- Milestone Triggered by Reaching Second Enrollment Goal in the
Fovista® Phase 3 Program -
NEW YORK--(BUSINESS WIRE)--
Ophthotech Corporation (Nasdaq:OPHT) today announced that it has
achieved a second $50 million enrollment milestone from Novartis Pharma
AG as part of the ex-US licensing and commercialization agreement
between the two companies focused on the treatment of wet age-related
macular degeneration (AMD). This second enrollment milestone from
Novartis was triggered as a result of Ophthotech reaching the second
enrollment goal under the agreement in its pivotal, multi-national
Fovista® Phase 3 clinical program. To date, Ophthotech
has attained $300 million in upfront fees and milestone payments. These
amounts consist of a $200 million upfront fee upon the execution of the
agreement in May of last year and $100 million of $130 million in
potential enrollment-based milestones under the agreement. Fovista®,
Ophthotech's anti-platelet-derived growth factor (PDGF) compound, is
being studied in combination with anti-vascular endothelial growth
factor (VEGF) therapy for the treatment of wet AMD.
The $50 million milestone will result in $40.6 million of revenue to be
recorded in the quarter ending March 31, 2015. The remaining $9.4
million will be deferred and recognized as revenue on a proportional
basis through 2017.
Under the agreement signed in May 2014, Ophthotech granted Novartis
exclusive rights to commercialize Fovista® in markets
outside the United States, with Ophthotech retaining sole rights to
commercialize Fovista® in the United States. Potential
payments to Ophthotech under the agreement could total over $1 billion
in upfront and milestone payments, not including future royalties on
ex-US Fovista® sales. In addition to the upfront fee
and enrollment-based milestone payments, Ophthotech is eligible to
receive contingent future ex-US marketing approval milestones totaling
up to $300 million and ex-US sales milestones up to $400 million. In
addition, Ophthotech is entitled to receive royalties on ex-US Fovista®
sales. Fovista® is the most advanced anti-PDGF agent
in development for the treatment of wet AMD and, if approved, Ophthotech
expects it to be first to market in this class of therapies for wet AMD.
About the Fovista® Phase 3 Program
The Fovista® Phase 3 program consists of three clinical
trials to evaluate the safety and efficacy of Fovista®
(anti-PDGF) therapy, which Ophthotech is developing for use in
combination with anti-VEGF therapy for the treatment of wet age-related
macular degeneration. The Company expects to enroll a total of 1,866
patients in the three trials in more than 225 centers worldwide.
Ophthotech expects to have initial, top-line data from the Fovista®
Phase 3 clinical program available in 2016.
About AMD
Age-related macular degeneration is a disease characterized by
progressive degenerative abnormalities in the macula of the eye, a small
area in the central portion of the retina. Age-related macular
degeneration (AMD) is classified into one of two general subgroups: the
"dry" (non-neovascular) form of the disease; and the "wet" (exudative or
neovascular) form of the disease. The "dry" form of AMD is characterized
by a slow degeneration of the macula resulting in atrophy of the central
retina, with gradual vision loss over a period of years. By contrast,
"wet" AMD typically causes sudden, often substantial, loss of central
vision and is responsible for most cases of severe loss of visual acuity
in this disease. AMD is characteristically a disease of individuals aged
50 years or older, and is the leading cause of blindness in developed
countries around the world.
About Ophthotech Corporation
Ophthotech is a biopharmaceutical company specializing in the
development of novel therapeutics to treat back of the eye diseases,
with a focus on developing innovative therapies for age-related macular
degeneration (AMD). Ophthotech's most advanced product candidate, Fovista®
anti-PDGF therapy, is in Phase 3 clinical trials for use in combination
with anti-VEGF therapy that represents the current standard of care for
the treatment of wet AMD. Ophthotech's second product candidate,
Zimura™, an inhibitor of complement factor C5, is being developed for
the treatment of geographic atrophy (a form of dry AMD) and, in
combination with anti-VEGF therapy and, potentially Fovista®,
for the treatment of wet AMD. For more information, please visit www.ophthotech.com.
Forward-looking Statements
Any statements in this press release about Ophthotech's future
expectations, plans and prospects constitute forward-looking statements
for purposes of the safe harbor provisions under the Private Securities
Litigation Reform Act of 1995. Actual results may differ materially from
those indicated by such forward-looking statements as a result of
various important factors. Any forward-looking statements represent
Ophthotech's views only as of the date of this press release. Ophthotech
anticipates that subsequent events and developments will cause its views
to change. While Ophthotech may elect to update these forward-looking
statements at some point in the future, Ophthotech specifically
disclaims any obligation to do so.
OPHT-G
Investors
Ophthotech Corporation
Kathy Galante,
212-845-8231
Vice President, Investor Relations and Corporate
Communications
kathy.galante@ophthotech.com
or
Media
SmithSolve
LLC on behalf of Ophthotech Corporation
Jarrod Aldom, 973-442-1555
ext. 112
jarrod.aldom@smithsolve.com
Source: Ophthotech Corporation
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