pSivida Out-licenses EMEA Rights for Durasert™ Three-year Treatment for Posterior Segment Uveitis While Retaining U.S. Comm...
July 10 2017 - 4:01PM
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development
of sustained release drug products and technologies, today
announced an amendment of its exclusive license and collaboration
agreement with Alimera Sciences, Inc. (NASDAQ:ALIM) that grants
Alimera rights to pSivida’s Durasert™ three-year treatment for
posterior segment uveitis (Durasert) in Europe, the Middle East and
Africa (EMEA). With this license, Alimera plans to pursue a
secondary indication for ILUVIEN for posterior segment uveitis in
EMEA, which could accelerate the uveitis indication approval as
well as commercialization. pSivida retains commercialization
rights for posterior segment uveitis in all other countries,
including the United States. The amended agreement also
modifies the companies’ existing global licensing agreement for
ILUVIEN for the treatment of diabetic macular edema (DME).
Key terms of the restructured global licensing
agreement for ILUVIEN include:
- pSivida grants Alimera the rights to Durasert in EMEA under the
ILUVIEN trademark in exchange for tiered sales-based royalty
payments.
- Converts the existing profit share arrangement for the global
ILUVIEN DME indication to the same tiered sales-based royalty
payments as the uveitis indication effective July 1, 2017, and
improves pSivida’s revenue generation from DME indication
sales.
- Sales-based royalty payments to pSivida start at 2% and
increases to 6% upon the earliest of (i) Alimera’s receipt of the
first EU country marketing approval for ILUVIEN for the treatment
of posterior segment uveitis; (ii) January 1, 2019 and (iii) one
year from Alimera’s filing of a marketing authorization application
in the EU for posterior segment uveitis. The sales-based royalty
payment will rise to 8% based on total ILUVIEN revenues in excess
of $75 million in any calendar year.
- Under the previous agreement, pSivida’s net profits were to be
partially offset by accumulated net ILUVIEN commercialization
losses. The balance of accumulated losses has now been capped
at $25 million, of which $10 million is cancelled in exchange for
granting Alimera license rights for posterior uveitis in EMEA. An
additional $5 million will be cancelled based on certain milestones
achieved by Alimera. The remaining $10 million of accumulated
ILUVIEN commercialization losses is subject to a partial offset
against sales-based royalty payments over time.
- pSivida will withdraw its EU marketing approval application
(MAA) and orphan drug designation for posterior segment uveitis and
Alimera will be responsible for filing a Type II variation for
ILUVIEN for the treatment of posterior segment uveitis in the 17
countries in the EU where ILUVIEN is currently approved for the
treatment of DME.
Benefits of the EMEA out-license and revised
ILUVIEN agreement for pSivida include:
- Standardizes and improves revenue generation from the ILUVIEN
global collaboration agreement and is expected to provide a more
predictable and steady flow of revenue for pSivida.
- Management of EMEA regulatory filings and manufacturing is
transferred to Alimera, thereby potentially accelerating the
uveitis indication approval and commercialization timing.
- Leverages Alimera’s established EMEA ILUVIEN field force with
retinal specialists.
- Reduces pSivida’s financial outlays for European regulatory and
manufacturing matters, allowing pSivida to focus resources on the
New Drug Application (NDA) with the US Food and Drug Administration
(FDA) and commercialization readiness efforts for Durasert for
posterior segment uveitis in the US.
“Today’s announcement fulfills a core pSivida
objective to out-license Durasert EMEA rights as a means to
optimize product value,” said Nancy Lurker, President and CEO of
pSivida. “We believe the EMEA out-license to Alimera, a
company that is familiar with the complexity of the EU
reimbursement environment and is currently marketing to target
specialty physicians, could accelerate commercialization uptake and
revenue realization for pSivida. The EMEA revenue opportunity
for Durasert is estimated to be $30 to $50 million, and in the US
it is estimated to be $80 to $120 million. We remain on track to
file an NDA with the FDA by the end of this year. In
parallel, the restructured global collaboration agreement benefits
our shareholders as we immediately begin to recognize royalty
income from sales of ILUVIEN as well as increase its long-term
revenue opportunity.”
