ATLANTA, Nov. 29, 2012 /PRNewswire/ -- Alimera Sciences,
Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that
specializes in the research, development and commercialization of
prescription ophthalmic pharmaceuticals, today announced that the
United Kingdom's National
Institute for Health and Clinical Excellence (NICE) has issued
final draft guidance indicating that ILUVIEN is not recommended for
the treatment of chronic diabetic macular edema (DME) considered
insufficiently responsive to available therapies. While the
Appraisal Committee acknowledged the clinical effectiveness of
ILUVIEN® in the treatment of vision impairment
associated with chronic DME considered insufficiently responsive to
available therapies, it noted that cost-effectiveness thresholds
for the product have not yet been met.
In response to the final draft guidance, Alimera is now
developing a Patient Access Scheme (PAS) to address the Appraisal
Committee's cost concerns that pose a barrier to access for people
in the United Kingdom with chronic
DME who might benefit from ILUVIEN. The goal of the PAS will be to
determine the appropriate pricing for ILUVIEN in order to ensure
that treatment decisions are based on patient need, rather than
cost.
Andrew Lotery, Professor of
Ophthalmology, University of Southampton, said, "I am very pleased
that NICE has recognized that ILUVIEN is clinically effective for
chronic diabetic macular oedema. I am hopeful that this
sustained-release therapy will become available to the thousands of
people affected with diabetes in the United Kingdom."
The International Diabetes Federation estimates that more than 3
million people are currently living with diabetes in the U.K.,
nearly 200,000 of whom, according to Alimera's estimates, suffer
with vision loss from DME.
"In recognition of the ongoing process with NICE, we have
immediately begun to develop a Patient Access Scheme which, if
accepted, will make ILUVIEN available to all chronic DME patients
in the United Kingdom considered
insufficiently responsive to available therapies," said
Dan Myers, president and chief
executive officer, Alimera.
About ILUVIEN®
ILUVIEN (190 micrograms fluocinolone acetonide intravitreal
implant in applicator) is a sustained release intravitreal implant
used to treat vision impairment associated with chronic DME
considered insufficiently responsive to available therapies. Each
ILUVIEN implant provides a therapeutic effect of up to 36 months by
delivering sustained sub-microgram levels of fluocinolone acetonide
(FAc). ILUVIEN is injected in the back of the patient's eye to a
position that takes advantage of the eye's natural fluid dynamics.
The applicator employs a 25-gauge needle, which allows for a
self-sealing wound. In the FAME Study, the most frequently reported
adverse drug reactions included cataract operation, cataract and
increased ocular pressure.
In July 2010, Alimera submitted a
Marketing Authorization Application (MAA) to seven European
countries via the Decentralized Procedure (DCP) with the Medicines
and Healthcare products Regulatory Agency of the U.K. (MHRA)
serving as the Reference Member State (RMS). The MAA included data
from two Phase 3 pivotal clinical trials (collectively known as the
FAME™ Study) for ILUVIEN conducted by Alimera. The trials involved
956 patients in sites across the United
States, Canada,
Europe and India to assess the efficacy and safety of
ILUVIEN for the treatment of DME. At the end of the DCP, a
consensus was reached by the RMS and the other six countries that
the MAA for ILUVIEN was approvable. To date, five of the seven
countries, Austria, the
United Kingdom, Portugal, France and Germany have granted national licenses for
ILUVIEN. ILUVIEN has not been approved by the United States Food
and Drug Administration.
About Alimera Sciences, Inc.
Alimera Sciences, Inc., based in Alpharetta, Georgia, is a biopharmaceutical
company that specializes in the research, development and
commercialization of prescription ophthalmic pharmaceuticals.
Presently Alimera is focused on diseases affecting the back of the
eye, or retina. Its primary product, ILUVIEN, is an intravitreal
implant containing fluocinolone acetonide (FAc), a non-proprietary
corticosteroid with demonstrated efficacy in the treatment of
ocular disease.
Forward Looking Statements
This press release contains "forward-looking statements," within
the meaning of the Private Securities Litigation Reform Act of
1995, regarding, among other things, Alimera's commercial plans for
ILUVIEN in the United Kingdom.
Such forward-looking statements are based on current expectations
and involve inherent risks and uncertainties, including factors
that could delay, divert or change any of them, and could cause
actual results to differ materially from those projected in its
forward-looking statements. Meaningful factors which could cause
actual results to differ include, but are not limited to, NICE's
acceptance of the Patient Access Scheme, uncertainty as to
Alimera's ability to commercialize, and market acceptance of
ILUVIEN in the United Kingdom, and
other factors discussed in the "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" sections of Alimera's Annual Report on Form 10-K for
the year ended December 31, 2011 and
Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, which are on file with the
Securities and Exchange Commission (SEC) and available on the SEC's
website at www.sec.gov. In addition to the risks described above
and in Alimera's Annual Report on Form 10-K, Quarterly Reports on
Form 10-Q, Current Reports on Form 8-K and other filings with
the SEC, other unknown or unpredictable factors also could
affect Alimera's results. There can be no assurance that the actual
results or developments anticipated by Alimera will be realized or,
even if substantially realized, that they will have the expected
consequences to, or effects on, Alimera. Therefore, no assurance
can be given that the outcomes stated in such forward-looking
statements and estimates will be achieved.
All forward-looking statements contained in this press release
are expressly qualified by the cautionary statements contained or
referred to herein. Alimera cautions investors not to rely too
heavily on the forward-looking statements Alimera makes or that are
made on its behalf. These forward-looking statements speak only as
of the date of this press release (unless another date is
indicated). Alimera undertakes no obligation, and specifically
declines any obligation, to publicly update or revise any such
forward-looking statements, whether as a result of new information,
future events or otherwise.
For
press inquiries:
Katie
Brazel, Fleishman-Hillard
for
Alimera Sciences
404-739-0150
Katie.Brazel@fleishman.com
|
For investor inquiries:
John Mills, ICR
for Alimera Sciences
310-954-1105
John.Mills@ICRINC.com
|
SOURCE Alimera Sciences, Inc.