Mylan 50 years young and still making history
Mylan was founded in White Sulphur Springs in 1961, in the U.S. state of West Virginia. It began as a distributor, buying finished goods and reselling them to pharmacies and physicians. In 1965, the company established manufacturing operations in Morgantown, W.Va., and began making vitamins and then empty gelatin capsules. The company’s cofounders soon decided to switch their production lines over to generic pharmaceuticals and market them to large drug companies, drug store chains and mail-order drug providers – all for resale under the customers’ own labels.
In 1966, Mylan received approval from the U.S. Food and Drug Administration to manufacture its first medicine, Penicillin G. The company also proceeded to broaden its product line to include other generic antibiotics, as well as analgesics, antihistamines and steroids. In 1969, Parke, Davis & Co. became the first major pharmaceutical company to purchase and privately label Mylan’s products. In addition, Mylan introduced a new logo – the letter “M” formed by three test tubes to suggest both scientific leadership and the teamwork necessary for success.
Milan “Mike” Puskar and Don Panoz
Don Panoz, 1961-1969
Jerome Lehman, 1969-1976
Roy McKnight, 1976-1993
Mike Puskar, 1993-2002
Robert J. Coury, 2002-2011
Heather Bresch, 2012-present
To fuel continued expansion, Mylan went public in 1973. By the end of the decade, the company was producing five of the 10 most prescribed generic drugs – all five, antibiotics. Mylan relied on antibiotics in part because of federal laws that tended to discourage development of generic equivalents for newer branded drugs.
That situation changed dramatically in 1984, when Congress passed the Drug Price Competition and Patent Term Restoration Act. At that time, generic utilization was less than 20%. The legislation, known also as the Hatch-Waxman Act after its sponsors, was a response to longstanding and mounting pressure to address the high price of branded drugs. Among the many groups lobbying for such relief was the Generic Pharmaceutical Industry Association, or GPIA, established in 1981. GPIA was the generics industry’s first trade organization and counted Mylan cofounder Milan “Mike” Puskar among its founders.
Hatch-Waxman created incentives for U.S. generic drug makers to challenge the patents upon which brand name drugs relied. The act also created an abbreviated process generic drug makers could use to secure approvals to produce and sell their products. The legislation struck a careful balance between innovation and competition, while bringing more affordable, high quality medications more quickly to American consumers. In the four years following the act’s passage, the number of Mylan drug applications approved by the Food and Drug Administration (FDA) was more than double that approved between 1980 and 1983.
The 1980s were important for Mylan in other ways. It received approval in 1984 for its first proprietary product – Maxzide(R), an antihypertensive drug – making Mylan the first generic manufacturer in the world to patent a new drug. The company also built a plant in Puerto Rico and established a distribution center in North Carolina to support its continued growth.
In the late 1980s, Mylan again helped shape the industry. In 1985, the company began experiencing irregularities in how and when the FDA acted on its ANDAs, or abbreviated new drug applications. The company investigated and shared its findings with Congress. The widespread probe that followed uncovered corruption within the agency’s generic drugs division, as well as unethical conduct by several competitors. The result, ultimately, was reform of the FDA’s review procedures for generic drugs, restoration of a level playing field for manufacturers and further precautions to help ensure consumer safety.
Also in the late 1980s and continuing throughout the 1990s, Mylan focused on diversification. The company’s aim was to rely less on its core generics business, as the market had become increasingly competitive as demand for high quality, affordable medication rose. Two of Mylan’s most important transactions during this period were the acquisitions of Bertek Inc. (now Mylan Technologies), an innovator of transdermal drug systems, and UDL Laboratories, the largest pharmaceutical unit-dose packaging company in the U.S. During this time, Mylan prospered, and by 1995 the company had created the most dispensed line of pharmaceuticals – branded or generic – in the country.
Through the 1990s, generic utilization rose steadily to approximately 47% and Mylan continued to capture market share, discontinued private labeling and grew its own Mylan label.
By the end of the 20th century, Mylan also had firmly established a well-deserved reputation throughout the industry for quality, reliability and innovation; meeting unmet needs and developing products that are difficult to formulate or manufacture. A great example was the company’s development of the orphan drug Cystagon(R), which controls a rare genetic disorder called cystinosis. Left untreated, the disease, which affected about 400 children worldwide in the mid-1990s, usually claimed its victims’ lives before they turned 11.
Mylan’s growth continued into the 21st century, and in 2002 the company achieved an important milestone, generating sales of more than $1 billion. In addition, the company continued to make its voice heard among policy makers, which led in 2003, for instance, to the adoption of legislation that closed loopholes which delayed the development and marketing of generic drugs. As a result of the Medicare Prescription Drug, Improvement, and Modernization Act and an aging population on Medicare, generic utilization grew, reaching 78% in 2010. Despite its influence and accomplishments, Mylan nonetheless was a mid-size company operating in a consolidating industry, and its leaders recognized the need to augment organic growth with acquisitions.
Recognizing an opportunity to create massive scale in its operations – and a huge competitive advantage, Mylan went global in 2007. The first step in that transformation occurred when Mylan acquired a controlling interest in Matrix Laboratories, an India-based leading supplier of active pharmaceutical ingredients. Matrix (now Mylan Laboratories Limited) had low-cost manufacturing facilities in India and China and marketing capabilities in Western Europe and Africa. The transaction allowed for vertical integration, providing the company unprecedented control over its supply chain. It also expanded Mylan’s dosage forms and therapeutic categories – notably, adding antiretroviral drugs that treat people living with HIV/AIDS, allowing the company to continue its drive to meet unmet needs.
The second step in Mylan’s transformation occurred when the company purchased Germany-based Merck KGaA's generics business, which sold products in more than 90 countries. The transaction further expanded Mylan’s product portfolio and gave it instant access to the expertise needed to successfully navigate complex local and regional regulatory environments. In addition, Mylan gained entry into commercial markets that allow for differentiation among generic companies.
As a result of its transformation, Mylan went from being the third largest generic pharmaceuticals company in the U.S. to being one of the largest generic and specialty pharmaceuticals companies in the world. Today (as of Dec. 31, 2011), Mylan has revenues of more than $6.13 billion, commercial operations in approximately 150 countries and territories and a workforce of more than 18,000 worldwide. It has one of the industry’s broadest and highest quality portfolios, with more than 1,100 separate products.
Looking ahead, Mylan’s mission is helping to provide the world's 7 billion people with access to high quality medicine.