Posterior segment uveitis is a chronic,
non-infectious inflammatory disease affecting the posterior segment
of the eye, often involving the retina, which is believed to be a
leading cause of blindness in the developed and developing
countries. It affects people of all ages, producing swelling and
destroying eye tissues, which can lead to severe vision loss and
blindness. In the U.S. and EU, posterior uveitis affects
approximately 200,000 people, annually. Today, patients with
posterior uveitis are typically treated with systemic steroids, but
over time frequently develop serious side effects that can limit
effective dosing. Patients then often progress to steroid-sparing
therapy with systemic immune suppressants or biologics, which
themselves can have severe side effects including an increased risk
of cancer.
About pSivida Corp.pSivida Corp.
(www.psivida.com), headquartered in Watertown, MA, is a leader in
the development of sustained-release drug products for treating eye
diseases. pSivida has developed three of only four FDA-approved
sustained-release treatments for back-of-the-eye diseases. The most
recent, ILUVIEN®, a micro-insert for diabetic macular edema,
licensed to Alimera Sciences, Inc. is currently sold directly in
the U.S. and three EU countries. Retisert®, an implant for
posterior uveitis, is licensed to and sold by Bausch & Lomb
Inc. pSivida's lead product candidate, Durasert™ micro-insert for
posterior segment uveitis is being independently developed. Two
pivotal Phase 3 clinical trials achieved their primary efficacy
endpoint at six months of follow-up with statistical
significance. pSivida's pre-clinical development program is focused
on using its core platform technology, Durasert, to deliver drugs
to treat wet age-related macular degeneration, glaucoma,
osteoarthritis and other diseases. To learn more about pSivida
please visit www.psivida.com and connect
on Twitter, LinkedIn, Facebook and Google+.
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. 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 include uncertainties with respect to:
our ability to achieve profitable operations and access to needed
capital; fluctuations in our operating results; further impairment
of our intangible assets; successful commercialization of, and
receipt of revenues from, ILUVIEN® for diabetic macular edema
(“ILUVIEN”), which depends on Alimera’s ability to continue as a
going concern and the effect of pricing and reimbursement decisions
on sales of ILUVIEN; the number of clinical trials and data
required for the Durasert three-year uveitis marketing approval
applications in the U.S. and EU; our ability to file and the timing
of filing and acceptance of the Durasert three-year uveitis
marketing approval applications in the U.S.; our ability to use
data in a U.S. NDA from clinical trials outside the U.S.; ours and
Alimera’s ability to successfully commercialize Durasert three-year
uveitis, if approved; consequences of fluocinolone acetonide side
effects; potential declines in Retisert® royalties; efficacy and
our future development of an implant to treat severe
osteoarthritis; our ability to successfully develop product
candidates, initiate and complete clinical trials and receive
regulatory approvals; our ability to market and sell products; the
success of current and future license agreements, including our
agreements with Alimera; termination or breach of current license
agreements, including our agreements with Alimera; our dependence
on contract research organizations, vendors and investigators;
effects of competition and other developments affecting sales of
products; market acceptance of products; effects of guidelines,
recommendations and studies; protection of intellectual property
and avoiding intellectual property infringement; retention of key
personnel; product liability; industry consolidation; compliance
with environmental laws; manufacturing risks; risks and costs of
international business operations; effects of the potential U.K.
exit from the EU; legislative or regulatory changes; volatility of
stock price; possible dilution; absence of dividends; and other
factors described in our filings with the Securities and Exchange
Commission. You should read and interpret any forward-looking
statements in light of these risks. Should known or unknown risks
materialize, or should underlying assumptions prove inaccurate,
actual results could differ materially from past results and those
anticipated, estimated or projected in the forward-looking
statements. You should bear this in mind as you consider any
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.
Contact:
EVC Group
Michael Polyviou/Doug Sherk – Investors
mpolyviou@evcgroup.com; dsherk@evcgroup.com
212.850.6020; 646-445-4800
Thomas Gibson – Media
tom@tomgibsoncommunications.com
201-476-0322
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