pSivida Corp. Announces Commercial Launch of ILUVIEN® in Germany with First Patient Treated

  pSivida Corp. Announces Commercial Launch of ILUVIEN® in Germany with First
  Patient Treated

Business Wire

WATERTOWN, Mass. -- May 07, 2013

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

Contact:

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
 
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