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Alimera
Sciences Inc.
as having a possible role in dry eye, and the activation of
NADPH oxidase in certain pollen grains upon hydration
implicates its role in allergic conjunctivitis.”
Founded: 2003
Based: Alpharetta, Georgia
Number of Employees: 27
On the Web: www.alimerasciences.com
Officers: C. Daniel Myers, Co-Founder, Chief
Executive Officer, and President; David R. Holland,
Co-Founder and Senior Vice President of Sales &
Marketing; Richard S. Eiswirth Jr., Chief Operating
Officer, Chief Financial Officer; Susan H. Caballa,
Senior Vice President of Regulatory and Medical
Affairs; Kenneth Green, PhD, Chief Scientific Officer.
Profile: Alimera Sciences, Inc., is a publicly traded
(NASDAQ:ALIM) biopharmaceutical company that
focuses on the research, development, and commercialization of ophthalmic pharmaceuticals for diseases
affecting the retina. The company’s product candidates
include Iluvien, an intravitreal insert under investigation
to provide a sustained therapeutic effect for up to
36 months in the treatment of diabetic macular edema
(DME), as well as wet and dry age-related macular
degeneration (AMD), and retinal vein occlusion. It
also conducts testing on two classes of nicotinamide
adenine dinucleotide phosphate (NADPH) oxidase
inhibitors. NADPH oxidase inhibitors have the potential
to prevent reactive oxygen species from becoming
excessive, thus managing the development and progression of diseases of the eye such as geographic atrophy.
“In the eye, the inhibition of NADPH oxidase has been
shown to prevent or slow pathology in various models
of ocular disease, including retinal degeneration, retinal
neovascularization, choroidal neovascularization and
uveitis,” according to Alimera. “In addition, the presence
of NADPH oxidase in corneal epithelial cells implicates it
26 I RETINA TODAY I JANUARY/FEBRUARY 2011
Background: Alimera Sciences was founded in June
2003 as a biopharmaceutical company specializing in
the research, development, and commercialization of
prescription ophthalmic pharmaceuticals.
The four founders—Dan Myers, Daniel White, Dave
Holland, and Mark Testerman—had worked together
and spent the majority of their careers in ophthalmology at a large pharmaceutical company but felt the big
corporate world in general was heading in a direction
that they did not want to pursue, Mr. Holland said.
“Given our knowledge base and relationships in ophthalmology, we set out to start Alimera. We had enjoyed
our experience in the retinal community with the launch
of Visudyne (verteporfin, Novartis) and wanted to get
back to retina,” Mr. Holland told Retina Today. “Our name
Alimera derives loosely from ancient Greek with the
intended meaning of 'day of truth'. We wanted a name
with meaning and one that would hold us accountable
for our actions as we started this venture.”
In 2004, Alimera introduced Soothe Emollient
(Lubricant) Eye Drops for dry eyes. Soothe was the first
multidose lubricant eye drop to feature Restoryl, a
unique lipid restorative that works to reestablish the
lipid layer of tears, promoting sustained moisture retention. Soothe was later sold to Bausch + Lomb.
Upon gaining support from top-notch venture capitalists, Alimera received funding to get back to the world of
retina. “In 2005, we met CDS (Control Delivery Systems,
now known as pSivida Inc.) and licensed a next-generation
intravitreal insert from them. Six years later we have completed 3 years of clinical trials, submitted our application
to the US Food and Drug Administration (FDA) and
Medicines and Healthcare products Regulatory Agency
(MHRA ) and prepared the company for the launch of
Iluvien,” Mr. Holland said.
In 2006, Alimera developed and submitted for FDA
approval an application for 0.025% ketotifen fumarate
(Alaway) for the temporary relief of ocular itch. Alaway was
approved by the FDA in December of 2006 and was then
sold along with a potential future line extension to Bausch +
RetinaToday.com
Lomb, which began marketing Alaway in the spring of 2007.
In the Pipeline: Alimera’s main product candidate is
Iluvien, licensed from pSivida Corp. (Watertown, MA),
a 20% profits interest holder. Iluvien is an intravitreal
insert for the sustained delivery of fluocinolone acetonide to the posterior segment. The insert, which is
injected with a 25-gauge needle through the pars plana,
contains approximately 190 µg of fluocinolone acetonide. The insert delivers a dose of approximately 0.2 µg
per day, with a delivery lifespan of more than 2 years.
Alimera filed a New Drug Application (NDA) for
Iluvien for the treatment of diabetic macular edema
with the FDA on June 29, 2010, including safety and efficacy data through month 24 of the FAME Study. The
FAME study consists of two 36-month phase 3 trials
involving 956 participants at 101 sites. On August 30,
2010, Iluvien was granted priority review by the FDA.
However, on December 23, 2010, the FDA sent Alimera
a Compete Response Letter, stating the drug “cannot be
approved in its present form.” According to an Alimera
news release, the FDA is seeking analyses of safety and
efficacy data through month 36 of the Iluvien FAME
study. Additionally, the FDA asked for further information relative to its manufacturing facilities. In response,
Alimera requested a meeting with the agency to clarify
the path to regulatory approval and is compiling
reports on its month-36 data, and its manufacturing,
packaging and sterilization process to provide to the
FDA in the first quarter of 2011. Alimera has also submitted applications for Iluvien in the United Kingdom,
Austria, France, Germany, Italy, Portugal and Spain.
“We are pursuing trials with Iluvien in several retinal
diseases and we are excited about the potential of our
NADPH oxidase inhibitor compounds. Our future is dedicated to moving the back of the eye to the forefront of
research and development,” Mr. Holland said. ■
Stock Price as of January 24: $8.973
• 52-Week High: $12.70
• 52-Week Low: $6.30
• 1-Year Return: N/A*
• Market Cap: 280.638
• Dividend Yield: N/A
Earnings
• Earnings per share for last quarter: -0.22%
• Analysts’ earnings per share estimate
for upcoming quarter: -0.14%
• Revenue/sales for last quarter: N/A
• Analysts’ revenue/sales estimate for
upcoming quarter: N/A
• P/E (price to earnings) ratio: N/A
*company began trading April 22, 2010
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