WATERTOWN, Mass.--(BUSINESS WIRE)--
pSivida Corp. (NASDAQ:PSDV
- News),
a leader in developing sustained release, drug delivery products for
treatment of back-of-the-eye diseases, announced today that the United
Kingdom's National Institute for Health and Clinical Excellence (NICE)
has published final guidance indicating that ILUVIEN® is not
cost effective for the treatment of chronic diabetic macular edema (DME)
considered insufficiently responsive to available therapies. This final
guidance is consistent with the final draft guidance issued on November
29, 2012.
pSivida's licensee for ILUVIEN for DME, Alimera Sciences, Inc., reported
that it has chosen to pursue a Patient Access Scheme (PAS) for ILUVIEN
for DME that is intended to allow treatment decisions to be based on
patient need, rather than cost. Alimera further reported that the PAS is
currently under review by the Patient Access Schemes Liaison Unit
(PASLU) at NICE and that, if approved by the Department of Health, the
PAS will be available to the Appraisal Committee for review and
consideration. Alimera stated its belief that the PAS could be
considered under NICE's rapid review facility should the PAS be accepted.
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, Spain and the U.K.
and is awaiting authorization in Italy. ILUVIEN for DME has not been
approved in the U.S. 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: 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; outcome of reimbursement for ILUVIEN in the U.K., 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.
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.
News Provided by Acquire Media
