Forest Laboratories, Inc. (NYSE:FRX) today announced that it
will present data on aclidinium, aclidinium/formoterol combination,
and roflumilast at the American Thoracic Society (ATS) 2014
International Conference scheduled for May 16-21, 2014, in San
Diego. Ten posters and two poster discussion sessions will be
presented for aclidinium and aclidinium/formoterol. Roflumilast
data will be highlighted in four posters and one mini symposia
presentation.
During the ATS session titled “It’s No Longer a Secret Service:
Updates in COPD Pharmacotherapy” on Monday, May 19, from 2:00
pm-4:30 pm PDT, the following two poster discussions will take
place:
“The Effect of Aclidinium/Formoterol Fixed-Dose Combination on
COPD Symptoms and Health Status in Patients with COPD: Results from
the ACLIFORM/COPD Study”
“Twice-Daily Aclidinium Bromide/Formoterol Fumarate Fixed-Dose
Combination: Lung Function Improvements in the AUGMENT COPD Trial
in Patients with Moderate to Severe COPD”
The roflumilast presentation will be included in the mini
symposium “The Smoke is Clearing: Translational Discoveries on COPD
Pathogenesis,” scheduled for Tuesday, May 20, from 8:15-10:45 am
PDT:
“Roflumilast Aids Airway Surface Liquid Recovery after Cigarette
Smoke Exposure in Primary Human Bronchial Epithelia Cultures”
Also being presented are the following posters:
Aclidinium and
Aclidinium/Formoterol
Efficacy And Safety Of Formoterol Fumarate Via Pressair® Versus
Foradil® Aerolizer® in Patients with Mild to Moderate Asthma
(poster #B34; May 18, 10:45 AM - 12:30 PM PDT), authored by J.A.
Bernstein, M.D.
Evaluation of the Psychometric Properties of the Nighttime
Symptoms of COPD Instrument (NiSCI), (poster #C78; May 21, 10:45 AM
- 12:30 PM PDT), authored by M. Mocarski
Aclidinium/Formoterol Fixed-Dose Combination Improves
Bronchodilation and is Well Tolerated in Patients with COPD:
Results from the ACLIFORM/COPD Study (poster #A114; May 21, 10:45
AM - 12:30 PM PDT), authored by D. Singh
Evaluation of Major Adverse Cardiovascular Events and COPD
Exacerbations in a Long-Term Study of Aclidinium Bromide in
Patients with Moderate to Very Severe COPD: ASCENT COPD Rationale
and Design (poster #A129; May 21, 10:45 AM - 12:30 PM PDT),
authored by R.A. Wise
Efficacy Of Fixed-Dose Combination Aclidinium Bromide/Formoterol
Fumarate on Bronchodilation Over 1 Year: AUGMENT COPD Extension
Trial in Patients with Moderate to Severe COPD (poster #A133; May
21, 10:45 AM - 12:30 PM PDT), authored by A.D. D’Urzo
Fixed-Dose Combination of Aclidinium Bromide/Formoterol Fumarate
Improve Breathlessness And Health Status In COPD Patients: AUGMENT
COPD Trial (poster #A134; May 21, 10:45 AM - 12:30 PM PDT),
authored by S.I. Rennard
Long-Term Safety of Fixed-Dose Combination Aclidinium
Bromide/Formoterol Fumarate in Patients with Moderate to Severe
COPD: The AUGMENT COPD Extension Trial (poster #A135; May 21, 10:45
AM - 12:30 PM PDT), authored by S.I. Rennard
Safety and Tolerability of Fixed-Dose Combination Aclidinium
Bromide/Formoterol Fumarate: Results of Two 6-Month Studies in
Patients with Moderate to Severe COPD (poster #A136; May 21, 10:45
AM - 12:30 PM PDT), authored by B.J. Make
Lung Function and Safety of Aclidinium Bromide/Formoterol
Fumarate Fixed-Dose Combination: Results of a 1-Year Trial in
Patients with COPD (poster #A137; May 21, 10:45 AM - 12:30 PM PDT),
authored by B.J. Make
Cardiovascular Safety of Fixed-Dose Combination Aclidinium
Bromide/Formoterol Fumarate: Results of Two 6-Month Studies in
Patients with Moderate to Severe COPD (poster #A138; May 21, 10:45
AM - 12:30 PM PDT), authored by J.F. Donohue
Roflumilast
Healthcare Costs Associated with Roflumilast Treatment among
Patients Hospitalized for COPD in a Managed Care Population (poster
#J14; May 18, 10:45 AM - 12:30 PM PDT), authored by S.X. Sun
Impact of Roflumilast on COPD Exacerbations, Healthcare
Utilization and Costs in a Medicare Advantage Population (poster
