ALTANA Pharma Receives Approval to Market Ciclesonide Nasal Spray in The U.S.* OMNARIS[TM] to Broaden Ciclesonide Product Platform BAD HOMBURG & KONSTANZ, Germany -- ALTANA AG (NYSE NYSE See: New York Stock Exchange :AAA AAA: see American Automobile Association. (Triple A) A common single-cell battery used in a myriad of electronic devices of all variety. Like its double A (AA) cousin, it provides 1.5 volts of DC power. When used in series, the voltage is multiplied. )(FWB (Fixed Wireless Broadband) See fixed wireless. :ALT)(GER GER German/Germany GER Gastroesophageal Reflux GER Geriatrics GER General Education Requirement GER Great Eastern Railway (UK) GER Gross Enrollment Ratio (education) GER Gain Electrons Reduction :ALT) announced today that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has granted marketing approval for OMNARIS[TM] (Ciclesonide nasal spray), 200[eth]- once-daily. OMNARIS[TM] is an intranasal corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and containing Ciclesonide as active substance. It is indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 12 years of age and older. In addition, the FDA determined OMNARIS[TM] approvable for the indication in children ages 2 to 11 years of age. "With the approval of OMNARIS we offer patients with allergic rhinitis an innovative treatment option," said Dr. Hans-Joachim Lohrisch, Member of the Board of ALTANA AG and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of ALTANA Pharma. "OMNARIS will extend our Ciclesonide product platform by an important new therapeutic from ALTANA Pharma's own research." OMNARIS[TM] is ALTANA Pharma's first product which is subject to the new out-licensing strategy regarding commercialization in the U.S. The market introduction of OMNARIS[TM] in the U.S. is being planned for 2007 depending on negotiations with external partners. 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. Ciclesonide: A broader product platform Based on Ciclesonide ALTANA Pharma is developping a broader product platform. Besides the nasal spray, Ciclesonide is also the active substance of an inhaled corticosteroid, that is already approved in 39 countries worldwide for the treatment of persistent asthma. A new drug application for this inhaled corticosteroid has also been filed with the U.S. FDA. A new drug submission (NDS See eDirectory. NDS - Netware Directory Services ) for Ciclesonide nasal spray was submitted to the Canadian regulatory authority Health Canada in January 2006. 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 Pharma 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 seasonal allergic rhinitis, n See hay fever. seasonal allergic rhinitis Allergic rhinitis in which Sx wax and wane as a function of environmental pollen. See 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 dander /dan·der/ (dan´der) small scales from the hair or feathers of animals, which may be a cause of allergy in sensitive persons. dan·der n. 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 The American Academy of Allergy, Asthma, and Immunology (AAAAI) is the largest medical specialty organization in the United States. It deals with issues of allergy at all levels, including 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. 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 planned market introduction of OMNARIS[TM] in the U.S. 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 ALTANA's ability to develop and launch new and innovative pharmaceutical products, the level of ALTANA's investment in pharmaceuticals related R&D, decisions of the competent regulatory authorities, the sales and marketing methods used by ALTANA to distribute its pharmaceuticals and the composition of ALTANA's pharmaceuticals portfolio. 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. This press release is also available on the Internet at www.altana.com. |
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