pSivida Reports Receipt by Alimera Sciences of Complete Response Letter from FDA for ILUVIEN(R) for DMEWATERTOWN, Mass.--(BUSINESS WIRE)--Nov. 11, 2011--
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. (Alimera) received a complete response letter (CRL) from
the
U.S. Food and Drug Administration (
FDA) in response to the New Drug
Application (NDA) for ILUVIEN® for the treatment of diabetic macular
edema (DME) associated with diabetic retinopathy.
The FDA stated in the CRL that it was unable to approve the ILUVIEN NDA
because the NDA 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 the
FAME® Study were significant and were not offset by the benefits
demonstrated by ILUVIEN in these clinical trials. The FDA stated that
Alimera will need to conduct two additional clinical trials to
demonstrate that the product is safe and effective for the proposed
indication. Alimera reported that it will be requesting a meeting with
the FDA to clarify next steps.
“We are obviously surprised and disappointed with the FDA’s decision,”
said Paul Ashton, PhD, president and chief executive officer of pSivida.
Alimera reported that for Europe, Alimera expects to submit its formal
response to the Preliminary Assessment Report to the Medicines and
Healthcare products Regulatory Agency (MHRA) later this month. Alimera
stated that based on this submission, the MHRA is expected to make a
recommendation on the approvability of ILUVIEN for DME to Alimera and
the Concerned Member States (Austria, France, Germany, Italy, Portugal
and Spain) by the end of this year, with a decision regarding the
approval of ILUVIEN for DME expected in the first half of 2012.
Conference Call to be Held Monday
pSivida Corp. will host a live webcast and conference call Monday,
November 14, 2011, at 9:00 am ET to discuss the CRL. Access information
will be announced later today.
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.
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: ability to
obtain additional capital if needed; future losses; impairment of
intangibles; fluctuations in the fair values of certain outstanding
warrants; fluctuations in operating results; decline of royalty income
from Bausch & Lomb; Alimera's ability to obtain regulatory approval of
ILUVIEN for DME; Alimera's ability to successfully commercialize ILUVIEN
for DME if approved; risk/benefit profile of ILUVIEN for DME; timeliness
of approval, if any, of ILUVIEN for DME and any limitations on uses
thereof; ability to complete clinical trials, reference data and obtain
regulatory approval of other product candidates; 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
publications; ability to protect intellectual property or 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 through exercise of
outstanding warrants and stock options or future stock issuances;
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.
Source: pSivida Corp.
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 8 9227 8327
brianl@psivida.com
