Arena Pharmaceuticals Announces Closing of Global License Agreement with United Therapeutics for Ralinepag
SAN DIEGO, Jan. 24, 2019 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (ARNA) today announced the closing of the global license agreement with United Therapeutics Corporation (UTHR) for the Arena-discovered, Phase 3 investigational drug candidate ralinepag, a next-generation, oral, selective and potent prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension (PAH). The global license agreement for ralinepag was announced on November 15, 2018.
Upon closing on January 24, 2019, United Therapeutics paid a non-refundable upfront cash payment of $800 million to Arena. In addition, Arena is eligible to receive potential milestone payments totaling up to $400 million based on the achievement of certain regulatory events and low double-digit tiered royalties on annual net sales of ralinepag.
About Ralinepag
Ralinepag (APD811)
is a next-generation, oral, selective potent, once-daily IP
receptor agonist intended for the treatment of pulmonary arterial
hypertension (PAH). Arena discovered and developed this drug
candidate internally. Ralinepag's potency on vasodilation,
inhibition of proliferation of vascular smooth muscle cells, and
inhibition of platelet aggregation, combined with an extended
half-life, support its application as a potentially best-in-class
agent for the treatment of PAH.
Ralinepag is an investigational compound that is not approved for any use in any country.
About Arena
Pharmaceuticals
Arena Pharmaceuticals is driven to
deliver novel, transformational medicines with optimized
pharmacology and pharmacokinetics to patients globally. Arena's
proprietary pipeline includes multiple potentially first- or
best-in-class assets with broad clinical utility. Etrasimod (APD334), with potential
utility in a broad range of immune and inflammatory conditions, is
being evaluated in later-stage clinical programs in ulcerative
colitis (UC) and Crohn's disease, as well as in programs for other
indications such as atopic dermatitis. Arena is also evaluating
olorinab (APD371) in a Phase 2 program
for gastrointestinal pain. Arena continues to assess other earlier
research and development stage drug candidates, including
APD418 for decompensated heart failure.
Arena's partner, United Therapeutics, is evaluating ralinepag
(APD811) in a Phase 3 program for pulmonary arterial hypertension
(PAH).
Arena has additional partnerships, including with Everest Medicines Limited (etrasimod in Greater China and select Asian countries), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain
statements in this press release are forward-looking statements
that involve a number of risks and uncertainties. These
forward-looking statements may be identified by introductory words
such as "eligible," "potential," "intended for," "potentially,"
"driven to," "being evaluated for," "evaluating," "focuses on,"
"are focused on," "estimate," "anticipate," "project," "forecast,"
"intend," or words of similar meaning, or by the fact that they do
not relate strictly to historical or current facts. Such
forward-looking statements include, without limitation, statements
about the license agreement between Arena and United Therapeutics,
including potential milestone and royalty payments to Arena
thereunder; the potential development, FDA approval and
commercialization of ralinepag; the potential of ralinepag,
including to be a next-generation or best-in-class agent; Arena's
drive; and the potential of Arena's assets, programs and
collaborations. For such statements, Arena claims the protection of
the Private Securities Litigation Reform Act of 1995. Actual events
or results may differ materially from Arena's expectations. Factors
that could cause actual results to differ materially from the
forward-looking statements include, without limitation, the
following: under the license agreement, United Therapeutics is not
obligated to Arena to use any particular efforts to develop or
commercialize ralinepag; results of clinical trials and other
studies are subject to different interpretations and may not be
predictive of future results; nonclinical and clinical data are
voluminous and detailed, and regulatory agencies may interpret or
weigh the importance of data differently and reach different
conclusions than Arena or others, request additional information,
have additional recommendations or change their guidance or
requirements before or after approval; the timing and outcome of
research, development and regulatory review is uncertain; the
ability to obtain debt or other additional financing on favorable
terms; Arena's expectations regarding the need to raise additional
funds to advance all of its programs; you and others may not agree
with the manner Arena allocates its resources; drug candidates may
not advance in development or be approved for marketing; clinical
trials and other studies may not proceed at the time or in the
manner expected or at all; enrolling patients in ongoing and
intended clinical trials is competitive and challenging; unexpected
or unfavorable new data; risks related to developing and
commercializing drugs, including regulatory, manufacturing and
supply issues and the availability and use of ralinepag; risks and
uncertainties relating to cash and revenues that may be generated
from product sales or other sources, including the impact of
competition; risks related to relying on partner performance; risks
related to government and other third party actions, including
decisions and other actions relating to approval, reimbursement and
pricing; our and third parties' intellectual property rights; and
satisfactory resolution of litigation or other disagreements with
others. Additional factors that could cause actual results to
differ materially from those stated or implied by forward-looking
statements are disclosed in Arena's filings with the Securities and
Exchange Commission (SEC), including but not limited to its most
recent Annual Report on Form 10-K and Quarterly Report on Form
10-Q. These forward-looking statements represent Arena's judgment
as of the time of this release. Arena disclaims any intent or
obligation to update these forward-looking statements, other than
as may be required under applicable law.
Corporate Contact:
Kevin R.
Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
[email protected]
858.210.3636
Media Contact:
Matt Middleman,
MD
LifeSci Public Relations
[email protected]
646.627.8384
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