Aventis Announces Five-Year ORIGIN Trial to Investigate Reduction in Heart Disease Risk With LANTUS(R) Insulin

Aventis Announces Five-Year ORIGIN Trial to Investigate Reduction in Heart
Disease Risk With LANTUS(R) Insulin
Released Earlier Today in Europe 


BRIDGEWATER, N.J., Feb. 17  /PRNewswire-FirstCall/ -- Aventis announced today
that the ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial has
entered the active recruitment phase and has enrolled over 400 patients to date.
 The trial is the first major clinical study to help determine whether the use
of LANTUS(R) (insulin glargine [rDNA origin] injection) -- a 24-hour basal
insulin analogue -- can reduce the incidence of cardiovascular events such as
heart attack and stroke in people with early diabetes or pre-diabetes who are at
high risk for cardiovascular disease.  The five-year trial,led by Dr. Hertzel
Gerstein and Dr. Salim Yusuf at the Population Health Research Institute,
McMaster University and Hamilton Health Sciences in Hamilton, Ontario, Canada,
and sponsored by Aventis, will include 10,000 participants from 600 sites in
more than 35 countries.

"ORIGIN should help us understand the impact of metabolic factors, including
impaired glucose metabolism, on long-term and potentially devastating
cardiovascular complications," said Frank Douglas, Executive Vice President of
Drug Innovation & Approval and a member of the Management Board of Aventis.
"This trial is an important step forward in addressing many of the questions
facing clinicians as the medical community moves into an era of preventive
medicine, and will study best practices for use of a true basal insulin like
LANTUS(R)."

Diabetes is strongly associated with increased risk for cardiovascular events
like myocardial infarction (heart attack) and stroke.  Milder degrees of
elevation of blood glucose that do not meet diagnostic criteria for diabetes,
like impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) --
collectively, pre-diabetes -- are also associated with increased risk for micro-
and macro-vascular damage.  "Dysglycemia" refers to blood glucose elevations
that are associated with increased risk for cardiovascular (CV) events.  The
ORIGIN trial will evaluate the effectiveness of LANTUS(R) compared with standard
management of blood glucose elevations in reducing cardiovascular morbidity and
mortality in people with dysglycemia.

Worldwide, approximately 194 million people have diabetes mellitus.  Type 2
diabetes, which accounts for some 90 percent of all diabetes cases, is the
result of a disease process that may adversely affect health long before the
diagnosis of diabetes.  A greater number of people worldwide have pre-diabetes,
including an estimated 20 million people in the United States alone. 
Pre-diabetes confers an increased risk of both progressing to type 2 diabetes
and developing cardiovascular disease.

Study participants (IFG, IGT, or early diabetes) will be selected based on
evidence of increased risk for future cardiovascular events.  Individuals must
have at least one high-grade cardiovascular risk factor such as a
microalbuminuria or left ventricular hypertrophy, or a previous cardiovascular
event such as a myocardial infarction or stroke.  Participants will be randomly
assigned to receive either LANTUS(R) or standard care for their dysglycemia. 
The importance of diet and lifestyle modification will be emphasized to
participants in both of these treatment arms.  The ORIGIN trial should provide
critical new data on the effects LANTUS(R) may have to reduce cardiovascular
risk in both people with diabetes and people with pre-diabetes.

Other objectives of the ORIGIN study include determining whether treatment with
LANTUS(R) can reduce all-cause mortality, the incidence of diabetic
microvascular complications (in which small blood vessels in the eyes, kidneys
or nervous system are damaged), or the rate of progression to type 2 diabetes in
people with IFG or IGT.  The study will also investigate whether Omacor(R)
(omega-3-acid ethyl esters 90) can reduce cardiovascular mortality in people
with impaired fasting glucose, impaired glucose tolerance or early type 2
diabetes.  Omacor(R) is manufactured by Pronova Biocare based in Norway.
Patients will be assigned to receive one capsule daily of Omacor(R) or placebo
throughout the duration of the study, independentlyof their treatment
assignment to LANTUS(R) or standard treatment for hyperglycemia.

About LANTUS(R) (insulin glargine [rDNA origin] injection) LANTUS(R) is
indicated for once-daily subcutaneous administration in the treatment of adult
patients with type 2 diabetes mellitus who require basal (long-acting) insulin
for the control of hyperglycemia and for adult and pediatric patients (6 years
of age and older) with type 1 diabetes mellitus. LANTUS(R) demonstrates a
consistent slow, prolonged absorptionand a relatively constant
concentration/time profile over 24 hours.

