Date: 2012-03-26
Type of information: Licensing agreement
Compound: aclidinium bromide
Company: Almirall (Spain) Menarini (Italy)
Therapeutic area: Respiratory diseases
Type agreement: licensing
commercialisation
Action mechanism: Aclidinium bromide is a novel, long-acting inhaled muscarinic antagonist which has a long residence time at M3 receptors and a shorter residence time at M2 receptors, and which is designed to be rapidly broken down in plasma, leading to high topical efficacy but low propensity for systemic anticholinergic effects. When given by inhalation, aclidinium leads to bronchodilation by inhibiting airway smooth muscle contraction. Aclidinium bromide is rapidly hydrolysed in human plasma to two major inactive metabolites.
Disease: chronic obstructive pulmonary disease (COPD)
Details: Almirall and Menarini have concluded an agreement by which Almirall grants Menarini marketing rights for aclidinium in most EU and other European countries for the treatment of COPD. The agreement includes both Aclidinium monotherapy and its combination with formoterol. Menarini will have joint commercialisation rights across the majority of EU member states (excluding the UK, the Netherlands and the Nordic countries where Almirall retains sole marketing rights for the product)as well as Russia, Turkey and other CIS countries. Aclidinium was filed for registration in the US and Europe in 2011, and regulatory feedback is expected within 2012.With this new licence-out agreement, Almirall extends the global reach of its research respiratory compound. Previous partnerships have been already established in the US, Japan and Korea.
Additionally, Phase III of the combination of Aclidinium + Formoterol BID2 in COPD is underway with global clinical trials to meet regulatory requirements for both North American and European authorities.
Financial terms:
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