- Ophthotech to Potentially Receive Over $1 Billion, Inclusive of
$330 Million in an Upfront Fee ($200 Million) and Near-term Enrollment
Milestones ($130 Million), Not Including Future Royalties -
- Ophthotech Grants Ex-US Commercialization Rights to Fovista®
while Retaining Sole US Commercial Rights -
- Ophthotech to Host Conference Call Today at 5:00 p.m. Eastern Time -
NEW YORK--(BUSINESS WIRE)--
Ophthotech Corporation (Nasdaq:OPHT) announced today that the Company
has entered into an ex-US licensing and commercialization agreement with
Novartis Pharmaceuticals focused on the treatment of wet age-related
macular degeneration (AMD). Under the agreement, Ophthotech grants
Novartis exclusive rights to commercialize Ophthotech's lead product
candidate, Fovista®, in markets outside the United
States while Ophthotech retains 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. 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 therapies
for wet AMD.
Ophthotech will continue to lead the global Fovista® Phase
3 wet AMD pivotal clinical program which is expected to have initial,
topline data available in 2016. Ophthotech will continue its lead role
in the potential registration of Fovista® in the
United States, while Ophthotech and Novartis will collaborate to seek
regulatory approvals outside the United States.
This collaboration continues the Fovista® development
strategy to remain agnostic with respect to the choice of the anti-VEGF
agent administered in combination with Fovista®. Separate
injections of the anti-VEGF agent and Fovista® would
allow physicians to choose their preferred anti-VEGF agent for the
combination therapy. The collaboration also provides for the potential
development of a fixed combination delivery of a co-formulation of
Fovista® with a Novartis proprietary anti-VEGF product
which would result in additional flexibility for physicians. Novartis
will also seek to develop and commercialize alternative innovative
delivery technologies such as a Fovista® pre-filled syringe
as part of this collaboration.
"As one of the largest ex-US partnering deals ever in the biotechnology
industry, this collaboration with Novartis is potentially
transformational for Ophthotech," stated David R. Guyer, M.D., Chief
Executive Officer and Chairman of the Board of Ophthotech. "This
agreement represents an important achievement for the Company as we
continue to execute on a strategy to deliver science-driven retinal
products and offer physicians multiple treatment options to improve
patient outcome. The collaboration also supports our previously stated
plan to partner Fovista® outside the United States while we
retain sole commercialization rights to Fovista® in the
United States. The collaboration not only provides a substantial
strategic and financial benefit to Ophthotech, it also begins to put in
place essential elements designed to expand the reach of Fovista®
outside the United States, following potential regulatory approvals."
Under the financial terms of the agreement:
-
Ophthotech to potentially receive over $1 billion in upfront and
milestone payments during the course of the collaboration, not
including future royalties.
-
Ophthotech could receive immediate payment and near-term
milestones totaling up to $330 million, including an upfront fee
of $200 million and Fovista® Phase 3
enrollment-based milestones of up to $130 million.
-
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.
-
Ophthotech is entitled to receive royalties on ex-US Fovista®
sales.
WilmerHale acted as legal counsel for Ophthotech in connection with the
transaction.
Ophthotech Conference Call / Web Cast
Information
Ophthotech's management will host a conference call and audio web cast
to discuss this announcement. The call is scheduled for May 19, 2014, at
5:00 p.m., Eastern Time. To participate in this conference call, dial
1-888-427-9411 (USA) or 719-325-2354 (International), passcode 9388136
shortly before 5:00 p.m. Eastern Time. A replay of the call will be
available from approximately two hours following the live call for two
weeks. The replay number is 1-888-203-1112 (USA) or 719-457-0820
(International), passcode 9388136. The audio webcast can be accessed at www.ophthotech.com.
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. 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 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. Age-related macular degeneration 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 standard of care for the
treatment of wet AMD. Ophthotech's second product candidate ZimuraTM,
an inhibitor of complement factor C5, is being developed for the
treatment of dry and wet forms of 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 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 anticipated
receipt of payments under its licensing and commercialization agreement
with Novartis, the conduct of the Fovista Phase 3 clinical program,
including obtaining initial, top-line data from the Fovista Phase 3
clinical program and seeking marketing approval for Fovista, the
potential of Fovista as a wet AMD combination therapy and the
development of new drug-delivery technologies. 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, including Ophthotech's ability to satisfy certain patient
enrollment milestones, availability of data from clinical trials,
expectations for regulatory approvals or other actions, including the
receipt of regulatory approvals outside of the United States which would
trigger the receipt of certain milestone payments, Ophthotech's ability
to comply with its obligations under and otherwise maintain its
licensing and commercialization agreement with Novartis 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.
Investors
Ophthotech Corporation
Kathy Galante,
212-845-8231
Vice President, Investor Relations and Corporate
Communications
kathy.galante@ophthotech.com
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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