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.
COPYRIGHT 2005 Worldwide
Videotex Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
Copyright 2005, Gale Group. All rights
reserved. Gale Group is a Thomson Corporation Company.
NOTE: All illustrations and photos have been removed from this article.