Arena Pharmaceuticals and Eisai Expand Marketing and Supply Agreement for
BELVIQ® (lorcaserin HCl) to Include Most Countries Worldwide
-- Collaboration to Focus on Global Commercialization and Development for
Weight Management and Potential New Indications --
SAN DIEGO, Calif. and WOODCLIFF LAKE, N.J., Nov. 7, 2013
SAN DIEGO, Calif. and WOODCLIFF LAKE, N.J., Nov. 7, 2013 /PRNewswire/ --Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today the
expansion of the BELVIQ^® (lorcaserin HCl) marketing and supply agreement
between Arena Pharmaceuticals, Inc.'s wholly owned subsidiary, Arena
Pharmaceuticals GmbH, and Eisai Inc. along with its parent company Eisai Co.,
Ltd. The expanded agreement provides Eisai with exclusive commercialization
rights for all countries worldwide, except for South Korea, Taiwan, Australia,
Israel and New Zealand. This agreement amends and restates the previous
agreement that granted Eisai rights to commercialize BELVIQ in most of North
and South America. Eisai's commercialization rights are subject to applicable
"This new agreement not only expands Eisai's territory for commercialization,
but it also prioritizes our global development program for BELVIQ," said Jack
Lief, Arena's President and Chief Executive Officer. "Expanding our
collaboration with Eisai provides the potential to make BELVIQ available to
physicians and patients worldwide for weight management and creates a powerful
platform to investigate this novel compound for possible new indications by
leveraging our combined drug development and regulatory expertise."
Lonnel Coats, Eisai Inc.'s President and Chief Executive Officer, added, "Our
expanded commitment to BELVIQ reflects the company's human health care mission
to bring new, innovative therapies to patients. Our belief in this product is
strengthened by the feedback we have received from patients, physicians and
payers since the US launch of BELVIQ. We have a strong foundation on which
Eisai and Arena can build a global franchise for BELVIQ."
Under the terms of the agreement, Arena will receive from Eisai an upfront
payment of $60 million and is eligible to receive up to a total of $176.5
million in regulatory and development milestone payments. The total for
milestone payments represents an increase of $123 million from the amount
remaining available under the previous agreement.
Arena will continue to sell BELVIQ to Eisai for commercialization in the US
and in the other territories in North and South America for a purchase price
starting at 31.5% and 30.75% of Eisai's net sales, respectively. With respect
to the new territories added under the amended agreement, the purchase price
starts at 27.5% of Eisai's net sales in Europe, China and Japan, and at 30.75%
of Eisai's net sales in all other territories. The purchase price will
increase on a tiered basis in the US and the other territories, other than
Europe, China and Japan, to as high as 36.5% and 35.75%, respectively, on the
portion of Eisai's annual net sales exceeding $750 million. The purchase price
will increase to 35% in Europe, China and Japan on the portion of Eisai's
annual net sales exceeding $500 million.
Arena is also eligible to receive a total of $1.56 billion in one-time
purchase price adjustment payments based on sales in the territories covered
by the agreement. The total for purchase price adjustment payments represents
an increase of $185 million from the amount available under the previous
In addition to pursuing regulatory approval for weight management in the
expanded territory, under the terms of the agreement, Eisai and Arena plan to
investigate the potential of BELVIQ in new areas, such as smoking cessation, a
once-daily formulation, a fixed-dose combination with phentermine, as well as
explore BELVIQ's impact on diabetes and cardiovascular outcomes.
About BELVIQ^® (lorcaserin HCl)
BELVIQ is believed to decrease food consumption and promote satiety by
selectively activating serotonin 2C receptors in the brain. The exact
mechanism of action of BELVIQ is not known.
BELVIQ^® (lorcaserin HCl) CIV is Approved by the US Food and Drug
BELVIQ is indicated in the United States as an adjunct to a reduced-calorie
diet and increased physical activity for chronic weight management in adult
patients with an initial body mass index of:
o30 kg/m^2 or greater (obese), or
o27 kg/m^2 or greater (overweight) in the presence of at least one
weight-related comorbid condition (e.g., hypertension, dyslipidemia, type
Limitations of Use:
oThe safety and efficacy of coadministration of BELVIQ with other products
intended for weight loss, including prescription drugs (e.g.,
phentermine), over-the-counter drugs, and herbal preparations, have not
oThe effect of BELVIQ on cardiovascular morbidity and mortality has not
IMPORTANT SAFETY INFORMATION
oBELVIQ should not be taken during pregnancy or by women who are planning
to become pregnant.
