Shares in Germany’s Altana took a knocking yesterday after market speculation that the European market launch of its asthma and chronic obstructive pulmonary disease therapy, Daxas (roflumilast), could face a three-year delay.
No-one from the company was available for comment at the time of going to press, but Reuters cites an Altana spokesman as saying: “We are not aware of a delay like it is being rumoured. We have never set any expected approval date.” He added that, as roflumilast belongs to a new class of drugs, it was not possible to estimate how long the regulators would need to grant approval.
This potential setback is not the first Daxas has faced. Its route to the regulators was delayed by several months [[06/09/02e]], while its US filing is being filed later than anticipated because of delays in patient recruitment into large clinical trials [[29/10/04c]].
The firm has high hopes for the product’s ability to generate peak sales of 1 billion euros, and says it intends to aggressively market the product once it has been approved. However, analysts are concerned that any pipeline failure, especially concerning Daxas, would be harmful to the company [[15/03/05f]].