New pediatric drug firm, Madeira, set up

Madeira Therapeutics, a new drug development company specializing in pediatric pharmaceuticals has been set up in Kansas, USA. The company's strategic focus will be on repositioning approved adult compounds and taking them into pediatrics; it will be one of the few drug development companies specifically focused on this population, says chief executive and founder Peter Joiner.

"More than 70% of the drugs prescribed for children are not approved by the Food and Drug Administration," notes Mr Joiner. "The current approach is to prescribe adult drugs by weight; however, children metabolize some drugs differently than adults so this not in the best interest of the patient. Our model focuses on reformulating off-patent adult drugs using the FDA's 505(b)(2) approval pathway. This pathway allows Madeira Therapeutics to develop formulations of drugs for children that have already shown substantial safety and efficacy. Since large clinical trials are not needed, these formulations can be brought to market faster," he explains.

"The pediatric drug market is over $20.0 billion in the USA alone," Mr Joiner says, "yet few of the major pharmaceutical manufacturers focus on this market segment. Madeira has a strategy to leverage this niche to its maximum advantage - for the company and the patients."