SAN DIEGO and RESEARCH TRIANGLE PARK, N.C., Nov. 15, 2018 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) and United Therapeutics
Corporation (Nasdaq: UTHR) today announced that the companies have
entered into a global license agreement for Arena's Phase 3
investigational drug candidate, ralinepag, a next-generation, oral,
selective and potent prostacyclin receptor agonist in development
for the treatment of pulmonary arterial hypertension (PAH).
Under the terms of the agreement, Arena will grant United
Therapeutics exclusive, worldwide rights to develop, manufacture
and commercialize ralinepag. In return, Arena will receive up to
$1.2 billion, including an upfront
payment of $800 million and potential
milestone payments totaling up to $400
million based on the achievement of certain regulatory
events. Additionally, Arena will receive low double-digit tiered
royalties on annual net sales of ralinepag.
"We believe ralinepag has the potential to transform the
treatment of PAH," said Amit D.
Munshi, President and Chief Executive Officer of Arena. "We
are thrilled to partner with United Therapeutics, based on their
long-standing, deep commitment to the PAH community. This
transaction represents a significant milestone in the development
of ralinepag and will strategically position Arena to aggressively
advance our best-in-class pipeline, anchored by etrasimod and
olorinab, with the focus and resources essential for long-term
success."
"We are very impressed with the clinical development plan and
FDA coordination being managed by Arena," said Martine Rothblatt, Ph.D., Chairman and Chief
Executive Officer of United Therapeutics. "We have conducted
extensive due diligence on ralinepag, applying our two decades of
knowledge about PAH. We are confident that after achieving FDA
approval via at least one of its several different potential
regulatory pathways to success, this product will help greater than
10,000 patients annually from the 2020s and well into the 2030s,
while complementing our existing portfolio of PAH therapies."
The effectiveness of the agreement is conditioned on expiration
or termination of the required waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended,
and other customary closing conditions.
Arena Conference Call and Webcast
Arena will host a
conference call and live webcast open to the public today,
November 15, 2018, at 8:30 AM EST / 5:30 AM
PST.
When: November 15, 2018, 8:30 AM EST / 5:30 AM PST
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: 4484624
Please join the conference call at least 10 minutes early to
register. You can access the live webcast under the investor
relations section of Arena's website at: www.arenapharm.com. A
replay of the conference call will be archived under
the investor relations section of Arena's website for 30
days shortly after the call.
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
progressing programs for primary biliary cholangitis (PBC) and
atopic dermatitis. Ralinepag (APD811) is being evaluated in a Phase
3 program for pulmonary arterial hypertension (PAH). 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.
In addition, Arena has several partnerships including with
Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries),
Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer
Ingelheim International GmbH (undisclosed target - preclinical),
Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai
Co., Ltd. and Eisai Inc. (BELVIQ® - marketed
product).
About United Therapeutics
United Therapeutics
Corporation focuses on the strength of a balanced, value-creating
biotechnology model. We are confident in our future thanks to our
fundamental attributes, namely our obsession with quality and
innovation, the power of our brands, our entrepreneurial culture
and our bioinformatics leadership. We also believe that our
determination to be responsible citizens – having a positive impact
on patients, the environment and society – will sustain our success
in the long term.
Through our wholly-owned subsidiary, Lung Biotechnology PBC, we
are focused on addressing the acute national shortage of
transplantable lungs and other organs with a variety of
technologies that either delay the need for such organs or expand
the supply. Lung Biotechnology is the first public benefit
corporation subsidiary of a public biotechnology or pharmaceutical
company. [uthr-g]
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 "will," "eligible,"
"potential," "in development for," "we believe," "we are
confident," "conditioned on," "can," "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 its effectiveness, focus and potential payments to Arena;
United Therapeutics' expertise and goals; the potential
development, FDA approval and commercialization of ralinepag; the
potential of ralinepag, including to be a best-in-class agent, to
transform the treatment of PAH and to help greater than 10,000
patients annually from the 2020s and well into the 2030s; Arena's
drive; the potential of Arena's assets, programs and
collaborations; and United Therapeutics' focus, future and
sustained long-term success. For such statements, Arena and United
Therapeutics claim the protection of the Private Securities
Litigation Reform Act of 1995. Actual events or results may differ
materially from Arena's and United Therapeutics' expectations.
Factors that could cause actual results to differ materially from
the forward-looking statements include, without limitation, the
following: the license agreement is subject to closing conditions,
including regulatory approval, which may not be satisfied or occur;
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, United
Therapeutics 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 and United Therapeutics allocate their 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 and United Therapeutics' filings with the Securities and
Exchange Commission (SEC), including but not limited to our most
recent Annual Reports on Form 10-K and Quarterly Reports on Form
10-Q. We are providing this information as of November 15, 2018, and Arena and United
Therapeutics disclaim any intent or obligation to update these
forward-looking statements, other than as may be required under
applicable law.
Arena Corporate
Contact:
|
United
Therapeutics Contact:
|
Kevin R.
Lind
|
James
Edgemond
|
Arena
Pharmaceuticals, Inc.
|
United Therapeutics
Corporation
|
Executive Vice
President and
|
Chief Financial
Officer & Treasurer
|
Chief Financial
Officer
|
jedgemond@unither.com
|
klind@arenapharm.com
|
301.608.9292
|
858.210.3636
|
|
|
|
Arena Media
Contact:
|
|
Matt Middleman,
M.D.
|
|
LifeSci Public
Relations
|
|
matt.middleman@lifescipublicrelations.com
|
|
646.627.8384
|
|
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SOURCE Arena Pharmaceuticals, Inc.; United Therapeutics
Corporation