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 , 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.
ALTANA Pharma US, Inc.