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.
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.