SAN DIEGO, July 21, 2014 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that its
wholly owned subsidiary, Arena Pharmaceuticals GmbH, has entered
into an exclusive marketing and supply agreement for BELVIQ®
(lorcaserin HCl) with Teva Pharmaceutical Industries Limited's
local Israeli subsidiary, Abic Marketing Limited. Under the
agreement, Arena granted Abic the rights to market and distribute
BELVIQ in Israel for weight loss
or weight management in obese and overweight patients, subject to
regulatory approval by the State of Israel Ministry of Health
(MOH).
"Founded in Israel in 1901,
Teva is the leading pharmaceutical company in the Israeli market,"
said Jack Lief, Arena's President and Chief Executive Officer.
"Their local presence and proven commercialization expertise are
important factors toward making BELVIQ available in Israel as a new treatment option for chronic
weight management."
Steadily rising obesity rates is a well-known phenomenon in
western countries, and Israel is
no exception. The number of overweight and obese Israelis has
nearly tripled between 1967 and 2003. In 2011, the MOH estimated
that approximately 48% of the population is overweight or
obese.
Abic is responsible for regulatory approval and, ultimately,
marketing and distribution of BELVIQ in Israel, including related costs and expenses.
Arena will manufacture finished drug product at its facility in
Switzerland, which it will sell to
Abic at a purchase price equal to a percentage of Abic's annual net
sales of BELVIQ. In addition, Arena will receive an upfront
payment, and is eligible to receive milestone payments upon
regulatory submission and regulatory approval of BELVIQ as well as
one-time purchase price adjustment payments based on Abic's annual
net sales.
About BELVIQ® (lorcaserin HCl)
BELVIQ is believed to decrease food consumption and promote
satiety by selectively activating serotonin 2C receptors in the
brain. Activation of these receptors may help a person eat less and
feel full after eating smaller amounts of food.
Arena has previously granted exclusive marketing and
distribution rights for BELVIQ to Eisai Inc. along with its parent
company Eisai Co., Ltd., for most territories worldwide, to Ildong
Pharmaceutical Co., Ltd., for South
Korea, and to CY Biotech Company Limited for Taiwan. Composition of matter patents for
BELVIQ are issued in major jurisdictions globally that, in most
cases, are capable of continuing into 2023.
About Arena Pharmaceuticals
Arena is embracing the challenge of improving health by seeking
to bring innovative medicines targeting G protein-coupled receptors
to patients. Arena is focused on discovering, developing and
commercializing additional drugs to address unmet medical
needs. 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 www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are registered service
marks of Arena Pharmaceuticals, Inc. BELVIQ® is a registered
trademark of Arena Pharmaceuticals GmbH.
About Teva Pharmaceutical Industries Limited
Teva Pharmaceutical Industries Limited is a leading global
pharmaceutical company, committed to increasing access to
high-quality healthcare by developing, producing and marketing
affordable generic drugs as well as innovative and specialty
pharmaceuticals and active pharmaceutical ingredients.
Headquartered in Israel, Teva is
the world's leading generic drug maker, with a global product
portfolio of more than 1,000 molecules and a direct presence in
approximately 60 countries. Teva's Specialty Medicines businesses
focus on innovative CNS, respiratory, oncology, pain, and women's
health therapeutic areas as well as biologics. Teva currently
employs approximately 45,000 people around the world and reached
$20.3 billion in net revenues in
2013.
Forward-Looking Statements
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, use, safety, efficacy,
mechanism of action, and potential of BELVIQ or lorcaserin; rights
and obligations under the marketing and supply agreement with Abic
and the significance of such agreement; expectations and future
activities related to such agreement, including the regulatory
submission, review and approval of BELVIQ, manufacture and sale of
finished drug product, upfront, milestone and other payments, and
commercialization of BELVIQ in Israel; the significance of local presence and
commercialization expertise in making BELVIQ available in
Israel; patent coverage; embracing
the challenge of improving health; seeking to bring innovative
medicines to patients; 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:
dependence on collaborators, including risks related to the
implementation and continuation of the marketing and supply
agreement with Abic; risks related to commercializing drugs,
including regulatory, manufacturing, supply and marketing 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; risks related to relying on collaborative
arrangements; the timing and receipt of payments and fees, if any,
from collaborators; 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 (or Arena or a collaborator may not pursue) 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 law.
Contact: Arena
Pharmaceuticals, Inc.
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Media Contact: Russo
Partners
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Craig M. Audet,
Ph.D., Senior Vice President,
Operations & Head
of Global Regulatory Affairs
caudet@arenapharm.com
858.453.7200, ext.
1612
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David Schull,
President
david.schull@russopartnersllc.com
858.717.2310
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www.arenapharm.com
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SOURCE Arena Pharmaceuticals, Inc.