|
Our development and commercial infrastructure
provides us the flexibility to pursue both early- and late-stage
inlicensing opportunities. During 2007, we intend to focus
more of our efforts on identifying and acquiring assets that
can further leverage our infrastructure.
LUNESTA® Brand
Eszopiclone
We continue to expand our clinical research on the use of
LUNESTA for the treatment of insomnia with co-existing conditions.
In late 2006, we provided the first overview of clinical results
from a study of LUNESTA in the treatment of insomnia in patients
with co-existing generalized anxiety disorder, at the American
College of Neuropsychopharmacology annual meeting. This study
adds to the wealth of clinical data for LUNESTA that we have
already produced, including the previous year’s completion
of significant, large-scale studies of the product in the
treatment of insomnia in patients with co-existing depression,
pain associated with rheumatoid arthritis and perimenopause.
This extensive Phase IIIB/IV database supports LUNESTA’s value
in the treatment of insomnia and its associated symptoms when
it co-exists with other common disorders. As part of our marketing
strategy for 2007, we have begun the rollout of a new physician
education campaign containing some of these data, which we
believe will further distinguish LUNESTA as a unique treatment
available for the millions of people in the U.S. who have
insomnia.
In 2006, we made significant progress in
our goal to extend the LUNESTA franchise outside the U.S.
In Japan, we are currently completing a Phase I study.We plan
to include data from our U.S. studies of LUNESTA in a submission
to the Japanese regulatory authorities. This bridging approach
has been accepted by the Japanese regulatory authorities,
allowing us to proceed directly into a truncated Phase III
program. This strategy has the potential to significantly
decrease the anticipated time and resources needed to complete
the clinical program and submit the Japanese New Drug Application.
In the European Union (E.U.), we have met
with several of the national regulatory authorities and believe
that
|
|
we are in a position to use the data from
our U.S. trials of LUNESTA, including those from our Phase
IIIB/IV program, as part of our marketing application. At
this time, we are targeting submission of the E.U. marketing
application for the second half of 2007.
XOPENEX® Brand
Levalbuterol Franchise
XOPENEX Inhalation Solution, our short-acting bronchodilator,
continued its track record of annual growth in revenue, contributing
$555 million to overall product sales, an increase of more
than 29 percent over 2005. Growth was driven principally in
the non-retail sector, with sales to hospitals and channels
reimbursed by Medicare providing the biggest gains. Future
growth of XOPENEX Inhalation Solution will be contingent on
a variety of factors, including appropriate coverage and reimbursement
under the Medicare Part B prescription drug benefit.
We were encouraged by the government’s action
in late 2006 to initiate a National Coverage Analysis (NCA)
of our product in the treatment of patients with chronic obstructive
pulmonary disease (COPD).While the resolution of this NCA
is not expected until the latter part of 2007, we remain optimistic
that reimbursement policy will continue to support access
to XOPENEX Inhalation Solution for the thousands of Medicare
beneficiaries who rely on XOPENEX as part of their treatment
regimen.
We launched XOPENEX HFA, our hydrofluoroalkane
(HFA) metered-dose inhaler (MDI), at the end of 2005, and
it showed steady revenue growth in 2006. Complementing our
XOPENEX Inhalation Solution product, XOPENEX HFA had revenues
of $41 million for 2006, bringing total XOPENEX franchise
revenues to $596 million for the year.
A transition is underway in the short-acting
beta2-agonist MDI market in which XOPENEX HFA competes. A
phase-out of chlorofluorocarbon-containing (CFCcontaining)
albuterol MDIs is occurring, providing us an opportunity to
offer XOPENEX HFA as a CFC-free alternative to these older
medications. In the coming
|