Forest Laboratories Receives European Marketing Approval for Colobreathe® Dry Powder Inhaler
February 24 2012 - 3:00AM
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.”
About Colobreathe
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.
About Turbospin
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.
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