ALTANA Submitted New Drug Applications for Ciclesonide Nasal Spray in the U.S. and Canada
07 3월 2006 - 7:27PM
PR Newswire (US)
Major Milestone in Broadening the Ciclesonide Product Platform
FLORHAM PARK, N.J., March 7 /PRNewswire-FirstCall/ -- ALTANA Pharma
US, Inc. announced today that the U.S. Food and Drug Administration
(FDA) has accepted for filing the company's new drug application
(NDA) for Ciclesonide nasal spray. A new drug submission (NDS) for
Ciclesonide nasal spray was also submitted to the Canadian
authority Health Canada. ALTANA is seeking marketing approval for
the treatment of nasal symptoms associated with seasonal and
perennial allergic rhinitis. "The submissions of Ciclesonide nasal
spray represent a major milestone for us, as they reinforce our
commitment to providing innovative treatments for respiratory
diseases," said Dr. Hans-Joachim Lohrisch, Member of the Board of
ALTANA AG and Chief Executive Officer of ALTANA Pharma. Intranasal
corticosteroids are considered to be the gold standard for the
treatment of allergic rhinitis, and they work by reducing
inflammation -- the major underlying cause of nasal symptoms. The
clinical development program for Ciclesonide nasal spray leading to
submission in the U.S. and Canada was performed by ALTANA Pharma
U.S. Acceptance for filing by the FDA does not mean that the NDA
has been or will be approved, nor does it represent an evaluation
of the adequacy of the data submitted. Ciclesonide: A broader
product platform Besides the nasal spray, Ciclesonide is the active
substance of an inhaled corticosteroid, that is already approved in
35 countries worldwide for the treatment of persistent asthma. A
new drug application has also been filed with the U.S. FDA. In
addition the Ciclesonide platform will also include a fixed
combination product with a long-acting beta-agonist, currently in
phase II of clinical development. ALTANA partners with
Sanofi-Aventis in the United States and with Teijin in Japan on
various Ciclesonide based products. About Allergic Rhinitis
Allergic rhinitis is a chronic inflammatory disease of the nasal
mucosa causing sneezing, itching, nasal congestion, and discharge.
Seasonal allergic rhinitis is caused by substances that trigger
allergies and is sometimes referred to as hay fever. Perennial
allergic rhinitis is a chronic condition caused by triggers such as
pet dander and dust. The result of poorly controlled allergies can
result in impairments in day-to-day activities as well as a
reduction in a patient's quality of life. According to the American
Academy of Allergy, Asthma, and Immunology, more than 40 million
Americans are currently estimated to suffer with allergic diseases
and allergies are the sixth leading cause of chronic disease in the
United States. About ALTANA Pharma ALTANA Pharma US, Inc. is a
wholly owned subsidiary of ALTANA Pharma AG. ALTANA Pharma AG is
the pharmaceutical division of ALTANA AG (FWB: ALT, NYSE: AAA),
headquartered in Konstanz, Germany. ALTANA Pharma is an
internationally successful, research-driven company producing
innovative pharmaceuticals that create a higher quality of life for
patients and modern jobs for highly qualified employees. The
product range of ALTANA Pharma focuses on therapeutics for the
treatment of gastrointestinal and respiratory diseases, which the
company develops with intense research commitment. In 2005, ALTANA
Pharma achieved sales of about euro 2.4 billion, up 12% from 2004.
Investment in Research and Development -- approximately 20% of
therapeutics sales revenues -- increased steadily and, in 2005,
stood at euro 419 million. ALTANA Pharma employs more than 8,800
people in more than 30 countries. Further information is available
at http://www.altanapharma.com/ . Safe Harbor Statement 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 development of ALTANA's pharmaceutical product
Ciclesonide Nasal Spray for the treatment of allergic rhinitis.
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. DATASOURCE: ALTANA Pharma US, Inc. CONTACT: David
Schemelia, Vice President, Media Director, HealthSTAR Public
Relations, +1-609-468-9325, Fax: +1-212-532-6907, Web site:
http://www.altanapharma.com/
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