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Mylan Pharmaceuticals: A West Virginia Formula for Access to Affordable Medicine

Author: 
by Jim Bunch

Morgantown, West Virginia, is home to the largest domestic manufacturer of generic prescription medicine-Mylan Pharmaceuticals Inc. While this may be surprising to most of us, it is not a surprise to the individuals living in and around Morgantown, West Virginia. Throughout the past 40 years, Mylan Pharmaceuticals has quietly grown to become a leader in the development and manufacturing of quality, affordable medicine. It has also become one of the largest employers in the Morgantown area and one of the most consistent contributors to "good causes" throughout West Virginia and neighboring Pennsylvania.

Established in 1961 by Milan "Mike" Puskar and his army friend Don Panoz, the original operation, called "Milan Pharmaceuticals Inc" was located in White Sulphur Springs. At that time, the company did not manufacture products but operated as a distributor, buying finished goods and reselling them to pharmacies and physicians. The founders had a simple formula for success: deliver a quality product at an affordable price and provide exemplary service to customers.

More than four decades later, Puskar is chairman of Mylan Laboratories Inc., the parent company of Mylan Pharmaceuticals. If you ask him why Mylan has been so successful, he will not take personal credit. Instead, he will tell you that the Mylan "family of employees" has been responsible for its growth and success. He will also explain that the company's reputation for quality, integrity and value has always been guided by the principle that he espouses: "We either do it right or we don't do it at all."

Today, the Mylan heritage is guided by Robert J. Coury, who became chief executive officer of Mylan Laboratories Inc. in September 2002. This appointment came as a result of working as a consultant with Mylan and Puskar for more than seven years. As a testament to the continuity in leadership that is ever-present and the conviction that Mylan employees are responsible for its success, last year's annual report-the first under Coury's direction-focused on individual Mylan employees who make a difference every day for customers and patients.

The Road to Succes

In 1966, just five years after its founding, Mylan Bertek Pharmaceuticals had net revenues of more than $596,000. Now almost 40 years later, in fiscal 2004, the company's net revenues were $1.37 billion. Obviously, a lot has changed over time. As a result of its early growth, Mylan moved to Princeton and then Morgantown by 1965. With fewer than 20 employees and a facility of fewer than 15,000 square feet, the company reached an important milestone in 1966 when it received Food and Drug Administration (FDA) approval to manufacture its first product: penicillin G tablets. Two years later, a second product, tetracycline capsules, was approved, and Mylan was beginning to establish itself as a manufacturer of pharmaceutical products. Word of its production expertise spread, and in 1969, the company had its first contract to manufacture pharmaceutical products for a major brand-name company.

With a growing product line and customer base, Mylan relinquished its private status and became a publicly owned company in February 1973. New management led to the departure of the company founders by the late 1960s early 1970s. As a result of a financial decline in subsequent years, however, Puskar agreed to return as president in May 1976, at the request of Roy McKnight, the company's chief executive officer. Together, Puskar and McKnight orchestrated a turnaround that most thought impossible. The 1980s were a tumultuous time for Mylan and the developing generic industry, despite a growing product line and approval of its first brand-name product-the anti-hypertensive medication, Maxzide(r). By the time Mylan was ready to celebrate its 25th anniversary, it found itself in an industry beset with corruption. In 1989, with their unwavering commitment to quality and integrity, Mylan, led by Puskar and McKnight, exposed corruption within the FDA and a number of generic companies. McKnight testified before the House Oversight and Investigations Committee regarding improprieties at the FDA, which prompted an investigation of the generic drug industry. The investigation exposed a pattern of cheating, bribery and payoffs by certain generic drug companies aimed at expediting the approval of their drug applications and delaying approval of applications filed by Mylan and others. The nationally reported investigation led to judicial and legislative action that eventually strengthened the entire generic pharmaceutical industry.

