WATERTOWN, Mass.--(BUSINESS WIRE)--
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.
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
Source: pSivida Corp.
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