PITTSBURGH, Aug. 6 President Bill Clinton, Mylan Chairman and CEO Robert J. Coury and Matrix Laboratories Founder and Vice Chairman N. Prasad today announced an important agreement to enable better, more affordable treatments for patients on "second-line" antiretroviral (ARV) therapy for HIV/AIDS in the developing world. For the first time, a second-line regimen of four ARVs will be available for under $500 annually.
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Addressing the need for more affordable second-line ARVs, Mylan Inc. (Nasdaq: MYL) and Matrix, a Mylan company, are making available all four drugs -- Atazanavir (ATV), Ritonavir (RTV), Tenofovir (TDF), and Lamivudine (3TC) -- needed to enable once-daily treatment of patients who have developed resistance to standard first-line ARVs. The four drugs will be available in three pills, with Tenofovir and Lamivudine combined into a single pill. The three pills are being made available today as separate products, with a total price of less than $475. Matrix also will sell the pills together in one package -- a "second-line-in-a-box" -- at $425 annually starting in 2010. These new products and prices will be available to governments that are members of the Clinton Foundation's Procurement Consortium across Africa, Asia, Latin America and the Caribbean. TDF+3TC is FDA approved, and ATV and RTV are pending approval by the World Health Organization (WHO).
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Mylan Chairman and CEO Robert J. Coury said: "Ensuring sustainable access to effective treatments in the developing world is a critical element in the global fight against HIV/AIDS. Mylan and Matrix are proud to continue our commitment of creating and introducing innovative and affordable pharmaceutical solutions. This includes our 'second-line-in-a-box,' which will reduce patient pill burden and facilitate patient compliance. Our affordable, heat-stable version of Ritonavir also represents another advance in the development of products that can withstand environmental conditions in parts of the world where treatment is desperately needed."
Coury continued: "We thank President Clinton and CHAI for their hard work and brilliant efforts in this battle and also appreciate their support of our efforts, which are intended to make these essential drugs more affordable and available to the patients who need them."
Matrix Founder and Vice Chairman N. Prasad added: "Enhancing the standards of care in the developing world is a top priority for Mylan and Matrix. Together we have done an extraordinary job developing a world-class ARV franchise in only a few years. Our efforts will continue along with other remarkable partner organizations such as CHAI."
"Second-line-in-a-box"
The new Matrix product announced today will create a more convenient second-line ARV treatment option. Patients will take three pills once a day instead of five or more pills twice a day (i.e. at least two in the morning and at least three in the evening) as required by alternative regimens. Additionally, the products will include the first-ever heat-stable version of Ritonavir, which does not require continuous refrigeration for its transport and distribution.
Noting advantages in convenience and affordability, WHO has identified the development of a second-line ARV therapy including Atazanavir and Ritonavir as a top priority. However, until now, this regimen has been largely unavailable since the existing Ritonavir formulation required continuous refrigeration, a major challenge for developing countries with limited infrastructure. Countries have begun to adopt this regimen in national treatment guidelines in anticipation of improved product features and pricing, and the Clinton Foundation expects many more to follow suit to take advantage of the agreements announced today.
If the new regimen is fully adopted, the new products and prices would enable cumulative cost savings of $400 million over the next five years, when compared with recent prices paid for alternative regimens. Although only 3% of total patients on treatment in low-income and sub-Saharan African countries are taking second-line ARVs today, these patients account for nearly 20% of total ARV expenditures because of the high cost of second-line drugs compared to first-line drugs. These percentages will grow steadily in the coming years as increasing numbers of HIV/AIDS patients experience first-line treatment failure. There were between 200,000 and 250,000 second-line patients across the developing world at the end of 2008. This number is expected to double over the next three years.
About Mylan
Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generics 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.
About Matrix
Matrix Laboratories Limited, a subsidiary of Mylan, is engaged in the manufacture of active pharmaceutical ingredients (API) and finished dosage forms (FDF). Matrix is one of the fastest growing API manufacturers in India and focuses on regulated markets such as the U.S. and the European Union. The company has a wide range of products in central nervous system, anti-bacterial, anti-AIDS, anti-asthmatic, cardiovascular, gastrointestinal, anti-fungal, pain management and lifestyle-related therapeutic segments. All Matrix API and FDF manufacturing facilities located in India are approved by the U.S. Food and Drug Administration. For more information, please visit www.matrixlabsindia.com.
About the Clinton HIV/AIDS Initiative
Since 2002, the Clinton HIV/AIDS Initiative (CHAI), a project of the William J. Clinton Foundation, has assisted countries in implementing large-scale, integrated care, treatment and prevention programs. CHAI works side-by-side with more than 20 countries in Africa, Asia, Eastern Europe, and Latin America and the Caribbean to build systems that will deliver HIV/AIDS treatment and healthcare by providing governments with technical assistance, leveraging human and financial resources, and facilitating the sharing of best practices across nationwide projects. CHAI also brokers agreements to lower prices of essential medicines and diagnostics, which are now accessible to more than 70 countries, representing more than 90 percent of people living with HIV/AIDS in the developing world. Learn more at www.clintonfoundation.org.
SOURCE Mylan Inc.
