Healthcare Industry News:  Grünenthal 


 News Release - September 15, 2009

Forest Laboratories UK Ltd Submits Marketing Authorisation Application for the First Dry Powder Inhalation Antibiotic for Cystic Fibrosis Patients

LONDON, September 15 -- (Healthcare Sales & Marketing Network) -- Forest Laboratories UK Ltd, (a wholly owned subsidiary of Forest Laboratories Inc) announced that following the successful completion of its pan-European multi-centre phase III study (the Freedom Study), it has applied to the European Medicines Evaluation Agency (EMEA) to licence its new formulation dry powder colistimethate sodium for inhalation (Colobreathe®) for use by Cystic Fibrosis patients. The new formulation which was wholly developed by Forest Laboratories UK has previously been granted orphan drug status by the European Medicines Evaluation Agency (EMEA) and when approved Colobreathe® will be made available throughout the EU in conjunction with its chosen partner Grünenthal GmbH.

Raymond Stafford, Chief Executive Officer of Forest Laboratories Europe, said regarding the application: "We are delighted to have successfully completed this challenging project, and demonstrating that Colobreathe® is an effective and safe medicine. We believe that we have created a real advance in the management of infection in cystic fibrosis and are grateful for the support, encouragement and co-operation that the cystic fibrosis centres across Europe have given us. The reaction from patients has been very encouraging, and this treatment really can make a difference to their day to day quality of life."

Notes to Editors:

About Colobreathe®

Colobreathe® (dry powder inhaled colistimethate sodium) belongs to the group of antibiotics called polymixins. It works by disrupting the structure of part of the bacterial cell membrane causing the vital contents to leak out. Ultimately this process leads to the bacteria death. This mode of action is unique and has meant that the development of resistance is almost non-existent. The Freedom Study's end points were to demonstrate non inferiority to its comparator (tobramycin nebuliser solution for inhalation, TOBI®) as well as evidence of a lack of emergence of antibiotic resistance and a reduced treatment burden for patients.

About Forest Laboratories UK Ltd

Forest Laboratories UK Ltd is a division of Forest Laboratories Europe and a wholly owned subsidiary of Forest Laboratories Inc. (NYSE: FRX ) a global pharmaceutical company employing in excess of 5,000 people and revenues in the 12 months to 31st March 2009 of $3,9 Billion.

Source: Forest Laboratories UK

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