Sepracor Inc. (Nasdaq: SEPR), Marlborough, Mass., has announced its
consolidated financial results for the second quarter of 2005. For the
three months ended June 30, 2005, Sepracor's consolidated revenues
were $185.1 million, of which revenues from pharmaceutical product sales
were $166.7 million ($83.2 million for sales of XOPENEX(R) brand
levalbuterol HCl Inhalation Solution and $83.5 million for sales of
LUNESTA(TM) brand eszopiclone, which was launched in April 2005).
The net loss for the second quarter of 2005 was $7.4 million, or
$0.07 per share. These consolidated results compare with consolidated
revenues of $70.0 million, of which revenues from pharmaceutical product
sales (XOPENEX Inhalation Solution) were $57.5 million, and a net loss
of $81.1 million, or $0.93 per share, for the three months ended June
30, 2004.
For the six months ended June 30, 2005, Sepracor's
consolidated revenues were $304.1 million, of which revenues from
pharmaceutical product sales were $273.4 million ($189.9 million for
sales of XOPENEX Inhalation Solution and $83.5 million for sales of
LUNESTA), and the net loss was $30.0 million, or $0.29 per share. These
consolidated results compare with consolidated revenues of $169.4
million, of which revenues from pharmaceutical product sales (XOPENEX
Inhalation Solution) were $142.5 million, and a net loss of $131.6
million, or $1.53 per share, for the six months ended June 30, 2004.
As of June 30, 2005, Sepracor had approximately $920 million in
cash and short- and long-term investments.
Commercial Operations
LUNESTA brand eszopiclone - During the quarter, Sepracor began
full-scale commercial launch of LUNESTA 1 mg, 2 mg and 3 mg tablets for
the treatment of insomnia. Marketed through Sepracor's 1,250-person
sales force, LUNESTA is available by prescription in the U.S.
Also during the quarter, Phase III and IV data related to LUNESTA
were presented at the annual meetings of the Associated Professional
Sleep Societies, the American Psychiatric Association and the
International Society for Pharmacoeconomics and Outcomes Research. Among
the data presented were:
-- Forecasting the Impact of Adding a New Drug on Formulary Using
Medical Claims Data and Clinical Literature: A Case Study of Insomnia
Treatment
-- Adjunctive Eszopiclone With Fluoxetine for Major Depressive
Disorder (MDD) and Insomnia: Sleep Effects
-- Adjunctive Eszopiclone With Fluoxetine for MDD and Insomnia:
Depression Effects
-- Analysis of the Treatment Effect of Eszopiclone on Sleep
Parameters That Affect Next-Day Function in the Elderly
-- A Crossover Study of Eszopiclone in the Treatment of Primary
Insomnia
-- Eszopiclone Co-Administered With Fluoxetine for Insomnia
Associated With MDD: Effects Following Eszopiclone Discontinuation
-- Trajectory Analysis of Treatment Response Across a Twelve-Month
Study of Nightly Eszopiclone in Patients With Chronic Insomnia
-- A Dose-Response Efficacy and Safety Study of Eszopiclone in the
Treatment of Primary Insomnia
-- Evaluation of the Safety and Efficacy of Eszopiclone in Patients
With Obstructive Sleep Apnea
In July 2005, Sepracor announced results from its Phase IIIB/IV,
410-patient, four-week, randomized, double-blind, placebo-controlled
study evaluating the safety and efficacy of LUNESTA for the treatment of
insomnia in perimenopausal and menopausal women suffering from insomnia.
The results of this study will be presented at The North American
Menopause Society's annual meeting in San Diego on Sept. 30, 2005.
In this study, nightly use of LUNESTA 3 mg resulted in statistically
significant improvement (p<0.01) compared with placebo in
patient-reported measures of sleep latency (onset of sleep), wake time
after sleep onset (WASO; a sleep maintenance measurement of the amount
of time spent awake after initially falling asleep), and total sleep
time for each week of the four-week study. LUNESTA was well tolerated
over the treatment period.
Compared to baseline and averaged over the double-blind period,
women treated with LUNESTA reported fewer nocturnal awakenings due to
hot flashes than those treated with placebo (p<0.003). A physician
global assessment, which evaluated the overall change in menopausal
symptoms, was statistically significantly improved (p<0.0001) for
women treated with eszopiclone 3 mg compared with those treated with
placebo. Perimenopause in women is the transition period from normal
reproductive function to complete cessation of the menstrual period, or
menopause. During this transition, which can be years in duration, and
continuing through to the post-menopausal period, the body experiences
both physical and hormonal changes, which can be associated with a
variety of symptoms. Problems sleeping and the resulting fatigue may
occur due to waking up in the middle of the night because of hot flashes
or the need to go to the bathroom, which can lead to trouble falling
back to sleep. During this time, women may also experience trouble
falling to sleep or waking up early in the morning. According to the
Agency for Healthcare Research and Quality, up to 40 to 60 percent of
perimenopausal, menopausal, and postmenopausal women experience sleep
disturbances.