Mylan established an even stronger presence in the overall pharmaceutical industry through acquisitions that would strategically impact its future. In 1988, the company entered into a joint-venture agreement and purchased one half of the common stock of Somerset Pharmaceuticals, which shortly thereafter received FDA approval to market Eldepryl, a new medication for Parkinson's disease. A few years later, additional acquisitions were made, including that of Dow B. Hickam Inc., known for its skilled sales force; Bertek Inc., which had made a name for itself in transdermal drug delivery; UDL Laboratories, Inc., the premier supplier of unit-dose multi-source pharmaceuticals to the institutional and long-term care marketplace and Penederm Inc., a recognized leader in dermatology.

During this period, Mylan continued to grow as a leader in the development and manufacturing of generic medicines. It continued to expand its production capacity, which reached 220,000 square feet at the Morgantown facilities by 1987. It also began to invest in manufacturing facilities in Puerto Rico. Recognizing the need for more rapid distribution of its growing line of products, Mylan opened a distribution facility in Greensboro, North Carolina.

Following the sudden death of McKnight in 1993, Puskar assumed the roles of chair and CEO of the parent company. By 1995, Mylan achieved a milestone that its founders could only have dreamed of when they started the company 34 years earlier-it became the number one, most dispensed line of pharmaceutical products in America. Since that time, Mylan has continued to grow and diversify. In 1996, it created Mylan Bertek Pharmaceuticals Inc., to develop, manufacture and market proprietary products.

The journey is still unfolding as the company positions itself for further expansion. Its tradition of quality and high standards continues through its current leadership, which includes Puskar, Coury, Louis J. DeBone, a 27-year veteran, who is president and chief operating officer of Mylan Laboratories Inc. and Dr. John O'Donnell, chief scientific officer, who has also been with Mylan for more than 20 years.

Today, Mylan companies employ more than 2,800 employees across its corporate, development, production and distribution sites. There are manufacturing facilities in West Virginia, Vermont, Illinois, Texas and Puerto Rico, which encompass approximately 1.1 million square feet. The company has offices in West Virginia, Pennsylvania and North Carolina as well. Equally impressive, Mylan ships nearly 29 million tablets and capsules daily, which translates to more than 500,000 prescriptions filled with Mylan Products daily. In fact, if you were to lay all of the Mylan tablets and capsules sold annually end-to-end, they would stretch for more than 73,000 miles.

A Solid Foundation

Creating a prosperous working environment has always been based on the belief that if you take care of your employees, they will take care of your customers, and if both of these constituencies are prospering, shareholders will naturally benefit. This philosophy was stated very clearly in Puskar's and Coury's address to shareholders in the 2003 Annual Report, in which they wrote "Mylan's vision lives through the imagination, dedication and integrity of our people, who understand that we prosper by helping others to succeed."

Throughout its offices, laboratories, manufacturing and distribution sites, an atmosphere of teamwork, a sense of purpose and a strong work ethic-sprinkled with the often-mentioned sense of family-prevail. When you ask them, employees will tell you that they have happily been a part of Mylan for years. They speak openly of being part of a team that feels like a family, working together to create quality products for patients. Not surprisingly, Mylan has many, many long-term employees-including many who have been with the company for more than 30 years.

A Commitment to Patients

Before there was a focus on the high cost of prescriptions, Mylan was committed to bringing quality, affordable medicine to the people who needed them. Ironically, when the company was started in 1961, the average annual medical expenses per person in the United States were $100, and a United States Senate subcommittee reported that patients were paying too much for prescription drugs!

Today, Mylan manufactures 136 different pharmaceutical products that includes more than 300 different strengths-each of the highest quality. It has products in many therapeutic categories, including asthma, allergy, angina, arthritis, cancer, depression, diabetes, high cholesterol (hyperlipidemia), gastrointestinal disorders and hypertension to name just a few of the 39 categories. Its commitment to manufacturing excellence continues to be recognized by pharmacists who rate its products highest in quality. In fact, independent surveys of pharmacists have ranked Mylan Products number one in quality among all generic companies for six years in a row.

As another measure of success, 49 percent of the products in the company's generic line rank first in market share based on the number of new and refilled prescriptions dispensed by pharmacists. And, 69 percent of its products rank first or second, according to a national prescription audit. (A complete list of the brand-name products for which Mylan offers a generic equivalent is provided in the table.)

