-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, NUcp5AIZ+21VulVk2RYo99LQviVh/Pr6ipieIm8E7WV2n5nY6AOYhVe3bnGOjFPa VpNjh8YUH+mDHvXvalntoQ== 0000950144-07-005295.txt : 20070530 0000950144-07-005295.hdr.sgml : 20070530 20070530154255 ACCESSION NUMBER: 0000950144-07-005295 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070525 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070530 DATE AS OF CHANGE: 20070530 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Adams Respiratory Therapeutics, Inc. CENTRAL INDEX KEY: 0001319439 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 752725552 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51445 FILM NUMBER: 07887419 BUSINESS ADDRESS: STREET 1: 4 MILL RIDGE LANE CITY: CHESTER STATE: NJ ZIP: 07930 BUSINESS PHONE: (908) 879-1400 MAIL ADDRESS: STREET 1: 4 MILL RIDGE LANE CITY: CHESTER STATE: NJ ZIP: 07930 FORMER COMPANY: FORMER CONFORMED NAME: Adams Laboratories, Inc. DATE OF NAME CHANGE: 20050302 FORMER COMPANY: FORMER CONFORMED NAME: Adams Respiratory Therapeutics, Inc. DATE OF NAME CHANGE: 20050301 8-K 1 g07705e8vk.htm ADAMS RESPIRATORY THERAPEUTICS, INC. ADAMS RESPIRATORY THERAPEUTICS, INC.
 

 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 25, 2007
Adams Respiratory Therapeutics, Inc.
 
(Exact name of registrant as specified in its charter)
         
Delaware   000-51445   75-2725552
         
(State or other jurisdiction
of incorporation)
  (Commission File Number)   (IRS Employer
Identification No.)
4 Mill Ridge Lane, Chester, New Jersey 07930
 
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (908) 879-1400
N/A
 
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o      Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o      Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o      Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o      Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


 

Item 8.01. Other Events.
     On May 25, 2007, Adams Respiratory Therapeutics, Inc. issued a press release reporting that the FDA had announced that companies must stop manufacturing and distributing unapproved timed-release guaifenesin products. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
  (d)   Exhibits
         
Exhibit    
Number   Description
  99.1    
Press Release, dated May 25, 2007.

2


 

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  ADAMS RESPIRATORY THERAPEUTICS, INC.
(Registrant)


 
 
May 30, 2007  By:   /s/ Walter E. Riehemann    
    Walter E. Riehemann   
    Executive Vice President, General Counsel,
Chief Compliance Officer and Secretary 
 

3


 

         
EXHIBIT INDEX
         
Exhibit    
Number   Description
  99.1    
Press Release, dated May 25, 2007.

4

EX-99.1 2 g07705exv99w1.htm EX-99.1 PRESS RELEASE DATED MAY 25, 2007 EX-99.1 PRESS RELEASE DATED MAY 25, 2007
 

EXHIBIT 99.1
(Letterhead)
FDA TAKES ACTION AGAINST UNAPPROVED TIMED-RELEASE GUAIFENESIN
PRODUCTS, INCLUDING PRESCRIPTION VERSIONS OF
MUCINEX® DM AND MUCINEX® D
CHESTER, N.J. (May 25, 2007) — Adams Respiratory Therapeutics, Inc. (NASDAQ: ARxT) reports that the Food and Drug Administration (FDA) announced today that companies must stop manufacturing and distributing unapproved timed-release dosage forms containing guaifenesin.
In a press release issued today, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01640.html, FDA indicated that companies marketing unapproved products containing guaifenesin in timed-release form are expected to stop manufacturing them within 90 days and must cease shipping them in interstate commerce within 180 days. A small amount of these products is expected to be available after these dates until supplies are exhausted.
Michael J. Valentino, president and CEO commented, “We are extremely pleased with the FDA announcement today. We have always believed that the FDA would take enforcement action against the unapproved prescription versions of our Mucinex DM and Mucinex D and remove them from the market in due course. Our initial review of this regulatory action is underway and we expect to be able to serve the additional market demand for our products as it develops.”
Valentino added, “I would also like to recognize the FDA’s determined effort to act on its new guidance, ‘Marketed Unapproved Drugs — Compliance Policy Guide,’ which was finalized last June. Since that time, the agency has been moving aggressively to implement this guidance policy and remove unapproved drugs from the market.”
Further information regarding today’s FDA announcement can be found on the FDA web page at http://www.fda.gov.
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 Adams’ expectation that the FDA’s decision to remove unapproved extended-release guaifenesin combination products will increase market demand for Adams’ products. Such forward-looking statements can be identified by the words “expect,” “anticipate,” 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 effectiveness of the FDA’s enforcement action and Adams’ ability to: maintain the success of its existing adult Mucinex brand products; preserve and successfully defend its patent position; compete against other branded products as well as generic competition; 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 quarter 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.
# # #
Investor/Media Contact: Janet M. Barth (908) 879-2428
Source: Adams Respiratory Therapeutics, Inc.

 

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