ATL 1103 is an Orphan Drug as Acromegaly is considered a rare disease.
Drug companies are increasingly taking advantage of the commercial benefits of developing so-called orphan drugs, which include extra patent protections, higher pricing and a streamlined review process by FDA.
Eleven of the 30 new drugs approved last year, or 37 percent, were for rare medical conditions, the highest percentage on record since the FDA began offering incentives to develop such therapies, known as orphan drugs, about 30 years ago. Additionally, nearly half of the 30 drugs were cleared under FDA's "fast track" program reserved for drugs that fill an unmet medical need.
The FDA grants companies seven years of exclusive, competition-free marketing for each newly approved orphan drug, as well as tax breaks on the costs of developing the drugs. Orphan drugs also typically command much higher prices than other drugs. Last year French drugmaker Sanofi paid $20 billion to acquire specialty drugmaker Genzyme, whose products range from $100,000 to $300,000 for one year's supply.
