Sepracor Inc. (Nasdaq: SEPR), Marlborough, Mass., has announced its
consolidated financial results for the second quarter of 2006. For the
three months ended June 30, 2006, Sepracor's consolidated revenues
were $264.4 million, of which revenues from pharmaceutical product sales
were $256.4 million (XOPENEX(R) brand levalbuterol franchise revenues
were $117.3 million and LUNESTA(TM) brand eszopiclone revenues were
$139.1 million). Net income for the second quarter of 2006 was
approximately $11.3 million, or $0.10 per diluted share. Reported
results for the second quarter of 2006 included charges of $10.6
million, or $0.09 per diluted share, for stock-based compensation due to
Sepracor's adoption in January 2006 of Statement of Financial
Accounting Standards or SFAS No. 123R. These consolidated results
compare with consolidated revenues of $185.1 million, of which revenues
from pharmaceutical product sales were $166.7 million ($83.2 million for
sales of XOPENEX(R) brand levalbuterol and $83.5 million for sales of
LUNESTA), and a net loss of $7.4 million, or $0.07 per share, for the
three months ended June 30, 2005.
For the six months ended June 30, 2006, Sepracor's
consolidated revenues were $550.1 million, of which revenues from
pharmaceutical product sales were $533.9 million (XOPENEX franchise
revenues were $256.7 million and LUNESTA revenues were $277.2 million).
Net income for the first six months of 2006 was approximately $21.5
million, or $0.19 per diluted share. Reported results for the first six
months of 2006 included charges of $20.4 million, or $0.18 per diluted
share, for stock-based compensation due to Sepracor's adoption of
SFAS No. 123R. These consolidated results compare with consolidated
revenues of $304.1 million, of which revenues from pharmaceutical
product sales were $273.4 million ($189.9 million for sales of XOPENEX
franchise products and $83.5 million for sales of LUNESTA), and a net
loss of $30.0 million, or $0.29 per share, for the six months ended June
30, 2005.
As of June 30, 2006, Sepracor had approximately $944.5 million in
cash and short- and long-term investments.
Commercial Operations
LUNESTA brand eszopiclone - During the second quarter of 2006,
Sepracor announced the publication of results of a study in which
LUNESTA was administered to patients with insomnia and co-existing major
depressive disorder. The Phase IIIB/IV, 545-patient study was published
in the June issue of Biological Psychiatry.
Data from LUNESTA Phase IIIB/IV studies were also presented at the
American Psychiatric Association annual meeting and the SLEEP 2006 20th
Anniversary Meeting of the Associated Professional Sleep Societies in
May and June. The presentations included results from the following
studies conducted by Sepracor:
-- The second long-term, placebo-controlled study examining the
safety and efficacy of LUNESTA for six months of nightly use in patients
with primary insomnia;
-- A study in which LUNESTA was administered to patients with
insomnia and co-existing major depressive disorder;
-- A study in which LUNESTA was administered to patients with
insomnia and co-existing rheumatoid arthritis;
-- A study in which LUNESTA was administered to patients with
insomnia and co-existing perimenopause/menopause symptoms; and
-- The Regimen of Eszopiclone Sleep Satisfaction Trial (RESST), a
patient satisfaction study.
In addition, Sepracor completed two driving studies of similar
design (randomized, double-blind, placebo-controlled crossover studies)
for LUNESTA. In July 2006, the results of a study which looked at the
effects of a single evening dose of 3 mg LUNESTA on next-day driving
ability and psychomotor/memory function in healthy volunteers compared
to placebo were presented at the Collegium Internationale
Neuro-Psychopharmacologicum 25th Biennial Congress. The primary
objective of this study was to assess next-day, on-the-road brake
reaction time (BRT) in subjects administered either LUNESTA 3 mg or
placebo the evening before. The study was conducted in 31 healthy adult
volunteers. In this study, there was no statistically significant
difference in the primary endpoint of on-the-road BRT following
nighttime administration of LUNESTA 3 mg compared with placebo. BRT is a
test sensitive to the effects psychotropic drugs (drugs that act on the
central nervous system) and provides results consistent with laboratory
measures of psychomotor performance.
During the second quarter of 2006, Sepracor completed a second
driving study that examined the effects of a single evening dose of 3 mg
LUNESTA on next-day driving ability and psychomotor/memory function in
patients with primary insomnia compared to placebo. Preliminary analysis
of the results of the second driving study confirm the next-day,
on-the-road BRT results of the first driving study.
