Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A.
(ALM.MC) today announced that they are presenting data from several
studies of two investigational inhaled respiratory compounds at the
annual American Thoracic Society International Conference taking
place in New Orleans May 14-19, 2010. Data on aclidinium bromide,
an inhaled muscarinic antagonist, which is in Phase III development
for COPD, and LAS100977, a long-acting beta 2-agonist, in Phase II
development for asthma, will be presented in 11 separate posters.
In addition, 3 posters reporting data on the Genuair® inhaler,
which is used to administer the compounds, will be presented.
“We are pleased to have the opportunity, along with our partner
Almirall, to present data on two of our key pipeline products at
the ATS conference. The data presented here reinforce the
commitment we have to the development of useful treatments for
important respiratory diseases,” said Lawrence S. Olanoff,
President and Chief Operating Officer of Forest Laboratories.
Key Aclidinium Bromide Data – Tuesday, May 18th
The following study results will be presented:
- Efficacy and safety of
aclidinium bromide 400 µg BID compared with placebo and tiotropium
in patients with moderate to severe COPD (F77, H. Magnussen)
- Aclidinium bromide improves
exercise endurance, dyspnea and inspiratory capacity in patients
with moderate to severe COPD (F65, F. Maltais)
- Safety and tolerability of
aclidinium bromide administered intravenously and absolute
bioavailability of inhaled aclidinium bromide in healthy subjects
(F101, S. Ortiz)
- Pharmacokinetics of aclidinium
bromide 200 µg and 400 µg in young and elderly patients with
chronic obstructive pulmonary disease (F83, S. de la Motte)
- Metabolism and excretion of
aclidinium bromide following intravenous administration of [14C]
aclidinium bromide in healthy subjects (F100, S. Flach)
In addition, two preclinical studies characterizing the profile
of aclidinium by comparison to glycopyrrolate will be presented
(A55, J. Beleta and F85, A. Galvada).
Key LAS100977 Data – Wednesday, May 19th
The following two clinical posters will be presented:
- Efficacy and safety of single
inhaled doses of LAS100997, a novel long acting B2-agonist in
patients with persistent asthma (221, J. Beier)
- Single doses of LAS100977, a
novel long acting beta 2-agonist, show high activity and long
duration in healthy subjects (E31, W. Timmer)
In addition, two preclinical studies assessing the potency,
selectivity and duration of action for LAS100977 will be presented
(E43, M. Aparici and E44, M. Miralpeix).
Genuair® Inhaler Data
Three posters assessing the reliability of the technical
features of the inhaler, stability of aclidinium bromide in the
inhaler under various storage conditions, and aerodynamics and
particle size of aclidinium bromide administered using the inhaler
will be presented (B57, R. Greguletz, B56, K. Block, and B58, K.
Block).
"The studies being presented here demonstrate that aclidinium
bromide administered BID provides significant bronchodilation and
is well tolerated,” said Per-Olof Andersson, Chief Scientific
Officer at Almirall. "Additionally the results of the LAS100977
studies show that the compound has potential for the treatment of
respiratory diseases. The presentations further explain the
reliability and technical features of the Genuair® inhaler used to
effectively deliver both compounds."
About aclidinium bromide and the Genuair®
inhaler
Aclidinium bromide, which is in Phase III testing for COPD, 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. Forest Laboratories, Inc.
licensed U.S. 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 is administered to patients using a novel,
state-of-the-art multidose dry powder inhaler (MDPI), Genuair®. The
Genuair® inhaler was designed with an easy-to-use intuitive
feedback system, which through a 'colored control window' and an
audible click confirms that the patient has inhaled correctly. It
contains multiple doses of aclidinium, includes a visible
dose-level indicator, and also incorporates significant 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 trademark owned by Almirall, S.A.
About LAS100977
LAS100977 is a highly potent, novel, once daily long-acting beta
2-agonist (LABA) that in early Phase II testing demonstrated fast
onset and long-lasting (24-hour) bronchodilating effects with a
good tolerability profile in patients with stable asthma after
multiple dosing. Forest entered an agreement with Almirall to
develop, market and distribute LAS100977 in the United States in
December 2009. The compound will be developed in combination with
an undisclosed corticosteroid using Almirall's proprietary Genuair®
inhaler for the treatment of both asthma and COPD.
About Almirall
Almirall, an international pharmaceutical company based on
innovation and committed to health, headquartered in Barcelona,
Spain, researches, develops, manufactures and commercializes 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's products are currently present in over 70 countries
while it has direct presence in Europe and Latin America through 11
affiliates.
For further information, please visit www.almirall.com.
About Forest Laboratories
Forest Laboratories, Inc. (NYSE: FRX) is a U.S.-based
pharmaceutical company with a long track record of building
partnerships and developing and marketing products that make a
positive difference in people's lives. In addition to its
well-established franchises in therapeutic areas of the central
nervous and cardiovascular systems, Forest's current pipeline
includes product candidates in all stages of development and across
a wide range of therapeutic areas. The Company is headquartered in
New York, NY. To learn more about Forest Laboratories, 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.
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