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pSivida Reports Complete Response Letter From FDA for ILUVIEN®

  pSivida Reports Complete Response Letter From FDA for ILUVIEN®

Business Wire

WATERTOWN, Mass. -- October 18, 2013

pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a specialty pharmaceutical company
that is a leader in developing sustained release drugs for treatment of
back-of-the-eye diseases, today announced that its licensee Alimera Sciences,
Inc. has received a Complete Response Letter (CRL) for the New Drug
Application (NDA) for ILUVIEN® from the U.S. Food and Drug Administration
(FDA).

Identifying concerns regarding the benefit to risk and safety profiles of
ILUVIEN, the FDA stated that the NDA could not be approved in its present
form. To address the clinical and statistical deficiencies identified, the FDA
indicated that results from a new clinical trial would need to be submitted,
together with at least 12 months of follow-up for all enrolled patients. The
FDA suggested that a meeting with the Dermatologic and Ophthalmic Drugs
Advisory Committee may be of assistance in addressing the deficiencies
identified above and providing advice whether a patient population can be
identified in which the benefits of the drug product might outweigh the risks.
Alimera reported that in a separate written communication from the staff of
the FDA, it was notified that an Advisory Committee meeting would be convened
on January 27, 2014. In the CRL, the FDA also referenced deficiencies at the
facility where ILUVIEN is manufactured.

“We are extremely disappointed by the FDA’s decision not to approve ILUVIEN at
this time,” said Paul Ashton, PhD, president and chief executive officer of
pSivida. “However, we are pleased that Alimera plans to continue to work with
the FDA, through the advisory committee, to determine whether there is a path
forward in the U.S. for ILUVIEN, and that Alimera believes it is well
positioned for growth in Europe, irrespective of the U.S. outcome, based on
current traction in the countries in which ILUVIEN has already been approved,
coupled with the continued pursuit of further country approvals.”

Alimera reported that its commercial focus is on Europe, where the ILUVIEN is
approved and commercially available in the United Kingdom and Germany and
slated to launch in France early next year. ILUVIEN is also approved in
Austria, Portugal and Spain and pending approval in Italy. In addition,
Alimera has filed with the Medicines and Healthcare Products Regulatory Agency
in the United Kingdom (U.K.) as the Reference Member State for 10 additional
European Union country approvals through the Mutual Recognition Procedure.

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™, including Tethadur™. The injectable, sustained
release micro-insert ILUVIEN® for the treatment of chronic Diabetic Macula
Edema (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, Portugal, and
Spain and is awaiting authorization in Italy. pSivida has instituted the first
of two planned pivotal Phase III clinical trials for Medidur™ for the
treatment of posterior uveitis, a chronic back-of-the-eye disease. 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: Alimera’s ability to obtain
regulatory approval for ILUVIEN for DME in the U.S. through the advisory
committee or otherwise, 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 complete pricing and
reimbursement discussions for, commercialize and achieve market acceptance of,
and generate revenues to pSivida from, ILUVIEN for DME in the EU;; 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 efficacy, side effects and risk/benefit profile, as well as
uncertainty as to the ultimate results of the investigator-sponsored trial for
Medidur for posterior uveitis; initiation, financing and success of
Latanoprost Product Phase II trials and exercise by Pfizer of its option;
ability to utilize Tethadur and BioSilicon 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. 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
President
+1 312-943-1123
M: +1 773 350 5793
bjedynak@janispr.com
or
In Australia:
pSivida Corp.
Brian Leedman
Vice President, Investor Relations
+61 (0) 41 228 1780
brianl@psivida.com
 
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