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, today announced that ILUVIEN®,
the first sustained release pharmaceutical product for the treatment of
chronic diabetic macular edema (DME), is now commercially available in
Germany. pSivida's licensee Alimera Sciences reported that the first
patient has been treated following the commercial launch in Germany.
"We are very pleased ILUVIEN is now available in Germany as well as for
privately insured and private pay patients in the U.K.," said Dr. Paul
Ashton, President and Chief Executive Officer. "We are also very pleased
by Alimera's resubmission of the NDA for ILUVIEN to the FDA and the
recently announced PDUFA goal date of October 17, 2013. We will be
entitled to 20% of net profits, as defined, in each of Germany and the
U.K. from sales of ILUVIEN by Alimera. If the FDA approves ILUVIEN, we
would also be entitled to an additional $25 million milestone payment
from Alimera as well as 20% of net profits on any sales in the U.S. by
Alimera."
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 considered insufficiently responsive to available therapies,
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. Alimera has resubmitted the New Drug
Application for ILUVIEN for DME to the U.S. Food and Drug
Administration. pSivida plans to institute pivotal Phase III clinical
trials for the treatment of posterior uveitis, a chronic back-of-the-eye
disease, 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 FDA-approved Retisert® licensed to Bausch & Lomb Incorporated
provides long-term, sustained drug delivery to posterior uveitis.
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 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.; 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.; 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.
Follow pSivida on social media:
Twitter: https://twitter.com/pSividaCorp
Facebook: https://www.facebook.com/pages/PSivida-Corp/544893792199562
LinkedIn: http://www.linkedin.com/company/psivida
Google+: https://plus.google.com/u/0/b/113754643626984244726/113754643626984244726/posts
The President's Blog: http://www.thechairmansblog.com/paul-ashton
Martin E. Janis & Company, Inc.
Beverly Jedynak
President
Tel:
+1 (312) 943 1123
bjedynak@janispr.com
or
pSivida
Corp.
Brian Leedman
Vice President, Investor Relations
Tel:
+61 (0) 41 228 1780
brianl@psivida.com
Source: pSivida Corp.
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