#J19; May 18, 10:45 AM - 12:30 PM PDT), authored by J.J. Ellis
Anti-Inflammatory Effects Of Dexamethasone, Roflumilast N-Oxide,
Formoterol and Their Combinations in Human Neutrophils From Healthy
and Chronic Obstructive Pulmonary Disease Patients (poster #B58;
May 19, 10:45 AM - 12:30 PM PDT), authored by J. Milara
Roflumilast Inhibits IL-13-Induced Mucous Metaplasia in Airway
Epithelium (poster #G1; May 20, 10:45 AM - 12:30 PM PDT), authored
by S.M. Kreda
About Aclidinium Bromide
TUDORZA PRESSAIR (aclidinium bromide inhalation powder) is an
anticholinergic indicated for the long-term, maintenance treatment
of bronchospasm associated with chronic obstructive pulmonary
disease (COPD), including chronic bronchitis and emphysema. When
given by inhalation, Tudorza produces bronchodilation by inhibiting
the muscarinic M3 receptor in the airway smooth muscle.
Important Safety Information
TUDORZA PRESSAIR is not indicated for the initial treatment of
acute episodes of bronchospasm (i.e., rescue therapy).
Inhaled medicines, including TUDORZA, may cause paradoxical
bronchospasm. In addition, immediate hypersensitivity reactions may
occur after administration of TUDORZA. If either of these occurs,
treatment with TUDORZA should be stopped and other treatments
considered.
TUDORZA should be used with caution in patients with
narrow-angle glaucoma or urinary retention. Instruct patients to
consult a physician immediately should any signs or symptoms of
narrow-angle glaucoma or prostatic hyperplasia or bladder-neck
obstruction develop.
Patients with a history of hypersensitivity reactions to
atropine should be closely monitored for similar hypersensitivity
reactions to TUDORZA. Use with caution in patients with severe
hypersensitivity to milk proteins.
The most common adverse reactions (≥3% incidence and greater
than placebo) were headache (6.6% vs. 5.0%), nasopharyngitis (5.5%
vs. 3.9%), and cough (3.0% vs. 2.2%), for TUDORZA vs. placebo,
respectively.
About Aclidinium/Formoterol
Aclidinium bromide/formoterol fumarate is an investigational
fixed dose combination of two approved long-acting bronchodilators
with different mechanisms of action and similar pharmocodynamic
profiles. Aclidinium bromide is an anticholinergic or long-acting
muscarinic antagonist (LAMA) that produces bronchodilation by
inhibiting the muscarinic M3 receptor in the airway smooth muscle.
Formoterol fumarate is a long-acting beta-agonist (LABA) that
stimulates the B2-receptors in the bronchial smooth muscle
resulting in bronchodilation.
Both aclidinium bromide (TUDORZA®/ EKLIRA®) and formoterol
fumarate are approved separately for the maintenance treatment of
COPD in the United States and Europe.
About Roflumilast
DALIRESP (roflumilast) is a selective PDE4 inhibitor that is
indicated as a treatment to reduce the risk of exacerbations in
patients with severe COPD associated with chronic bronchitis and a
history of exacerbations. DALIRESP is not a bronchodilator and is
not indicated for the relief of acute bronchospasm.
Important Safety Information
Contraindications
DALIRESP is contraindicated in patients with moderate to severe
liver impairment (Child-Pugh B or C).
Warnings and Precautions
Treatment of Acute Bronchospasm
DALIRESP is not a bronchodilator and should not be used for the
relief of acute bronchospasm.
Psychiatric Events including Suicidality
Prescribers should advise patients, their caregivers, and
families to be alert for the emergence or worsening of insomnia,
anxiety, depression, suicidal thoughts or other mood changes, and
if such changes occur, to contact their healthcare provider.
Prescribers should carefully evaluate the risks and benefits of
continuing treatment if such events occur. Before using DALIRESP in
patients with a history of depression and/or suicidal thoughts or
behavior, prescribers should carefully weigh the risks and benefits
of treatment with DALIRESP.
