Ophthotech Completes Patient Recruitment in Phase 3 Trial of Fovista® Anti-PDGF Therapy in Combination with Eylea® or Avastin® in Wet Age-Related Macular Degeneration
– $30 Million Milestone Triggered by Reaching Final Enrollment Goal
in the Third Phase 3 Trial in the Fovista®
Program –
NEW YORK–(BUSINESS WIRE)–Ophthotech Corporation (Nasdaq: OPHT) today announced the completion of
patient recruitment in its Phase 3 trial of Fovista®
(pegpleranib), anti-PDGF therapy, in combination with Eylea®
(aflibercept) or Avastin® (bevacizumab) for the treatment of
wet age-related macular degeneration (AMD). Ophthotech also announced
that it has achieved a $30 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 AMD.
The Fovista® Phase 3 program consists of three clinical
trials to evaluate the safety and efficacy of Fovista® in
combination with multiple anti-VEGF agents for the treatment of wet AMD.
The Company completed enrollment in its two other Phase 3 trials of
Fovista® in combination with Lucentis®
(ranibizumab) last year, and expects to announce initial, topline data
from these two studies in the fourth quarter of this year.
“We are thankful for the steadfast commitment of the participating
clinical investigators and their staff for their diligent effort to
complete the enrollment of our Phase 3 trials. We are excited by the
potential of Fovista to be paired with all anti-VEGF agents to address
the growing unmet need for wet AMD patients,” said Samir C. Patel, M.D.,
President and Vice Chairman of the Board of Ophthotech.
The FDA granted Fast Track status for Fovista® for the
treatment of wet AMD in September 2013. The Company believes Fovista®
is the most advanced anti-PDGF agent in development for the treatment of
wet AMD and, if approved, is expected to be first to market in this
class of novel therapies for wet AMD.
The third and final recruitment milestone from the Company’s ex-US
partner for Fovista®, Novartis Pharma AG, was triggered as a
result of Ophthotech reaching this patient enrollment goal. To date,
Ophthotech has attained $330 million in upfront fees and milestone
payments from Novartis. These amounts consist of a $200 million upfront
fee upon the execution of the agreement in May 2014 and $130 million in
enrollment-based milestones under the agreement. Additionally,
Ophthotech is eligible to receive up to an aggregate of $300 million
upon achievement of specified regulatory milestones, including marketing
approval and reimbursement approval in certain ex-US territories, and
ex-US sales milestones of up to $400 million. In addition, Ophthotech is
entitled to receive royalties on ex-US Fovista® sales.
The $30 million milestone will result in approximately $27.0 million of
revenue to be recorded in the quarter ending June 30, 2016. The
remaining $3.0 million will be deferred and recognized as revenue on a
proportional basis through 2018.
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 in wet AMD patients. 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 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 the timing and
progress of the Fovista® Phase 3 clinical
program and the future recognition of milestone revenue. 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
expressed 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
Contacts
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
Jennifer Devine,
973-442-1555 ext. 102
jennifer.devine@smithsolve.com
