R&DProducts
Almirall moving forward in the development of aclidinium bromide
- Almirall announces joint plans with Forest for regulatory filings and new clinical trials
- Almirall shows solid fundamentals in the business and a robust R&D pipeline
Barcelona, 15 October 2008 - Laboratorios Almirall, S.A. (ALM.MC) today announced plans to progress the development of aclidinium bromide, an inhaled anticholinergic medicine for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD), jointly with their US partner Forest Laboratories, Inc. (NYSE:FRX).
The phase III studies, ACCLAIM/COPD 1&2, show that aclidinium bromide 200mcg once daily (OD) improved lung function and was well tolerated without any apparent safety signals. There was a consistent and statistically significant improvement in FEV1 throughout both studies and health related quality of life benefit. Also, in the ACCLAIM/COPD 2 study, a decrease in time to first moderate to severe exacerbation was shown.
ACCLAIM's trough FEV1 increases were highly statistically significant versus placebo and were consistent between the two trials. Somewhat higher values for trough FEV1 were observed in the earlier Phase II dose ranging trial. Factors likely contributing to this difference were a greater number of patients on background medication in the ACCLAIM trials and the use of centralized spirometry.
"Almirall is moving forward with aclidinium bromide. It continues to show great promise as a new treatment option in COPD, where there are considerable unmet medical needs." said Dr Jorge Gallardo, Chairman and Chief Executive Officer, Almirall. "We believe this medicine remains a substantial engine for long term growth and value creation that can bring significant upside to our business. Negotiations with potential partners in Europe and Japan will continue" he added.
From Q4 2008, Almirall will be working with the European regulatory authorities to evaluate options for filing aclidinium bromide in the EU as a monotherapy. EU filing is currently anticipated for 2011.
In the US, Almirall and Forest will be meeting with the Food and Drug Administration (FDA) in early 2009, to review the ACCLAIM/COPD 1&2 study results and discuss development plans for aclidinium bromide as a monotherapy. Forest is fully committed to the updated development plan for aclidinium bromide and plans to file the NDA with current ACCLAIM/COPD data in between Q4 2009 and Q1 2010, pending FDA feedback.
Almirall and Forest aim to further fully explore the utility of aclidinium at higher doses once daily and/or BID (twice daily). The adverse event profile from the ACCLAIM studies clearly suggests that higher doses will be well tolerated. New studies will be initiated to evaluate different dosing regimens.
The results of the ACCLAIM/COPD 1&2 studies facilitate, and potentially accelerate, the development of BID aclidinium bromide in combination with formoterol. The current Phase II programme will be expanded to evaluate BID dosing, and the launch of aclidinium bromide in combination with formoterol is anticipated within 2 to 3 years after the launch of aclidinium bromide as a monotherapy. Almirall and Forest are also evaluating further combination programmes.
Almirall remains committed to aclidinium bromide and to research and development in the respiratory arena. Almirall's pipeline is currently the widest and deepest it has been in the company's history. It includes a promising phase II compound, LAS100977, a once daily inhaled long acting beta agonist (LABA) being developed for the treatment of asthma and COPD. Almirall also has a strong programme focusing on the development of innovative drugs for the treatment of inflammatory diseases such as asthma, rheumatoid arthritis, multiple sclerosis, psoriasis and dermatology in general.
Base business and guidance
"Almirall has solid fundamentals in the current portfolio", comments Dr Gallardo. "We have a stable, branded, patented and well balanced product portfolio that has shown resilience in adverse market conditions and with limited exposure to significant price or volume erosion due to generics until 2011/2012. Financial guidance for 2008 is reiterated, and a 35-40% dividend will be proposed to the Annual General Meeting next year."
The signing of a relevant in-licensing product in Spain is expected before the end of 2008.
The company also extended the financial guidance for 2009 with expected single digit growth in sales, EBITDA and Normalised Net Income and R&D expense, while maintaining the pay-out policy of 35-40%.
About Almirall
Almirall, an international pharmaceutical company based on innovation and committed to health, headquartered in Barcelona, Spain, researches, develops, manufactures and commercialises its 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 is currently present in over 70 countries with direct presence in Europe and Latin America through 11 affiliates.
For further information please visit the website at: www.almirall.com
Media contact:
Rachel Bannister
Tonic Life Communications
+ 44 (0)20 798 9900
Press release