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Aventis Comments On ANDA Filing Of Enoxaparin Sodium in the United States
Ad-hoc-announcement transmitted by DGAP.
The issuer is solely responsible for the content of this announcement.
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Aventis Comments On ANDA Filing Of Enoxaparin Sodium in the United States
Strasbourg, France, June 26, 2003 – Aventis S.A. announced today that it
received a notice on June 23 that an Abbreviated New Drug Application (ANDA)
effective as of April 21 has been filed with the U.S. Food and Drug
Administration with a Paragraph IV certification against U.S. Patent Number
5,389,618 (expires on February 14, 2012) by Amphastar Pharmaceuticals, Inc.
seeking authorization to produce and market a generic version of enoxaparin
sodium in the United States. This filing is not unexpected since the five-year,
non-patent data exclusivity for enoxaparin sodium as a compound had expired in
1998. Aventis markets enoxaparin sodium in the U.S. under the brand name
Lovenox.
Generic competition neither certain nor imminent
The notice does not include a Paragraph IV certification with respect to U.S.
Patent Number 4,692,435, which is the second of two patents for enoxaparin
sodium listed in the Orange Book, the FDAs official listing of approved drug
products. The absence of a Paragraph IV certification means that the FDAs
approval of a generic version of enoxaparin sodium under Amphastars ANDA cannot
be made effective prior to the expiry of this patent on December 24, 2004.
At this point, the ANDA review process is just beginning and generic competition
is neither certain nor imminent.
As previously announced, Aventis filed an application with the U.S. Patent and
Trademark Office (USPTO) in May 2003 for the re-issuance of the 618 patent
relating to enoxaparin sodium. A re-issue application is typically used to seek
modifications in specifications of a granted patent. Aventis believes the re-
issuance procedure for the 618 patent could be completed prior to the end of
2004.
In light of this, Aventis is reviewing its legal options, which include whether
or not to assert the existing 618 patent, in order to position the company most
effectively to defend the exclusivity of Lovenox in the U.S.
end of ad-hoc-announcement (c)DGAP 26.06.2003
Issuer’s information/explanatory remarks concerning this ad-hoc-announcement:
Lovenox a complicated product to manufacture
Enoxaparin sodium is a highly complex mixture of macromolecules derived from
heparin that is used to treat a number of life-threatening conditions. Due to
limitations in technology, the larger macromolecules cannot be completely
characterized. Aventis employs a sophisticated process for manufacturing
enoxaparin sodium, which Aventis believes is essential for the therapeutic
effectiveness of the product. Some products claiming to be enoxaparin sodium
have been removed from the market by regulatory authorities in some countries
due to lack of equivalency.
About Lovenox
Lovenox is a low-molecular-weight heparin (LMWH) approved by the FDA for seven
indications. Numerous clinical studies have demonstrated the product`s benefits
as a safe and effective way to significantly reduce the incidence of deep vein
thrombosis in a wide range of patient populations, and also as effective
prophylaxis of ischemic complication of unstable angina (UA) and non-Q wave
myocardial infarction (NQWMI) when administered concomitantly with aspirin. The
safety and efficacy of Lovenox, which is marketed as Clexane in certain areas of
the world, is reflected by its use in the treatment of more than 100 million
patients in 96 countries.
About Aventis
Aventis is dedicated to treating and preventing disease by discovering and
developing innovative prescription drugs and human vaccines. In 2002, Aventis
generated sales of Euro 17.6 billion, invested Euro 3.1 billion in research and
development and employed approximately 71,000 people in its core business.
Aventis corporate headquarters are in Strasbourg, France. For more information,
please visit: http://www.aventis.com
Statements in this news release regarding the probability or timing of FDA
approval of an ANDA for any generic version of Lovenox, the onset of generic
competition for Lovenox, the re-issuance of the 618 patent related to Lovenox,
and any action Aventis may take in relation to Amphastar`s ANDA filing are
forward-looking statements subject to risks and uncertainties. Actual results
could differ materially depending on factors such as the substance of
Amphastar`s ANDA filing, whether Aventis initiates legal proceedings to enforce
the 618 patent and the timing of any such action, the relative strengths and
weaknesses of the legal positions of the parties in any such proceedings, the
filing of any additional ANDAs for generic versions of Lovenox, and the timing
and substance of any actions by the U.S. Patent and Trademark Office relating to
Aventis` application for re-issuance of the 618 patent. 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.
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WKN: 925 700; ISIN: FR0000130460; Index: Euro Stoxx 50
Listed: Amtlicher Markt in Frankfurt (General Standard); Freiverkehr in Berlin-
Bremen, Düsseldorf, Hamburg, Hannover, München, Stuttgart; Paris
260759 Jun 03
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