pSivida Reports Updates on ILUVIEN® for Planned Resubmission to FDA and European Launch

  pSivida Reports Updates on ILUVIEN® for Planned Resubmission to FDA and
  European Launch

Business Wire

WATERTOWN, Mass. -- March 22, 2013

pSivida Corp. (NASDAQ:PSDV)(ASX:PVA), a specialty pharmaceutical company that
is a leader in the development of sustained release ophthalmic drug
treatments, today announced that its licensee Alimera Sciences, Inc. reported
a number of updates with respect to ILUVIEN® for chronic diabetic macular
edema (DME).

Alimera announced that it intends to resubmit its New Drug Application for
ILUVIEN for DME to the U.S. Food and Drug Administration (FDA) by the end of
March 2013. Using data from Alimera’s two previously completed pivotal Phase
III clinical trials (FAME™ Study), the resubmission will focus on the safety
aspects of ILUVIEN and the population of patients with chronic DME considered
insufficiently responsive to available therapies, the same group for which
marketing approval for ILUVIEN has been granted in various EU countries,
according to Alimera. Approval in the U.S. would entitle pSivida to a $25
million milestone payment from Alimera and 20% of net profits, as defined,
from U.S. sales of ILUVIEN by Alimera.

Alimera also announced that shipments of ILUVIEN to the German market are
expected to begin in the second quarter of 2013 upon acceptance from the
Medicine and Health products Regulatory Agency of the intended commercial
batch size, a delay from Alimera’s previous expectation that this would occur
in the first quarter of 2013. Alimera further reported that it also expects to
begin shipments to the U.K. in the second quarter of 2013 for treatment of
privately insured patients.

Alimera reported the submission of a patient access scheme (PAS) for ILUVIEN
for DME has been agreed to by the UK’s Department of Health and is now under
consideration by NICE for inclusion in its rapid review facility. NICE had
previously issued final guidance that ILUVIEN is not a cost-effective
treatment for chronic DME considered insufficiently responsive to available
therapies. Alimera reported that under the review facility, NICE is expected
to assess the impact of the PAS on ILUVIEN’s cost effectiveness and determine
whether an update to the final guidance is warranted.

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 Diabetic Macula Edema (DME), licensed to
Alimera Sciences, Inc., has received marketing authorization in Austria,
France, Germany, Portugal, the U.K. and Spain and is awaiting authorization in
Italy. ILUVIEN® for DME has not been approved in the US. 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: the timing of the resubmission of
the NDA for ILUVIEN or of the commercial launch in Germany and the UK, any
effect of the PAS on the NICE final guidance, 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; 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.

Contact:

In US:
Martin E. Janis & Company, Inc.
Beverly Jedynak, 312-943-1123; 773-350-5793 (cell)
President
bjedynak@janispr.com
or
In Australia:
pSivida Corp.
Brian Leedman, +61 (0) 41 228 1780
Vice President, Investor Relations
brianl@psivida.com
 
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