URGENT: Tim Coté Advises Ovarian Cancer Drug Developers Run, Don't Walk, To Get Orphan Designation.


Biotechs and pharma groups who are developing therapies for ovarian cancer have long counted on the exclusivity, tax credits, and fee exemption benefits of the Orphan Drug Act (ODA).  Indeed, FDA has issued 85 designations for products to treat ovarian cancer since 1983.  This is about to change. 

According to Tim Coté MD, MPH, CEO of Coté Orphan LLC, and former Director of FDA’s Office of Orphan Products Development, the US prevalence of ovarian cancer will soon exceed the statutory criteria for orphan designation.  “As of March 10, 2016 we calculated the prevalence of ovarian cancer to be 198,678, statistics that come from the National Cancer Institute’s (NCI’s) Surveillance Epidemiology and End Result (SEER) program.  Given the steady rise in the US population, we estimate the statutory prevalence limit of 200,000 will be exceeded on or about January 1, 2017.” Coté further warns that there is no guarantee of steady growth in the prevalence of ovarian cancer and therefore the number could be exceeded even sooner.

Coté advises that the law affords full orphan drug benefits for companies who submit orphan designation applications for ovarian cancer therapies prior to the date the prevalence exceeds 200,000.  Any deficiencies in satisfying the medical rational criterion (typically met through animal model xenografts) can be corrected through the OOPD abeyance procedure, but waiting now means foregoing the benefits of the ODA for ovarian cancer therapies.

Coté Orphan LLC is the world leader in orphan drug regulatory affairs, featuring a regulatory team with approximately 125 years combined experience in regulatory affairs and preclinical drug development.  Led by Dr. Tim Cote’s FDA experience as the deciding official for 1400+ orphan designation applications and overseer of 150+ orphan drug marketing authorizations, Coté Orphan LLC currently submits more FDA and EMA orphan designation applications than any other firm.