Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in the
commercialization and development of prescription ophthalmic
pharmaceuticals, today announced that it secured the rights to
pursue posterior uveitis, a secondary indication for ILUVIEN, in
the European Union (EU), the Middle East and Africa.
Alimera secured the rights by signing a Second Amended and
Restated Collaboration Agreement (the New Collaboration Agreement)
with pSivida, US, Inc. (pSivida), a subsidiary of pSivida
Corporation (NASDAQ:PSDV). The New Collaboration Agreement amends
and restates the previous agreement entered into between the
parties. Under the previous agreement, Alimera held the worldwide
license from pSivida to sell ILUVIEN for the treatment of all
ocular diseases other than uveitis. The New Collaboration Agreement
allows Alimera to pursue the indication for posterior uveitis for
ILUVIEN in the EU, the Middle East and Africa. ILUVIEN is currently
approved in the U.S. and 17 EU countries and is currently marketed
for diabetic macular edema (DME) in the U.S., the United Kingdom,
Germany, Portugal, Spain, Italy, Austria, Ireland and several
countries in the Middle East.
Under the terms of the New Collaboration Agreement, pSivida will
withdraw its centralized application in the EU for posterior
uveitis, and Alimera will be responsible for filing an application
for a new indication for ILUVIEN for the treatment of posterior
uveitis in the 17 countries in the EU where ILUVIEN is currently
approved for the treatment of DME.
“We are excited to be able to move forward with securing rights
to a possible second indication for ILUVIEN in the EU, Middle East
and Africa,” said Dan Myers, CEO of Alimera. “pSivida has met its
primary end point at 6 months in two Phase 3 clinical trials for
posterior uveitis, which we anticipate will support the approval of
ILUVIEN for the treatment of posterior uveitis in these regions.
Retina specialists in Europe and the Middle East regularly ask us
about the availability of ILUVIEN for this debilitating disease, so
we believe an expanded label will result in greater physician
uptake in the future.”
The New Collaboration Agreement converts Alimera’s current
obligation to share 20% of its net profits from ILUVIEN on a
country-by-country basis with pSivida to a royalty payable by
Alimera to pSivida on global net revenues. Alimera will begin
paying a 2% royalty on net revenues and other related consideration
to pSivida beginning in the third quarter of 2017. This royalty
amount will increase to 6% upon the earliest of January 1, 2019,
the receipt by Alimera of the first marketing approval for ILUVIEN
for the treatment of posterior uveitis, or one year from Alimera’s
filing of a marketing authorization application in the EU for
posterior uveitis. Alimera will pay an additional 2% royalty on
global net revenues and other related consideration in excess of
$75 million in any year.
The New Collaboration Agreement does not require an upfront cash
payment by Alimera. In connection with the New Collaboration
Agreement, Alimera has agreed to forgive approximately $10 million
of pSivida’s share of previous losses associated with the
commercialization of ILUVIEN, which were to be utilized to offset
profit sharing payments under the previous agreement. Following the
signing of the New Collaboration Agreement, Alimera retains the
right to recover an additional $15 million of pSivida’s share of
the previous losses as a partial offset to future royalty payments
following approval.
Alimera will forgive an additional $5 million of pSivida’s
outstanding share of previous losses upon the approval of ILUVIEN
for posterior uveitis in any EU country or January 1, 2020,
whichever occurs first, unless certain conditions under the New
Collaboration Agreement are not met. If the amounts
recoverable by Alimera are less than $5 million at that time,
Alimera will pay pSivida the difference in cash.
About ILUVIEN
www.ILUVIEN.com.
ILUVIEN’S EU Indication
ILUVIEN is indicated for the treatment of vision impairment
associated with chronic diabetic macular oedema, considered
insufficiently responsive to available therapies.
