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 announced that the United Kingdom's
National Institute for Health and Clinical Excellence (NICE) issued
final draft guidance indicating that ILUVIEN is not recommended for the
treatment of chronic diabetic macular edema (DME) considered
insufficiently responsive to available therapies. While ILUVIEN has
received marketing authorization in the U.K., the independent Appraisal
Committee concluded that the evidence provided did not show that the
benefits ILUVIEN provides to patients justify the proposed price.
pSivida's licensee, Alimera Sciences, reported that in response to the
final draft guidance, it has immediately begun to develop a Patient
Access Scheme (PAS) to address NICE's cost concerns. According to
Alimera, the PAS being developed, if accepted, will make ILUVIEN
available to all chronic DME patients in the United Kingdom considered
insufficiently responsive to available therapies.
The International Diabetes Federation estimates that more than 3 million
people are currently living with diabetes in the U.K., nearly 200,000 of
whom, according to Alimera's estimates, suffer with vision loss from DME.
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. 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: outcome of
reimbursement for ILUVIEN in the U.K., 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; 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.
US Public Relations
Beverly Jedynak
President
Martin
E. Janis & Company, Inc
Tel: +1 (312) 943 1123
bjedynak@janispr.com
or
pSivida
Corp.
Brian Leedman
Vice President, Investor Relations
pSivida
Corp.
Tel: +61 (0) 41 228 1780
brianl@psivida.com
Source: pSivida Corp.
News Provided by Acquire Media
