However, these programs commonly lack resources, contacts, and the drug development expertise necessary to move projects beyond the early phases of discovery. This is where Cerium Pharmaceuticals excels. Our team leverages the basic discovery work performed by others and enters after project feasibility has been established. From this point, we create collaborative networks, tailored to each project, which provide a wide range of support to new drug candidates. The goal of Cerium is to move these new medicines through the clinical development and regulatory processes and into final approval and availability.
Cerium does not shy away from challenging development projects, such as medicines targeting pediatric indications and complex biologic agents. In addition, we seek to make our medicines available globally with the help of “Orphan Drug” legislation programs and “Named Patient” access programs, which are increasingly available around the world.
What is the Orphan Drug Act of 1983?
The U.S. Orphan Drug Act was passed in 1983 and signed into law by President Ronald Reagan. The legislation gives incentives to pharmaceutical companies to develop drugs, biologics, or other therapeutics that will treat diseases that affect fewer than 200,000 people in the United States. The Orphan Drug law offers tax breaks and a seven-year period of market exclusivity to help support the development and manufacturing of such products, which are often difficulty to financially support because of the small potential market. Since the passage of the law nearly 350 new medicines have been approved to treat rare disease. Prior to the passage of the Act less than 10 medicines were approved for rare disease indications.