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 the submission of its response to the second Complete Response
Letter from the U.S. Food and Drug Administration (FDA) with respect to
ILUVIEN® for chronic diabetic macular edema (DME).
Alimera reported in its 10-K filing that it submitted the response,
which includes additional analyses of the risks and benefits of ILUVIEN
based on the clinical data available from the previously completed Phase
III studies (FAME), following a meeting with the FDA in the second
quarter 2012. Alimera said that the resubmission focuses on the safety
aspects of ILUVIEN and the population of patients with chronic DME. This
is the same group for which marketing approval of ILUVIEN has been
granted in six EU countries thus far. Alimera reported that it will
communicate the Prescription Drug User Fee Act (PDUFA) date once it is
known from the FDA and that Alimera does not plan to conduct additional
trials for ILUVIEN for DME at this time.
"We are pleased to see the resubmission of the NDA to the FDA," said Dr.
Paul Ashton, president and CEO of pSivida Corp. "To date, we have
received over $30m from Alimera from its license of ILUVIEN for DME, and
if the FDA approves ILUVIEN, we would be entitled to an additional $25
million milestone payment as well as 20% of net profits, as defined, on
any sales in the U.S. by Alimera."
pSivida is entitled to the same net profit share on sales of ILUVIEN for
DME by Alimera in the EU. Alimera has announced its intent to
commercially launch ILUVIEN in Germany and for private patients in the
UK in the second quarter of 2013, upon approval of the commercial batch
size.
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 FDA's acceptance of Alimera's resubmission of its
NDA for ILUVIEN® for DME and 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 timing 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; 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,
President
312-943-1123; 773-350-5793 (cell)
bjedynak@janispr.com
or
In
Australia:
pSivida Corp.
Brian Leedman, Vice President,
Investor Relations
+61 (0) 41 228 1780
brianl@psivida.com
Source: pSivida Corp.
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