WATERTOWN, Mass.--(BUSINESS WIRE)--
pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in developing
sustained release, drug delivery products for treatment of
back-of-the-eye diseases, today reported that its licensee Alimera
Sciences, Inc. has indicated its intention to resubmit its application
for ILUVIEN® for diabetic macular edema (DME) to the U.S. Food and Drug
Administration (FDA). Based on a recent meeting with the FDA, Alimera
intends to use data from Alimera's two previously completed pivotal
Phase III clinical trials (FAME® Study). pSivida expects the
resubmission to address the issues raised by the FDA in its November
2011 Complete Response Letter (CRL) and in its recent meeting with
Alimera.
pSivida anticipates the resubmission will focus on the population of
patients with chronic DME considered insufficiently responsive to
available therapies, the same indication for which regulatory approval
for ILUVIEN has been granted in various EU countries. Alimera has not
reported an expected time for resubmission.
"We are very pleased at this development in the U.S. in addition to the
recent marketing authorizations in Austria, France, Germany, Portugal
and the U.K.," said Dr. Paul Ashton, President and CEO of pSivida.
Under a collaboration agreement with Alimera, pSivida granted Alimera an
exclusive worldwide license to manufacture and sell ILUVIEN for the
treatment and prevention of eye diseases in humans other than uveitis.
Alimera agreed to fund all development costs, pay pSivida a $25.0
million milestone payment upon FDA approval of ILUVIEN and 20% of any
net profits, as defined, on sales of ILUVIEN by Alimera.
In November 2011, the FDA stated in the CRL that it was unable to
approve the ILUVIEN new drug application because it did not provide
sufficient data to support that ILUVIEN is safe and effective in the
treatment of patients with DME. The FDA stated that the risks of adverse
reactions shown for ILUVIEN in Alimera's clinical trials were
significant and were not offset by the benefits demonstrated by ILUVIEN
in these clinical trials and indicated that Alimera would need conduct
two additional clinical trials.
pSivida is a US listed company with a primary listing on NASDAQ. It is
also listed on the ASX and subject to the ASX's continuous disclosure
rules
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, licensed to Alimera Sciences, Inc., has received marketing
authorization in Austria, France, Germany, Portugal and the U.K. and is
awaiting authorization in Italy and Spain. The FDA has cleared pSivida's
Investigational New Drug application (IND) to treat posterior uveitis
with the same micro-insert. An investigator-sponsored clinical trial is
ongoing for an injectable, bioerodible 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: no assurance
that Alimera will resubmit its application or be able to demonstrate to
the FDA that the benefits outweigh the risks of ILUVIEN for DME using
data from the FAME Study, that additional clinical trials will not be
required, that the population of chronic DME patients will be acceptable
to the FDA or that Alimera will be able to obtain regulatory approval
for ILUVIEN for DME in the U.S.; ability of Alimera to consummate its
pending financing; the timing and conditions for additional regulatory
approvals are subject to decisions by regulators; necessity to raise
additional capital to finance Phase III uveitis trials as well as other
working capital needs; ability to obtain additional capital; ability to
initiate and complete clinical trials and obtain regulatory approval of
product candidates; adverse side effects; Alimera's ability to
successfully obtain regulatory approval of and commercialize ILUVIEN for
DME in the EU; actions with respect to regulatory approval of ILUVIEN
for DME in the U.S.; ability to attain profitability; exercise by Pfizer
of the Latanoprost Product option; further impairment of intangible
assets; fluctuations in operating results; decline in royalty revenues;
ability to find partners to develop and market products; termination of
license agreements; competition; market acceptance of products and
product candidates; reduction in use of products as a result of future
guidelines, recommendations or studies; ability to protect intellectual
property and avoid infringement of others' intellectual property;
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; ability to pay
any registration penalties; absence of dividends; and other factors
described in our filings with the Securities and Exchange Commission.
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.
US Public Relations
Martin E. Janis & Company, Inc.
Beverly
Jedynak, +1 (312) 943 1123
President
bjedynak@janispr.com
or
pSivida
Corp.
Brian Leedman, +61 (0) 41 228 1780
Vice President,
Investor Relations
brianl@psivida.com
Source: pSivida Corp.
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