SAN DIEGO, Dec. 5, 2017 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA), a biopharmaceutical company
focused on developing novel, small molecule drugs across multiple
therapeutic areas, and Everest Medicines Limited ("Everest"), a
C-Bridge Capital-backed biopharmaceutical company focused on
developing and commercializing innovative pharmaceutical products
in China,
announced today that they have entered into a development
and commercialization partnership for ralinepag and etrasimod in
mainland China, Taiwan, Hong
Kong, Macau, and
South Korea (the
"Territories"). C-Bridge Capital has invested $50 million to fund Everest and has assembled a
veteran leadership team with an established track record in both
the development of innovative drugs and commercialization in
China and globally to rapidly
advance select product candidates towards approval and
launch. Everest was founded to leverage the evolving
regulatory landscape in China
aimed at enhancing the drug approval process related to
transformative foreign drugs.
"We are very pleased to establish a partnership with Everest and
C-Bridge Capital around two of our potential best-in-class product
candidates," said Amit D. Munshi,
President and Chief Executive Officer of Arena. "With new
regulations in place in China to
expedite approvals, a significant opportunity for ralinepag and
etrasimod exists in early synchronization of development
programs. Based on their development and commercialization
expertise, as well as strategy for leveraging changes in the
regulatory environment, we view Everest as the ideal partner to
maximize the value of our drugs in the rapidly growing Chinese
market. Arena and Everest are both committed to ensuring that
these products are available to patients in China as expeditiously as possible."
Arena is developing ralinepag, a Phase 3-ready next-generation,
oral, selective prostacyclin receptor (IP) agonist for the
treatment of pulmonary arterial hypertension (PAH), and etrasimod,
a Phase 2 oral, next-generation, S1P receptor modulator, being
evaluated for multiple autoimmune diseases, including ulcerative
colitis, a form of inflammatory bowel disease.
China is the second largest
pharmaceutical market in the world, with healthcare expenditures
forecasted to grow rapidly in the coming years (>10% annual
growth rate from 2017 to 2025).1
"We are very excited to partner with Arena to bring these two
highly differentiated investigational drugs to China. We see
great promise in the potential for both ralinepag and etrasimod to
address significant unmet medical needs in Greater China and we hope to bring them to
patients as quickly as possible," said Sean
Cao, President of Everest.
"Our strong belief in Everest's capability to be the
partner-of-choice for companies with innovative assets with large
commercial potential in China is
illustrated by our significant investment in Everest's Series A
round," said Fu Wei, Chief Executive Officer of C-Bridge
Capital. "Arena's potentially best-in-class programs lay a
strong foundation for Everest's growing pipeline."
Under the terms of the agreement, Arena has granted Everest
exclusive rights to develop and commercialize ralinepag and
etrasimod in the Territories. In return, Arena will receive
an upfront payment of $12 million, is
eligible to receive up to $212
million in development and commercial milestone payments and
is entitled to receive up to low double-digit royalties on net
annual sales of both ralinepag and etrasimod.
The parties plan to collaborate on development on both products;
however, Everest is generally responsible for funding development
and commercialization in the Territories.
About Everest Medicines
Everest Medicines is a
biopharmaceutical company focused on developing and commercializing
transformative pharmaceutical products that address critical unmet
medical needs for patients in Greater China. The Everest
Medicines team has deep expertise and an extensive track record of
high quality clinical development, regulatory affairs, CMC,
business development and operations both in China and for leading global pharmaceutical
companies. Everest's $50 million
Series A financing was led by C-Bridge Capital. For more
information, please visit its website at
www.everestmedicines.com.
About C-Bridge Capital
C-Bridge Capital is a
healthcare dedicated private equity firm, focused on growth and
late stage investment opportunities. The firm has over US
$800 million of assets under
management and a notable limited partner base of family foundations
and institutional investors around the globe, such as Pavilion
Capital, a subsidiary of Singapore
state-owned holding company, Temasek. C-Bridge Capital's current
portfolio includes China's leading
players in pharmaceuticals, medical devices, diagnostics and
healthcare services. C-Bridge Capital is committed to supporting
commercialization of innovative technologies and companies that
fulfill unmet medical needs, thus continuously improving the
standard and quality of care for patients. For more information,
please visit its website at www.cbridgecap.com/en.
About Etrasimod
Etrasimod (APD334), is an oral, next
generation, selective sphingosine 1-phosphate (S1P) receptor
modulator, discovered by Arena, designed to provide systemic and
local cell modulation by selectively targeting S1P receptor
subtypes 1, 4 and 5, while avoiding subtypes 2, 3. Etrasimod
exhibits potentially best-in-class pharmacokinetics and
pharmacodynamics with rapid onset of action and rapid recovery of T
lymphocytes. Selective binding with S1P receptor subtype 1 is
believed to inhibit a specific subset of activated lymphocytes from
migrating to sites of inflammation. The result is a reduction of
circulating T and B lymphocytes that leads to anti-inflammatory
activity and immune surveillance is maintained. The receptor
subtypes 4, 5 exhibit similar activity on additional proliferating
immune cell types. Optimized pharmacology and pharmacokinetics may
allow superior clinical utility across a broad range of autoimmune
conditions.
