Altana AG, Germany, announced that its pharmaceutical division Altana Pharma, in partnership with Pfizer Inc., would submit the registration dossier for its respiratory drug Daxas (Roflumilast) for European approval to the EMEA (European Agency for the Evaluation of Medicinal Products) in February 2004.
Daxas is being developed as an oral, once daily, anti-inflammatory, selective phosphodiesterase-4 (PDE4)-inhibitor for the treatment of COPD (chronic obstructive pulmonary disease) and asthma.
"We are delighted that the approval process in Europe can be initiated. The efficacy and safety of Daxas will provide an important option for patients suffering from COPD and asthma", said Dr Hans-Joachim Lohrisch, Member of the Management Board of Altana AG and CEO of Altana Pharma.
Daxas is being developed with Pfizer in the United States and other markets. A cooperation agreement has also been made with Tanabe Seiyaku in Japan.