Aai's Methimazole Receives Fda Approval; Facility Expansion Complete

BT Catalyst, April, 2000

Applied Analytical Industries Inc. (Nasdaq: AAII) of Wilmington has received approval from the U.S. Food and Drug Administration to market methimazole in 5 milligram and 10 milligram strengths for the treatment of hyperthyroidism.

"We are pleased to have received this approval so closely following our tentative approval for buspirone," said Fred Sancilio, Ph.D., CEO and chairman of AAI. "The timely approvals of azathioprine, buspirone, and methimazole and several product approvals in Germany in the last few months provide continued evidence of the success of our internal pharmaceutical product development program," Sancilio said.

Methimazole inhibits the production of thyroid hormones and is currently marketed under the trade name Tapazolec (R). Commercialization efforts for AAI's methimazole are ongoing and the company anticipates the product will be launched late in the second quarter or early in the third quarter of 2000.

AAI announces expansion of molecular structure research facilities

In other company news, AAI has expanded its molecular structure laboratory at its Wilmington facilities. The state-of-the-art research laboratory will further enhance AAI's efforts in the discovery of new molecular modifications and improvements of existing drug classes.

The expanded laboratory is part of a 74,000 square-foot project started over two years ago. The new facility combines executives and scientific leadership under one roof, which reduces the distance between ideas and their implementation, Sancilio said.

AAI will provide limited contract research service in this expanded laboratory, but the majority of the laboratory is being dedicated to AAI-developed products.