Etrasimod is an investigational compound not approved for any
use in any country.
About Ralinepag
Ralinepag (APD811) is an oral,
next-generation, selective prostacyclin receptor agonist intended
for the treatment of pulmonary arterial hypertension (PAH).
Ralinepag was designed by Arena with the goal of achieving
therapeutic activity superior to currently available oral
prostacyclin receptor agonists and comparable to parenteral
treatment options. In non-clinical experiments, ralinepag
demonstrated potentially best-in-class activation of the IP
receptor resulting in vasodilation, inhibition of smooth muscle
cell proliferation and inhibition of platelet aggregation.
Additionally, ralinepag pharmacokinetics in humans revealed an
approximately 24-hour half-life and a low peak to trough ratio
supporting therapeutic blood levels with once daily (QD)
dosing.
Ralinepag is an investigational compound not approved for any
use in any country.
About Arena Pharmaceuticals
Arena Pharmaceuticals is a
biopharmaceutical company focused on developing novel, small
molecule drugs with optimized receptor pharmacology designed to
deliver broad clinical utility across multiple therapeutic areas.
Our proprietary pipeline includes potentially first- or
best-in-class programs for which we own global commercial rights.
Our three most advanced investigational clinical programs are
ralinepag (APD811) which has completed a Phase 2 trial for
pulmonary arterial hypertension (PAH), etrasimod (APD334) in Phase
2 evaluation for multiple autoimmune indications, and APD371 in
Phase 2 evaluation for the treatment of pain associated with
Crohn's disease. In addition, Arena has collaborations with the
following pharmaceutical companies: Eisai Co., Ltd. and Eisai Inc.
(commercial stage), Axovant Sciences (Phase 2 candidate), and
Boehringer Ingelheim International GmbH (preclinical
candidate).
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 "up to," "focused on,"
"aimed at," "potential," "opportunity," "view," "committed to,"
"developing," "forecasted," "hope," "belief," "capability," "will,"
"designed to," "believed to," "may," "intended," "goal," 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 activities to be
performed by Arena or Everest; responsibilities of Arena or
Everest; the significance of the agreement with Everest; the
payments Arena may receive from Everest; the ongoing clinical
programs for etrasimod and ralinepag; the ability to complete
planned trials; the expected timing of clinical data; the
opportunity and potential of etrasimod and ralinepag, including to
improve the treatment of patients, to meet unmet medical needs, to
deliver clinical utility across a range of autoimmune conditions,
to be best-in-class and to reach patients quickly; the potential of
Arena's drugs and drug candidates; and Arena's focus, 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: the implementation of the agreement with Everest;
dependence on counterparty performance; risks related to developing
and commercializing drugs, including regulatory, manufacturing and
supply issues and the availability and use of etrasimod and
ralinepag; risks and uncertainties relating to cash and revenues
that may be generated from product sales or other sources,
including the impact of competition; government and third party
actions, including decisions and other actions relating to
approval, reimbursement and pricing; unexpected or unfavorable new
data; the ability to defend patent rights; enrolling patients in
our ongoing and intended clinical trials is competitive and
challenging; clinical trials and other studies may not proceed at
the time or in the manner expected or at all; results of clinical
trials and other studies are subject to different interpretations
and may not be predictive of future results; the timing and outcome
of research, development and regulatory review is uncertain;
topline data may not accurately reflect the complete results of a
particular study or trial; 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; we expect to need additional
funds to advance all of our programs, and you and others may not
agree with the manner we allocate our resources; our drug
candidates may not advance in development or be approved for
marketing; Arena's revenues may be based in part on estimates,
judgment and accounting policies, and incorrect estimates or
disagreement regarding estimates or accounting policies may result
in changes to Arena's guidance or previously reported results; the
entry into or modification or termination of collaborative
arrangements; Arena's 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
Arena's forward-looking statements are disclosed in Arena's filings
with the Securities and Exchange Commission, including but not
limited to our Annual Report on Form 10-K which was filed on
March 15, 2017 and our Quarterly
Report on Form 10-Q which was filed on November 8, 2017. 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.
1 IMS MIDAS database, IMS prognosis,
BMI Research Report, August
2017
Arena Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Arena Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt@lifescipublicrelations.com
646.627.8384
Everest Corporate Contact:
Sean Cao, Ph.D
Everest Medicines Limited
President
sean.cao@everestmedicines.com
908.391.9352
Everest Media Contact:
James
Heins
ICR
james.Heins@icrinc.com
203.682.8251
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SOURCE Arena Pharmaceuticals, Inc.; Everest Medicines
Limited