BUSINESS WIRE
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 its partner Alimera Sciences disclosed an
agreement for a $40 million equity financing. Alimera identified the
development and commercialization of ILUVIEN® as an intended use of the
net proceeds from the offering.
“We are very pleased that Alimera has announced its intention to proceed
with the direct commercialization of ILUVIEN in the United Kingdom,
France and Germany, to the extent that ILUVIEN has received French and
German approval, in 2013 and has arranged financing to provide the
necessary capital to launch ILUVIEN in Europe,” said Dr. Paul Ashton,
pSivida’s President and Chief Executive Officer. Under pSivida’s license
agreement with Alimera, pSivida is entitled to 20 percent of net
profits, as defined, on sales by Alimera and, in the event Alimera
sublicenses commercialization in certain countries, pSivida will be
entitled to receive 20 percent of royalties and 33 percent of
non-royalty consideration received by Alimera, less certain permitted
deductions.
Alimera reported that the closing of its proposed financing is subject
to customary closing conditions, including the approval of the holders
of a majority of the outstanding shares of common stock of Alimera, as
required under the applicable regulations of The NASDAQ Global Market,
at a special meeting of its stockholders. Stockholders holding
approximately 56% of Alimera’s common stock, as of July 17, 2012, have
entered into agreements with Alimera whereby they have agreed to vote
all of their shares in favor of the financing transaction.
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™.
ILUVIEN® for the treatment of Diabetic Macular Edema (DME), which is
licensed to Alimera Sciences, Inc., is pSivida’s most advanced product
candidate. It has received marketing authorization for chronic DME
considered insufficiently responsive to available therapies in the UK,
Austria and Portugal following a positive review by Austria, France,
German, Italy, Portugal, Spain and the UK under the Decentralized
Procedure. Marketing authorization in the remaining countries is
anticipated in the coming months. An investigator-sponsored clinical
trial is ongoing for an injectable, bioerodible 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. These include
statements regarding Alimera completing its proposed financing, the
allocation of net proceeds by Alimera to the development and
commercialization of ILUVIEN, and the potential for and timing of French
and German market authorization of ILUVIEN. 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: conditions to the Alimera
capital raise may not be satisfied, if the Alimera’s proposed offering
closes, Alimera may fail to deploy substantial net proceeds to the
commercialization of ILUVIEN; the timing and conditions for additional
regulatory approvals are subject to decisions by regulators; necessity
to raise additional capital to finance Phase III uveitis trials as well
as other working capital needs; ability to obtain additional capital;
ability to initiate and complete clinical trials and obtain regulatory
approval of product candidates; adverse side effects; Alimera’s ability
to successfully obtain regulatory approval of and commercialize ILUVIEN
for DME in the EU; actions with respect to regulatory approval of
ILUVIEN for DME in the U.S.; ability to attain profitability; exercise
by Pfizer of the Latanoprost Product option; further impairment of
intangible assets; fluctuations in operating results; decline in royalty
revenues; 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 guidelines, recommendations or studies; ability to
protect intellectual property and avoid 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; 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.