EXHIBIT 99.1
[LOGO]
FOR IMMEDIATE RELEASE
MAJOR STUDY LAUNCHED TO TEST WHETHER PATIENT RESPONSE TO
RHEUMATOID ARTHRITIS DRUGS CAN BE PREDICTED BY COMMON
GENETIC MARKERS
-- Study to Be Conducted by Interleukin Genetics and UnitedHealth Group,
a Novel Partnership Between Biotechnology and Managed Care --
WALTHAM, MA - MAY 29, 2002 -Interleukin Genetics, Inc. (NASDAQ:ILGN) and
researchers at UnitedHealth Group's Center for Health Care Policy & Evaluation
announced today the launch of a new clinical study to determine the influence of
genetic markers on an individual's response to anti-IL-1 and anti-TNFa therapy
in adults with rheumatoid arthritis. While new biologic agents for the treatment
of rheumatoid arthritis offer tremendous hope to some patients, many may receive
little to no clinical benefit. Furthermore, these drugs have been associated
with an increasing risk of adverse side effects and treatment costs can exceed
$10,000 per year. Interleukin Genetics plans to combine the results of this
study with economic modeling data and additional clinical study results to
develop an inexpensive test to assist physicians and patients in selecting which
of the biologic rheumatoid arthritis drugs would bring the greatest clinical
benefit.
Rheumatoid arthritis (RA) is a chronic disease of unknown cause characterized by
prolonged inflammation, swelling, and pain of multiple joints. RA is a
debilitating and costly disease that affects quality of life. Although the
underlying cause of the variable clinical expression is not known, results of
several studies indicate that differences in individual genetic factors play a
central role.
"By combining our expertise in the genetics of inflammation with the clinical
leadership provided by UnitedHealth Group, we believe this study will elucidate
a strong association between an individual's genetic make-up and response to
rheumatoid arthritis therapy," said Dr. Paul (Kip) Martha, Chief Medical Officer
at Interleukin Genetics. "This study is part of our TARxGET RA program, a
worldwide, comprehensive clinical, economic and functional genetics program
directed toward the development of a pharmacogenetic test to help doctors and
patients choose the best course of rheumatoid arthritis therapy. We believe that
this test will not only enhance the quality of life for rheumatoid arthritis
patients, but will also serve as a valuable tool to help the managed care
industry better allocate their resources by enabling patients to get on the
right treatment path from the start."
Dr. Martha added, "In the next phase of our TARxGET RA program, Interleukin
Genetics will
conduct a cost modeling study of our pharmacogenetic test with the School of
Health and Related Research (ScHARR - UK) to determine its economic impact on
the healthcare systems in both the U.S. and U.K."
STUDY DESIGN
The study has recently received IRB approval (Institutional Review Board) and
will be conducted through collaboration between UnitedHealth Group's Center for
Health Care Policy & Evaluation, Interleukin Genetics and the University of
Sheffield, U.K. Investigators will examine whether specific variations in the
IL-1 and TNF(alpha) gene families, alone or in combination, are associated with
the response to anti-TNFa therapy in adults with rheumatoid arthritis. The study
will enroll approximately 2000 patient volunteers with a previous history of RA
and use of the drugs Enbrel(R) or Remicade(R) within a 12-month period. The
study will test responders and non-responders to determine if there is a useful
clinical difference between the two groups based on their genotypes.
Participants will be asked to sign an informed consent form, complete a
questionnaire and provide a cheek swab sample for genotyping. Each sample will
be coded and blinded to ensure the confidentiality of each volunteer's genetic
information. Individual identities and records will not be shared with
Interleukin Genetics and UnitedHealth group personnel.
