Mylan's Matrix receives WHO approval for generic Lopinavir/Ritonavir tablets

Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, received the first and only World Health Organization (WHO) approval for Lopinavir/Ritonavir Tablets, 200 mg/50 mg. Matrix's version of this product is heat-stable and affordable, making it practical for distribution and use in warm climates.

Lopinavir/Ritonavir Tablets are the generic version of Abbott Laboratories' Kaletra Tablets, the brand marketed in the U.S. and Europe, and Alluvia Tablets, the brand marketed in the developing world. It is used in combination with other medications to control HIV infection and is included in the antiretroviral (ARV) class of drugs known as HIV protease inhibitors.

Mylan Vice Chairman and CEO Robert J. Coury said: "Mylan and Matrix are committed to our growing and high quality ARV franchise. Our goal is to provide HIV treatments to patients around the world -- especially in developing countries. With Matrix's heat-stable and affordable version of Lopinavir/Ritonavir, patients in remote parts of developing nations now have access to this important medicine."

A WHO approval indicates that a drug meets international safety, efficacy and manufacturing quality standards. With such status, Matrix can sell the treatment in most countries outside the United States and Europe.

Matrix's wide range of ARV products includes active pharmaceutical ingredients (API) and first- and second-line finished doses; patients use second-line therapies if and when they develop resistance to initially prescribed treatments. The company's emphasis on producing affordable products has allowed it to drive down the average annual cost per patient of effective therapies. Approximately 30% of HIV/AIDS patients in the developing world depend on Matrix's ARV products.