- Initial Milestone Payment Triggered by Reaching First Enrollment
Goal in the Fovista® Phase 3 Program -
NEW YORK--(BUSINESS WIRE)--
Ophthotech Corporation (Nasdaq:OPHT) today announced that it has
achieved a $50 million enrollment milestone payment 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 enrollment milestone payment from
Novartis was triggered as a result of Ophthotech reaching the first
enrollment goal under the agreement in its pivotal, multi-national
Fovista® Phase 3 clinical program and is the first of
a total 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.
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. Ophthotech received an upfront
payment of $200 million upon execution of the agreement and Fovista®
Phase 3 enrollment-based milestones could total $130 million of which
$50 million has now been achieved by the Company. 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.
In connection with the receipt of this $50.0 million milestone payment,
the Company expects to recognize approximately $40.1 million as revenue
during the three months ended September 30, 2014. The remaining $9.9
million is expected to be deferred and recognized as revenue on a
proportional performance basis through 2017.
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 drugs for the treatment of wet age-related
macular degeneration (AMD). The Company expects to enroll up to 1,866
patients in the three trials in more than 225 centers worldwide and to
have initial, topline data from the Fovista® Phase 3
clinical program available in 2016.
About Wet 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 diseases of the eye, 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 drugs that represent 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 Fovista®
and anti-VEGF therapy for 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. Forward-looking statements include any
statements about Ophthotech's strategy, future operations and future
expectations and plans and prospects for Ophthotech and its product
candidates, and any other statements containing the words "anticipate,"
"believe," "estimate," "expect," "intend", "goal," "may", "might,"
"plan," "predict," "project," "target," "potential," "will," "would,"
"could," "should," "continue," and similar expressions. In this press
release, Ophthotech's forward looking statements include statements
about potential receipt of milestone payments and royalties under its
ex-US licensing and commercialization agreement, the conduct of the
Fovista Phase 3 clinical program, including obtaining initial, top-line
data from the Fovista Phase 3 clinical program and seeking and obtaining
marketing approval for Fovista, the potential of Fovista to be
the first anti-PDGF agent in its class, the potential of Fovista as a
wet AMD combination therapy, the initiation of additional clinical
trials for Fovista and Zimura and obtaining data from these additional
planned trials. Such forward-looking statements involve substantial
risks and uncertainties that could cause Ophthotech's clinical
development programs, future results, performance or achievements to
differ significantly from those express or implied by the
forward-looking statements. Such risks and uncertainties include, among
others, those related to the initiation and conduct of clinical trials,
availability of data from clinical trials and expectations for
regulatory approvals or other actions and other factors discussed in the
"Risk Factors" section contained in the quarterly and annual reports
that Ophthotech files with the SEC. 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 except as required by law.
OPHT-G
Ophthotech
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
News Provided by Acquire Media