About Diabetic Macular Edema (DME)
DME, the primary cause of vision loss associated with diabetic
retinopathy, is a disease affecting the macula, the part of the
retina responsible for central vision. When the blood vessel
leakage associated with diabetic retinopathy results in swelling of
the macula, the condition is called DME. The onset of DME is
painless and may go unreported by the patient until it manifests
with the blurring of central vision or acute vision loss. The
severity of this blurring may range from mild to profound loss of
vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy
found that over a 10-year period approximately 19% of people with
diabetes included in the study were diagnosed with DME. All people
with type 1 or type 2 diabetes are at risk of developing DME. As
the population of people with diabetes increases, Alimera expects
the annual incidence of diagnosed DME to increase, as well.
In the United Kingdom and parts of Europe, diabetic macular
edema is instead referred to as diabetic macular oedema or DMO.
About Posterior Segment Uveitis
Posterior segment uveitis is a chronic, non-infectious
inflammatory disease affecting the posterior segment of the eye,
often involving the retina, which is 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. alone,
posterior uveitis affects between 80,000 - 100,000 people.
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 Alimera Sciences, Inc.
www.alimerasciences.com
Alimera, founded in June 2003, is a pharmaceutical company
that specializes in the commercialization and development of
prescription ophthalmic pharmaceuticals. Alimera is presently
focused on diseases affecting the back of the eye, or retina,
because these diseases are not well treated with current therapies
and will affect millions of people in our aging populations.
Alimera’s commitment to retina specialists and their patients is
manifest in Alimera’s product and development portfolio designed to
treat early- and late-stage diseases. For more information, please
visit www.alimerasciences.com.
Forward Looking Statements
This press release contains “forward-looking statements,” within
the meaning of the Private Securities Litigation Reform Act of
1995, regarding, among other things, Alimera’s filing for and
obtaining regulatory approval of ILUVIEN in the EU, Middle East and
Africa for the treatment of posterior uveitis. Such forward-looking
statements are based on current expectations and involve inherent
risks and uncertainties, including factors that could delay, divert
or change any of them, and could cause actual results to differ
materially from those projected in its forward-looking statements.
Meaningful factors which could cause actual results to differ
include, but are not limited to, Alimera’s ability to obtain
marketing authorization for ILUVIEN for the treatment of posterior
uveitis in the EU, Middle East and Africa and Alimera’s ability to
generate revenue from the sale, following the receipt of marketing
authorization, of ILUVIEN for the treatment of posterior uveitis in
these regions, as well as other factors discussed in the “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” sections of Alimera’s Annual
Report on Form 10-K for the year ended December 31, 2016 and
Quarterly Report on Form 10-Q for the quarter ended March 31,
2017, which are on file with the Securities and Exchange
Commission (SEC) and available on the SEC’s website
at www.sec.gov. Additional factors may be set forth in those
sections of Alimera's Quarterly Report on Form 10-Q for the quarter
ended June 30, 2017, to be filed in the third quarter of 2017 with
the SEC. In addition to the risks described above and in Alimera’s
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current
Reports on Form 8-K and other filings with the SEC, other
unknown or unpredictable factors also could affect Alimera’s
results. There can be no assurance that the actual results or
developments anticipated by Alimera will be realized or, even if
substantially realized, that they will have the expected
consequences to, or effects on, Alimera. Therefore, no assurance
can be given that the outcomes stated in such forward-looking
statements and estimates will be achieved.
All forward-looking statements contained in this press release
are expressly qualified by the cautionary statements contained or
referred to herein. Alimera cautions investors not to rely too
heavily on the forward-looking statements Alimera makes or that are
made on its behalf. These forward-looking statements speak only as
of the date of this press release (unless another date is
indicated). Alimera undertakes no obligation, and specifically
declines any obligation, to publicly update or revise any such
forward-looking statements, whether as a result of new information,
future events or otherwise.
For press inquiries:
Katie Brazel
for Alimera Sciences
404-317-8361
kbrazel@bellsouth.net
For investor inquiries:
CG Capital
for Alimera Sciences
877-889-1972
investorrelations@cg.capital
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