SAN DIEGO, Feb. 3, 2015 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that Ildong
Pharmaceutical Co., Ltd., has informed Arena that the Ministry of
Food and Drug Safety has approved BELVIQ® (lorcaserin HCl) for
marketing for weight management in South
Korea. Ildong will market and distribute BELVIQ in
South Korea under its marketing
and supply agreement with Arena's wholly owned subsidiary, Arena
Pharmaceuticals GmbH, or Arena GmbH. In connection with the
approval, Arena GmbH will receive a milestone payment of
$3.0 million from Ildong.
"We are pleased with this achievement, and continue to work with
our collaborators to obtain approval for BELVIQ in additional
territories," said Jack Lief, Arena's President and Chief Executive
Officer. "As a leading pharmaceutical company in South Korea with significant experience
marketing obesity products, we are confident in Ildong's ability to
make this novel therapy available to patients in South Korea."
BELVIQ is approved in South
Korea as an adjunct to a reduced-calorie diet and increased
physical activity for weight management in adult patients with an
initial body mass index (BMI) of 30 kg/m2 or greater
(obese), or 27 kg/m2 or greater (overweight) in the
presence of at least one weight related comorbid condition (e.g.,
hypertension, dyslipidemia, type 2 diabetes).
Arena GmbH will manufacture BELVIQ at its facility in
Switzerland, and sell BELVIQ to
Ildong for a purchase price starting at 35% of Ildong's annual net
sales. The purchase price will increase on a tiered basis up to 45%
on the portion of annual net sales exceeding $15.0 million.
About BELVIQ® (lorcaserin HCl)
BELVIQ (pronounced "BEL-VEEK") 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.
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's internally discovered drug, BELVIQ®
(lorcaserin HCl), was launched in the
United States in 2013, and Arena is focused on discovering,
developing and commercializing novel 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 Ildong Pharmaceutical Co., Ltd.
Ildong Pharmaceutical Co., Ltd., based in Seoul, Korea, is a leading Korean company
focused on the development, manufacturing and marketing of
pharmaceuticals and OTC products. Ildong, founded in 1941, is known
to have leading expertise in various therapeutic categories,
including antibiotics, gastrointestinal, anti-diabetics,
cardiovascular and oncology. For more information, visit Ildong's
website at www.ildong.com.
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; the marketing and
distribution of BELVIQ in South
Korea, including Ildong's ability to make BELVIQ available
to patients; the use of BELVIQ to address an unmet medical need;
rights, obligations and activities under the marketing and supply
agreement between Arena and Ildong, including future payments;
working with collaborators and obtaining approval for BELVIQ in
additional territories; embracing the challenge of improving
health; seeking to bring innovative medicines to patients; and
Arena's focus, plans, goals, strategy, optimism, 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: whether the specifics of the
approval of BELVIQ in South Korea
vary from the information Ildong provided Arena, including with
respect to the scope of the approval and any related limitations;
the effectiveness of Ildong in marketing and distributing BELVIQ,
and the use of BELVIQ by physicians and patients in South Korea; the potential commercial and
other impact of the designation of BELVIQ as a controlled substance
in South Korea; 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; the risk that Arena's revenues are 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 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 and
third parties' intellectual property rights; 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.
|
Media Contact: Russo
Partners
|
|
|
Craig M. Audet,
Ph.D., Senior Vice President,
Operations & Head of Global Regulatory Affairs
caudet@arenapharm.com
858.453.7200, ext. 1612
|
David Schull,
President
david.schull@russopartnersllc.com
858.717.2310
|
|
|
www.arenapharm.com
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-announces-marketing-approval-in-south-korea-of-belviq-lorcaserin-hcl-for-weight-management-300029591.html
SOURCE Arena Pharmaceuticals, Inc.