Adams Respiratory Therapeutics Seeks Approval For New Prescription Cough Suppressant

Main Category: Respiratory / Asthma
Also Included In: Ear, Nose and Throat;  Clinical Trials / Drug Trials
Article Date: 30 Dec 2006 - 0:00 PDT

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Adams Respiratory Therapeutics, Inc. (Nasdaq: ARxT) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for 600 mg and 1200 mg oral solid extended-release guaifenesin combination products for the treatment of cough. This new drug represents the first prescription product in Adams' current portfolio of respiratory products.

"This NDA filing is an important milestone for Adams," said president and CEO Michael J. Valentino. "Upon FDA approval of the NDA, this new drug will be our first prescription product offering and will move us closer to our vision of becoming a pre-eminent specialty pharmaceutical company, with leading products in both the over-the-counter and prescription respiratory drug markets. Secondly, it exemplifies our core strategy to build upon our successful guaifenesin business, utilizing our patented extended-release technology platform. Finally, it demonstrates our internal capabilities and technical know-how as a company to develop our own brand name prescription products." Adams has two other guaifenesin-based combination products currently under development in addition to the ongoing clinical program for erdosteine, a mucoregulator product, currently in Phase IIb.

At this time, Adams is not disclosing the name of the second active ingredient in the combination product for competitive reasons. However, the prescription market for products that treat cough is significant. Approximately 24 million prescriptions are written by physicians in the United States every year for the treatment of cough caused by the common cold, chronic bronchitis and other respiratory disorders, according to IMS Health. In addition, cough is among the most common reasons for a doctor visit, as reported by Dr. Peter Dicpinigaitis, a leading physician in the field of cough, and Fellow of the American College of Chest Physicians.

About Adams Respiratory Therapeutics, Inc.

Adams is a specialty pharmaceutical company focused on the late-stage development, commercialization and marketing of over-the-counter and prescription pharmaceuticals for the treatment of respiratory disorders.

Forward-Looking Statements

This press release contains certain "forward-looking" statements, including the Company's belief and anticipation that the FDA will approve the NDA. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Factors that could cause actual results to differ materially include, among others, the FDA's denial of the NDA and other risk factors set forth Item 1A. Risk Factors in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2006. Except to the extent required by applicable securities laws, Adams is not under any obligation to (and expressly disclaims any such obligation to) update its forward-looking statements, whether as a result of new information, future events, or otherwise. All statements contained in this press release are made only as of the date of this presentation.

Adams Respiratory Therapeutics, Inc.
http://www.adamsrt.com

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