Warnings and Precautions
oBELVIQ is a serotonergic drug. The development of potentially
life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome
(NMS)-like reactions have been reported during use of serotonergic drugs,
including, but not limited to, selective serotonin-norepinephrine reuptake
inhibitors, and selective serotonin reuptake inhibitors, tricyclic
antidepressants, bupropion, triptans, dietary supplements such as St.
John's Wort and tryptophan, drugs that impair metabolism of serotonin
(including monoamine oxidase inhibitors), dextromethorphan, lithium,
tramadol, antipsychotics or other dopamine antagonists, particularly when
used in combination. Patients should be monitored for the emergence of
serotonin syndrome symptoms or NMS-like reactions, including agitation,
hallucinations, coma, tachycardia, labile blood pressure, hyperthermia,
hyperreflexia, incoordination, nausea, vomiting, diarrhea, and muscle
rigidity. Treatment with BELVIQ and any concomitant serotonergic or
antidopaminergic agents should be discontinued immediately if the above
events occur, and supportive symptomatic treatment should be initiated.
oPatients should not take BELVIQ in combination with drugs that have been
associated with valvular heart disease (e.g., cabergoline). In clinical
trials, 2.4% of patients taking BELVIQ and 2.0% of patients taking placebo
developed valvular regurgitation: none of these patients was symptomatic.
BELVIQ should be used with caution in patients with congestive heart
failure (CHF). Patients who develop signs and symptoms of valvular heart
disease, including dyspnea, dependent edema, CHF, or a new cardiac murmur,
should be evaluated and discontinuation of BELVIQ should be considered.
oImpairment in attention, memory, somnolence, confusion, and fatigue, have
been reported in patients taking BELVIQ. Patients should not drive a car
or operate heavy machinery until they know how BELVIQ affects them.
oThe recommended dose of 10 mg twice daily should not be exceeded, as
higher doses may cause euphoria, hallucination, and dissociation. Monitor
patients for the development or worsening of depression, suicidal thoughts
or behaviors, and/or any changes in mood. Discontinue BELVIQ in patients
who develop suicidal thoughts or behaviors.
oWeight loss may increase the risk of hypoglycemia in patients with type 2
diabetes mellitus who are being treated with antidiabetic medications, so
measurement of blood sugar levels before and during treatment with BELVIQ
is recommended. Decreases in doses of antidiabetic medications or changes
in medication regimen should be considered.
oMen who experience priapism should immediately discontinue BELVIQ and seek
emergency medical attention. BELVIQ should be used with caution with
erectile dysfunction medications. BELVIQ should be used with caution in
men who have conditions that might predispose them to priapism (e.g.,
sickle cell anemia, multiple myeloma, or leukemia), or in men with
anatomical deformation of the penis (e.g., angulation, cavernosal
fibrosis, or Peyronie's disease).
oBecause BELVIQ may cause a slow heartbeat, it should be used with caution
in patients with a history of bradycardia or heart block greater than
oConsider monitoring for CBC changes, prolactin excess, and pulmonary
Most Common Adverse Reactions
oIn patients without diabetes: headache (17%), dizziness (9%), fatigue
(7%), nausea (8%), dry mouth (5%), and constipation (6%).
oIn patients with diabetes: hypoglycemia (29%), headache (15%), back pain
(12%), cough (8%), and fatigue (7%).
oBELVIQ should not be taken by women who are nursing.
For more information about BELVIQ, click here for the full US FDA-approved
Product Information or visit www.BELVIQ.com.
In addition to granting exclusive marketing and distribution rights to Eisai
for most territories worldwide, Arena has granted rights for BELVIQ to Ildong
Pharmaceutical Co., Ltd., for South Korea, and to CY Biotech Company Limited
for Taiwan. Arena plans to enter into additional collaborations to
commercialize BELVIQ outside of these territories.
