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Alimera Sciences, Psivida Limited Amend Medidur™ FA
Collaboration Agreement
March 17, 2008
ATLANTA / BOSTON, March 17, 2008 - Alimera Sciences and pSivida
Ltd (NASDAQ:PSDV, ASX:PSD, Xetra:PSI) today announced that they
have amended their license and collaboration agreement relating
to Medidur™ FA, the companies' Phase III investigative treatment
for diabetic macular edema (DME), and other Medidur products. Alimera
is increasing its equity in the future profits of Medidur FA from
50 to 80 percent in exchange for consideration of up to approximately
$78m to pSivida.
Consideration to pSivida includes an up-front payment of $12m,
a $25m milestone payment upon FDA approval of Medidur™ FA, other
payments of up to approximately $21m by September 30, 2012, and
assumption of pSivida's research and development funding obligations
estimated at approximately $20m.
"We are very pleased with this agreement as it provides us with
the opportunity to increase our stake and consolidate the development
and commercialization of our late stage DME product Medidur FA," said
Dan Myers, President and CEO of Alimera Sciences. "In addition,
we will further advance the delivery system's application in other
serious ophthalmic conditions like dry age-related macular degeneration
(AMD), using exploratory treatments such as the groundbreaking
work we are doing around NADPH oxidase inhibitors."
"We believe this is a great deal for pSivida and its shareholders
as it gives the company a significant financial interest in very
exciting products and economics that eliminate our need for equity
financing for the foreseeable future under our current plans," said
pSivida Managing Director, Dr. Paul Ashton. "This new agreement
with Alimera Sciences is expected to significantly reduce our burn
rate going forward as the Company's two lead ophthalmology programs
in development are now funded by our partners."
Diabetic retinopathy (DR), a complication of diabetes mellitus,
is the leading cause of blindness in the working-age population
of developed countries. At any time during progression of diabetic
retinopathy, patients can develop DME, which involves retinal thickening
of the macular area. In the United States, as many as 200,000 people
are diagnosed with DME each year and an estimated 1,000,000 people
suffer from DME. Currently there are no FDA approved drug treatments
for DME.
About Alimera Sciences Inc.
Alimera Sciences Inc. is singularly
focused on the development and commercialization of prescription
ophthalmology pharmaceuticals. Founded by an executive team with
extensive development and revenue growth expertise, Alimera Sciences'
products are focused on improving the delivery of therapeutic agents
to enhance patients' lives and strengthen physicians' ability to
manage ocular conditions.
Alimera completed enrollment in October 2007 of its 956-patient
Phase III clinical trial of fluocinolone acetonide in the Medidur™ drug
delivery system for the treatment of diabetic macular edema. Alimera
has also has entered into an exclusive worldwide agreement with
Emory University to explore oxidative stress management -- specifically
the reduction of reactive oxygen species (ROS) -- as a treatment
for ophthalmic diseases. The agreement gives Alimera the exclusive
option to license compounds which are NADPH (nicotinamide adenine
dinucleotide phosphate reduced form) oxidase inhibitors as potential
treatments for conditions such as the dry form of age-related macular
degeneration (AMD), particularly the late stage of this condition
known as geographic atrophy. Alimera retains the right to use the
Medidur delivery system for two of these compounds.
About pSivida Limited
pSivida is a global drug delivery company
committed to the biomedical sector and the development of drug
delivery products. Retisert® is FDA approved for the treatment
of uveitis. Vitrasert® is FDA approved for the treatment of AIDS-related
CMV Retinitis. Bausch & Lomb owns the trademarks Vitrasert® and
Retisert®. pSivida has licensed the technologies underlying both
of these products to Bausch & Lomb. The technology underlying Medidur™ for
diabetic macular edema is licensed to Alimera Sciences and is in
Phase III clinical trials. pSivida has a worldwide collaborative
research and license agreement with Pfizer Inc. for other ophthalmic
applications of the Medidur™ technology (excluding FA).
pSivida owns the rights to develop and commercialize a modified
form of silicon (porosified or nano-structured silicon) known as
BioSilicon™, which has applications in drug delivery, wound healing,
orthopedics, and tissue engineering. The most advanced BioSilicon™ product,
BrachySil™ delivers a therapeutic, P32 directly to solid tumors
and is presently in Phase II clinical trials for the treatment
of pancreatic cancer.
pSivida's intellectual property portfolio consists of 64 patent
families, 113 granted patents, including patents accepted for issuance,
and over 280 patent applications. pSivida conducts its operations
from Boston in the United States, Malvern in the United Kingdom
and Perth in Australia.
pSivida is listed on NASDAQ (PSDV), the Australian Stock Exchange
(PSD) and on the Frankfurt Stock Exchange on the XETRA system (PSI).
pSivida is a founding member of the NASDAQ Health Care Index and
the Merrill Lynch Nanotechnology Index.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION
REFORM ACT OF 1995: Various statements made in this release are
forward-looking and involve a number of risks and uncertainties.
All statements that address activities, events or developments
that we intend, expect or believe may occur in the future are forward-looking
statements. The following are some of the factors that could cause
actual results to differ materially from the forward-looking statements:
achievement of milestones and other contingent contractual payment
events; failure to prove efficacy for BrachySil; inability to raise
capital; continued losses and lack of profitability; inability
to develop or obtain regulatory approval for new products; inability
to protect intellectual property or infringement of others' intellectual
property; inability to obtain partners to develop and market products;
termination of license agreements; competition; inability to pay
any registration penalties; costs of international business operations;
manufacturing problems; insufficient third-party reimbursement
for products; failure to retain key personnel; product liability;
inability to manage change; failure to comply with laws; failure
to achieve and maintain effective internal control over financial
reporting; amortization or impairment of intangibles; issues relating
to Australian incorporation; potential delisting from ASX or NASDAQ;
possible dilution through exercise of outstanding warrants and
stock options or future stock issuances; potential restrictions
from capital raises; possible influence by Pfizer; and other factors
that may be described in our filings with the Securities and Exchange
Commission. Given these uncertainties, readers are cautioned not
to place undue reliance on such forward-looking statements. We
do not undertake to publicly update or revise our forward-looking
statements even if experience or future changes make it clear that
any projected results expressed or implied in such statements will
not be realized.
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