Adams Respiratory Therapeutics Receives Approvable Letter From FDA for Mucinex(R) With Codeine
29 Octubre 2007 - 4:00AM
PR Newswire (US)
Other Developments Expected to Benefit Fiscal 2008 Financial
Results CHESTER, N.J., Oct. 29 /PRNewswire-FirstCall/ -- Adams
Respiratory Therapeutics, Inc. (NASDAQ:ARxT) 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(R) 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. Forward-Looking Statements 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 http://www.adamsrt.com/. DATASOURCE: Adams Respiratory
Therapeutics, Inc. CONTACT: Investors & Media, Janet M. Barth,
+1-908-879-2428 for Adams Respiratory Therapeutics, Inc. Web site:
http://www.adamsrt.com/
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