Companies developing treatments for rare diseases can actually gain valuable financial incentives from an ‘orphan drug designation.’

Such a designation not only provides partial tax credit for clinical trial expenditures and waived user fees (e.g. for scientific advice) – but also eligibility for 7/10 years of marketing exclusivity in the US/EU, respectively.

Additionally, according to a recent study (- https://ojrd.biomedcentral.com/articles/10.1186/s13023-017-0665-6 LINK TO THE study), the ‘orphan’ designation appears to be successful at generating positive value for companies, as seen by the positive and significant average increases in stock prices.

The expert regulatory consulting team at ADRES has extensive experience in obtaining orphan drug status, in both the US and EU.

We can advise and prepare such applications for a variety of technologies and indications – including for challenging circumstances in which a strong scientific rationale is required.

If you’re interested in learning more about rare diseases, including how to determine if a drug is eligible for Orphan Drug Designation, the process for submitting to OMPD, and how to justify the investment needed for drug development, then downloading the file is definitely recommended. It contains valuable information on all of these topics and more.

Download the file

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