Seems that it's possible to get a PDE4 inhibitor to work, after all:
BAD HOMBURG, Germany--(BUSINESS WIRE)--Sept. 28, 2003--ALTANA AG (NYSE:AAA - News; FWB:ALT), Bad Homburg, Germany, reported today that the top line efficacy and safety results of the RECORD study on Roflumilast in patients suffering from COPD (chronic obstructive pulmonary disease, smoker's lung) were presented at a scientific symposium sponsored by ALTANA Pharma during the 13th Annual Congress of the European Respiratory Society (ERS) in Vienna. This study enrolled over 1,400 patients in eleven countries. These patients were treated for 24 weeks with either placebo or 250ug or 500 ug Roflumilast.
The top line results include:
* FEV1 (forced expiratory volume in 1 second) was significantly improved in patients with both 250 ug and 500 ug doses in a dose-related manner. After 24 weeks the difference of FEV1 between 500 ug and placebo amounted to approximately 100 ml.
* Quality of life, measured by means of St. George's Respiratory Questionnaire (SGRQ), improved in a dose-related manner significantly versus placebo.
* Roflumilast treatment was well tolerated. The most frequent drug related adverse event was diarrhea. Like in previous studies only few events of nausea were reported, vomiting was not observed.
Sidney Braman, MD, FACP, FCCP, Professor of Medicine, Brown University and Director, Pulmonary Critical Care and Sleep Disorder Medicine, Rhode Island Hospital, Providence, Rhode Island, USA, who chaired the ALTANA sponsored symposium, said "I am really impressed with the new Roflumilast RECORD COPD study of more than 1,400 patients. This is the first time we have seen such significant changes in FEV1 and QOL in a PDE4 inhibitor compared to placebo. The FEV1 difference from placebo was approximately 100ml. The safety and tolerability is the best we have seen in a PDE4 inhibitor to date."
ALTANA Pharma is preparing to submit more detailed data on the RECORD study at the next major respiratory society meeting (ATS) in 2004.
Roflumilast is a selective phosphodiesterase4-inhibitor for the treatment of COPD and asthma. Roflumilast is being developed worldwide - with the exception of Japan - together with Pfizer Inc. Our partner in Japan is Tanabe Seiyaku Co., Ltd. Roflumilast is intended for oral, once daily administration and shall be marketed worldwide after approval under the brand name Daxas®. ALTANA intends to file an application for approval in Europe towards the end of 2003.
ALTANA will provide an Analysts' Conference Call on Tuesday, September 30, 3 pm (CET). For an audio webcast please visit www.altana.com |
