Sepracor Announces Approvable Action for ESTORRA(TM) Brand Eszopiclone for the Treatment of Insomnia and Provides Update on Launch Plans
MARLBOROUGH, Mass., March 1 /PRNewswire-FirstCall/ — Sepracor Inc.
(Nasdaq: SEPR) announced that it has received an “approvable” letter from the
U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for
ESTORRA(TM) brand eszopiclone 2 mg and 3 mg tablets for the treatment of
insomnia characterized by difficulty falling asleep, and/or difficulty
maintaining sleep during the night and early morning for adult and elderly
patients, and a 1 mg tablet for elderly patients whose primary complaint is
difficulty falling asleep. The FDA has not requested additional clinical or
preclinical trials for final approval.
The ESTORRA NDA, which was submitted to the FDA on January 31, 2003,
contained a total of 24 clinical trials, which included more than 2,700 adult
and elderly subjects, and more than 60 preclinical studies. A total of six
randomized, placebo-controlled Phase III studies, including one with a
positive control, for the treatment of chronic or transient insomnia were
conducted in both adult and elderly patients and were part of the NDA package.
Pre-launch activities are well underway. ESTORRA data, including more than
20 abstracts and several oral presentations, will be introduced at upcoming
medical society meetings, including the American Psychiatric Association, the
Associated Professional Sleep Societies, the American Geriatrics Society, the
American Association for Geriatric Psychiatry, the American Academy of
Neurology and the American College of Obstetricians and Gynecologists.
Having achieved this pivotal development milestone, Sepracor is now
finalizing its commercial launch plans.
“The approvable notification provides the go-ahead to begin the
implementation of the final stage of the sales force expansion. This will
bring our sales infrastructure to a total of approximately 1,250 sales
professionals. It is our intention to have our entire sales force of
experienced sales professionals ready for launch by mid-year,” said William J.
O’Shea, President and Chief Operating Officer of Sepracor Inc.
According to the National Institutes of Health web site, insomnia affects
more than 50 million Americans. 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.
According to the National Sleep Foundation (NSF) Sleep in America Poll
2003, 37 million older Americans suffer from frequent sleep problems that, if
ignored, can complicate the treatment of several other medical conditions,
from arthritis to diabetes, heart and lung disease and depression. This NSF
poll shows that poor sleep among older adults often goes unnoticed by the
medical community. While only about seven million elderly patients have been
diagnosed with sleep problems, the majority of older adults (67%) report
frequent sleep problems.
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The U.S. market for prescription sleep products, not including off-label
(not indicated for the treatment of insomnia) use of central nervous system
agents for the treatment of insomnia, was approximately $1.5 billion in 2002.
The U.S. prescription sleep agent market grew at a rate of almost 25 percent
for the past two years, according to IMS Health information.
Webcast and Conference Call Today
Sepracor will host a live conference call and webcast on Monday, March 1,
2004 at 8:30 a.m. ET to discuss the approvable letter for ESTORRA and provide
an update of Sepracor’s sales force expansion plan. To participate via
telephone, dial (612) 332-1214; (651) 224-7472; (612) 338-1040; (612) 326-
1013; (651) 224-7497; (612) 338-1294; (651) 291-0561; (612) 332-1210; (612)
332-7515; (612) 338-1652; (651) 224-7558; (612) 332-1213; or (612) 332-1025.
Reference the “ESTORRA FDA Action” conference call. Please call ten minutes
prior to the scheduled conference call time. For live webcasting, go to the
Sepracor web site at http://www.sepracor.com. The webcast will be accessible from
either the homepage or the Investor Information section. Click on either the
live webcast link or microphone icon to listen. Please go to the web site at
least 15 minutes prior to the call in order to register, download, and install
any necessary software. A replay of the call will be accessible by telephone
after 12:00 p.m. ET on March 1, 2004 and will be available for approximately
one week. To replay the call, dial (320) 365-3844 using access code 722906.
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,
including candidates for the treatment of respiratory and central nervous
system disorders. Sepracor’s corporate headquarters are located in
This news release contains forward-looking statements that involve risks
and uncertainties, including statements with respect to the anticipated
regulatory approval, potential benefits and successful development and
commercialization of ESTORRA. Among the factors that could cause actual
results to differ materially from those indicated by such forward-looking
statements are: the timing and success of submission, acceptance and approval
of regulatory filings; the scope of Sepracor’s patents and the patents of
others; the commercial success of Sepracor’s products; the ability of the
company to attract and retain qualified personnel; the performance of
Sepracor’s licensees; the availability of sufficient funds to continue
research and development efforts; the continued ability of Sepracor to meet
its debt obligations when due; and certain other factors that may affect
future operating results and are detailed in Sepracor’s current report on Form
8-K filed with the Securities and Exchange Commission on December 8, 2003.
In addition, the statements in this press release represent Sepracor’s
expectations and beliefs as of the date of this press release. Sepracor
anticipates that subsequent events and developments may cause these
expectations and beliefs to change. However, while Sepracor may elect to
update these forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so. These forward-looking
statements should not be relied upon as representing Sepracor’s expectations
or beliefs as of any date subsequent to the date of this press release.
Estorra is a trademark of Sepracor Inc.