Treatment with DALIRESP is associated with an increase in
psychiatric adverse reactions. In controlled clinical trials 5.9%
of patients treated with DALIRESP reported psychiatric adverse
reactions vs. 3.3% treated with placebo. The most common
psychiatric adverse reactions were insomnia (2.4% vs. 1.0%),
anxiety (1.4% vs. 0.9%), and depression (1.2% vs. 0.9%). Three
patients treated with DALIRESP experienced suicide-related adverse
reactions (one completed suicide and two suicide attempts) compared
to one patient (suicidal ideation) treated with placebo.
Weight Decrease
Patients should have their weight monitored regularly. If
unexplained or clinically significant weight loss occurs, weight
loss should be evaluated and treatment discontinuation
considered.
In addition to weight loss being reported as a common adverse
reaction (7.5% of patients treated with DALIRESP vs. 2.1% placebo),
weight was prospectively assessed in two 1-year clinical trials. In
these studies that compared DALIRESP to placebo, 20% vs. 7%
experienced moderate weight loss (5-10% of body weight) and 7% vs.
2% experienced severe weight loss (>10% body weight). During the
follow-up period after discontinuing DALIRESP, the majority of
patients regained some of the weight they had lost.
Drug Interactions
Use with strong cytochrome P450 enzyme inducers (e.g.,
rifampicin, phenobarbital, carbamazepine, phenytoin) is not
recommended, as they decrease the exposure and may reduce the
therapeutic effectiveness of DALIRESP.
Adverse Reactions
In clinical trials the most common adverse reactions (≥2% and
greater than placebo) were diarrhea (9.5% vs. 2.7%), weight loss
(7.5% vs. 2.1%), nausea (4.7% vs. 1.4%), headache (4.4% vs. 2.1%),
back pain (3.2% vs. 2.2%), influenza (2.8% vs. 2.7%), insomnia
(2.4% vs. 1.0%), dizziness (2.1% vs. 1.1%), and decreased appetite
(2.1% vs. 0.4%).
About COPD
The World Health Organization (WHO) has described COPD as a
global epidemic; an estimated 64 million people have COPD
worldwide. 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. WHO predicts that COPD will become the
third leading cause of death worldwide by 2030. COPD is already the
third leading cause of death in the U.S.
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 chronic cough. As the
condition worsens and breathlessness increases, daily activities,
such as walking up a short flight of stairs or carrying a suitcase,
can become very difficult. New therapies to treat this debilitating
disease may be of value.
About Forest Laboratories, Inc.
Forest Laboratories (NYSE:FRX) is a leading, fully integrated,
specialty pharmaceutical company largely focused on the United
States market. Forest markets a portfolio of branded drug products
and develops new medicines to treat patients suffering from
diseases principally in five therapeutic areas: central nervous
system, cardiovascular, gastrointestinal, respiratory, and
anti-infective. Forest’s strategy of acquiring product rights for
development and commercialization through licensing, collaborative
partnerships and targeted mergers and acquisitions allows Forest to
take advantage of attractive late-stage development and commercial
opportunities, thereby managing the risks inherent in drug
development. In January 2014, Forest acquired Aptalis
Pharmaceuticals for $2.9 billion in cash in order to gain access to
its GI and Cystic Fibrosis products, including treatments for
Ulcerative Proctitis, Duodenal Ulcers, H. Pylori, Anal Fissures,
and Pancreatic Insufficiency. In February 2014, Forest and Actavis
plc announced an agreement where Forest would be acquired for about
$25 billion in cash and stock. The acquisition of Forest by Actavis
is contingent upon regulatory and shareholder approvals.
Forest is headquartered in New York, NY.
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 potential that the presentations identified above are not given
at all or at the times or locations specified, in addition to the
risk factors listed from time to time in each of Forest's and
Ironwood's Annual Reports on Form 10‐K, Quarterly Reports on Form
10‐Q, and other SEC filings. Neither Forest nor Ironwood undertakes
any obligation to update these forward-looking statements to
reflect events or circumstances occurring after this press release.
These forward looking statements speak only as of the date of this
press release. All forward‐looking statements are qualified in
their entirety by this cautionary statement.
Forest Laboratories, Inc.Media Relations:Amanda Kaufman,
646-231-7316amanda.kaufman@frx.comorInvestor Relations:Frank J.
Murdolo, 212-224-6714media.relations@frx.com
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