Unfortunately, financial investment for the development of pediatric cancer specific drugs remains dismal
with only three pediatric specific drugs granted approval in the last 20 years versus 180 for adults
The development of pediatric cancer drugs faces several challenges such as:
Twelve types and multiple subtypes
Low incidence rates
Overcome regulatory complexity
Access to expert researchers
Need of pediatric formulations
Hidden HOPE
There is currently a portfolio of critical therapeutic targets in academic labs and a plethora of compounds in biopharmaceutical companies that hold the real promise for creating effective treatments against many forms of childhood cancer whose prognosis remains dismal
Regulatory Incentives contribute to make investment on pediatric cancer drug development highly Capital Efficiency and Profitable
The Orphan Drug Designation Program in the US provides important financial incentives to encourage companies to develop drugs and biologics for rare diseases
The Pediatric Exclusivity Act (PREA) provides an additional six months of patent protection for a drug, if a manufacturer also conducts studies of the effect of the drug on children
The Research to Accelerate Cures and Equity (RACE) for Children Act: a major update to PREA requiring companies developing cancer drugs do studies of their drugs in children
And last but not least...
The Creating Hope Act, a significant market incentive for the development of drugs for rare pediatric diseases through the establishment of a Priority Review Voucher (PRV)
Success Story
Mar 13, 2015
United Therapeutics received PRV after its orphan drug (Unituxin) was approved by the FDA to treat neuroblastoma, a type of pediatric cancer
Aug 19, 2015
United sells its PRV to Abbvie for $350M and reported $76M on sales for Unituxin in the US on 2017
Positioning Oncokids as the leading pediatric oncology organization in the world
Become the World-Wide Leader in Development and Commercialization of Pediatric Oncology Drugs
Learn more →
Become the Partner of Choice to support Innovation, Accelerate Research Breakthroughs and Out-License Oncology Assets for Pediatric Indications
Learn more →
Become the Partner of Choice for Foundations and Patient Associations to Support and Invest in Drug Discovery and Development
Learn more →
An unprecedented combination of ingredients for success for pediatric oncology
Expertise. First-class mission-driven team with extensive experience in business management in life science, drug discovery, development and commercialization
Operational diminished risk. Established links to Pediatric Oncology KOLs and strategic alliances and consortiums with leading institutions
Capital Efficiency. Unique and aggressive approach for orphan designation providing fast-track strategic guidance to create value for patients and stakeholders
Let’s Move THe Needle On Childhood Cancer NEw Therapies!