SAN DIEGO, July 25, 2013 /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 with CY Biotech Company Ltd. (CYB) for BELVIQ® (lorcaserin HCl) in Taiwan. Under the agreement, Arena granted CYB the rights to market and distribute BELVIQ in Taiwan for weight loss or weight management in obese and overweight patients, subject to regulatory approval of BELVIQ by the Taiwan Food and Drug Administration (TFDA).
Arena will manufacture BELVIQ at its facility in Switzerland, and sell finished product to CYB for a purchase price at 45% of CYB's annual net sales. In addition, Arena received from CYB a net upfront payment of $2 million, and is eligible to receive purchase price adjustment payments based on CYB's annual net sales, as well as a milestone payment upon approval of the first additional indication for BELVIQ by the TFDA. CYB is responsible for the development, regulatory approval and, ultimately, marketing and distribution of BELVIQ in Taiwan, including related costs and expenses.
"We will continue to expand the geographic footprint for BELVIQ through agreements with pharmaceutical companies that demonstrate a combination of local regulatory expertise and proven marketing strength," said Jack Lief, Arena's President and Chief Executive Officer. "CYB was formerly part of TTY Biopharm, a leading Taiwanese pharmaceutical company. While part of TTY, CYB was the operating group that previously co-marketed the weight loss drug Reductil® with Abbott in Taiwan, and we believe CYB is well positioned to bring BELVIQ to a territory where new weight management pharmacotherapies are needed."
According to published media reports, half of adult men and a third of adult women in Taiwan are overweight or obese, which are defined in Taiwan as a body mass index >24 kg/m2 or >27 kg/m2,respectively. Eight out of the 10 leading causes of death in Taiwan are associated with obesity, and approximately 10% of total healthcare spending goes to treat problems related to obesity.
"Health and a focus on weight management have become a countrywide movement in Taiwan," said Jacky Wang, CYB's Chairman and President. "This addition to our product portfolio reflects our commitment to innovation and our strong belief in the safety and efficacy of BELVIQ. Our previous experience in building the weight management market will be important for the regulatory approval and marketing of BELVIQ. CYB has a comprehensive sales network in place as well as relationships with the academic and physician thought leaders throughout Taiwan."
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 granted exclusive marketing and distribution rights for BELVIQ to Eisai Inc. for most of North and South America, to Ildong Pharmaceutical Co., Ltd., for South Korea and to CYB for Taiwan, and plans to enter into additional collaborations to commercialize BELVIQ outside of these territories. 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 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 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 CY Biotech Company Ltd.
CY Biotech Company Ltd. is a Taiwanese pharmaceutical company. CYB was formerly part of TTY Biopharm, a leading Taiwanese pharmaceutical company, and was the operating group that previously co-marketed the weight loss drug Reductil® with Abbott in Taiwan. TTY is a significant shareholder of CYB.
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; rights and obligations under the marketing and supply agreement with CYB and the significance of such agreement; expectations and future activities related to such agreement, including, with respect to Taiwan, the development, regulatory approval, manufacture, sale, marketing and distribution of BELVIQ and upfront, milestone and other payments; expanding the geographic footprint for BELVIQ, entering into additional collaborations and related strategy; CYB's ability and positioning to commercialize BELVIQ; the need for new weight management pharmacotherapies in Taiwan and BELVIQ's impact on such need; patent coverage; 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 marketing and supply agreement with CYB and relying on collaborative arrangements; 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 management's estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding Arena's 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 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 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.
SOURCE Arena Pharmaceuticals, Inc.