Almirall and Menarini : licence agreement and commercial alliance for Aclidinium in the majority of European member states and a number of non-EU countries

26 March 2012 - Almirall and Menarini sign a licence agreement and commercial alliance for Aclidinium in the majority of European member states and a number of non-EU countries -

• Partnership fulfills Almirall's key criteria: territorial complementarity, non-competing portfolio assets, strong primary care capabilities and proven track record 
• Aclidinium, a new therapeutic option, is awaiting regulatory feedback in the US and Europe, while partnerships have already been established in the US, Japan and Korea 
• Chronic Obstructive Pulmonary Disease (COPD) affects nearly 44 million people in Europe1 and is considered by the World Health Organization (WHO) a global epidemic 

Almirall and Menarini announce 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.

In the territories for which Menarini holds rights to market aclidinium, it currently has a commercial infrastructure of over 5,000 sales representatives. These strong commercial capabilities and excellent track record in partnering have been key for Almirall in selecting Menarini. The commercial capabilities of Menarini are especially strong in Germany, Italy and France as well as Turkey, Central and Eastern Europe... Almirall's Press Release - Menarini's Press Release -

Almirall and BioFocus : collaboration to find new hit compounds against key targets

November 15, 2011 - Targets are related to the treatment of respiratory and inflammatory conditions -

The pharmaceutical company Almirall S.A. and BioFocus, an integrated drug discovery partner, announced they have entered into a collaboration agreement to find new hit compounds against key targets of interest to Almirall. These compounds will be used to support projects aimed at the treatment of respiratory and inflammatory conditions.

Under the terms of the collaboration, BioFocus will apply its screening technologies and compound collections to an undisclosed number of Almirall projects.

“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 working on respiratory and inflammatory conditions”, said Dr. Bertil Lindmark, CSO, Executive Director R&D of Almirall.

“We are delighted to form a drug discovery alliance with one of Europe’s leading research-based pharmaceutical companies,” added Dr. Kate Hilyard, VP Biological Sciences, BioFocus... BioFocus' Press Release - Almirall's Press Release -

Almirall strengthens its respiratory franchise with a new generation of Chronic Obstructive Pulmonary Disease (COPD) treatment

April 11th, 2011 - New class of dual action long-acting Muscarinic Antagonist Beta-2 Agonist (MABA) has potential to change the paradigm of COPD treatment - Almirall is aiming at starting clinical studies during first half of 2012 - Almirall strengthens its position in the respiratory field with apositive development progress of another New Chemical Entity (NCE). LAS190792 is a new dual long-acting Muscarinic Antagonist β2 Agonist (MABA), which combines two bronchodilator mechanisms in a single molecule for the treatment of COPD. This new class of inhaled long-acting bronchodilators is expected to provide additional symptom relief in patients living with COPD, and to form the basis of so called triple combinations together with ICS (inhaled corticosteroids). The MABA franchise (MABA and MABA/ICS combination) offer the convenience of different mechanisms of action in one inhaler therapy, and is envisaged to become a future block buster in COPD.

“Almirall’s MABA (LAS190792) represents an exciting opportunity for the treatment of COPD and shows the strength of Almirall´s commitment to research in respiratory disease”, said Dr Bertil Lindmark, MD, PhD, and Chief Scientific Officer at Almirall.

MABA compounds offer the advantage over the two-molecule bronchodilator combinations (LABA/LAMA), in that MABA/ICS combinations can be developed with a reasonable size development programme.

In preclinical models, LAS190792 has shown to have a long duration of action and high anti-muscarinic activity combined with β2 agonism. The molecule shows very favourable drug properties and safety.

Almirall is planning to priorize the finalization of the pre-clinical phase, aiming at starting clinical studies during first half of 2012.

LAS190792 will be developed in the Genuair® inhaler, a novel, state-of-the-art, multi-dose dry powder inhaler... Almirall's Press Release -

Forest Laboratories and Almirall : Phase III Clinical Studies of Aclidinium Bromide Show Statistical Significance vs. Placebo in Patients With COPD

Sept. 3, 2008 - Forest Laboratories, Inc. (NYSE: FRX) and Laboratorios Almirall, S.A. announced results from two global Phase III studies of aclidinium bromide, a novel long-acting inhaled anticholinergic for the treatment of patients with chronic obstructive pulmonary disease (COPD).

In both the ACCLAIM/COPD I&II (AClidinium CLinical Trial Assessing Efficacy and Safety In Moderate to Severe COPD Patients) studies, once-daily aclidinium bromide showed a statistically significant difference vs. placebo in the primary endpoint trough FEV1, a measure of pulmonary function that is decreased in moderate to severe COPD patients... Forest Laboratories' Press Release -

Almirall & Forest : Positive Results of Clinical Studies for Aclidinium Bromide, a Novel, Long-Acting Anticholinergic for the Treatment for COPD

May 20, 2008 - Forest Laboratories, Inc. and Laboratorios Almirall, S.A. presented results from four clinical trials assessing the efficacy and safety of aclidinium bromide, an investigational treatment for chronic obstructive pulmonary disease (COPD). Data from four preclinical studies further describing the properties of aclidinium were also presented at the meeting.

Presentations included data from a 464-patient randomized, double-blind, four-week, Phase IIb study that evaluated both the efficacy and tolerability of once-daily aclidinium (25 mcg, 50 mcg, 100 mcg, 200 mcg or 400 mcg) or placebo in patients with moderate to severe COPD. An open-label tiotropium (18 mcg) arm was included as an active control... Forest Laboratories' Press Release - Almirall's Press Release -