The prescription drugs listed above are registered trademarks or trademarks of their respective owners, manufacturers or distributors, and are as follows:

1. American Cyanamid Company 2. G.D. Searle & Co. 3. Pharmacia & Upjohn Company 4. Merck & Co., Inc. 5. Sherwood Services AG 6. Syntex Puerto Rico, Inc. 7. Wyeth 8. Reliant Pharmaceuticals, LLC 9. Eli Lilly and Company 10. Merrell Pharmaceuticals Inc. 11. Schering Aktiengesellschaft 12. Hoffmann-La Roche Inc. 13. Bristol-Myers Squibb Company 14. Par Pharmaceutical, Inc. 15. Syntex (U.S.A.) LLC 16. TWFC, Inc. 17. Pfizer Inc. 18. Novartis Corporation 19. Boehringer Ingelheim International GMBH 20. Novartis AG 21. SmithKline Beecham 22. King Pharmaceuticals, Inc. 23. ICN Pharmaceuticals, Inc. 24. AAI Pharma, Inc. 25. Pfizer Pharmaceuticals, Inc. 26. RPR Investments Inc. 27. Warner-Lambert Company 28. SmithKline Beecham Pharmaceuticals Co. 29. AstraZeneca Pharmaceuticals LP 30. Somerset Pharmaceuticals, Inc. 31. Abbott Laboratories 32. Galen Chemicals Limited 33. Alza Corporation 34. LIPHA 35. Johnson & Johnson 36. Rorer Pharmaceutical Corporation 37. Abbott GMBH & Co. KG 38. Aventis Pharma Deutschland GMBH 39. Biofarma 40. Solvay Pharma Properties, Inc. 41. Procter & Gamble Pharmaceuticals Puerto Rico, Inc. 42. Bertek Pharmaceuticals Inc. 43. Parke-Davis 44. Stada Pharmaceuticals, Inc. 45. Watson Laboratories, Inc. 46. Ranbaxy Pharmaceuticals Inc. 47. Zeneca Ltd. 48. Riker Laboratories, Inc. 49. Aventis Pharma S.A. 50. Sanofi-Synthelabo 51. AstraZeneca AB Corporation 52. Roberts Laboratories Inc. 53. E.R. Squibb & Sons, L.L.C. 54. Schering Corporation 55. Glaxo Group Limited 56. Organon 57. AstraZeneca UK Limited 58. New River Pharmaceuticals, Inc. 59. Jerome Stevens Pharmaceuticals, Inc. 60. Roche Products Inc. 61. Biovail Laboratories Inc. 62. Elan Corporation, PLC 63. BW USA, Inc. 64. American Home Products Corporation 65. Elan Pharmaceuticals, Inc. 66. Prometheus Laboratories, Inc.

Despite the ever-growing number of products in the Mylan line, and the enviable position of being the largest United States-based generic pharmaceutical company, Mylan has an unblemished manufacturing record and has never received an FDA warning letter.

In contrast to medicine needed by large numbers of patients, Mylan has also been instrumental in developing products for a limited number of patients. The first of these "Orphan Drugs," Cystagon(r), was approved in 1993 by the FDA to treat the disease cystinosis, which only affects about 2,000 children in the world.

Another such product is Sulfamylon(r) Powder for 5 percent Topical Solution, which was introduced in 1998 for victims of severe burns. In April 2004, Mylan received approval for yet another Orphan Drug, Apokyn(tm) (apomorphine hydrochloride injection). The first and only therapy approved in the United States for the acute intermittent treatment of hypomobility (off episodes) associated with advanced Parkinson's disease.

As a result of its commitment to Orphan Drugs, the company received recognition from the National Organization of Rare Disorders (NORD) in 2003. Mylan was honored as one of 20 companies with significant achievements in rare disease research and Orphan Drug development.

