Drug approval sought

GERMAN drugmaker Altana expects to submit its key roflumilast drug for asthma and smoker’s lung for European approval in February, slightly later than planned.

Altana will make the once-daily tablets first in Germany and later at a new plant near Cork. Altana is investing about €70 million in the Cork unit.

The statement hit Altana shares, as the company had earlier said it would file by the end of 2003, and analysts said they would now not be surprised by a similar delay to the US filing for the drug, planned for the end of 2004.

“We wanted to make sure we have the best registration dossier possible for submission,” an Altana spokesman said.

“This has been discussed with our partner Pfizer and has their full support,” he said. Pfizer, the world’s top drugmaker, is Altana’s marketing partner for roflumilast worldwide, with the exception of Japan.

Altana shares were down 1.11% at 48.19 in early trade, the leading decliner on the German DAX index, and underperformed other European pharmaceutical stocks.

Altana predicts peak annual sales of over €1 billion ($1.23 billion) for the drug.