CHESTER, N.J., Oct. 29 /PRNewswire-FirstCall/ -- Adams Respiratory Therapeutics, Inc. (Nasdaq: ARxT - News) today announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter related to the New Drug Application (NDA) for Mucinex® with Codeine (guaifenesin 600/1200 mg and codeine phosphate 30/60 mg) extended-release bi-layer tablets. The approvable letter relates to the use of Mucinex with Codeine in the prescription treatment of cough associated with the common cold, inhaled irritants and stable chronic bronchitis.
The FDA stated in the letter that it has completed its review of the Mucinex with Codeine NDA and that it is approvable. In addition to some preliminary labeling comments, the FDA has requested additional data to support the use of the product with food, and has suggested various approaches to address this issue. Adams is evaluating the information contained in the letter and plans to respond to the FDA in a timely manner.
"An approvable letter for Mucinex with Codeine is a positive step in the FDA review process," said COO Robert D. Casale. "As a next step, we intend to seek a meeting with the agency in order to agree on an approach. We will then move as expeditiously as possible to fulfill the requirements for final approval."
Adams does not expect this development to impact its financial guidance for fiscal 2008. The Company's previously stated net sales guidance issued on Aug. 21, 2007, did not include any potential revenue from Mucinex with Codeine.
Other Developments Expected to Benefit Adams' Fiscal 2008 Financial Results
By Nov. 26, 2007, manufacturers of unapproved timed-release guaifenesin combination products -- similar to Adams' Mucinex D and Mucinex DM -- must cease retail distribution of their product resulting from the FDA's May 2007 enforcement action.
As a result of a recent assessment by the Company of early customer response to the FDA enforcement action, Adams now expects its fiscal 2008 net sales to be at the higher end of the previously stated guidance range of $400 million to $440 million, and expects its fiscal 2008 diluted earnings per share (EPS) to be at the higher end or slightly exceed the previously stated diluted EPS range of $1.55 to $1.75.
Furthermore, Adams reiterates its belief that diluted EPS will grow in excess of 30 percent in fiscal 2009, reflecting the continued strength of our current business, including the full year benefit of the FDA enforcement action.
Adams to Report Fiscal 2008 First Quarter Results on Nov. 8, 2007
Adams is scheduled to report its fiscal 2008 first quarter results on Nov. 8, 2007. At 9:00 a.m. (ET) on that day, Adams management will conduct a conference call to review the fiscal first quarter results.
To listen live to the call, dial 1-877-669-8882 or 1-706-758-9391. A replay of the call will be available starting at approximately 11 a.m. on Nov. 8 through 5 p.m. on Nov. 15. To listen to the replay, dial 1-800-642-1687 or 1-706-645-9291 and enter the conference ID # 19788386.
A live audio webcast of the conference call also will be available by going to the Investor Relations section of the Adams web site, http://www.adamsrt.com. A replay of the webcast will be available starting at approximately 11 a.m. on Nov. 8 through 5 p.m. on Dec. 7.
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.
This press release contains certain "forward-looking" statements, including the FDA's approval of Adams' NDA for Mucinex with Codeine and the removal from the market of unapproved timed-release guaifenesin products; and Adams' future financial performance and growth. Such forward-looking statements can be identified by the words "plan," "belief," "will," "intend," "expect," "estimate" and similar expressions and 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 Company's ability to maintain the success of its existing products and successfully introduce and commercialize new products; the Company's ability to achieve projected growth and sales; competition from other branded and generic products; the FDA's failure to take enforcement action to remove from the market unapproved timed-release guaifenesin products; an FDA decision not to approve Mucinex with Codeine; the severity of the cough and cold season; the Company's ability to preserve and successfully defend its patent position; 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 and under Item 1A. Risk Factors in Adams' Quarterly Report on Form 10-Q for the period ended March 31, 2007. 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 release.
For additional information about Adams, please visit the web site at www.adamsrt.com.
Source: Adams Respiratory Therapeutics, Inc.