BACKGROUND ON IL-1 AND TNFa VARIABILITY IN RHEUMATOID ARTHRITIS
Inflammation in rheumatoid arthritis involves the action of several proteins in
the body known as inflammatory cytokines. Two of these cytokines, IL-1
(Interleukin-1) and TNFa (Tumor Necrosis Factor Alpha), influence the overall
disease severity through their relative levels of activity. Recent research
indicates that the contribution of IL-1 versus TNFa to disease activity differs
among individuals with rheumatoid arthritis. As is true for all regulatory
proteins, individual genes direct production of IL-1 and TNFa, and some of the
common differences in these genes (called single nucleotide polymorphisms or
SNPs) produce significant alterations in the level of IL-1 or TNFa activity in
the human body.
Currently, there are three protein-based drugs on the market in the United
States and Europe for rheumatoid arthritis that act by blocking IL-1 or TNFa
activity, Enbrel(R), Remicade(R) and more recently, Kineret(R). Enbrel(R) and
Remicade(R) act by blocking TNFa action, while Kineret(R) selectively blocks
IL-1. There is substantial variation in individual responses to each compound.
ABOUT INTERLEUKIN GENETICS' TARxGET RA PROGRAM
This study with UnitedHealth Group's Center for Health Care Policy & Evaluation
is part of Interleukin Genetics' TARxGET program (Translating Advanced Research
in Genomics into more Effective Therapeutics) for rheumatoid arthritis. The
TARxGET RA Program is comprised of several clinical, economic and functional
genomics studies to examine the role that common variations in genes involved in
the critical pathways play in determining an individual's response to anti-IL-1
and anti-TNFa rheumatoid arthritis therapies. Interleukin Genetics will use the
results of these studies to develop a single, pharmacogenetic test to help
doctors choose the right treatment for patients based on an individual's genetic
make-up.
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Note to editors: For a copy of a statement released by the Arthritis Foundation
on the value of pharmacogenetics research to the treatment and care of
rheumatoid arthritis patients, please call one of the company contacts listed
below or Debbie Gruver, Arthritis Foundation, at (404) 965-7857.
Enbrel(R)is a registered and marketed in the U.S. by Immunex.
Remicade(R)is a registered and marketed in the U.S. by Centocor.
Kineret(R)(anakinra) is registered and marketed in the U.S. by Amgen.
About Interleukin
Interleukin Genetics is a biotechnology company focused on inflammation. The
company uses functional genomics to develop diagnostic and therapeutic products
based on the genetic variations in people to help prevent or treat diseases of
inflammation. Interleukin's TARxGET (Translating Advanced Research in Genomics
into more Effective Therapeutics) programs focus on the areas of cardiovascular
disease, rheumatoid arthritis and osteoporosis and include the development of
tests to assess a person's risk for heart disease and osteoporosis as well as a
test to help doctors and patients choose the best course of therapy for
rheumatoid arthritis. These products will enable the managed care industry to
improve patient care and better allocate resources. In addition to its research
partnerships with numerous academic centers in the U.S. and Europe,
Interleukin's corporate collaborators include the leading healthcare
organizations, Kaiser Permanente and UnitedHealth Group. For more information
about Interleukin and its ongoing programs, please visit
HTTP://WWW.ILGENETICS.COM
Certain statements contained herein are "forward-looking" statements (as such
term is defined in the Private Securities Litigation Reform Act of 1995).
Because such statements include risks and uncertainties, actual results may
differ materially from those expressed or implied by such forward-looking
statements. Factors that could cause actual results to differ materially from
those expressed or implied by such forward-looking statements include, but are
not limited to, risk of market acceptance of Company products, ability of the
Company to raise necessary capital, risk of technology and products
obsolescence, delays in development of products, reliance on partners,
competitive risks and those risks and uncertainties described in the Company's
Form 10-K as filed on March 28, 2002, and in other filings made by the Company
with Securities and Exchange Commission. The Company disclaims any obligation to
update these forward-looking statements.
FOR INTERLEUKIN GENETICS:
SHARON LEIBOWITZ KARI LAMPKA
Interleukin Genetics, Inc. MacDougall BioCommunications, Inc.
(781) 398-0700 (508) 647-0209
OR
PETER STEINERMAN
(516) 374-3031
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