LANTUS(R) must not be diluted or mixed with any other insulin or solution. If
mixed or diluted, the solution may become cloudy, and the onset of action/time
to peak effect may be altered in an unpredictable manner.

The adverse events commonly associated with LANTUS(R) include the following:
hypoglycemia, lipodystrophy, skin reactions (such as injection-site reaction,
pruritus, rash), and allergic reactions.  Hypoglycemia is the most common
adverse effect of insulins, including LANTUS(R).  For additional information,
please visit: http://www.lantus.com/ .

About Aventis' Diabetes Products

Lantus(R) (insulin glargine [rDNA origin] injection), which was launched in
Germany in 2000,in the U.S. in 2001, in the UK and Ireland in 2002, and in
France and Japan and over 40 other countries in 2003, is expected to become the
flagship of the Aventis diabetes portfolio. This novel basal insulin analogue
with no pronounced peaks, which provides 24-hour basal glucose control while
being administered just once per day, generated sales of  ? 487 million in
2003. The global rollout of Lantus(R) will continue in 2004. In addition to
Lantus(R), Aventis also offers Amaryl(R) (glimepiride tablets), a once-daily
oral sulfonylurea as an adjuvant to diet and exercise that lowers blood glucose
levels in type 2 diabetes.  Amaryl(R) generated global sales of ? 596 million
in 2003.  The Insuman(R) family of insulins generated sales of ? 176 million
globally in 2003.

In clinical studies, the most common side effects with Amaryl(R) are blood sugar
levels that are too low (0.9% to 1.7%), dizziness (1.7%), weakness (1.6%),
headache (1.5%), and nausea (1.1%).  If you have liver or kidney problems,
Amaryl(R) can be given with caution to people with those problems. As with other
drugs similar to Amaryl(R), there is a possibility of experiencing blood sugar
levels that are severely low.

Pipeline products include Exubera(R) (human insulin powder), currently in phase
III clinical trials, which is being developed in partnership with Pfizer, Inc.,
and DiaPep277(TM), a licensed compound that is under investigation in phase I/II
clinical trials for the treatment of type 1 diabetes and Latent Auto-immune
Diabetes of the Adult (LADA) which is being developed in cooperation with
Peptor.

Apidra(TM) (insulin glulisine [rDNA origin] injection), an injectable
rapid-acting insulin analogue was submitted for registration in the European
Union and the United States in June 2003. Also in June 2003, Aventis signed a
licensing agreement with Zealand for the development and worldwide
commercialization of AVE-0010, a GLP-1 (glucagon-like peptide-1) receptor
agonist of the exendin class currently in phase I/II.

About Aventis

Aventis is dedicated to treating and preventing disease by discovering and
developing innovative prescription drugs and human vaccines. In 2003, Aventis
generated sales of euro 16.79 billion (US $18.99), invested euro 2.86 billion
(US $3.75) in research and development and employed approximately 69,000 people
in its core business. Aventis corporate headquarters are in Strasbourg, France.
The company's prescription drugs business is conducted in the U.S. by Aventis
Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. For
more information, please visit: http://www.aventis-us.com/ .

Statements in this news release containing projections or estimates of revenues,
income, earnings per share, capital expenditures, capital structure, or other
financial items; plans and objectives relating to future operations, products,
or services; future economic performance; or assumptions underlying or relating
to any such statements, are forward-looking statements subject to risks and
uncertainties.  Actual results could differ materially depending on factors such
as the timing and effects of regulatory actions, the results of clinical trials,
the company's relative success developing and gaining market acceptance for new
products, the outcome of significant litigation, and the effectiveness of patent
protection.  Additional information regarding risks and uncertainties is set
forth in the current Annual Report on Form 20-F of Aventis on file with the
Securities and Exchange Commission and in the current Annual Report -- "Document
de Reference" -- on file with the "Commission des Operations de Bourse" in
France. 

DATASOURCE: Aventis



CONTACT:  Corinne Hoff, [phone], , or

Lisa Kennedy, [phone], , or Bethann Coyle,

[phone], , or Marisol Peron, [phone],

, all of Aventis



Web site:  http://www.aventis-us.com/

http://www.lantus.com/ 

Copyright