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months, we plan to take advantage of the
opportunity to present XOPENEX HFA’s unique attributes and
underscore XOPENEX HFA’s appropriate role in the treatment
of these patients.
BROVANA™ Brand
Arformoterol Tartrate
We successfully achieved U.S. Food and Drug Administration
(FDA) approval of BROVANA as a longterm maintenance treatment
of COPD, in October 2006. Today, COPD is the fourth leading
cause of death in the U.S. There are more than 12 million
people in the U.S. diagnosed with COPD. An estimated 24 million
people have evidence of impaired lung function as seen with
COPD, indicating that COPD may be underdiagnosed, and the
incidence of COPD in this country is expected to increase.
BROVANA is the first approved long-acting bronchodilator that
can be inhaled with the use of a nebulizer. Since COPD typically
develops later in life, and older adults frequently favor
inhaling their medications with the use of a nebulizer, we
believe that this differentiated product will be a welcome
addition for patients with COPD and the physicians who care
for them.
We plan to complete our launch preparations
and commercially introduce BROVANA during the second quarter
of 2007. Upon launch, our sales force will promote BROVANA
in hospitals and to primary care physicians and pulmonologists
who treat patients with COPD.
Research & Development
Pipeline
In addition to the ongoing clinical activities relating to
commercialized products, we advanced SEP-227162, a serotonin
and norepinephrine reuptake inhibitor, into Phase I for the
treatment of depression.We have also completed a Phase I study
for SEP-225289, which is a serotonin, norepinephrine and dopamine
triple reuptake inhibitor that we are investigating for treatment
of patients with depression who do not respond after a trial
use of an antidepressant.We expect to advance both candidates
into Phase II proof-of-concept studies in 2007.
Increasingly, our focus will be on future
opportunities in the form of candidates that we generate from
our internal
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discovery capabilities. In 2007, we expect
to substantially increase our overall commitment to research
and development, particularly to our discovery efforts.
It is also our objective to move at least
two new compounds from our discovery programs through to Investigational
New Drug (IND) application submissions to the FDA in 2007.We
are currently focused on four main initiatives:
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Monoamine reuptake
inhibitors program |
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M1
agonist program |
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D-amino acid
oxidase inhibitor program |
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Alpha2 - and
alpha3-selective GABAA agonist program |
We believe that these mechanisms hold great
promise as new treatment paradigms for depression, anxiety,
cognition, schizophrenia and neuropathic pain.
We are committed to the success of our shareholders
and our employees, and to the welfare of the patients we serve.
We believe 2006 was a year in which the company achieved several
significant milestones, which should contribute to the long-term
success of all of our stakeholders.
We look forward to reporting on our continued
progress in the future.
Sincerely,

Timothy J. Barberich
Chairman and Chief Executive Officer

Adrian Adams
President and Chief Oprating Officer
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