Almirall and Forest Laboratories will have to wait a bit longer before getting US approval for their chronic obstructive pulmonary disease drug aclidinium bromide.
The US Food and Drug Administration says it require a three-month extension to complete its review of the data supporting the New Drug Application for aclidinium, a long-acting antimuscarinic for the maintenance treatment of COPD. A final decision is now expected by July.
The good news is that no additional data has been requested by the agency to complete the review. Most observers believe the drug, which will be sold by Forest in the USA as Tudorza Pressair, will get the green light, given that last month the agency's Pulmonary-Allergy Drugs Advisory Committee voted 12 to 2 in favour of approval.
The drug will challenge Boehringer Ingelheim's blockbuster Spiriva (tiotropium), which is marketed by Pfizer and is also a long-acting antimuscarinic. Analysts believe it could have sales of $150-$200 million.
Menarini named as EU partner for aclidinium
Aclidinium was submitted to the European Medicines Agency for approval in July last year and earlier this week, Almirall granted joint commercialisation rights for the drug to Italy's Menarini across the majority of EU member states (excluding the UK, the Netherlands and the Nordic countries where the Barcelona-based group retains sole marketing rights).
The agreement also covers Turkey, Russia, Turkey and the Commonwealth of Independent States. In the territories for which Menarini will hold rights, it currently has over 5,000 sales representatives. Eduardo Sanchiz, Almirall's chief executive, noted that "amongst a number of interested partner candidates, Menarini stood out as it combines a powerful commercial platform with an impressive track record in successfully commercialising distinctive medicines".