-----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, UxE1VwbE+ON45aA0i+CoFN8rZipyquCW1DHd/DKnQVWnfforH7lTwxupi7YTKdkD tCZm5fIOt2wDq9Lj7AjbAQ== 0001107601-07-000073.txt : 20071109 0001107601-07-000073.hdr.sgml : 20071109 20071109172800 ACCESSION NUMBER: 0001107601-07-000073 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20071109 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071109 DATE AS OF CHANGE: 20071109 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ATHEROGENICS INC CENTRAL INDEX KEY: 0001107601 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 582108232 STATE OF INCORPORATION: GA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-31261 FILM NUMBER: 071233076 BUSINESS ADDRESS: STREET 1: 8995 WESTSIDE PARKWAY CITY: ALPHARETTA STATE: GA ZIP: 30004 BUSINESS PHONE: 6783362500 8-K 1 form8kfdameeting.htm FORM 8-K FDA MEETING form8kfdameeting.htm



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):  November 9, 2007
ATHEROGENICS, INC.
(Exact Name of Registrant as Specified in its Charter)

Georgia
0-31261
58-2108232
(State or other jurisdiction
(Commission
(I.R.S. Employer
of incorporation)
File Number)
Identification Number)

8995 Westside Parkway
Alpharetta, GA  30004
(Address of principal executive offices)

Registrant's telephone number, including area code (678) 336-2500

_________________

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 November 9, 2007, AtheroGenics, Inc. issued a press release to announce that after discussions with the U.S. Food and Drug Administration, the 300 mg dose of AGI-1067 in the ARISE clinical trial will be discontinued based on a further review of the overall risk/benefit profile observed in the ARISE clinical trial.  A copy of the press release is attached to this current report on Form 8-K as Exhibit 99.1.

Item 9.01.  Financial Statements and Exhibits.

The following exhibit is furnished as part of this current report on Form 8-K.

Exhibit No.
 
Description
     
99.1
Press Release dated November 9, 2007
     



____________________





SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.


 
ATHEROGENICS, INC.
   
Date:  November 9, 2007
/s/MARK P. COLONNESE
 
Mark P. Colonnese
 
Executive Vice President, Commercial Operations
 
   and Chief Financial Officer

____________________






EXHIBIT INDEX

Exhibit No.
 
Description
     
99.1
Press Release dated November 9, 2007
     




EX-99.1 2 exhibit99_1fdapressrelease.htm EXHIBIT 99_1 FDA MTG PRESS RELEASE exhibit99_1fdapressrelease.htm


 
 
Exhibit 99.1
 
[ATHEROGENICS, INC.]
 
FOR IMMEDIATE RELEASE
 


AtheroGenics Modifies ANDES Clinical Trial Discontinuing Highest Dose of AGI-1067
- ANDES to Continue with Two Lower Doses -

ATLANTA, GA – November 9, 2007 -- AtheroGenics, Inc. (NASDAQ: AGIX), today announced that after discussions with the U. S. Food and Drug Administration (FDA), the 300 mg dose of AGI-1067 in the ANDES trial will be discontinued based on a further review of the overall risk/benefit profile observed in the ARISE clinical trial. The ANDES trial will continue with the 75 mg and 150 mg doses.  ANDES is a dose ranging study to confirm the important pre-specified diabetes findings from the Company’s recently completed ARISE Phase lll clinical trial.

“We believe that AGI-1067, at the doses now being studied in ANDES, continues to represent an important opportunity as a novel treatment for patients with diabetes and heart disease,” said Russell M. Medford, M.D., Ph.D., President and Chief Executive Officer of AtheroGenics.  “AtheroGenics remains focused on completing ANDES enrollment by year end.”

The action taken today was based on a further review of the rare occurrence of adverse effects on the liver with the 300 mg dose of AGI-1067 seen in the ARISE trial and additional discussion with the FDA about these data.

ANDES enrollment continues on schedule and is expected to be completed before the end of 2007, with an interim analysis of the study’s primary endpoint planned to be reported out in the second quarter next year.

About AGI-1067
AGI-1067 is an anti-inflammatory antioxidant agent that works by inhibiting signaling pathways that are activated in response to oxidative stress and pro-inflammatory stimuli. Oxidative stress and inflammation have been demonstrated to play a central role in the pathogenesis of insulin resistance and diabetes.

AGI-1067 has been evaluated at various doses in numerous preclinical and clinical studies, including a recent cardiovascular clinical outcomes study comprised of 6,144 subjects followed for up to three years. In that study, AGI-1067 dosed at 300 mg achieved significant results in important pre-specified diabetes endpoints, demonstrating an improvement in glycemic control in patients with diabetes already being managed by conventional therapies. In addition, the number of study subjects who developed diabetes for the first time was reduced by more than 60 percent. Based upon those findings, AtheroGenics has commenced ANDES, a Phase III clinical trial to determine the optimal dose for glycemic control.

About AtheroGenics
AtheroGenics is focused on the discovery, development and commercialization of novel drugs for the treatment of chronic inflammatory diseases, including diabetes and coronary heart disease (atherosclerosis). AtheroGenics has commenced ANDES (AGI-1067 as a Novel Anti-Diabetic Agent Evaluation Study), a Phase III clinical trial to study its lead antioxidant and anti-inflammatory drug candidate, AGI-1067, in patients with diabetes. In addition, the Company has other clinical and preclinical anti-inflammatory compounds, including AGI-1096, an oral agent for the prevention of organ transplant rejection. For more information about AtheroGenics, please visit http://www.atherogenics.com.


Disclosure Regarding Forward-Looking Statements
Statements contained in this press release that relate to events or developments that we expect or anticipate will occur in the future are deemed to be forward-looking statements, and can be identified by words such as "believes," "intends," "expects" and similar expressions. AtheroGenics cautions investors not to place undue reliance on the forward-looking statements contained in this release. These and other such statements are subject to certain factors, risks and uncertainties that may cause actual results, events and performances to differ materially from those referred to in such statements. For example, additional information relating to the safety, efficacy or tolerability of AGI-1067, may be discovered upon further analysis of trial data. The U.S. Food and Drug Administration might not allow us to conduct further studies of the efficacy of AGI-1067 for the same or new endpoints, and, to the extent approved, additional clinical trial work may take a significant period of time to complete or require significant additional resources to complete. We cannot ensure that AGI-1067 will ever be approved or be proven safe and effective for use in humans. These and other risks are discussed in AtheroGenics' Securities and Exchange Commission filings, including, but not limited to, the risks discussed in AtheroGenics' Annual Report on Form 10-K for the fiscal year ended December 31, 2006 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 and are specifically incorporated by reference into this press release. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
 

 
CONTACTS:
 
AtheroGenics, Inc.
Media Inquiries
Investor Inquiries
Mark P. Colonnese
Jayme Maniatis / Dana Conit
Lilian Stern
Executive Vice President
Schwartz Communications, Inc.
Stern Investor Relations, Inc.
678-336-2511
781-684-0770 or 781-301-1051
212-362-1200
investor@atherogenics.com
atherogenics@schwartz-pr.com
lilian@sternir.com



 



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