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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): October 4, 2001
ATHEROGENICS, INC.
(Exact Name of Registrant as Specified in its Charter)
GEORGIA 0-31261 58-210832
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
8995 WESTSIDE PARKWAY
ALPHARETTA, GA 30004
(Address of principal executive offices)
Registrant's telephone number, including area code (678) 336-2500
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ITEM 5. OTHER EVENTS
On October 4, 2001, AtheroGenics, Inc. issued the following press release:
ATHEROGENICS REACQUIRES FULL RIGHTS TO AGI-1067 TO EXPEDITE
DEVELOPMENT OF NOVEL CARDIOVASCULAR DRUG
ATLANTA, GA - October 4, 2001 - AtheroGenics, Inc. (Nasdaq: AGIX), an emerging
pharmaceutical company focused on the treatment of chronic inflammatory
diseases, today announced that it has reached an agreement with Schering-Plough
Corporation (NYSE: SGP) to reacquire AGI-1067, a novel orally-available
cardiovascular compound discovered by AtheroGenics scientists. AGI-1067 was
co-developed during a two-year collaboration between AtheroGenics and
Schering-Plough. The reacquisition of rights to AGI-1067 was mutually agreed
upon by both parties and will enable AtheroGenics to expedite its clinical
development process.
"This is an exciting opportunity for AtheroGenics, to resume control over the
development of this compound that has shown a clear benefit to patients in a
large Phase II clinical trial," stated Russell M. Medford, M.D., Ph.D.,
AtheroGenics' President and C.E.O. "We have made significant progress through
our collaboration with Schering-Plough over the past two years, and are pleased
that they have allowed us to regain all rights to this potential breakthrough
treatment."
Medford added, "Our primary objective is to accelerate the development of
AGI-1067. With the combined resources from our IPO and our recent Private
Investment in Public Equity (PIPE) financing, the Company is well positioned to
advance the development of AGI-1067 for the treatment of restenosis and
atherosclerosis. Accordingly, the Company plans to initiate its next Phase II
clinical study for AGI-1067 before the end of this year."
AGI-1067 is the first of a promising new class of orally-deliverable compounds
targeting chronic inflammatory diseases, known as vascular protectants, or
v-protectants. In May 2001, AtheroGenics announced encouraging top-line results
from a Phase II clinical trial involving 305 patients, which assessed the
tolerability and efficacy of AGI-1067 as an agent to prevent post-angioplasty
restenosis. An analysis of these top-line results indicated that six months
after angioplasty, patients who received AGI-1067 had greater luminal diameters
of their coronary arteries than those patients who received placebo. This
improvement showed a statistically significant dose response. There were no
deaths or increase in the incidence of serious adverse events when comparing
AGI-1067 to placebo.
A complete analysis of the safety and efficacy data on AGI-1067 will be
presented in November at the American Heart Association Scientific Sessions 2001
in Anaheim, California.
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CONFERENCE CALL
AtheroGenics will host a conference call at 9:00 a.m. EST on Friday, October 5,
2001 to discuss these developments. Investors, analysts, brokers and media
wishing to participate in this call may dial 1-800-296-6518 five minutes prior
to the start time. For those who are unable to listen to the call live, a
telephone postview service will be in place from approximately one hour after
the conference ends until midnight (EDT) Friday, October 12, 2001. The postview
can be accessed by dialing 1-800-633-8284 (domestic) or +1-858-812-6440
(international) and entering reservation number 19814922.
ABOUT ATHEROGENICS
AtheroGenics (Nasdaq: AGIX) is focused on the discovery, development and
commercialization of novel drugs for the treatment of chronic inflammatory
diseases, such as heart disease (atherosclerosis), rheumatoid arthritis and
asthma. In May, the Company announced top-line results from its Phase II
clinical trial with its lead compound, AGI-1067, a novel oral agent being
developed for the treatment and prevention of post-angioplasty restenosis.
AtheroGenics has two products in Phase I clinical trials. AGIX-4207, the
Company's second clinical compound derived from its proprietary v-protectant
technology platform, is a novel oral agent being developed for the treatment of
rheumatoid arthritis. AGIX-4207 I.V. is an intravenous treatment designed for
rheumatoid arthritis patients in whom the rapid attainment of target drug levels
in the blood is desirable. For more information about AtheroGenics, please visit
www.atherogenics.com.
This press release may contain forward-looking statements made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
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. These risks include statements which address
operating performance, events or developments that we expect or anticipate will
occur in the future, such as projections about our future results of operations
or our financial condition, our collaborative efforts with Schering-Plough
Corporation, the development of our product candidates, anticipated trends in
our business, and other risks that could cause actual results to differ
materially. These risks are discussed in AtheroGenics' Securities and Exchange
Commission filings, including the Company's registration statements on Form S-1,
Registration Nos. 333-31140 and 333-64228, filed with the SEC, and including but
not limited to the risks discussed in AtheroGenics' Form 10-K for fiscal 2000,
and our most recent Quarterly Report on Form 10-Q for the quarter ended June 30,
2001, all of which are incorporated by reference into this press release. These
documents may also be examined at public reference facilities maintained by the
SEC or, to the extent filed via EDGAR, accessed through the SEC's web site
(http://www.sec.gov).
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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: October 9, 2001 By: /s/ RUSSELL M. MEDFORD
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RUSSELL M. MEDFORD, M.D., PH.D.
President and Chief Executive Officer
(Principal Executive Officer)
Date: October 9, 2001 By: /s/ MARK P. COLONNESE
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MARK P. COLONNESE
Vice President of Finance and
Administration and Chief Financial Officer
(Principal Accounting and Financial Officer)