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8-K - FORM 8-K - ALIMERA SCIENCES INC | g25619e8vk.htm |
Exhibit
99.1
FOR IMMEDIATE RELEASE
For press inquiries: |
For investor inquiries: |
|
Katie Brazel, Fleishman-Hillard |
John Mills, ICR |
|
for Alimera Sciences |
for Alimera Sciences |
|
404-739-0150 |
310-954-1105 |
|
katie.brazel@fleishman.com |
John.Mills@ICRINC.com |
FDA ISSUES COMPLETE RESPONSE LETTER TO ALIMERA SCIENCES
REGARDING NEW DRUG APPLICATION FOR ILUVIEN®
REGARDING NEW DRUG APPLICATION FOR ILUVIEN®
ATLANTA, December 23, 2010 Alimera Sciences, Inc., (NASDAQ: ALIM) (Alimera), a
biopharmaceutical company that specializes in the research, development and commercialization of
prescription ophthalmic pharmaceuticals, today announced that it received a Complete Response
Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application
(NDA) for the investigational drug ILUVIEN®. The FDA issued the CRL to communicate its decision
that the NDA cannot be approved in its present form.
The application seeks the approval to market ILUVIEN (fluocinolone acetonide intravitreal insert),
Alimeras investigational, sustained drug delivery system that releases sub-microgram levels of
fluocinolone acetonide for the treatment of diabetic macular edema (DME). Alimera submitted the
ILUVIEN NDA to the FDA on June 29, 2010 with safety and efficacy data through month 24 of the FAME
Study. The FDA granted the NDA Priority Review status on August 30, 2010.
No new clinical studies were requested in the CRL. However, the FDA asked for analyses of the
safety and efficacy data through month 36 of the FAME Study,
including exploratory analyses in addition to those previously
submitted to the FDA, to further assess the relative benefits
and risks of ILUVIEN. The NDA included data through month 24. Alimera has completed month 36 of the
study and is preparing the analyses the FDA requested. The FDA is also seeking additional
information regarding controls and specifications concerning the manufacturing, packaging and
sterilization of ILUVIEN, which Alimera is in the process of compiling.
The FDA also indicated that it had observed deficiencies in current good manufacturing practices
(cGMP) during its facility inspections of two of Alimeras third-party manufacturers, which were
completed in August and September of 2010, and that all facilities and controls will need to comply
with cGMP. Alimeras third-party manufacturers are in the process of resolving these deficiencies.
We appreciate the FDAs efforts to complete a Priority Review of our NDA and look forward to
working closely with the FDA toward approval of ILUVIEN for the treatment of DME, said
Dan Myers, president and chief executive officer of Alimera. To expedite the process, we have
requested a meeting with the FDA to clarify the path to regulatory approval.
About the FAME Study
Alimera conducted two Phase 3 pivotal clinical trials (collectively known as the FAME Study) for
ILUVIEN involving 956 patients in sites across the United States, Canada, Europe and India to
assess the efficacy and safety of ILUVIEN with two doses, a high and low dose, for the treatment of
DME. The primary efficacy endpoint for the FAME Study is the difference in the percentage of
patients whose best corrected visual acuity improved by 15 or more letters from baseline on the
ETDRS eye chart at month 24 between the treatment and control groups. The study concluded
in October 2010 with the final patient visit at the three-year data point.
Following its NDA submission to the FDA, Alimera submitted a Marketing Authorization Application to
the Medicines and Healthcare products Regulatory Agency in the United Kingdom. Applications have
also been submitted to regulatory agencies in Austria, France, Germany, Italy, Portugal and Spain.
Based upon the analysis of the FAME Study, all filings included the 24-month data.
About DME
DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting
the macula, the part of the retina responsible for central vision. When the blood vessel leakage of
diabetic retinopathy causes swelling in the macula, the condition is called DME. The onset of DME
is painless and may go undetected by the patient until it manifests with the blurring of central
vision or acute vision loss. The severity of this blurring may range from mild to profound loss of
vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period
approximately 19 percent of people with diabetes studied were diagnosed with DME. As the population
of people with diabetes increases, Alimera expects the annual incidence of diagnosed DME to
increase, as well.
About ILUVIEN
ILUVIEN is an investigative, extended release intravitreal insert that Alimera is developing for
the treatment of DME. Each ILUVIEN insert is designed to provide a therapeutic effect of up to 36
months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). ILUVIEN is
inserted in the back of the patients eye to a position that takes advantage of the eyes natural
fluid dynamics. The insertion device employs a 25-gauge needle, which allows for a self-sealing
wound.
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 advanced product candidate ILUVIEN is an intravitreal insert containing fluocinolone acetonide,
a non-proprietary corticosteroid with demonstrated efficacy in the treatment of ocular
disease. ILUVIEN is in development for the treatment of DME, a disease of the retina that affects
individuals with diabetes and can lead to severe vision loss and blindness.
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, Alimeras future results
of operations and financial position, business strategy and plans and objectives of management for
Alimeras future operations. Words such as anticipate, believe, estimate, expect, intend,
may, plan, predict, project, likely, will, would, could, and similar expressions
are intended to identify forward-looking statements, although not all forward-looking statements
contain these identifying words. The events and circumstances reflected in Alimeras
forward-looking statements may not occur and actual results could 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, delay in or failure to obtain regulatory approval of
Alimeras product candidates, uncertainty as to Alimeras ability to commercialize, and market
acceptance of, its product candidates, the extent of government regulations, uncertainty as to
relationship between the benefits of Alimeras product candidates and the risks of their
side-effect profiles, dependence on third-party manufacturers to manufacture Alimeras product
candidates in sufficient quantities and quality, uncertainty of clinical trial results, limited
sales and marketing infrastructure, and Alimeras ability to operate its business in compliance
with the covenants and restrictions that it is subject to under its credit facility, as well as
other factors discussed in the Risk Factors and Managements Discussion and Analysis of
Financial Condition and Results of Operations sections of Alimeras quarterly reports on Form 10-Q
for the quarters ended March 31, 2010, June 30, 2010, and September 30, 2010, which are on file
with the Securities and Exchange Commission (SEC) and available on the SECs website at
www.sec.gov.
All forward-looking statements contained in this press release are expressly qualified by the above
paragraph in their entirety. 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.
###