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.
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.
Media Contact: Russo Partners
Craig M. Audet, Ph.D., Senior Vice President,
Operations & Head of Global Regulatory Affairs
858.453.7200, ext. 1612
David Schull, President
SOURCE Arena Pharmaceuticals, Inc.