Aventis Submits New Drug Application To FDA For Asthma Drug Alvesco-R- -Ciclesonide-.Business Editors/Health/Medical Writers BAD HOMBURG, Germany & STRASBOURG, France--(BUSINESS WIRE)--Dec. 30, 2003 ALTANA (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) and Aventis announced today that a new drug application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) has been submitted to the US 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. ) for Alvesco(R) (Ciclesonide). The companies are seeking marketing approval of Alvesco(R) for the treatment of persistent asthma (regardless of severity) in adults, adolescents and children four years of age and older. ALTANA and Aventis signed an agreement in 2001 to jointly develop and market Alvesco(R) in the United States. Alvesco is a new generation inhaled 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 with novel release and distribution properties. Inhaled corticosteroids Corticosteroids, Inhaled Definition Inhaled corticosteroids are glucocorticoids (a class of steroid hormones that are synthesized by the adrenal cortex and have anti-inflammatory activity) formulated to be used in the respiratory tract and lungs. 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(R) US clinical trials were nasopharyngitis, headache and upper respiratory tract infection upper respiratory tract infection URI Infectious disease A nonspecific term used to describe acute infections involving the nose, paranasal sinuses, pharynx, and larynx, the prototypic URI is the common cold; flu/influenza is a systemic illness involving the URT . "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." "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." 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 lens opacity Cataract, see there 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 US FDA. About Asthma Asthma is a chronic disease of the lungs and airways. It is characterized by wheezing Wheezing Definition Wheezing is a high-pitched whistling sound associated with labored breathing. Description Wheezing occurs when a child or adult tries to breathe deeply through air passages that are narrowed or filled with mucus as a , coughing and a tightening of the airways, which causes shortness of breath Shortness of Breath Definition Shortness of breath, or dyspnea, is a feeling of difficult or labored breathing that is out of proportion to the patient's level of physical activity. 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. 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 Un`fore`see´a`ble a. 1. Incapable of being foreseen. Adj. 1. unforeseeable - incapable of being anticipated; "unforeseeable consequences" unpredictable - not capable of being foretold 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called 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". This press release is also available on the Internet at www.altana.com or visit the Aventis Web site at www.aventis.com |
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