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Alimera IPO To Fund Eye Treatment Launch?
VentureWire
By Brian Gormley
January 17, 2008
Alimera Sciences Inc. is looking to go public as early as this
fall to fund what it hopes will be the launch of the first approved
treatment for the blinding disease diabetic macular edema, VentureWire
has learned.
The Alpharetta, Ga., company is testing the drug in Phase III,
with partner pSivida Ltd., and hopes to gain U.S. approval in 2010,
said Chief Financial Officer Rick Eiswirth. An initial public offering
would enable the company to hire 30 to 40 sales representatives
to market the drug, Medidur, to the 1,600 retinal specialists in
the U.S. It intends to raise $75 million, Eiswirth said.
Alimera has made the most of the $58.5 million it has raised through
two rounds from BA Venture Partners (now Scale Venture Partners),
Domain Associates, Intersouth Partners, Polaris Venture Partners,
Venrock Associates and others. In addition to enrolling 956 participants
in the Phase III study of Medidur in diabetic macular edema, the
company also plans to begin clinical testing of the drug for the
treatment of the wet form of age-related macular degeneration,
Eiswirth said.
Alimera formed initially to acquire and sell over-the-counter
products. Chief Executive Dan Myers, who launched the macular-degeneration
drug Visudyne as head of Novartis Ophthalmics, started Alimera
in 2003 and launched the OTC product Soothe, an eye-drop for dry
eyes, in 2004. In December 2006 Alimera secured U.S. approval for
a switch from prescription-to-OTC for the drug Alaway, a treatment
for ocular itch.
That same month it sold Alaway to Bausch & Lomb Inc., which also
acquired Soothe in August 2007. The $17 million netted from these
sales served as a non-dilutive Series C. Since divesting these
drugs Alimera has focused on bigger opportunities.
In 2005, Alimera partnered with Control Delivery Systems Inc.
(now pSivida) to develop a treatment for diabetic macular edema,
a complication of diabetes that blurs vision as fluid leaks into
the center of the macula, a portion of the retina required for
central vision. Two hundred thousand new cases are diagnosed annually
in the U.S., and the total treatable patient population numbers
about 500,000, according to Alimera. There are no approved treatments,
though laser photocoagulation is sometimes used to seal leaky vessels.
The Alimera and pSivida treatment, Medidur, is inserted into the
back of the eye, where it releases daily doses of the corticosteroid
fluocinolone acetonide for up to three years. The companies - which
will split Medidur profits - hope their approach will not just
stall the disease but improve vision. The steroid reduces inflammation,
fluid leakage and edema, and lowers levels of vascular endothelial
growth factor, or VEGF, which drives abnormal blood-vessel growth.
Alimera expects to have data from the Phase III, ongoing in the
U.S., Canada, Europe and India, in the fall of 2009 and to file
for approval in the U.S., Canada and Europe in 2010. (The timing
of the filing in India is not yet determined.) Alimera, which has
sole marketing rights, may find partners to assist with sales outside
the U.S. or hire marketing teams in various countries.
In addition to hiring salespeople, Alimera's IPO proceeds would
help it get the word to retinal doctors that its drug is on the
way, according to Eiswirth. Competitors include Fovea Pharmaceuticals
SA, a Paris company backed by Abingworth Management and Sofinnova
Partners among others. Fovea is readying treatments for acute and
chronic diabetic macular edema for clinical trials.
Medidur may also work against the wet form of age-related macular
degeneration, another disease in which blood and fluid spills into
the back of the eye. Today, patients taking the anti-VEGF drug
Lucentis get injections every four to six weeks. This year Alimera
plans to initiate a Phase II study of 30 patients to see if Medidur
can enhance Lucentis' benefits enough to eliminate the need for
regular shots. Depending on the results, Alimera may seek U.S.
approval for Medidur as a concomitant therapy to Lucentis, Eiswirth
said.
Alimera has 20 employees.

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