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Mylan

Company Overview

Mylan is one of the world's leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 18,000, Mylan has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service. The company ranks among the top five generics companies in several international markets and is the largest U.S.-based generics manufacturer in the world. Through its India-based subsidiary, Mylan Laboratories Limited, Mylan has direct access to one of the world's largest active pharmaceutical ingredient (API) manufacturers. This relationship makes Mylan one of only two global generics companies with a comprehensive, vertically integrated supply chain. Mylan’s business in India also is one of the world's largest producers of API used to make generic antiretroviral (ARV) therapies for the treatment of HIV/AIDS. Additionally, Mylan operates a fully integrated specialty pharmaceutical business, Mylan Specialty, which produces innovative medicinal therapies, including EpiPen® Auto-Injector and Perforomist® Inhalation Solution.

Mylan Laboratories, based in India, manufactures and supplies low cost, high quality API for Mylan's products and pipeline, as well as for third parties. Through this subsidiary, Mylan also offers a line of finished dosage form products, most of which are ARVs and include adult and pediatric therapies. Mylan Laboratories has more than 600 research and development scientists, an impressive inventory of drug master files and more than 150 APIs in the market or under development. Its nine state-of-the-art manufacturing facilities have been approved by several regulatory agencies.

HIV/AIDS Profile

Meeting unmet needs: Less than a decade ago, Matrix Laboratories (now Mylan Laboratories Limited) decided to take action in the fight against HIV/AIDS. Their vision was to develop ARV drugs that people in the developing world could afford and make them widely available. On the other side of the world in the U.S., Mylan's sense of social responsibility took expression in many ways, including a commitment to produce affordable versions of orphan drugs. In 2007, when Mylan acquired Matrix, the two companies joined forces, motivated by a shared passion to serve others by addressing unmet needs.

Bringing hope through affordability: The hallmark of Mylan's ARV franchise to date is affordability. Mylan has continually reduced the cost of first-line therapies and significantly reduced that of second-line therapies. In 2009, for instance, the company made available the world's first second-line regimen costing less than $500 per person per year, down from $15,000. In addition, the company partners with a wide variety of external organizations that share its humanitarian goals. Many of these organizations, such as the Clinton HIV/AIDS Initiative, or CHAI, focus in part on securing affordable supplies of ARVs - and have found in Mylan a tremendous ally.

Bringing hope through access: Today, approximately one out of three people in the developing world being treated for HIV/AIDS depends on a Mylan ARV product. But millions more receive no treatment. So Mylan is striving to do for ARV access what it has done already for affordability. Actions include vigorously supporting guidelines that recommend earlier initiation of ARV therapy and helping eliminate barriers to access. The result will help get ARVs quickly to where they are needed, while building a platform that can be used to distribute other life-saving therapies, such as those for malaria and other infectious diseases.

Bringing hope through innovation: Mylan currently offers an extensive ARV product portfolio, components of which have no brand counterpart. The portfolio is a testament to the ingenuity of the company’s scientists, among whose recent ARV innovations are:

  • New Drug Applications tentatively approved by the U.S. Food and Drug Administration under the President’s Emergency Plan for AIDS Relief (PEPFAR), for products such as a once-daily, fixed-dose combination tablet containing Tenofovir, Lamivudine and Efavirenz.
  • Heat-stable generic Lopinavir/Ritonavir. The product can be distributed and used in warm climates where refrigeration infrastructure is not widely available.
  • An offering called "second-line-in-a-box," which contains a once-daily dose of three tablets in a blister packet, reducing pill burden and increasing adherence to treatment compared to existing alternative regimens, which involve five or more pills taken twice a day.

New Drug Applications tentatively approved by the U.S. Food and Drug Administration under the President’s Emergency Plan for AIDS Relief (PEPFAR), for pediatric HIV/AIDS therapies such as a fixed-dose combination tablet containing Abacavir Sulfate and Lamivudine.

http://www.mylan.com/our_businesses/antiretroviral_franchise.aspx