Insomnia can include difficulty falling asleep as well as
difficulty maintaining sleep through the night. The recommended dosing
for LUNESTA to improve sleep onset and/or maintenance is 2 mg or 3 mg
for adult patients (ages 18 to 64). In older adult patients (ages 65 and
older), 2 mg is recommended for improving sleep onset and/or
maintenance, while the 1 mg dose is recommended for improving sleep
onset in older adult patients whose primary complaint is difficulty
falling asleep.
An estimated 100 million adult Americans suffer from either chronic
or occasional insomnia.(a) Symptoms of insomnia include difficulty
falling asleep, awakening frequently during the night, waking up too
early, an inability to fall back to sleep, or awakening feeling
unrefreshed. Insomnia can be a serious condition. If left untreated, it
may become progressively worse and in turn potentially affect a
person's emotional, mental and physical health.
XOPENEX(R) brand levalbuterol HCl - Marketed through
Sepracor's sales force, XOPENEX Inhalation Solution is a
short-acting bronchodilator indicated for the treatment or prevention of
bronchospasm in patients 6 years of age and older with reversible
obstructive airway disease, such as asthma. XOPENEX is available for use
in a nebulizer at 0.31 mg and 0.63 mg dosage strengths for routine
treatment of children 6 to 11 years old, and in 0.63 mg and 1.25 mg
dosage strengths for patients 12 years of age and older.
Asthma is a chronic lung disorder characterized by reversible
airway obstruction and the pathologic finding of airway inflammation.
According to the American Lung Association, approximately 26 million
Americans have been diagnosed with asthma in their lifetime. It is the
most common childhood illness and affects approximately 8.6 million
children in the U.S. under the age of 18.
ALLEGRA(R) brand fexofenadine HCl - Sepracor earns royalties from
Aventis for sales of ALLEGRA, a nonsedating antihistamine, in the U.S.
and other countries where Sepracor holds patents relating to
fexofenadine (including Japan, Europe, Canada and Australia).
CLARINEX(R) brand desloratadine - Sepracor earns royalties from
Schering-Plough Corporation on sales of all formulations of CLARINEX
brand desloratadine in the U.S. and in other countries where Sepracor
holds patents relating to desloratadine. CLARINEX is indicated for the
treatment of allergic rhinitis and chronic idiopathic urticaria (CIU),
also known as hives of unknown cause, in patients 12 years of age and
older.
XYZAL(R)/ XUSAL(TM) brand levocetirizine - Sepracor earns royalties
from UCB on sales of levocetirizine in European countries where the
product is sold. Levocetirizine is marketed as XUSAL in Germany and is
marketed under the brand name XYZAL in other member states of the
European Union. A single isomer of ZYRTEC(R), levocetirizine is
indicated for the treatment of symptoms of seasonal and perennial
allergic rhinitis and CIU, in adults and children aged 6 years and
older. XYZAL is also indicated for persistent allergic rhinitis, which
is characterized as allergic symptoms that are present for at least four
days per week, and last at least four consecutive weeks.
XOPENEX HFA(TM) (levalbuterol tartrate) MDI - On March 11, 2005,
the U.S. Food and Drug Administration (FDA) approved Sepracor's New
Drug Application (NDA) for XOPENEX HFA (hydrofluoroalkane) MDI
(metered-dose inhaler) for the treatment or prevention of bronchospasm
in adults, adolescents and children 4 years of age and older with
reversible obstructive airway disease. Reversible obstructive airway
disease includes respiratory disorders such as asthma and chronic
obstructive pulmonary disease (COPD). An MDI is a portable, hand-held
device consisting of a pressurized canister containing medication and a
mouthpiece through which the medicine is inhaled.
Sepracor continues to work to resolve outstanding manufacturing
issues and complete process validation work relating to XOPENEX HFA.
Sepracor is targeting launch of XOPENEX HFA by the end of the year. Upon
launch, Sepracor's sales force will promote XOPENEX HFA to primary
care doctors, specialists including allergists and pulmonologists, and
hospitals in the U.S.
The MDI development program included approximately 1,870 pediatric
and adult subjects and 54 studies (preclinical and clinical). In each of
the three, large-scale, pivotal Phase III trials that Sepracor
conducted, the XOPENEX HFA MDI was well tolerated and met the targeted
efficacy endpoints in both adults and children with asthma. In the
primary airway function measure, FEV(1) (a test of lung function that
measures the amount of air forcefully exhaled in one second), the
XOPENEX HFA MDI produced statistically (p<0.001) and clinically
significant improvements relative to placebo. Approximately 96 percent
of the short-acting beta-agonist inhalers sold in 2004 contained
chlorofluorocarbon (CFC) propellants, according to IMS Health
information. Under provisions in the Montreal Protocol on Substances
that Deplete the Ozone Layer, an international agreement that requires
the phase-out of substances that deplete the ozone layer, MDIs
containing CFC propellants would qualify for removal from the
marketplace. In March 2005, the FDA issued its final rule for the
removal of the essential use exemption for albuterol, which currently
permits the use of CFC-containing albuterol inhalers despite
environmental concerns. Under the rule, all production and sales of
albuterol CFC MDIs in the U.S. must cease by the end of 2008. The
XOPENEX MDI uses HFA technology and does not contain a CFC propellant.