About Arena Pharmaceuticals
Arena is a biopharmaceutical company focused on discovering, developing and
commercializing novel drugs that target G protein-coupled receptors, or GPCRs,
to address unmet medical needs. BELVIQ^® (lorcaserin HCl), Arena's internally
discovered drug, is approved in the United States, and is under review for
regulatory approval in additional territories. Arena's US operations are
located in San Diego, California, and its operations outside of the United
States, including its commercial manufacturing facility, are located in
Zofingen, Switzerland. For more information, visit Arena's website at
Arena Pharmaceuticals^® and Arena^® are registered service marks of Arena
Pharmaceuticals, Inc. BELVIQ^® is a registered trademark of Arena
About Eisai Inc.
At Eisai Inc., human health care is the goal. Eisai gives its first thoughts
to patients and their families, and helping to increase the benefits health
care provides. As the US pharmaceutical subsidiary of Tokyo-based Eisai Co.,
Ltd., Eisai's passionate commitment to patient care is the driving force
behind its efforts to help address unmet medical needs. Eisai is a fully
integrated pharmaceutical business with discovery, clinical, manufacturing and
marketing capabilities. Eisai's key areas of commercial focus include oncology
and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To
learn more about Eisai Inc., please visit www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation
organization that includes R&D facilities in Massachusetts, New Jersey, North
Carolina and Pennsylvania, as well as a global demand chain organization that
includes manufacturing facilities in Maryland and North Carolina. Eisai's
global areas of R&D focus include neuroscience; oncology; metabolic disorders;
vascular, inflammatory and immunological reaction; and antibody-based
Certain statements in this press release are forward-looking statements that
involve a number of risks and uncertainties. Such forward-looking statements
include statements about the advancement, therapeutic indication and use,
safety, efficacy, mechanism of action, regulatory review and approval, and
potential of BELVIQ or lorcaserin; the expanded agreement with Eisai, the
significance of such agreement and related expectations and plans, including
payments, leveraging of expertise, product development (including potential
indications and formulations), registration and commercialization;
prioritization of the BELVIQ global development program; the building of a
global franchise for BELVIQ and potential to make BELVIQ available worldwide;
Eisai's commitment; plans to enter into additional collaborations and the
commercialization of BELVIQ in additional territories; and Arena's focus,
plans, goals, strategy, expectations, research and development programs, and
ability to discover and develop compounds and commercialize drugs. 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, but are not limited
to, the following: risks related to the implementation and continuation of the
Second Amended Agreement and dependence on collaborators; the timing and
receipt of payments and fees, if any, from collaborators; risks related to
commercializing drugs, including regulatory, manufacturing and supply issues
and the availability and use of BELVIQ; cash and revenues generated from
BELVIQ, including the impact of competition; Arena's revenues will 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 timing and
outcome of regulatory review is uncertain, and BELVIQ may not be approved for
marketing when expected or ever in combination with another drug, for another
indication or using a different formulation or in any other territory for any
indication; regulatory decisions in one territory may impact other regulatory
decisions and Arena's business prospects; government and commercial
reimbursement and pricing decisions; the entry into or modification or
termination of collaborative arrangements; unexpected or unfavorable new data;
nonclinical and clinical data is 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; data and other information related to any of Arena's
research and development may not meet regulatory requirements or otherwise be
sufficient for further research and development, regulatory review or approval
or continued marketing; Arena's ability to obtain and defend patents; the
timing, success and cost of Arena's research and development; results of
clinical trials and other studies are subject to different interpretations and
may not be predictive of future results; clinical trials and other studies may
not proceed at the time or in the manner expected or at all; having adequate
funds; 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.
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
Contacts: Eisai Inc.
Investor Inquiries: Media Inquiries:
Alex Scott Lynn Kenney
Contact: Arena Pharmaceuticals, Inc.
Investor Inquiries: Media Inquiries:
Cindy McGee, Vice President, David Schull, President
Investor Relations & Alliance Management email@example.com
858.453.7200, ext. 1479
SOURCE Arena Pharmaceuticals, Inc.
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