Arena Pharmaceuticals Reports on Launch of BELVIQ® (lorcaserin HCl) CIV for Chronic Weight Management in Adults who are Overweight with a Comorbidity or Obese
-- BELVIQ Available in US Pharmacies within One Week -- -- Arena Achieves $65 Million in Milestones and is Eligible for Additional Payments Based on Product Sales --
SAN DIEGO, June 7, 2013 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) reported today on the launch of BELVIQ (pronounced BEL-VEEK) in the United States. BELVIQ will be available to patients by prescription in US pharmacies beginning June 11. Eisai Inc. is responsible for the marketing and distribution of BELVIQ under its agreement with Arena Pharmaceuticals GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc.
BELVIQ is approved by the US Food and Drug Administration for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic 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). The indication includes the following limitations of use: The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss and the effect of BELVIQ on cardiovascular morbidity and mortality have not been established.
"Our team discovered and developed BELVIQ with the goal of providing physicians with a new tool to help fight the global obesity epidemic," said Dominic P. Behan, Ph.D., Arena's Executive Vice President and Chief Scientific Officer. "We are proud to provide physicians in the United States with a new treatment option that along with diet and exercise can help committed patients effectively manage their weight."
Arena manufactures BELVIQ at its facility in Switzerland, and sells finished commercial product to Eisai for a purchase price starting at 31.5% of Eisai's annual net product sales. The purchase price increases on a tiered basis up to 36.5% on the portion of annual net product sales exceeding $750 million. In connection with the US launch of BELVIQ, Arena has achieved $65 million in milestones from Eisai. Arena is also eligible to receive $1.19 billion in purchase price adjustment and other payments based on Eisai's annual net sales levels of BELVIQ.
"BELVIQ is the product of our vision and commitment to bring novel treatments to physicians and patients for unmet medical needs," said Jack Lief, Arena's President and Chief Executive Officer. "Our collaboration with Eisai is an integral component of the strong foundation we have in place to make BELVIQ available to eligible patients."
Arena's marketing and supply agreement with Eisai covers most of North and South America. Eisai has submitted a marketing authorization application for BELVIQ in Mexico, and plans to submit applications for the approval of BELVIQ in Canada and Brazil this year. Arena also has a BELVIQ marketing and supply agreement with Ildong Pharmaceutical Co., Ltd., for South Korea, and Ildong plans to submit an application for the approval of BELVIQ in
South Korea around the end of this year. Arena plans to enter into additional collaborations to support the commercialization of BELVIQ in other territories.
Composition of matter patents for BELVIQ are issued in major jurisdictions globally that, in most cases, are capable of continuing into 2023. Arena has filed applications for patent extension in the United States, which, if granted, will extend the patent term for BELVIQ into 2026.
About BELVIQ (lorcaserin HCl) CIV
BELVIQ is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. The exact mechanism of action of BELVIQ is not known. For more information about BELVIQ, click here for the full Product Information or visit www.BELVIQ.com.
IMPORTANT SAFETY INFORMATION
BELVIQ should not be taken during pregnancy or by women who are planning to become pregnant.
Warnings and Precautions
BELVIQ is a serotonergic drug. The development of potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported during use of serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors, and selective serotonin reuptake inhibitors, tricyclic antidepressants, bupropion, triptans, dietary supplements such as St. John's Wort and tryptophan, drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors), dextromethorphan, lithium, tramadol, antipsychotics or other dopamine antagonists, particularly when used in combination. Patients should be monitored for the emergence of serotonin syndrome symptoms or NMS-like reactions, including agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting,
diarrhea, and muscle rigidity. Treatment with BELVIQ and any concomitant serotonergic or antidopaminergic agents should be discontinued immediately if the above events occur, and supportive symptomatic treatment should be initiated.
Patients should not take BELVIQ in combination with drugs that have been associated with valvular heart disease (e.g., cabergoline). In clinical trials, 2.4% of patients taking BELVIQ and 2.0% of patients taking placebo developed valvular regurgitation: none of these patients was symptomatic. BELVIQ should be used with caution in patients with congestive heart failure (CHF). Patients who develop signs and symptoms of valvular heart disease, including dyspnea, dependent edema, CHF, or a new cardiac murmur, should be evaluated and discontinuation of BELVIQ should be considered.
Impairment in attention, memory, somnolence, confusion, and fatigue, have been reported in patients taking BELVIQ. Patients should not drive a car or operate heavy machinery until they know how BELVIQ affects them.
The recommended dose of 10 mg twice daily should not be exceeded, as higher doses may cause euphoria, hallucination, and dissociation. Monitor patients for the development or worsening of depression, suicidal thoughts or behaviors, and/or any changes in mood. Discontinue BELVIQ in patients who develop suicidal thoughts or behaviors.
Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus who are being treated with antidiabetic medications, so measurement of blood sugar levels before and during treatment with BELVIQ is recommended. Decreases in doses of antidiabetic medications or changes in medication regimen should be considered.
Men who experience priapism should immediately discontinue BELVIQ and seek emergency medical attention. BELVIQ should be used with caution with erectile dysfunction medications. BELVIQ should be used with caution in men who have conditions that might predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease).
Because BELVIQ may cause a slow heartbeat, it should be used with caution in patients with a history of bradycardia or heart block greater than first degree.
Consider monitoring for CBC changes, prolactin excess, and pulmonary hypertension.
Most Common Adverse Reactions
In patients without diabetes: headache (17%), dizziness (9%), fatigue (7%), nausea (8%), dry mouth (5%), and constipation (6%).
In patients with diabetes: hypoglycemia (29%), headache (15%), back pain (12%), cough (8%), and fatigue (7%).
BELVIQ should not be taken by women who are nursing.
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 Eisai Inc.
At Eisai Inc., human health care is the goal. Eisai gives its first thoughts to patients and their families, and helping to increase the benefits health care provides. As the US pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., Eisai's passionate commitment to patient care is the driving force behind its efforts to help address unmet medical needs. Eisai is a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Eisai's key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's
global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
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, tolerability, selectivity, mechanism of action, launch and availability of BELVIQ; the potential of BELVIQ, including with respect to the global obesity epidemic and management of weight; the commercialization of BELVIQ, including Arena's related foundation; rights, obligations, milestones, payments, expectations and future activities related to the marketing and supply agreements with Eisai and Ildong; future BELVIQ collaborations; regulatory filings, review and approval of BELVIQ; bringing novel treatments for unmet medical needs; patent coverage; and Arena's vision, commitment, 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 commercializing drugs, including regulatory, manufacturing and supply issues and the availability of BELVIQ and pace of market acceptance; 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 by any other regulatory agency; regulatory decisions in one territory may impact regulatory decisions in other territories 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 safety, efficacy or other 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 programs; 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.