Clinical Development Program of Roflumilast for COPD

Main Category: COPD
Article Date: 28 Oct 2004 - 13:00 PDT


ALTANA AG continues to make progress with the developmental program for Roflumilast in the U.S., an investigational phosphodiesterase4- (PDE4-) inhibitor being studied for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.

Roflumilast has been studied in 16 clinical studies involving more than 4,400 patients with asthma and COPD. Data from these trials will be augmented by 10 additional phase III clinical trials that will enrol approximately 4,100 patients.

During the implementation of this extensive clinical program for Roflumilast, it turned out that enrolment will take longer than originally anticipated. Therefore, it is now expected that the application for the U.S. approval of Roflumilast, originally planned for the first half of 2005, will take place later.

"We are happy with the quality of the existing clinical data set on Roflumilast," said Dr. Hans-Joachim Lohrisch, Member of ALTANA's Management Board and President and CEO of ALTANA Pharma. "COPD and asthma are severe diseases which are two of the most frequent causes of death. Therefore we are delighted that we have developed a new therapy, which is expected to offer patients a safe and effective option to existing therapies worldwide. We are convinced that we are in a position to launch this breakthrough innovation likely as first in class PDE4-inhibitor."

"The Roflumilast program is a large development program that addresses two important areas of medical need, asthma and COPD," said Dr. Joseph Feczko, President of Worldwide Development at Pfizer. "While we have encountered some delay in enrolment in the U.S. trials, we are pleased with overall progress and have a strong working relationship with Altana."

A marketing authorization application (MAA) for Roflumilast is under evaluation by regulatory agencies in Europe.

Roflumilast is being developed with Pfizer in the United States and other markets. A cooperation agreement has also been made with Tanabe Seiyaku in Japan.

ALTANA remains confident that Roflumilast will be an important treatment option for patients suffering from COPD and asthma, two respiratory diseases associated with substantial morbidity and mortality. COPD affects 600 million people worldwide and kills more than 2.75 million people each year, according to estimates by the World Health Organization. Asthma affects more than 300 million people worldwide and kills 180,000 people each year.

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 ALTANA's expectations that the application for the U.S. approval of Roflumilast will take place later, that Roflumilast is likely to be launched as first in class PDE4 inhibitor and that Roflumilast is expected to offer a safe and effective treatment option for patients suffering from COPD and asthma. 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 granting of marketing approvals by the competent authorities, price regulations for pharmaceuticals and budgeting decisions of local governments and health care providers, the level of ALTANA's investment in pharmaceuticals related R&D, the sales and marketing methods used by ALTANA to distribute its pharmaceuticals.

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.

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