July 17, 2008

Madeira Therapeutics Developing a Statin, a Cholesterol-Lowering Product, Formulated Specifically for Children

The American Academy of Pediatrics (AAP) released new guidelines on July 7, 2008, recommending that some children as young as 8 years old be given cholesterol-fighting drugs to ward off future heart problems. It is the strongest guidance ever given by the AAP. Madeira Therapeutics, a pediatric drug-development company, currently has a statin, a cholesterol-lowering product, in the development pipeline focused on this need. The new guidelines set by the AAP are based on evidence showing that damage leading to heart disease, the nation's leading killer, begins early in life.

"Our statin product focuses on a true case of need in a population with an inherited cholesterol gene that often leads to early heart disease," stated Peter R. Joiner, CEO and president of Madeira Therapeutics. "We are proud to be in a position to bring a much needed drug to the pediatric population; pediatric medication has been an area neglected for far too long."

Children who are at least 8 years old and have too much LDL, the "bad" cholesterol, along with other risky conditions, including obesity and high blood pressure, should be considered for cholesterol-lowering drugs. Pediatricians should routinely check the cholesterol of children with a family history of inherited cholesterol disease and also check children after age 2, but not later than age 10, for cholesterol levels. With one-third of U.S. children overweight and about 17 percent obese, the new recommendations are important.

Madeira Therapeutics specializes in pediatric medicine by reformulating compounds currently approved for adults and determining an accurate pediatric dosage. Often adult drugs are prescribed by weight; however, children metabolize some drugs differently than adults. Madeira focuses on reformulating off-patent adult drugs using the FDA's 505(b)(2) approval pathway. They are one of the few drug development companies with a dedicated focus on this niche market. In addition to the cholesterol-lowering drug already in the development pipeline, the company has plans to develop formulations for acute pain management and diabetes.

Peter R. Joiner has a 30 year history in sales, sales management, and marketing for pharmaceutical companies and has launched over 15 major pharmaceutical products in the health care industry. Madeira Therapeutics is comprised of an impressive team of industry experts to pursue this strategy, including Ken Phelps as the Chief Scientific Officer. Phelps, CEO of Camargo Pharmaceuticals, is the industry expert in 505(b)(2) applications.

About Madeira Therapeutics

Madeira Therapeutics is a new drug-development company specializing in pediatric pharmaceuticals. The Madeira strategy focuses on reformulating approved adult drugs for better dosage control in children. A cholesterol drug is already in the development pipeline and the company has plans to develop formulations for acute pain management and diabetes. Madeira intends to utilize the FDA's 505(b)(2) approval method, which relies in part on the FDA's findings for a previously approved drug, thereby shortcutting IND approval by years and tens of millions of dollars. For more information, contact Peter Joiner, 913.661.1962, or via email at [email protected]