Trusted by Pharmacists

Pharmacists have played an important part in the company's growth and success because they dispense Mylan products to the patients who need them. In this regard, pharmacists place their trust in Mylan every day. Mylan has reciprocated by supporting the pharmacy profession through the Mylan Institute of Pharmacy. Important initiatives have included:

-The Mylan Excellence in Pharmacy Award: Now in its 18th year, this award recognizes tomorrow's leaders in pharmacy practice;

-On-line and Printed Continuing Education (CE) Programs: Mylan has long-supported pharmacy education through the development of CE Programs that provide pharmacists with practical information and credits necessary for ongoing state licensing. One such program developed in 2002 has already been completed by over 65,000 pharmacists;

-Local Continuing Education Programs: For pharmacists in and around the Morgantown area, Mylan organizes "live" CE Programs in conjunction with West Virginia University; and

-The Mylan School of Pharmacy at Duquesne University: As a result of its support of the Pharmacy School at Duquesne University, that school bears the name Mylan.

A Giving Nature

While production numbers and sales figures are an important measure of a company's success, what a company "gives back" to the communities in which it operates speaks volumes to the character and commitment of the organization and the individuals who run it. In this regard, Mylan "the company" and Milan "Mike" Puskar "the philanthropist" have long been recognized as having big hearts because of their willingness to generously support local, statewide and national charities. Each year, "Mylan & Mike" have quietly contributed millions of dollars to a wide variety of worthy causes ranging from secondary schools to college and universities; to organizations that help children and families; to associations that support research in different disease areas, as well as groups that represent various patient groups.

To continue its long history of civic and philanthropic activity, the company established the Mylan Laboratories Charitable Foundation in 2002 with a contribution of $5 million. The Foundation is a 501(c)(3) nonprofit organization dedicated to providing support through grants to other qualified charitable organizations. Its mission is to foster support to recipients in health and welfare, education, culture and the arts. Since its inception, the Mylan Laboratories Charitable Foundation has granted funding to a wide range of groups and associations.

In the process, it has touched the lives of countless individuals throughout the state of West Virginia; in particular, those in and around its facility. This commitment to the Morgantown area-in which Mylan is the largest private employer-is built on a belief that "giving back" acknowledges those people and communities that have contributed to your success. Regardless of the charity supported or the magnitude of the donation, the motivation has remained the same-to help and enrich the lives of others. Mylan is also a vital donor to Global Links, a nonprofit organization that collects medical supplies for people throughout the world who desperately need them. Since 1989, Mylan has supplied millions of dollars worth of medicines. Its donations of antibiotics, antihypertensives, anti-inflammatories, antidiabetics and analgesics have reached needy patients in 16 countries, including the United States. Global Links has shared donated medicines with other international charitable organizations, extending the benefit of these donations to millions more patients worldwide.

Amidst this myriad of donations, some contributions in particular are notable for their sheer size. In November 2003, Puskar personally donated $20 million to West Virginia University (WVU) for athletics and academic scholarships-the single largest gift ever made to the West Virginia University Foundation on behalf of the school. Gifts to WVU are not new for Puskar. Today, WVU's Athletic Center and Football Stadium all carry his name.

Recent Awards and Recognition

Mylan Laboratories and its Bertek Pharmaceuticals division received the 2003 Award for Outstanding Achievement in Parkinson's Disease from The Parkinson's Institute. The company received this award for its leadership in Parkinson's pharmacology and its dedication to the development of neurological treatments that target unmet needs. The Wellness Council of West Virginia awarded Mylan Pharmaceuticals its Well Workplace Gold Award for 2002-2003 in recognition of the company's focus on providing employees with an environment of health and wellness in the workplace.

Recently, Milan "Mike" Puskar was recognized by Morgantown Health Right-a local organization that provides a safety net for those who are unable to access medical treatment through the traditional health care system. Recently, this organization was renamed the "Milan Puskar Health Right."

Looking to the Future

Throughout the course of more than 40 years, Mylan Pharmaceuticals has touched the lives of millions of people through the products it has developed, manufactured and distributed. It has impacted the lives of thousands of employees who have become part of the Mylan family, and it has contributed in a positive way to countless others through its generosity. Although time has passed and some of the players have changed, its focus on quality, integrity and value, and its commitment to its founding principle-"We either do it right or we don't do it at all"-has remained the same.