pSivida Corp. Reports Positive Regulatory Outcome for ILUVIEN®; Moves to National Phase for Marketing Authorizations in 10 More

  pSivida Corp. Reports Positive Regulatory Outcome for ILUVIEN®; Moves to
  National Phase for Marketing Authorizations in 10 More EU Countries

Business Wire

WATERTOWN, Mass. -- June 30, 2014

pSivida Corp. (NASDAQ: PSDV)(ASX: PVA), a leader in the development of
sustained release, drug delivery products for treating eye diseases, today
announced that the regulatory process for marketing authorizations in Belgium,
the Czech Republic, Denmark, Finland, Ireland, Luxembourg, the Netherlands,
Norway, Poland and Sweden has entered the national phase following the
successful completion of the Mutual Recognition Procedure (MRP) for subsequent
authorizations. In the national phase, each of these countries will grant a
marketing authorization for ILUVIEN for the treatment of vision impairment
associated with chronic DME considered insufficiently responsive to available
therapies. ILUVIEN initially received marketing authorizations in Austria,
France, Italy, Portugal, Spain as well as the United Kingdom and Germany where
it is now commercially available.

The application was submitted through the Mutual Recognition Procedure (MRP).
After a medicine is first authorized in one EU member state in accordance with
its national procedures, the same authorization can be subsequently used to
obtain marketing authorization in other member states not involved in the
original, authorization. These member states agree to recognize the validity
of the original national marketing authorization.

“Continuing to expand the countries where ILUVIEN can reach patients with this
devastating disease is important, and we look forward to the addition of these
ten countries,” said Dr. Paul Ashton, president and chief executive officer of
pSivida.

Alimera also resubmitted the New Drug Application for ILUVIEN for chronic DME
in March 2014, and the U.S. Food and Drug Administration (FDA) has set a PDUFA
goal date of September 26, 2014. If ILUVIEN is approved by the FDA, we are
entitled to a $25 million milestone payment from our licensee Alimera
Sciences. We are also entitled to share in the net profits from Alimera’s
sales of ILUVIEN on a country-by-country basis.

About pSivida Corp.

pSivida Corp., headquartered in Watertown, MA, is a leader in the development
of sustained release, drug delivery products for treating eye diseases.
pSivida is currently focused on treatment of chronic diseases of the back of
the eye utilizing its core technology systems, Durasert™ and BioSilicon™,
including Tethadur™. The injectable, sustained release micro-insert ILUVIEN®
for the treatment of chronic DME considered insufficiently responsive to
available therapies, licensed to Alimera Sciences, Inc., is marketed in the
U.K. and Germany and has also received marketing authorization in Austria,
France, Italy, Portugal and Spain. Alimera has filed for ten additional EU
country approvals through the Mutual Recognition Procedure. Alimera
resubmitted its NDA for ILUVIEN in March 2014 and the FDA has set a PDUFA goal
date of September 26, 2014. pSivida has instituted a Phase III clinical trials
of Medidur™ for the treatment of posterior uveitis, a chronic back-of-the-eye
disease, which uses the same micro-insert as ILUVIEN. An
investigator-sponsored clinical trial is ongoing for an injectable,
bioerodible micro-insert to treat glaucoma and ocular hypertension, a product
candidate on which Pfizer Inc. has an option. pSivida's FDA-approved
Retisert®, licensed to Bausch & Lomb Incorporated, provides long-term,
sustained drug delivery to treat 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: the number of clinical trials
necessary to support an NDA for Medidur; Alimera’s ability to finance, achieve
additional marketing approvals, obtain adequate pricing and reimbursement for,
successfully commercialize and achieve market acceptance of, and generate
revenues to pSivida from, ILUVIEN for DME in the EU; 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.; the ability to finance, complete
and achieve a successful outcome for Phase III trials for, and file and
achieve marketing approvals for, Medidur for posterior uveitis, including
achieving acceptable risk-to-benefit and safety profiles in light of the CRL
for ILUVIEN; initiation, financing and success of Latanoprost Product Phase II
trials and any exercise by Pfizer of its option; ability of Tethadur to
successfully deliver proteins, peptides and other large biologic molecules;
ability to develop product candidates and products and potential related
collaborations; initiation and completion of clinical trials and obtaining
regulatory approval of product candidates; continued sales of Retisert;
adverse side effects; ability to attain profitability; ability to obtain
additional capital; further impairment of intangible assets; fluctuations in
operating results; decline in royalty income; 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; 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. Should known or unknown risks materialize, or
should underlying assumptions prove inaccurate, actual results could differ
materially from past results and those anticipated, estimated or projected in
the 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

For more information on pSivida, visit www.psivida.com.

Contact:

In US:
Martin E. Janis & Company, Inc.
Beverly Jedynak, +1 312-943-1123 (President)
M: +1 773 350 5793
bjedynak@janispr.com
or
In Australia:
Monsoon Communications
Rudi Michelson, 03 9620 3333
M: 0411 402 737
rudim@monsoon.com.au
 
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