About Mallinckrodt, the Pharmaceuticals business of Covidien
Mallinckrodt is a global company that develops, manufactures, markets and distributes specialty pharmaceutical products and diagnostic imaging agents. Our specialty pharmaceutical products are sold to major wholesalers and retail drug store chains. We use our active pharmaceutical ingredients products in the manufacture of our generic pharmaceuticals and also sell them to other pharmaceutical companies. We market our global medical imaging products primarily to physicians, technologists and purchasing administrators at hospitals, imaging centers, cardiology clinics and radiopharmacies.
We are the largest U.S. supplier, by prescription, of opioid pain medications and a leading manufacturer of active pharmaceutical ingredients. We are also the largest global supplier of the medical isotope technetium-99m and an industry leader in radiopharmaceuticals, contrast media, and delivery systems. Mallinckrodt encompasses more than 5,500 dedicated employees around the globe, all focused on our core values of quality, integrity and service to meet the needs of patients globally.
Established as G. Mallinckrodt & Company in 1867, the $2 billion St. Louis-based business was acquired by Tyco International in 2000. In 2007, Tyco spun off its healthcare business into Covidien, a leading global healthcare products company. On December 15, 2011, Covidien announced plans to spin off Mallinckrodt as a standalone public company. The Company expects to complete the spin-off by mid-2013.
Mallinckrodt’s mission is to reveal and relieve disease for a healthier world.
Mallinckrodt pioneered the use of various medications in pain management and we are currently expanding our proprietary franchise in pain and near adjacencies while remaining among the top ten generic pharmaceutical companies in the U.S.
From 2007 to 2012, Mallinckrodt received U.S. Food and Drug Administration (FDA) approval for a total of nine branded or generic pharmaceutical products as well as a prior approval supplement for an existing product which included a new tablet strength. In mid-2010, Mallinckrodt launched two new branded pharmaceutical products and one generic product for pain management. In 2011, we launched two generic pain products, and a significant generic Attention-Deficit Hyperactivity Disorder product in 2012.
Mallinckrodt also continued to focus on strategic growth opportunities with key acquisitions and agreements in 2012, with the acquisition of CNS Therapeutics, a private, specialty pharmaceutical company with a focus on intrathecal-delivered drug products, including products for the treatment of severe or intractable spasticity and development products designed for treatment of pain. We executed two co-promotion agreements and acquired a pain product. These agreements leverage our therapeutic leadership and sales channels across the spectrum pain. Our products and co-promoted products treat pain from a broad range of disorders such as pain associated with osteoarthritis, rheumatoid arthritis and migraine, and include options for management of chronic moderate to severe pain.
Building on Mallinckrodt’s core strengths in development, formulation and manufacturing, we are pursuing a robust pipeline of proprietary and generic drugs. We currently have one new drug application (NDA) and five generic drug applications under FDA review and two NDAs in development. Supporting our pipeline is a Research and Development group staffed with talent from leading pharmaceutical companies and universities.
Mallinckrodt promotes the safe prescribing and appropriate use of controlled pain medications, as well as patient education and safety, through voluntary initiatives and activities in the industry. In the fall of 2010, we launched the C.A.R.E.S. (Collaborating and Acting Responsibly to Ensure Safety) AllianceSM to enhance the responsible prescribing and safe use of opioid pain medications.
Building on over a century of leadership in helping to diagnose disease through imaging procedures, for decades Mallinckrodt has manufactured and marketed imaging products to serve patients in every region of the world. Our future growth in imaging will predominantly come from emerging markets like Latin America, Asia Pacific, and Eastern Europe.
In recent years, Mallinckrodt has launched several important products to expand its imaging portfolio. Radiofrequency identification- (RFID-) enabled Optivantage™ dual-head computed tomography contrast delivery systems combined with RFID-enabled Ultraject™ prefilled contrast media syringes can help reduce the risk of certain medication errors (available in U.S. only at this time). The Optistar™ Elite magnetic resonance (MR) contrast delivery system is used in MR imaging procedures. Mallinckrodt is a leading producer of contrast media prefilled syringes and, in many regions, the only supplier of contrast media in a prefilled and prelabeled syringe, helping to reduce certain risks and improve efficiency of contrast media administration. We also introduced our Kit for the Preparation of Technetium Tc-99m Sestamibi Injection in recent years.
We continue to make investments to further secure the global supply chain of molybdenum-99 (Mo-99), an important radioisotope from which the medical isotope technetium-99m (Tc 99m) is derived. Tc 99m is used in more than 80 percent of the world’s 35 million nuclear medicine diagnostic procedures. Producing Mo-99 at our facility in Petten, The Netherlands, we are the only vertically integrated supplier of Tc 99m generators, demonstrating our long-term commitment to the nuclear medicine industry. Mallinckrodt is one of the world’s leading manufacturers of Tc 99m generators and we are committed to working with all U.S. and international stakeholders to ensure the future stability of Mo-99 production for patients worldwide. In 2010, we added exclusive rights to the Maria Research Reactor in Poland for our global Mo-99 supply chain. Mallinckrodt also has made substantial investments in projects that are underway to convert fully to low-enriched uranium-produced Mo-99.