BUSINESS WIRE
WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of
sustained release back of the eye drug delivery systems for
difficult-to-treat conditions, today announced that its licensee,
Alimera Sciences (NASDAQ:ALIM) has been notified that the U.S. Food and
Drug Administration (FDA) has granted Priority Review status for the New
Drug Application (NDA) filed for Iluvien for the treatment diabetic
macular edema (DME).
FDA Priority Review status is given to therapies that offer major
advances in treatment, or provide a treatment where no adequate therapy
exists. This status reduces the review time goal from 10 months to six
months.
Dr. Paul Ashton, President and CEO of pSivida said, “With priority
review a response from the FDA regarding Iluvien could be received in
the fourth quarter of this year. Approval of Iluvien would trigger a $25
million milestone payment to pSivida from Alimera. Under the license
agreement pSivida is also to receive 20 percent of net profits on sales
by Alimera.”
The news regarding priority review follows the submission last month of
the Marketing Authorization Application to the Medicines and Healthcare
products Regulatory Agency in the United Kingdom. Applications have also
been submitted to regulatory agencies in Austria, France, Germany,
Italy, Portugal and Spain. Filing in Canada is expected to take place in
September. pSivida has joint ownership and reference rights to these
regulatory filings.
pSivida continues to work to develop new products for the sustained
release of drugs and proteins based on its existing and new
technologies. Additionally, Pfizer and pSivida are collaborating to
develop ophthalmic products based on pSivida technology. While the
Company remains primarily focused in ophthalmology, pSivida is exploring
other therapeutic areas.
About pSivida Corp.
pSivida Corp. is a world leader in the development of tiny, sustained
release, drug delivery products and technologies that are administered
by implantation, insertion or injection. The Company uses these systems
to develop treatments for serious, unmet, medical needs. pSivida’s
intellectual property portfolio consists of over 50 patent families,
more than 100 granted patents, including patents accepted for issuance,
and more than 150 patent applications. pSivida conducts its operations
from Boston in the United States and Malvern in the United Kingdom.
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: maintaining
collaboration agreements with Alimera and Pfizer; modifications of
existing terms of collaboration agreements with Alimera and Pfizer;
achievement of milestones and other contingent contractual events;
ability to prove safety and efficacy of, and achieve regulatory
approvals for, and successfully commercialize Iluvien, BrachySil and
other products;; ability to raise capital; ability to achieve
profitability; ability to derive revenues from Retisert; ability to
develop new products; impairment of intangibles; fluctuations in the
fair values of certain outstanding warrants; fluctuations in operating
results; termination of license agreements; ability to obtain partners
to develop and market products; competition; extent of third-party
reimbursement for products; product liability; ability to protect
intellectual property or infringement of others’ intellectual property;
retention of key personnel; consolidation in the pharmaceutical and
biotechnology industries; compliance with laws; maintaining effective
internal control over financial reporting; manufacturing risks; risks
and costs of international business operations; 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; 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.