Mallinckrodt Specialty Generics: Some People Talk About the Future, We Invest in It

For nearly 150 years, the Mallinckrodt name has represented quality products, business integrity, and service—to patients, customers and the communities in which we live and work. Our future-focused vision and dedication to improving lives is matched only by our distinct approach to managing complexity.

As an independent global specialty biopharmaceutical company focused on controlled substances and adjacent areas, as well as therapeutic drugs for autoimmune and rare disease specialty areas, neonatal critical care respiratory therapies, analgesics and central nervous system drugs, and diagnostic medical imaging agents, Mallinckrodt Pharmaceuticals continues to apply its unique strengths, experience, and expertise to bring products to the market that provide unmet value for physicians and patients we jointly serve.

At Mallinckrodt, the common thread critical to our past and future success is our strong ability to master and manage complexity. Simply put, we strive to make the complex simple. We are driven by an intense energy, and led by engaged and high-performing people. This forward momentum promises to expand our horizons even further toward our continued goal to be a top-performing specialty biopharmaceutical company.

Specialty Generics Leader

Mallinckrodt’s Specialty Generics business developed as a natural extension of the company’s Active Pharmaceuticals Ingredients (APIs) business in the mid-1990s. Many of the company’s generic products use the APIs produced by Mallinckrodt, which allows us to ensure reliable and high-quality supply.

Today, our Specialty Generics business offers a comprehensive product portfolio with industry-leading expertise across pain management, attention-deficit/hyperactivity disorder and addiction treatment. More than 60 million prescriptions are filled annually with Mallinckrodt’s generic products.¹ Mallinckrodt is also one of the world’s leading producers of bulk acetaminophen. Our top 8 generic products are each within the top 3 in market share for their respective categories.²

We are vertically integrated to ensure quality control during every step of a product’s development—from active ingredient processing through formulation, manufacturing, and distribution. Through our global operations platform, our ability to manufacture complex products and deliver them efficiently to our customers reflects Mallinckrodt’s core values that we have held true to since 1867—quality, integrity and service.

Investing in the Future

The same goal of providing high-quality, innovative products that began almost a century and a half ago with the Mallinckrodt brothers still exists today. We have benefited from a productive Research and Development (R&D) team, with U.S. Food and Drug Administration approval of 12 new products companywide since 2010. The company’s development pipeline remains focused in areas where we think we can bring differentiated value to the marketplace, and the Specialty Generics portfolio is a high priority for R&D.

The company has also invested millions of dollars in research efforts focusing on exploring the abuse-deterrent potential of its proprietary formulation technologies. Mallinckrodt understands the importance of developing abuse-deterrent technologies that can be used in both branded and generic medicines that will effectively make products less attractive to potential abusers, while at the same time providing patients, who depend on our medicines for relief of diagnosed pain, with a wide range of safe, affordable options.

Specifically, Mallinckrodt’s Specialty Generics supply chain continues to invest in several infrastructure and capacity improvements to consistently deliver the high-quality products customers need. Recent expansion of the high-volume manufacturing facility in Hobart, New York, will increase production of our generic pharmaceuticals, and new packaging lines will improve product output. We have also invested in Mallinckrodt’s API business to increase capacity and reliability of raw materials for generic pharmaceuticals.

In closing, Mallinckrodt’s specialty generic drug products allow for patient accessibility to broader healthcare options, and continue to be a key area of focus for the company.

For more information, visit http://www.mallinckrodt.com/.

References

• IMS Health National Sales Perspective, 2014
• National Analytics, July 2014