Peter R. Joiner, CEO, announced the launch of Madeira Therapeutics, a new drug-development company specializing in pediatric pharmaceuticals. 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.
“More than 70% of the drugs prescribed for children are not approved by the FDA,” said 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.”
Joiner has a 30-year history in sales, sales management, and marketing for pharmaceutical companies. He has launched over 15 major pharmaceutical products and established significant partnerships with key organizations in the health care industry. In addition, Madeira Therapeutics is comprised of an impressive team of industry experts to pursue the strategy, including Ken Phelps as the Chief Scientific Officer. Phelps, CEO of Camargo Pharmaceuticals, is the industry expert in 505(b)(2) applications.
“The pediatric drug market is over $20 billion in the United States alone,” Joiner said, “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.”
The Madeira strategy focuses on reformulating adult drugs in liquid form to better control dosage in children. The 505(b)(2) process relies in part on the FDA’s findings for a previously approved drug, shortcutting FDA approval by years and tens of millions of dollars, Joiner said. In addition to the cholesterol drug already in the development pipeline, the company has plans to develop formulations for acute pain management and diabetes.
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