WHO OKs Mylan 'Second-Line-in-a-Box' HIV/AIDS treatments

US generic drugs major Mylan (Nasdaq: MYL) says its subsidiary Mylan Laboratories has received approval for three antiretroviral (ARV) therapies used to treat HIV/AIDS under the World Health Organization's Prequalification of Medicines Program. The products include:

• atazanavir capsule, 300mg, ritonavir tablet, 100mg (heat-stable), and tenofovir disoproxil fumarate and lamivudine tablet 300 mg/300mg, or "second-line-in-a-box;"
• fixed-dose combination atazanavir sulfate and ritonavir tablets, 300mg/100mg; and
• fixed-dose combination abacavir sulfate, lamivudine and zidovudine tablets, 300mg/150mg/300 mg.

Mylan President Heather Bresch said: "With these three approvals, Mylan will further enhance our portfolio of more convenient, more affordable treatment options for people in the developing world living with HIV/AIDS. In particular, we are proud to deliver on a previous commitment that we made through an announcement with President Bill Clinton on August 6, 2009, to lower the price of second-line treatments for patients with drug-resistant HIV in developing countries. Further, these product combinations and packaging solutions are an example of our continued commitment to innovation in an effort to increase treatment adherence and effectiveness. By bringing these medicines to market through WHO's Prequalified Medicines Programme, we are again delivering on our promise to expand access to critical, life-saving ARV medicines for patients who need them in the developing world."