Aventis to Move Forward With Reissuance Process for Contested Lovenox Patent

Aventis to Move Forward With Reissuance Process for Contested
Lovenox Patent 


BRIDGEWATER, N.J., July 27  /PRNewswire-FirstCall/ -- Aventis announced today
that it received a second rejection from the United States Patent Office
(USPTO) on Aventis' application for reissuance of U.S. Patent no. 5,389,618
('618 patent), relating to Lovenox.  Aventis remains committed to continuing
with the reissuance process.  Even though this rejection is characterized as a
"final rejection" by the USPTO, Aventis has the option of continuing the
reissuance process or filing an appeal.  Aventis believes that if its arguments
in response to this rejection are favorably received, the USPTO could issue a
notice of approval on Aventis' application by the end of this year and finally
reissue the patent in 2005.

(Logo:  http://www.newscom.com/cgi-bin/prnh/20000501/NYM197 )

Aventis filed an application with the USPTO in May 2003 seeking reissuance of
the '618 patent.  A reissuance application is typically used to seek
modifications in the specifications of a granted patent.  During the reissuance
process, the '618 patent remains in force.

Aventis also previously announced in August of 2003 that it filed lawsuits to
enforce the '618 patent (which expires on February 14, 2012) against Amphastar
Pharmaceuticals, Inc. and Teva Pharmaceuticals USA who were seeking to market
generic versions of Lovenox by filing Abbreviated New Drug Applications (ANDAs)
with the U.S. Food and Drug Administration (FDA).  By suing to enforce the '618
patent, Aventis initiated an automatic stay prohibiting the FDA from approving
these ANDAs for 30 months, or until an earlier court decision adverse to
Aventis in a patent infringement lawsuit. Aventis has agreed to be bound in the
lawsuit by the ultimate non-appealable outcome of the reissuance proceeding.

About Lovenox(R)

The No. 1-selling low-molecular-weight heparin in the world, Lovenox(R) was
approved in the United States and Canada in 1993.  It has been available in
Europe since 1987 and is known under the brand names Lovenox(R), Clexane(R) and
Klexane(R).  Lovenox(R) is the only low-molecular-weight heparin approved by
the FDA for all of the following indications:

   * Prophylaxis of deep-vein thrombosis, which may lead to pulmonary
     embolism:
        -- for medical patients who are at risk for thromboembolic
           complications due to severely restricted mobility during acute
           illness;
        -- for patients undergoing abdominal surgery who are at risk for
           thromboembolic complications;
        -- for patients undergoing hip replacement surgery, during and
           following hospitalization;
        -- for patients undergoing knee replacement surgery.
   * Prophylaxis of ischemic complications of unstable angina and non-Q-wave
     myocardial infarction, when concurrently administered with aspirin.
   * Inpatient treatment of acute deep-vein thrombosis with or without
     pulmonary embolism, when administered in conjunction with warfarin
     sodium.
   * Outpatient treatment of acute deep-vein thrombosis without pulmonary
     embolism when administered in conjunction with warfarin sodium.

  IMPORTANT SAFETY INFORMATION


LOVENOX(R) (enoxaparin sodium injection) cannot be used interchangeably with
other low-molecular-weight heparins or unfractionated heparin, as they differ
in their manufacturing process, molecular weight distribution, anti-Xa and
anti-IIa activities, units, and dosage.

When epidural/spinal anesthesia or spinal puncture is employed, patients
anticoagulated or scheduled to be anticoagulated with low-molecular-weight
heparins or heparinoids are at risk of developing an epidural or spinal
hematoma, which can result in long-term or permanent paralysis.

The risk of these events is increased by the use of postoperative indwelling
epidural catheters or by the concomitant use of drugs affecting hemostasis.
Patients should be frequently monitored for signs and symptoms of neurological
impairment.  (See boxed WARNING.)

As with other anticoagulants, use with extreme caution in patients with
conditions that increase the risk of hemorrhage.  Dosage adjustment is
recommended in patients with severe renal impairment.  Unless otherwise
indicated, agents that may affect hemostasis should be discontinued prior to
LOVENOX(R) therapy. Bleeding can occur at any site during LOVENOX(R) therapy.
An unexplained fall in hematocrit or blood pressure should lead to a search for
a bleeding site. (See WARNINGS and PRECAUTIONS.)

Thrombocytopenia can occur with LOVENOX(R). In patients with a history of
heparin-induced thrombocytopenia, LOVENOX(R) should be used with extreme
caution.  Thrombocytopenia of any degree should be monitored closely.  If the
platelet count falls below 100,000/mm(3), LOVENOX(R) should be discontinued.
Cases of heparin-induced thrombocytopenia have been observed in clinical
practice.  (See WARNINGS.)

The use of Lovenox has not been adequately studied for thromboprophylaxis in
pregnant women with mechanical prosthetic heart valves (See WARNINGS.)

LOVENOX(R) is contraindicated in patients with hypersensitivity to enoxaparin
sodium, heparin, or pork products, and in patients with active major bleeding.

Please see accompanying information or go to http://www.lovenox.com/ for
complete prescribing information, including boxed WARNING, and additional
important information.

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 $3.24) 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 "Autorite des marches
financiers" in France.

Pursuant to Article 7 of the COB Regulation no. 2002-04, this press release was
transmitted to the Autorite des marches financiers before its release. 

http://www.newscom.com/cgi-bin/prnh/20000501/NYM197DATASOURCE: Aventis



CONTACT:  Terri Pedone, [phone], , or

Susan Brooks, [phone], , both of Aventis US

Communications



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

http://www.lovenox.com/

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

Copyright