News | January 15, 2009

Dr. Gregory L. Kearns, Pharm.D., Ph.D., Joins Madeira Therapeutics Board Of Advisors

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Madeira Therapeutics, a company specializing in pediatric pharmaceuticals, is pleased to announce that Dr. Gregory L. Kearns, Pharm.D., Ph.D., Chairman of the Department of Medical Research and Director of the Pediatric Pharmacology Research Unit at Children's Mercy Hospitals and Clinics in Kansas City, Missouri, has elected to serve as a member of the Company's Board of Advisors. Dr. Kearns brings an extensive amount of experience in pediatric research and drug development to Madeira's Advisory Board.

"Dr. Kearns will be a wonderful addition to Madeira's Advisory Board with his extensive research specifically focused in pediatric clinical pharmacology and the evaluation of adverse drug reactions in the pediatric population," stated Madeira President and CEO, Peter Joiner. "He is well known for his medical and pharmacology work in pediatrics worldwide."

There is a profound need for children's products that have been tested and approved safe and effective for use by children. Greater than 70% of the drugs that are prescribed for children have not been studied and labeled for pediatric use. Currently adult drugs are being prescribed by weight; however, during their growth, children's metabolisms change and the pharmacokinetics or pharmacodynamics may differ from adults. The Madeira 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.

"I am excited to be asked to contribute my knowledge and expertise toward the success of a company such as Madeira Therapeutics which is dedicated to the mission of improving pediatric therapeutics," said Dr. Gregory Kearns. Dr. Kearns adds, "The need for medicines that are appropriately formulated and developed for infants and children is huge, worldwide and growing. Every day we delay in producing needed pediatric medicines leads to more adverse events and related complications in children."

About Dr. Gregory L. Kearns
Dr. Kearns served as a faculty member in the departments of Pediatrics and Pharmaceutics at the University of Arkansas for Medical Sciences where he developed and directed a program in Pediatric Clinical Pharmacology at the Arkansas Children's Hospital. In 1996, Dr. Kearns moved to Kansas City, Missouri, where he was the first recipient of the Marion Merrell Dow/Missouri Chair in Pediatric Pharmacology at the University of Missouri-Kansas City, where he holds professional appointments in pediatrics and pharmacology. From 1996 to 2008, he served as Chief of the Division of Pediatric Pharmacology and Medical Toxicology and Director of the Pediatric Pharmacology Research Unit at Children's Mercy Hospitals and Clinics. In October 2006, Dr. Kearns was named as the recipient of the Marion Merrell Dow/Missouri Chair in Pediatric Medical Research and also the Director of Medical Research and Associate Chairman of Pediatrics at Children's Mercy. Dr. Kearns received his undergraduate degree from the St. Louis College of Pharmacy and his Pharm.D. degree from the University of Cincinnati. He completed a 2-year residency in pediatric clinical pharmacy at the Children's Hospital Medical Center in Cincinnati, followed by a postdoctoral fellowship in clinical pharmacology and toxicology at the Louisiana State University Medical Center in Shreveport, Louisiana. In 2002, Dr. Kearns received his Ph.D. degree in Clinical Pharmacology from the Erasmus University School of Medicine in Rotterdam, the Netherlands. Throughout his career, Dr. Kearns has gained numerous leadership experiences in organizations, has authored/co-authored over 280 peer-reviewed publications and has served as a Visiting Professor on over 15 occasions to universities and children's medical centers in the U.S. and abroad. In 2008, Dr. Kearns was appointed as a regular member of the World Health Organization Committee on Essential Medicines.

About Madeira Therapeutics
Madeira Therapeutics, LLC, is a privately held, specialty pharmaceutical company focused on providing safe and effective medicine to pediatric and geriatric patients, parents and the healthcare professionals that serve them. The Madeira strategy focuses on reformulating adult drugs for better dosage control in children. Madeira utilizes the FDA's 505(b)(2) approval method, which relies in part on the regulatory agency's findings for a drug previously approved for adults, thereby shortcutting IND approval by years and saving tens of millions of dollars in development costs. The company's lead program, MT-001, is the first ever liquid preparation of a statin developed for the geriatric and pediatric population. The second product is MT-003 for acute pain relief. For more information, visit http://www.madeiratherapeutics.com.

SOURCE: Madeira Therapeutics