Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A.
(ALM.MC) today announced that they are presenting additional data
from ATTAIN, a pivotal Phase III study comparing the efficacy and
safety of inhaled aclidinium bromide 200μg and 400μg twice daily
(BID) versus placebo in patients with moderate to severe COPD, at
ATS 2011, the annual International Conference of the American
Thoracic Society taking place in Denver May 13-18, 2011. Positive
top-line results from this six-month double-blind
placebo-controlled study were first reported in January 2011.
Additional detail from the ATTAIN study, which was accepted as a
late-breaker, will be presented in poster format on Sunday, May
15th (8:15 am - 4:30 pm, Session A45, D100, PW Jones).
Three other clinical posters on aclidinium will also be
presented at ATS on Sunday, May 15th. These posters include
additional analyses from the Phase III ACCORD COPD I study
regarding the effects of aclidinium therapy on symptoms and quality
of life, as well as the use of rescue medication (8:15 am - 4:30
pm, Session A45, D75, EM Kerwin; D97, A D'Urzo; D99, AF Gelb).
Results from one pharmacokinetic study with aclidinium BID
(Sunday, May 15th at 8:15 am - 4:30 pm, Session A45, D98, K
Lasseter) and five preclinical studies (Sunday, May 15th Session
A45, D66, J Milara; and Monday, May 16th Session B69,
L21, J Milara; L30, J Milara; L29, D Dominguez-Fandos;
L23, E Ferrer) will also be presented.
About ATTAIN Phase III study
ATTAIN (Aclidinium To Treat Airway
obstruction In COPD patieNts) was conducted in Europe
and South Africa. It was a 24-week study, which assessed the
long-term bronchodilator efficacy and safety of inhaled aclidinium
bromide 200μg and 400μg, both administered BID, compared to placebo
in 828 moderate to severe COPD patients (mean baseline FEV1=
1480mL). In addition, it assessed the benefits of aclidinium
bromide 200μg and 400μg, compared to placebo in disease-related
health status and COPD symptoms.
About aclidinium bromide and the Genuair® inhaler
Aclidinium bromide is a novel, long-acting inhaled
anticholinergic bronchodilator which has a long residence time at
the M3 receptors and a shorter residence time at the M2 receptors.
Aclidinium is rapidly hydrolyzed in human plasma to two major
inactive metabolites. In clinical trials evaluating aclidinium for
the treatment of COPD, the two most frequently reported side
effects were headache and nasopharyngitis. Forest Laboratories,
Inc. licensed US rights for aclidinium from Almirall, while
Almirall maintains rights for the rest of the world. The companies
are jointly involved in the development of the compound.
Aclidinium bromide was administered to patients in the trials
using a novel, investigational, state-of-the-art multidose dry
powder inhaler (MDPI), Genuair®. The Genuair® inhaler was designed
with a feedback system, which through a 'colored control window'
and an audible click helps confirm that the patient has inhaled
correctly. It contains multiple doses of aclidinium, includes a
visible dose-level indicator and also incorporates safety features
such as an anti-double-dosing mechanism and an end-of-dose lock-out
system to prevent use of an empty inhaler. Genuair® is a registered
trademark owned by Almirall, S.A.
About COPD
The World Health Organization (WHO) has described COPD as a
global epidemic; an estimated 210 million people have COPD
worldwide and more than 3 million people died of the condition in
2005, which is equal to 5% of all deaths globally that year. Total
deaths from COPD are projected to increase by more than 30% in the
next 10 years without interventions to cut risks, particularly
exposure to tobacco smoke.
In patients with COPD the airways in the lungs typically lose
their elasticity, produce excess mucus and become thick and
inflamed, limiting the passage of air. The most common symptoms of
COPD are breathlessness (or a "need for air"), abnormal sputum (a
mix of saliva and mucus in the airway), and a chronic cough. Daily
activities, such as walking up a short flight of stairs or carrying
a suitcase, can become very difficult as the condition gradually
worsens. There are significant unmet needs in the treatment of COPD
and new therapies may be of value.
About Almirall
Almirall is an international pharmaceutical company based on
innovation and committed to health. Headquartered in Barcelona,
Spain, it researches, develops, manufactures and commercializes its
own R&D and licensed drugs with the aim of improving people’s
health and wellbeing.
Almirall focuses its research resources on therapeutic areas
related to the treatment of asthma, COPD (Chronic Obstructive
Pulmonary Disease), gastrointestinal disorders, psoriasis and other
dermatological conditions.
Almirall’s products are currently present in over 70 countries
while it has direct presence in Europe and Latin America through 12
affiliates.
For further information please visit: www.almirall.com.
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 Report on Form 10-K, Quarterly Reports on Form
10-Q, and any subsequent SEC filings.
Photo Notes:
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