Kaly has four O.D.D. The Orphan Drug Act, applicable only to the US market, was created to provide industry with incentives to develop drugs that are designed to treat, or prevent, diseases affecting fewer than 200,000 people in the United States. An application for Orphan Drug Designation (ODD) includes critical aspects such as, the scientific mechanism of action for the drug's role in the target disease, the prevalence of the rare disease in the USA. Typically, the mechanistic rationale involves the company providing experimental data supporting the claim that its drug may be effective.
There are important financial benefits to corporations that follow an Orphan Drug development path. If granted, an ODD provides the drug with a status which gives exclusive marketing and development rights as well as financial benefits to help recover part of the costs of clinical development. More specifically a 50% tax credit on the cost of clinical trials performed in the USA, a 7 year marketing exclusivity following drug approval, a fast-track type approach to file and review submissions, waiver of the new drug approval fees (estimated at $3 million US), as well as other financial benefits.