R&DProducts
Promising results with Almirall's once daily long acting beta agonist (LABA) expected to lead to a development and commercialization partnership in 2009
·The pharmaceutical company Almirall successfully completed a phase II study demonstrating superior bronchodilation to twice daily salmeterol and 24-hour efficacy from a single administration of LAS100977, in stable asthmatic patients.
·Results of an ongoing multi-dose study in asthma are expected 1st quarter 2009 and further studies in both asthma and chronic obstructive pulmonary disease (COPD) are planned for 2009. Almirall expects to conclude a development and commercialization partnership in 2009.
Barcelona, 10 December 2008 - Almirall, the international pharmaceutical company based in Spain, announces its intention to push ahead developing LAS100977 its new once daily inhaled Long Acting Beta Agonist (LABA) for the treatment of asthma / COPD (Chronic Obstructive Pulmonary Disease), with a yet to be selected partner in 2009.
In a Phase IIa single dose, double-blind, placebo and active (salmeterol 50 mcg bid) controlled, cross-over study in 25 stable asthmatic patients to assess the safety tolerability, activity, and pharmacokinetics of different doses of LAS100977, a clinically relevant and statistically significant improvement in peak, AUC -area under the curve- (0-24) and trough (24-hour) FEV1 -forced expiratory volume in one second- vs both placebo and salmeterol were seen for all doses of LAS100977. Single doses of LAS100977 have been safe and well tolerated in asthmatic patients. Adverse events related with adrenergic stimulation were reported in a dose-dependent manner, none of them clinically relevant.
«With these positive initial results we believe that LAS100977 may represent an important step for the treatment of asthma and COPD. We are already starting discussions with potential partners towards development and future commercialization of the product» says Eduardo Sanchiz, Chief Executive for Corporate Development and Finance.
The Genuair®[i] inhaler
LAS100977 is being developed using Genuair®, the Almirall's state-of-the-art patient friendly MDPI (Multidose Dry Powder Inhaler). With a simple ‘one press and inhale' operation, Genuair® is very easy to use thanks to a novel intuitive feedback system, which through a ‘coloured control window' guides the correct use of the inhaler. Genuair® also has a visible dose level indicator and incorporates significant safety features such as an anti-double dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler.
About Asthma[ii]
Asthma is a chronic disease characterized by recurrent attacks of breathlessness and wheezing, which vary in severity and frequency from person to person. Symptoms may occur several times in a day or week in affected individuals, and for some people become worse during physical activity or at night.
According to the World Health Organization (WHO) estimates, 300 million people suffer from asthma and 255,000 people died of asthma in 2005. This is an under-diagnosed and under-treated disease that creates a substantial burden to individuals and families and possibly restricting individuals' activities for a lifetime.
About COPD[iii]
COPD is not one single disease but an umbrella term used to describe chronic lung diseases that cause limitations in lung airflow. The more familiar terms 'chronic bronchitis' and 'emphysema' are no longer used, but are now included within the COPD diagnosis. Its most common symptoms are breathlessness, or a 'need for air', excessive sputum production, and a chronic cough. However, COPD is not just simply a "smoker's cough", but an under-diagnosed, life threatening lung disease that may progressively lead to death.
According to the latest WHO estimates (2007), currently 210 million people have COPD and 3 million people died of COPD in 2005. WHO predicts that COPD will become the third leading cause of death worldwide by 2030.
About Almirall
Almirall, an international pharmaceutical company based on innovation and committed to health, headquartered in Barcelona, Spain, researches, develops, manufactures and commercialises own R&D and licensed drugs with the aim of improving people's health and wellbeing.
The therapeutic areas on which Almirall focuses its research resources are related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), rheumatoid arthritis, multiple sclerosis, psoriasis and dermatology in general.
Almirall's products are currently present in over 70 countries while it has direct presence in Europe and Latin America through 11 affiliates.
For further information please visit the website at: www.almirall.com
More information Ketchum/SEIS Sonia San Segundo / Patricia Mansilla sonia.sansegundo@ketchum.com Phone : +34 91 788 32 00
[i] Genuair is a registered trademark of Laboratorios Almirall, S.A. It is the proposed registered trademark for the Multiple-Dose Dry Powder Inhaler (MDPI) and is pending regulatory approval.
[ii] Extracted from www.who.int - Fact sheet N°307, May 2008.
[iii] Extracted from www.who.int - Fact sheet N°315, May 2008
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