The results of the above-mentioned driving studies are consistent
with and supportive of the multiple other studies assessing next-day
residual effects that are discussed in some detail in the current
LUNESTA prescribing information.
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.
XOPENEX(R) brand levalbuterol HCl Inhalation Solution - 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, which is a machine that converts liquid medication into
a fine mist that is inhaled through a mask, 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 . XOPENEX HFA(TM) (levalbuterol
tartrate) MDI - XOPENEX HFA is a hydrofluoroalkane (HFA) metered-dose
inhaler (MDI), which is a portable, hand-held device consisting of a
pressurized canister containing medication and a mouthpiece through
which the medication is inhaled. Indicated for the treatment or
prevention of bronchospasm in adults, adolescents and children 4 years
of age and older with reversible obstructive airway disease, XOPENEX HFA
complements the XOPENEX Inhalation Solution product line and provides
patients with a portable means of administering XOPENEX.
Approximately 95 percent of short-acting beta-agonist inhalers sold
in 2005 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 qualify for removal from the marketplace. In
March 2005, the U.S. Food and Drug Administration (FDA) issued its final
rule for removal of the essential use exemption for albuterol, which
currently permits use of CFC-containing albuterol inhalers despite
environmental concerns. Under the rule, all production and sales of
albuterol CFC MDIs in the U.S. are required to cease by the end of 2008.
The XOPENEX MDI uses an HFA propellant and does not contain CFCs.
Currently, the U.S. short-acting bronchodilator MDI market potential, at
XOPENEX HFA branded prices, is approximately $2.9 billion.
Sepracor Pipeline Progress
Arformoterol New Drug Application Under FDA Review
A New Drug Application (NDA) for arformoterol tartrate inhalation
solution remains under review at the FDA. The NDA for arformoterol
tartrate was submitted to the FDA in December 2005 and was accepted for
filing by the FDA in February 2006. Arformoterol tartrate is a
long-acting beta-agonist formulation, submitted for approval for
long-term maintenance treatment of chronic obstructive pulmonary disease
(COPD). Arformoterol, a single isomer of formoterol, is the first
long-acting bronchodilator to be developed in an inhalation solution for
use with a nebulizer; other long-acting bronchodilators currently
available are formulated in dry-powder inhalers.
The Prescription Drug User Fee Act (PDUFA) date for arformoterol is
October 12, 2006. A PDUFA date is the date by which the FDA is expected
to review and act on an NDA submission.
Sepracor completed more than 100 preclinical and 16 clinical
studies of arformoterol involving more than 2,000 patients. Among the
clinical studies conducted were two 12-week pivotal studies, each with
more than 700 patients, as well as a large-scale, 12-month safety study.
In Phase III studies, patients treated with arformoterol demonstrated a
statistically significant improvement in FEV(1), which is a test of lung
function, versus those patients administered placebo.
In May 2006, Sepracor presented data from two of its clinical
studies of arformoterol inhalation solution, including: a multicenter,
double-blind, double-dummy, randomized Phase III study of 717 patients
with COPD; and a 62-patient, 5-way crossover study in patients with
COPD. Both posters were presented at the International Conference of the
American Thoracic Society.
Phase I and Preclinical Development
SEP-225289 - Sepracor has completed a Phase I, single-blind,
randomized, placebo-controlled safety, tolerability and pharmacokinetic
clinical study for SEP-225289, a serotonin, norepinephrine and dopamine
reuptake inhibitor (SNDRI), for the treatment of major depressive
disorder and plans to initiate a multiple dose pharmacokinetic study
during the third quarter of 2006. Based on preclinical data, SEP-225289
appears to be a highly potent reuptake inhibitor, with a triple
mechanism that has a balanced action across the three neurotransmitters.
About Sepracor
Sepracor Inc. is a research-based pharmaceutical company dedicated
to treating and preventing human disease by discovering, developing and
commercializing innovative pharmaceutical products that are directed
toward serving unmet medical needs. Sepracor's drug development
program has yielded a portfolio of pharmaceutical products and
candidates with a focus on respiratory and central nervous system
disorders. Sepracor's corporate headquarters are located in
Marlborough, Massachusetts. For more information, call 508/481-6700 or
visit http://www.sepracor.com.
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