Mylan's Enhances HIV Care with Distribution Agreement

Mylan Inc. (Pittsburgh, PA, USA) has entered into an exclusive agreement with Zyomyx, Inc. for the rights to distribute Zyomyx's (Fremont, CA, USA) proprietary point-of-care (POC) CD4 T-cell count test in the developing world. As part of the agreement, Mylan made a strategic equity investment in Zyomyx.

Under the terms of the distribution and supply agreement, Zyomyx will supply the test to Mylan, and Mylan will pay development and commercial milestones and a share of profits to Zyomyx for the exclusive rights to distribute the POC CD4 test in Africa; Asia (excluding Japan and South Korea but including (without limitation) Russia, Central Asia, and the Middle East); CEE; CIS; South America and Central America (including Mexico); and the Caribbean Islands.

The Zyomyx CD4 count test is easy-to-use providing results in less than 10 minutes with minimal training. The test is portable and disposable–small enough to fit into a backpack and requiring no grounded electricity. It is accurate and is ideal for use in developing markets and rural settings, and is equivalent in accuracy to flow cytometry, the current gold standard in CD4 count testing.

CD4 count testing is a critical diagnostic component in treating HIV/AIDS, because medical professionals refer to a patient's CD4 count to determine when to begin and/or alter HIV treatment.

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.

Mylan also 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 will 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, “[….] 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 Rajiv Malik, Mylan's president, added that 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."

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