WATERTOWN, Mass.--(BUSINESS WIRE)--
pSivida Corp. (NASDAQ:PSDV
- News),
a leader in developing sustained release, drug delivery products for
treatment of back-of-the-eye diseases, announced today that the Spanish
Agency of Drugs and Medical Devices (Agencia Espanola de Medicamentos y
Productos Sanitarios) granted marketing authorization to ILUVIEN®
for the treatment of vision impairment associated with chronic diabetic
macular edema (DME) considered insufficiently responsive to available
therapies.
The Spanish authorization is the sixth national approval for ILUVIEN in
the EU, preceded by Austria, the United Kingdom, Portugal,
France and Germany. pSivida's licensee Alimera Sciences, Inc. reported
that it continues to work closely with the Italian regulatory
authorities to secure marketing authorization in Italy. These marketing
authorizations follow the completion of the Decentralized Regulatory
Procedure (DCP) in the European Union (EU), in which the Medicines and
Healthcare products Regulatory Agency (MHRA) in the United Kingdom,
serving as the Reference Member State (RMS), delivered a positive
outcome for ILUVIEN along with six Concerned Member States (CMS).
Dr. Paul Ashton, President and CEO, said, "We are pleased that ILUVIEN
has now been granted marketing authorizations in six of the seven EU
countries in which approval has been sought and look forward to its
commercial launch in the EU."
Alimera reported that it continues to expect the initial commercial
launch of ILUVIEN in Germany during the first quarter of 2013 with its
European management team now on board.
The International Diabetes Federation estimates that more than three
million people are currently living with diabetes in Spain,
approximately 160,000 of whom Alimera estimates suffer from vision loss
associated with DME.
About pSivida Corp.
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained
release, drug delivery products designed to deliver drugs at a
controlled and steady rate for months or years. pSivida is currently
focused on treatment of chronic diseases of the back of the eye
utilizing its core technology systems, Durasert™ and BioSilicon™. The
injectable, sustained release micro-insert ILUVIEN® for the treatment of
chronic DME, licensed to Alimera Sciences, Inc., has received marketing
authorization in Austria, France, Germany, Portugal, Spain and the U.K.
and is awaiting authorization in Italy. ILUVIEN for DME has not been
approved in the U.S. pSivida plans to institute pivotal Phase III
clinical trials for the treatment of posterior uveitis with the same
micro-insert as ILUVIEN for DME. An investigator-sponsored clinical
trial is ongoing for an injectable, bioerodible micro-insert to treat
glaucoma and ocular hypertension. pSivida's two FDA-approved products,
Retisert® and Vitrasert®, are implants that provide long-term, sustained
drug delivery to treat two other chronic diseases of the retina.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995: Various statements made in this release are
forward-looking, and are inherently subject to risks, uncertainties and
potentially inaccurate assumptions. 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 anticipated results or other expectations expressed,
anticipated or implied in our forward-looking statements: uncertainties
with respect to: Alimera's ability to finance, achieve additional
marketing approvals, successfully commercialize and achieve market
acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in
the EU; outcome of reimbursement for ILUVIEN in the U.K., Alimera's
resubmission of its NDA for ILUVIEN for DME and its ability to obtain
regulatory approval for, and if approved, to finance, successfully
commercialize and achieve market acceptance of, and generate revenues to
pSivida from, ILUVIEN for DME in the U.S.; financing and success of
Phase III posterior uveitis trials including efficacy, side effects and
risk/benefit profile of the posterior uveitis micro-insert; initiation,
financing and success of Latanoprost Product Phase II trials and
exercise by Pfizer of its option; development of products using Tethadur
and BioSilicon; initiation and completion of clinical trials and
obtaining regulatory approval of product candidates; adverse side
effects; ability to attain profitability; ability to obtain additional
capital; further impairment of intangible assets; fluctuations in
operating results; decline in royalty revenues; ability to, and to find
partners to, develop and market products; termination of license
agreements; competition and other developments affecting sales of
products; market acceptance; protection of intellectual property and
avoiding intellectual property infringement; retention of key personnel;
product liability; consolidation in the pharmaceutical and biotechnology
industries; compliance with environmental laws; manufacturing risks;
risks and costs of international business operations; credit and
financial market conditions; legislative or regulatory changes;
volatility of stock price; possible dilution; possible influence by
Pfizer; absence of dividends; and other factors described in our filings
with the SEC. Given these uncertainties, readers are cautioned not to
place undue reliance on such forward-looking statements. Our
forward-looking statements speak only as of the dates on which they are
made. We do not undertake any obligation to publicly update or revise
our forward-looking statements even if experience or future changes
makes it clear that any projected results expressed or implied in such
statements will not be realized.
US Public Relations
Martin E. Janis & Company, Inc
Beverly
Jedynak, +1 312-943-1123
President
bjedynak@janispr.com
or
pSivida
Corp.
Brian Leedman, +61 (0) 41 228 1780
Vice President,
Investor Relations
brianl@psivida.com
Source: pSivida Corp.
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