas, the challenges of travel to testing sites and the cost of the tests. Mylan's investment in Zyomyx and collaboration with the foundation will potentially greatly enhance access to testing and treatment in the developing world."

The Zyomyx CD4 count test, the first product developed using Zyomyx's breakthrough diagnostic platform, is easy-to-use and the fastest yet, providing results in less than 10 minutes with minimal training. The test is portable and disposable – small enough to fit into a back-pack and requiring no grounded electricity  – making it ideal for use in developing markets and rural settings. Importantly, the test is highly accurate and has proven to be equivalent in accuracy to flow cytometry, the current gold standard in CD4 count testing.

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