NEW YORK & DUBLIN--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer, today announced that it has been granted European Medicines Agency (EMA) approval to market Colobreathe dry powder colistimethate sodium for inhalation for treating cystic fibrosis patients aged 6 years and older with chronic lung infection caused by P. aeruginosa. The pivotal clinical study of Colobreathe demonstrated the benefits and its ability to prevent deterioration of respiratory function in Cystic Fibrosis patients.
The pivotal study which was submitted to EMA for authorization was an open-label active comparator study comparing the efficacy of Colobreathe to TOBI® (tobramycin nebuliser solution for inhalation). This study also demonstrated better patient acceptability of Colobreathe. Importantly, data from the study of Colobreathe showed that overall the product was well tolerated and there was no emergence of antibacterial resistance.
Forest Laboratories Europe has marketed a nebulised form of colistimethate sodium, an antibiotic used to treat the principal bacterial infections in cystic fibrosis patients, under the brand name Colomycin®, in the UK and Ireland for many years. In 2011 Forest Laboratories acquired all rights held by Gruenenthal to colistimethate sodium in several European countries and also reacquired rights to Colobreathe previously licensed from Forest. The acquisition was a strategic fit for Forest as a first step to expand its commercial capabilities in Austria, Belgium, Germany, The Netherlands, Russia and Switzerland, in addition to its existing presence in the UK and Ireland.
Raymond Stafford, Chief Executive Officer of Forest Laboratories Europe, said “Colistimethate sodium has been available from Forest for many years in a standard nebulised presentation in the UK and Ireland. Instead of requiring up to thirty minutes of inhalation from a nebuliser Colobreathe is an advance to aid patient compliance and convenience utilizing the Turbospin® inhaler which is small enough to be easily carried and is easy to administer the necessary dose in less than a minute. Colobreathe was fully developed in-house by Forest Europe, and its approval is a significant milestone as Forest expands our European footprint. Forest will be establishing affiliates in several additional European countries and some territories outside the EU to support the launch and commercialization of Colobreathe, as well as additional products in the Forest pipeline. We plan to introduce Colobreathe first in Germany by mid 2012 closely followed by other European countries and the UK in September.”
Colobreathe is a capsule containing 1,662,500 IU of colistimethate sodium which is approximately equal to 125 mg. It is used with a Turbospin inhaler device which is a relatively small (10 cm long), portable medical inhalation device, and uses the patients inspiratory flow to activate delivery of the dry powder into the lung. Each pack of Colobreathe will contain 56 capsules which is enough for 28 days treatment, and one Turbospin inhaler device, which is discarded at the end of the period.
Colobreathe is administered via the Turbospin inhaler and is administered as one capsule, twice daily from the device, in a procedure that should take less than 60 seconds. Colobreathe can be taken without medical supervision after the first dose is administered. There is a competitive product that requires administration of four capsules twice daily. The Turbospin inhaler is a relatively smaller, portable medical inhalation device which uses the patient’s inspiratory flow to activate delivery of the dry powder into the lung.
About Cystic Fibrosis
Cystic fibrosis is a chronic, debilitating multi-system genetic disease that affects approximately 70,000 people worldwide, including 35,000 people in the European Union. Chronic pulmonary infections due to P. aeruginosa are the single greatest cause of morbidity and mortality among patients with cystic fibrosis. The normal management of these patients includes the regular inhalation of appropriate antibiotics, which suppress the infection, and improve the quality of life and life expectancy of patients.
About Forest Laboratories UK Ltd.
Forest Laboratories UK Ltd. is a subsidiary of Forest Laboratories Inc of New York, U.S.A. It develops markets and sells healthcare products in the United Kingdom and Ireland. Forest Laboratories UK Ltd. has marketed the nebulised version of colistimethate sodium (Colomycin®) for use in cystic fibrosis patients for over 20 years. Colobreathe was exclusively developed by Forest Laboratories UK Ltd.
Forest Laboratories previously acquired the European cystic fibrosis franchise from Grünenthal GmbH and is now building on this with plans in all major European Markets. The enlarged operation will market and sell Colobreathe throughout Europe.
About Forest Laboratories
Forest Laboratories’ (NYSE: FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective and respiratory medicine. The Company’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
Forest Laboratories, Inc.
Frank J. Murdolo, +1-212-224-6714
Vice President - Investor Relations