Almirall Start Phase III trials & Announce Collaboration with BioFocus

Spain’s Almirall yesterday announced that they have linked up with UK drug discovery firm BioFocus to find new hit compounds against key targets of interest to Almirall.  These compounds will be used to support projects targeted at the treatment of respiratory and inflammatory conditions.

BioFocus, the service division of Belgium’s Galapagos, will apply their screening technologies and compound collections to an undisclosed number of Almirall projects.

Almirall R&D executive director, Beryl Lindemark said “we have been impressed by the depth of the BioFocus technology platforms, the size, content and diversity of the available compound decks and the obvious strength and experience of the scientists that will be engaged on our projects”.

The Barcelona-based group have also announced today that, together with their US partner Forest, they have initiated a Phase III programme of a fixed-dose combination of aclidinium and formoterol twice daily delivered in the Genuair inhaler, for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD).

The Phase III programme involves around 3,500 patients with moderate to severe COPD and consists of two large pivotal studies, one conducted mainly in Europe and another in North America, evaluating the efficacy and safety of the FDC of aclidinium plus formoterol during 24 weeks, as well as a long-term safety study of 52 weeks which is also performed in North America.

In January, Almirall and Forest announced positive results of two Phase IIb studies which demonstrated that the combo demonstrated improved bronchodilation compared to aclidinium and formoterol alone.  Aclidinium as monotherapy was filed in Europe and the USA in the summer.

Meanwhile, Almirall has posted their financials for the first nine months of 2011 which show that sales fell 12.5% to 591.9 million euros, while net income was down 23.1% to 93.7 million euros.

Chief executive Eduardo Sanchiz commented that “in a challenging environment, we maintain solid financial fundamentals” and “we are highly focused on cost management and in the growth of our international business.”  He added that “now is the time to ensure that the anticipated forthcoming launches of aclidinium and linaclotide [irritable bowel syndrome with constipation], with unprecedented sales potential for Almirall, are optimally promoted.”

Almirall’s other key growth driver is Sativex (delta-9-tetrahydrocannabinol and cannabidiol) for the treatment of spasticity due to multiple sclerosis.  Sativex has now been launched by the firm in Spain, Germany and Denmark and will hit the market in Austria, the Czech Republic, Italy and Sweden during 2012.


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