Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR for First Generic, Heat-Stable Version of HIV Protease InhibitorProvides first affordable protease inhibitor for patients in developing
countries Complements recent WHO approval earned for the same product
PITTSBURGH, March 12 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL)
today announced that Matrix Laboratories Limited, its India-based subsidiary
in which it holds a 71.5% controlling interest, has received the first and
only tentative approval from the U.S. Food and Drug Administration (FDA) under
the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated
New Drug Application (ANDA) 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.
Mylan Vice Chairman and CEO Robert J. Coury said: "Mylan and Matrix are
committed to our growing and high quality antiretroviral 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 will have
access to this important life-saving drug. This is the second regulatory
approval that this important product has recently earned, which further
confirms our commitment to providing high-quality medicines at affordable
prices."
Lopinavir/Ritonavir Tablets are the generic version of Abbott
Laboratories' Kaletra® Tablets, the brand marketed in the U.S. and Europe,
and Aluvia® Tablets, the brand marketed in developing countries. 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.
Last month, Matrix was awarded the first and only World Health
Organization (WHO) approval for the same product. These approvals indicate
that Matrix's Lopinavir/Ritonavir tablets meet international safety, efficacy
and manufacturing quality standards. This status will significantly increase
access to affordable, high quality medicines in many countries, particularly
priority countries with high AIDS prevalence rates.
Matrix's wide range of ARV products includes active pharmaceutical
ingredients (API) and first- and second-line finished doses. Patients often
use second-line therapies if and when they develop resistance to initially
prescribed treatments or experience clinical failures. 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 developing countries depend on Matrix ARV products.
Mylan Inc., which provides products to customers in more than 140
countries and territories, ranks among the leading diversified generic and
specialty pharmaceutical companies in the world. The company maintains one of
the industry's broadest - and highest quality - product portfolios, supported
by a robust product pipeline; owns a controlling interest in the world's third
largest active pharmaceutical ingredient manufacturer; and operates a
specialty business focused on respiratory and allergy therapies. For more
information, please visit www.mylan.com.
SOURCE Mylan Inc.
03/12/2009
/CONTACT: Media, Michael Laffin, +1-724-514-1968, or Investors, Dan
Crookshank, +1-724-514-1813, both of Mylan Inc.
/Web Site: http://www.mylan.com
(MYL)