Currently, the U.S. short-acting bronchodilator MDI market
potential at branded prices, assuming parity pricing to branded
PROVENTIL(R) HFA, is approximately $1.8 billion.
NDA-Preparation Program
Arformoterol - Sepracor has completed more than 100 preclinical
studies and 16 clinical studies for arformoterol inhalation solution as
a maintenance treatment for COPD. In 2004, Sepracor completed Phase III
studies for arformoterol in which patients treated with arformoterol
demonstrated a significant improvement in FEV(1) after dosing with a
duration of action of up to 24 hours, versus those taking placebo.
Sepracor is currently preparing the arformoterol NDA and is targeting
submission of the NDA to the FDA in the fourth quarter of 2005.
Bronchodilators have the potential to improve lung function,
decrease symptoms, help increase mucus clearance and reduce the number
of exacerbations in patients suffering from COPD. The U.S. market for
long-acting bronchodilators, including the combination product
ADVAIR(R), was approximately $4.2 billion in 2004, according to IMS
Health information.
Sepracor's Phase II Programs and Additional Clinical
Candidates
SEP-226330 - SEP-226330 is a norepinephrine and dopamine reuptake
inhibitor (NDRI). Sepracor initiated a Phase II study of SEP-226330 for
the treatment of restless legs syndrome in the fourth quarter of 2004.
This compound may have advantages over currently used dopamine agonists
in the treatment of restless legs syndrome, which is a movement disorder
that is reported to afflict approximately 16 percent of the U.S. adult
population.(b) Sepracor is also conducting preclinical evaluations of
SEP-226330 as a potential novel mechanistic approach for the treatment
of Parkinson's disease. (S)-Amlodipine - Sepracor has conducted
both Phase I and Phase II studies of (S)-amlodipine for the treatment of
hypertension. Amlodipine, marketed by Pfizer Inc. as NORVASC(R), is the
leading calcium channel antagonist approved for use for the treatment of
hypertension and angina. The evolving paradigms for hypertension
treatment are focusing on the use of multiple mechanistic approaches as
initial therapy, such as the use of calcium channel blockers (CCBs) with
angiotensin converting enzyme (ACE) inhibitors or angiotensin II
receptor blockers (ARBs).
SEP-225289 - Sepracor plans to submit an Investigational New Drug
(IND) application to the FDA and begin a Phase I clinical study for
SEP-225289, a norepinephrine, dopamine and serotonin reuptake inhibitor,
for the treatment of depression, in 2005. According to the National
Institutes of Mental Health, in a given year, approximately 18.8 million
Americans have a depressive disorder.
SEP-227162 - SEP-227162 is a serotonin and norepinephrine reuptake
inhibitor that Sepracor plans to investigate for the treatment of
depression. Other dual reuptake inhibitors have been shown in studies to
be successful in the treatment of depression.
Important Safety Information - LUNESTA
LUNESTA works quickly and should only be taken immediately before
bedtime. Be sure you have at least eight hours to devote to sleep before
becoming active. You should not engage in any activity after taking
LUNESTA that requires complete alertness, such as driving a car or
operating machinery. You should use extreme care when engaging in these
activities the morning after taking LUNESTA. Do not use alcohol while
taking any sleep medicine. All sleep medicines carry some risk of
dependency. Do not use sleep medicines for extended periods without
first talking to your doctor. Side effects may include unpleasant taste,
headache, drowsiness and dizziness. For more product information or for
the full prescribing information, please refer to the Sepracor web site
at www.sepracor.com.
About Sepracor
Sepracor Inc. is a research-based pharmaceutical company dedicated
to treating and preventing human disease through the discovery,
development and commercialization of innovative pharmaceutical products
that are directed toward serving unmet medical needs. Sepracor's
drug development program has yielded an extensive portfolio of
pharmaceutical compound candidates with a focus on respiratory and
central nervous system disorders. The company's commercialization
efforts are carried out by its U.S.-based, 1,250-person, primary care
and specialty-oriented sales force. Sepracor's corporate
headquarters are located in Marlborough, Massachusetts. Forward-Looking
Statement (a) Extrapolated to current population from 2000 census based
on Ancoli-Israel et al. SLEEP. 1999;22 (suppl 2):S347-S353 (b) Data
Monitor, October 2004
For more information, visit http://www.sepracor.com or call
508/481-6700.
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