dsmb supports continuation of the phase iii

ASX / Media Release September 26, 2008
DSMB Supports continuation of the Phase III clinical
trial of IluvienTM for the treatment of DME
Boston, MA (September 26, 2008) – Global drug delivery company, pSivida Corp. (NASDAQ:
PSDV, ASX: PVA, FF: PV3) today announced that after completing its review of safety and
efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has
once again recommended that the two pivotal Phase III clinical trials, known collectively as
the FAME™ (Fluocinolone Acetonide in Diabetic Macular Edema) Study continue under the
current protocol, without change. The trial is studying the use of MedidurTM FA for the
treatment of diabetic macular edema (DME) being conducted by our licensing partner,
Alimera Sciences. MedidurTM FA will be marketed under the name IluvienTM.
FAME are two, duplicate, double-masked, randomized, multi-center studies following 956
patients in the U.S., Canada, Europe and India for 36 months in support of a planned global
registration filing, with safety and efficacy assessed after two years of follow-up. Enrolment
for the FAME study was completed in October 2007. All patients have now been followed for
at least approximately one year and many have been followed for two or more years.
“pSivida is very pleased that the DSMB has once again supported the continuation of this
pivotal trial and remain on track to file an NDA for this product in early 2010,” said pSivida
Managing Director, Dr. Paul Ashton. “Following the recent amendment to the licensing
agreement with our development partner, we continue to have a significant financial interest
in IluvienTM and other products developed under this agreement without an obligation to fund
the development of the products.”
In March, pSivida announced that it had amended its licensing agreement with development
partner, Alimera Sciences to reduce its share in the future profits of Medidur FA from 50% to
20% in return for consideration of up to approximately US$78m from Alimera.
Medidur, a tiny, injectable insert, is being studied as a way to deliver fluocinolone acetonide,
a corticosteroid, to the retina for up to three years as a treatment for diabetic macular edema
(DME). Using a proprietary 25 gauge injector system, an eye care professional injects the
Medidur insert into the vitreous through a minimally invasive procedure in an outpatient
setting.
Currently, nearly 8 percent of the US population has diabetes. Over time, almost all diabetics
will develop some form of diabetic retinopathy, of which diabetic macular edema is the
primary cause of vision loss. Based on published data, pSivida estimates that in the United
States as many as 300,000 people are diagnosed with DME each year and an estimated
1,000,000 people suffer from DME. Currently, there are no FDA approved drug treatments
for DME.
A DSMB provides an independent evaluation of all trial data to identify potential safety issues
that might warrant modification or early termination of ongoing studies. The FAME DSMB, a
group comprised of four ophthalmologists and a biostatistician, met to review the Medidur FA
Phase III clinical trial data. The DSMB’s charter stipulates that a formal review occur every
six months in addition to their ongoing review of the trial.
-2-
Released by:
pSivida Corp.
Brian Leedman
Vice President, Investor Relations
pSivida Corp.
Tel: +61 8 9227 8327
[email protected]
US Public Relations
Beverly Jedynak
President
Martin E. Janis & Company, Inc
Tel: +1 (312) 943 1100 ext. 12
[email protected]
About pSivida Corp.
pSivida is a leading drug delivery company committed to the biomedical sector and the development of drug
delivery products. Retisert® is FDA approved for the treatment of uveitis. Vitrasert® is FDA approved for the
treatment of AIDS-related CMV Retinitis. Bausch & Lomb owns the trademarks Vitrasert® and Retisert®.
pSivida has licensed the technologies underlying both of these products to Bausch & Lomb. The technology
underlying Medidur™ FA for diabetic macular edema is licensed to Alimera Sciences under an agreement
with total consideration of up to US$78m plus a 20% share of future profits and is in fully recruited Phase III
clinical trials. If approved, it is anticipated that MedidurTM FA will be marketed under the name IluvienTM.
pSivida has a worldwide collaborative research and license agreement with previous and future payments
of up US$165m with Pfizer Inc. for certain other ophthalmic applications of the Medidur™ technology.
pSivida owns the rights to develop and commercialize a nano-porousform of elemental silicon, known as
BioSilicon™, which has potential applications in drug delivery, wound healing, orthopedics, and tissue
engineering. The most advanced BioSilicon™ product, BrachySil™, delivers a therapeutic, P32, directly to
solid tumors and is presently in dose ranging clinical trials as a device for the treatment of pancreatic
cancer.
pSivida’s intellectual property portfolio consists of 64 patent families, 122 granted patents, including patents
accepted for issuance and 282 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 involve a number of risks and uncertainties. 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 forward-looking statements: achievement of milestones and other contingent contractual
payment events; failure to prove efficacy for Medidur FA or BrachySil; inability to raise capital; continued losses
and lack of profitability; inability to develop or obtain regulatory approval for new products; inability to protect
intellectual property or infringement of others’ intellectual property; inability to obtain partners to develop and
market products; termination of license agreements; competition; inability to pay any registration penalties; costs
of international business operations; manufacturing problems; insufficient third-party reimbursement for products;
failure to retain key personnel; product liability; inability to manage change; failure to comply with laws; failure to
achieve and maintain effective internal control over financial reporting; amortization or impairment of intangibles;
possible dilution through exercise of outstanding warrants and stock options or future stock issuances; potential
restrictions from capital raises; possible influence by Pfizer; and other factors that may be 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. We do not undertake to publicly update or revise our forwardlooking
statements even if experience or future changes make it clear that any projected results expressed or
implied in such statements will not be realized.