Decision Resources, Inc., one of the world's leading research and advisory firms focusing on pharmaceutical and health care issues, finds that legislation in the United States, Japan, and Europe provides financial incentives to biopharmaceutical companies producing orphan drugs.
According to the new DR Pipeline Report entitled Orphan Drugs Pipeline Analysis: Wider Incentives Encourage Orphan Drug R&D, the United States passed the Orphan Drug Act in 1983, providing seven years of marketing exclusivity for orphan drugs approved by the FDA for the treatment of rare diseases. Rare diseases are defined as those affecting less than 200,000 people in the United States.
Japan developed an orphan drug plan in 1993 that allows for market exclusivity following approval. The Japanese Ministry of Health, Labor and Welfare (MHLW) approves orphan drugs for the treatment of rare diseases, which it defines as those with less than 50,000 prevalent cases.
The European Union first implemented a centralized policy pertaining to orphan drug development in 2000. The European United Medicinal Products Regulation grants sponsors ten years of market exclusivity for products with orphan drug designation. The maximum disease prevalence for a drug to qualify for orphan status is 50 cases per 100,000 people.
The report also finds that orphan drugs are most likely to be created for indications in three therapeutic categories: genetic diseases, including cystic fibrosis and lysosomal storage disorders; autoimmune diseases, including multiple sclerosis and myasthenia gravis; and cancer.
About DR Pipeline Reports from Decision Resources
DR Pipeline Reports is a series of comprehensive reports that focuses on pharmaceutical and biotech company drug development and commercialization strategies. DR Pipeline Reports expose major players in a therapeutic market and, more importantly, shed light on the emerging players that could significantly impact the current market once their pipelines are launched.
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SOURCE: Decision Resources, Inc.
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