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Aventis Submits New Drug Application To FDA for Asthma Drug Alvesco(R)
(ciclesonide)
STRASBOURG, France and BAD HOMBURG, Germany, Dec. 30 /PRNewswire- FirstCall/ --
Aventis and Altana announced today that a new drug application (NDA) has been
submitted to the US Food and Drug Administration (FDA) for Alvesco(R)
(ciclesonide). The companies are seeking marketing approval of Alvesco for the
treatment of persistent asthma (regardless of severity) in adults, adolescents
and children four years of age and older. Aventis and Altana signed an agreement
in 2001 to jointly develop and market Alvesco in the United States.
(Logo: http://www.newscom.com/cgi-bin/prnh/20000501/NYM197 )
Alvesco is a new generation inhaled corticosteroid with novel release and
distribution properties. Inhaled corticosteroids are considered to be the
foundation of asthma treatment, and they work by reducing inflammation - the
underlying disease process - in the lungs and airways.
The most frequently reported adverse events seen in Alvesco US clinical trials
were nasopharyngitis, headache and upper respiratory tract infection.
"Alvesco represents our continued commitment to providing patients with
innovative new therapies for the treatment of respiratory disease," said Frank
L. Douglas, Executive Vice President for Drug Innovation and Approval and a
member of the Management Board of Aventis. "Based on what we have seen in our
clinical trials, we expect Alvesco to help fulfill an unmet medical need that
still exists in the treatment of asthma."
"Alvesco is an innovative new asthma therapy that, if approved, we believe
offers an important treatment for patients with asthma," said Hans-Joachim
Lohrisch, Member of the Board of Altana AG and Chief Executive Officer of Altana
Pharma. "Alvesco is an important product in Altana's respiratory franchise, as
it provides the company with a product with which to expand our presence in the
US market and reinforce our commitment to providing innovative treatments for
respiratory diseases."
Concurrent with the submission, Aventis has initiated a Phase IIIb, 12- month
trial to further profile the safety and tolerability of high doses of Alvesco in
adult patients with moderate to severe asthma. This trial will characterize the
occurrence of lens opacity ocular events, as sometimes seen in patients who are
treated with high doses of inhaled corticosteroids, including a small number of
patients during one phase III Alvesco trial. The study was not a prerequisite
for submission of the NDA to the USFDA.
Asthma is a chronic disease of the lungs and airways. It is characterized by
wheezing, coughing and a tightening of the airways, which causes shortness of
breath and can be life-threatening. According to the American Academy of
Allergy, Asthma and Immunology, more than 17 million Americans are currently
estimated to have asthma.
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 EUR17.6 billion (US $16.6 billion), invested EUR3.1 billion
(US $3 billion) in research and development and employed approximately 71,000
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 about Aventis in the U.S., please visit:
http://www.aventis-us.com/.
About ALTANA
ALTANA AG is an international pharmaceuticals and chemicals group with sales of
about EUR2.6 billion and more than 10,000 employees worldwide. Its
pharmaceuticals group, ALTANA Pharma, concentrates on areas such as therapeutics
and self-medication, and focuses on innovative pharmaceutical research in the
areas of gastrointestinal, respiratory, and oncology. Located in Konstanz,
Germany, ALTANA Pharma represents a group of 28 subsidiaries and associated
companies in Europe, the Americas and Asia.
To receive a copy of this release or any recent release, visit the Aventis
Pharmaceuticals U.S. Web site at http://www.aventis-us.com/ or the ALTANA Web
site at http://www.altana.com/.
For Altana
This press release contains forward-looking statements, i.e., current estimates
or expectations of future events or future results. The forward- looking
statements appearing in this press release include information on the expected
advantage in the treatment of asthma with ALTANA's pharmaceutical Alvesco(R).
These statements are based on beliefs of ALTANA's management as well as
assumptions made by and information currently available to ALTANA. Many factors
that ALTANA is unable to predict with accuracy could cause ALTANA's actual
results, performance or achievements to be materially different from those that
may be expressed or implied by such forward-looking statements. These factors
include currently unknown and unforeseeable side effects of ALTANA's product.
Forward-looking statements speak only as of the date they are made. ALTANA does
not intend, and does not assume any obligation, to update forward-looking
statements to reflect facts, circumstances or events that have occurred or
changed after such statements have been made.
For Aventis
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, recently renamed "Autorite des marches financiers".
http://www.newscom.com/cgi-bin/prnh/20000501/NYM197DATASOURCE: Aventis
Pharmaceuticals Inc.
CONTACT: Steffen Mueller, +49-6172-1712-160, ,
Sandra Fabian, +49-6172-1712-163, , or Harald Schafer,
+49-6172-1712-165, all of Altana Corporate Communications; Lise Geduldig,
+1-215-416-9211, or , or Melissa Feltmann,
+1-908-243-7080, or , both of Aventis US Product
Communications
Web site: http://www.aventis.com/
http://www.aventis-us.com/
http://www.altana.com/