Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a
biotechnology company devoted to discovering and developing
innovative therapies designed to treat immune-mediated diseases,
today announced that it has entered into an exclusive option
agreement with AbbVie Inc. (AbbVie).
Under the terms of the option agreement, AbbVie has the option
to acquire a co-exclusive license to develop, manufacture, and
commercialize reproxalap in the U.S. and an exclusive license to
develop, manufacture, and commercialize reproxalap outside the U.S.
Aldeyra will receive a non-refundable option fee of $1 million and
an upfront payment of $100 million less option fees if AbbVie
chooses to exercise the option. Under the terms of the license
agreement, Aldeyra would be eligible to receive up to $300 million
in regulatory and commercial milestone payments, inclusive of a
$100 million milestone payment upon U.S. Food and Drug
Administration approval of reproxalap in dry eye disease; in the
United States, Aldeyra and AbbVie would share profits and losses
from the commercialization of reproxalap according to a split of
60% for AbbVie and 40% for Aldeyra; and for markets outside the
U.S., Aldeyra would be eligible to receive tiered royalties on net
sales of reproxalap.
Exercise of the option will also grant AbbVie the right of first
negotiation for compounds that are owned or otherwise controlled by
Aldeyra in the field of ophthalmology relating to treating
conditions of the ocular surface. The right of first negotiation is
in addition to a right to review data for any other compounds that
are owned or otherwise controlled by Aldeyra in the fields of
ophthalmology and immunology before such data is shared with any
other third party. Additional details regarding the terms of the
option agreement may be found in a Current Report on Form 8-K filed
by Aldeyra with the Securities and Exchange Commission.
Goodwin Proctor acted as legal advisor and Aquilo Partners, L.P.
acted as financial advisor to Aldeyra in this transaction.
About Aldeyra
Aldeyra Therapeutics is a biotechnology company devoted to
discovering innovative therapies designed to treat immune-mediated
diseases. Our approach is to develop pharmaceuticals that modulate
immunological systems, instead of directly inhibiting or activating
single protein targets, with the goal of optimizing multiple
pathways at once while minimizing toxicity. Our product candidates
include RASP (reactive aldehyde species) modulators ADX‑629,
ADX‑246, ADX‑248, and chemically related molecules for the
potential treatment of systemic and retinal immune-mediated
diseases. Our pre-commercial product candidates are reproxalap, a
RASP modulator for the potential treatment of dry eye disease
(under U.S. Food and Drug Administration New Drug Application
Review) and allergic conjunctivitis, and ADX-2191, a novel
formulation of intravitreal methotrexate for the potential
treatment of proliferative vitreoretinopathy and retinitis
pigmentosa.
Safe Harbor Statement
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, statements regarding the likelihood
and timing of the U.S. Food and Drug Administration’s potential
approval of the new drug application for reproxalap; the likelihood
and timing of the exercise of the option or extension of the option
exercise period; and Aldeyra’s ability to successfully
commercialize (alone or with others) reproxalap. Aldeyra intends
such forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. In some cases, you can identify
forward-looking statements by terms such as, but not limited to,
“may,” “might,” “will,” “objective,” “intend,” “should,” "could,"
“can,” “would,” “expect,” “believe,” “anticipate,” “project,” “on
track,” “scheduled,” “target,” “design,” “estimate,” “predict,”
“contemplates,” “likely,” “potential,” “continue,” “ongoing,”
“aim,” “plan,” or the negative of these terms, and similar
expressions intended to identify forward-looking statements. Such
forward-looking statements are based upon current expectations that
involve risks, changes in circumstances, assumptions, and
uncertainties. Aldeyra is at an early stage of development and may
not ever have any products that generate significant revenue. All
of Aldeyra's development timelines may be subject to adjustment
depending on recruitment rate, regulatory review, preclinical and
clinical results, funding, and other factors that could delay the
initiation, enrollment, or completion of clinical trials. Important
factors that could cause actual results to differ materially from
those reflected in Aldeyra's forward-looking statements include,
among others, the timing of enrollment, commencement and completion
of Aldeyra's clinical trials, the timing and success of preclinical
studies and clinical trials conducted by Aldeyra and its
development partners; delay in or failure to obtain regulatory
approval of reproxalap or Aldeyra's other product candidates,
including as a result of the FDA not accepting Aldeyra’s regulatory
filings, issuing a complete response letter, or requiring
additional clinical trials or data prior to review or approval of
such filings; the ability to maintain regulatory approval of
Aldeyra's product candidates, and the labeling for any approved
products; the risk that prior results, such as signals of safety,
activity, or durability of effect, observed from preclinical or
clinical trials, will not be replicated or will not continue in
ongoing or future studies or clinical trials involving Aldeyra's
product candidates in clinical trials focused on the same or
different indications; the scope, progress, expansion, and costs of
developing and commercializing Aldeyra's product candidates;
uncertainty as to Aldeyra’s ability to commercialize (alone or with
others) and obtain reimbursement for Aldeyra's product candidates
following regulatory approval, if any; the size and growth of the
potential markets and pricing for Aldeyra's product candidates and
the ability to serve those markets; Aldeyra's expectations
regarding Aldeyra's expenses and future revenue, the timing of
future revenue, the sufficiency or use of Aldeyra's cash resources
and needs for additional financing; the rate and degree of market
acceptance of any of Aldeyra's product candidates; Aldeyra's
expectations regarding competition; Aldeyra's anticipated growth
strategies; Aldeyra's ability to attract or retain key personnel;
Aldeyra’s commercialization, marketing and manufacturing
capabilities and strategy; Aldeyra's ability to establish and
maintain development partnerships; Aldeyra’s ability to
successfully integrate acquisitions into its business; Aldeyra's
expectations regarding federal, state, and foreign regulatory
requirements; political, economic, legal, social, and health risks,
public health measures, and war or other military actions, that may
affect Aldeyra’s business or the global economy; regulatory
developments in the United States and foreign countries; Aldeyra's
ability to obtain and maintain intellectual property protection for
its product candidates; the anticipated trends and challenges in
Aldeyra's business and the market in which it operates; and other
factors that are described in the “Risk Factors” and “Management's
Discussion and Analysis of Financial Condition and Results of
Operations” sections of Aldeyra's Annual Report on Form 10-K for
the year ended December 31, 2022, and Aldeyra’s Quarterly Report on
Form 10-Q for the quarter ended June 30, 2023, which are on file
with the Securities and Exchange Commission (SEC) and available on
the SEC's website at https://www.sec.gov/. Additional factors may
be described in those sections of Aldeyra's Quarterly Report on
Form 10-Q for the quarter ended September 30, 2023, expected to be
filed with the SEC in the fourth quarter of 2023, and Aldeyra’s
other filings with the SEC.
In addition to the risks described above and in Aldeyra's other
filings with the SEC, other unknown or unpredictable factors also
could affect Aldeyra's results. No forward-looking statements can
be guaranteed and actual results may differ materially from such
statements. The information in this release is provided only as of
the date of this release, and Aldeyra undertakes no obligation to
update any forward-looking statements contained in this release on
account of new information, future events, or otherwise, except as
required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20231101862243/en/
Investor & Media Contact: David Burke Tel: (917)
618-2651 investorrelations@aldeyra.com
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