Jan 4, 2017
WOODCLIFF LAKE, N.J., Jan. 4, 2017 /PRNewswire/ -- Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd. (collectively, "Eisai"), announced today that it has reached an agreement with Arena Pharmaceuticals, Inc. to revise the November 2013 marketing and supply agreement it concluded with Arena's wholly-owned subsidiary, Arena Pharmaceuticals GmbH (collectively, "Arena"), for the chronic weight management treatment lorcaserin hydrochloride CIV (generic name, U.S. brand name: BELVIQ® / BELVIQ XR®). Under the new agreement, Eisai acquires all of Arena's rights to develop and market lorcaserin.
Under this agreement, Eisai becomes solely responsible for all decision-making and implementation related to global development and submissions for regulatory approvals, as well as global marketing for lorcaserin. The previously negotiated financial terms such as purchase price based on net sales have also been reduced and modified. Arena remains eligible to earn $26 million in potential and regulatory milestones, including $25 million upon global net sales reaching $250 million in any 12 month period, and $1 million for approval in Brazil. All other unearned purchase price adjustments and clinical and commercial milestones from the original agreements have been eliminated. In addition, a technology transfer will take place to allow Eisai the option to participate in the manufacture of lorcaserin.
Eisai will also assume Arena's exclusive distribution agreements with third-parties to develop and market lorcaserin in South Korea, Taiwan and Israel. Eisai will now serve as the third parties' exclusive supplier and receive income in the form of payment for the supply of product to the distributors.
BELVIQ was approved by the FDA in 2012 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 co-morbid condition, and has been available to patients in the United States since June 2013. In addition, BELVIQ has been made available in South Korea via a third-party distributor contracted by Arena from 2015. In 2016, lorcaserin was approved in both Brazil and Mexico, and will be launched in Mexico under the brand name VENESPRI®. In addition, BELVIQ XR, a once-daily formulation of lorcaserin was approved in the United States in 2016.
By seeking to further the development of lorcaserin and to expand its availability to more patients, Eisai anticipates that the new agreement will give it greater freedom in its development and submission strategy, support its goal of making contributions to address unmet medical needs in the clinical management of obesity, and increase the benefits for patients and their families worldwide.
About BELVIQ® and BELVIQ XR®
BELVIQ® (lorcaserin HCl) CIV and BELVIQ XR® are FDA-approved prescription weight-loss medications that, when used with diet and exercise, can help some overweight (Body Mass Index [BMI] ≥27 kg/m²) adults with a weight-related medical problem, or obese (BMI ≥30 kg/m²) adults, lose weight and keep it off.
It is not known if BELVIQ or BELVIQ XR when taken with other prescription, over-the-counter, or herbal weight-loss products is safe and effective. It is not known if BELVIQ or BELVIQ XR changes your risk of heart problems, stroke, or death due to heart problems or stroke.
Important Safety Information
Pregnancy: Do not take if you are pregnant or planning to become pregnant, as weight loss offers no potential benefit during pregnancy and BELVIQ or BELVIQ XR may harm your unborn baby.
Hypersensitivity Reactions: Do not take if you are allergic to either of these medicines or any of their ingredients.
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions: Before using, tell your healthcare provider about all the medicines you take, especially medicines that treat depression, migraines, mental problems, or the common cold. These medicines may cause serious or life threatening side effects if taken with BELVIQ or BELVIQ XR. Call your healthcare provider right away if you experience agitation, hallucinations, confusion, or other changes in mental status; coordination problems; uncontrolled muscle spasms; muscle twitching; restlessness; racing or fast heartbeat; high or low blood pressure; sweating; fever; nausea; vomiting; diarrhea; or stiff muscles.
Valvular heart disease: Some people taking medicines like BELVIQ or BELVIQ XR have had heart valve problems. Call your healthcare provider right away if you experience trouble breathing; swelling of the arms, legs, ankles, or feet; dizziness, fatigue, or weakness that will not go away; or fast or irregular heartbeat. Before taking BELVIQ or BELVIQ XR, tell your healthcare provider if you have or have had heart problems.
Changes in attention or memory: BELVIQ or BELVIQ XR may slow your thinking. You should not drive a car or operate heavy equipment until you know how BELVIQ or BELVIQ XR affects you.
Mental problems: Taking too much BELVIQ or BELVIQ XR may cause hallucinations, a feeling of being high or in a very good mood, or feelings of standing outside your body.
Depression or thoughts of suicide: Call your healthcare provider right away if you notice any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings, or if you have depression or thoughts of suicide.
Low blood sugar: Weight loss can cause low blood sugar in people taking medicines for type 2 diabetes, such as insulin or sulfonylureas. Blood sugar levels should be checked before and while taking BELVIQ or BELVIQ XR. Changes to diabetes medication may be needed if low blood sugar develops.
Painful erections: If you have an erection lasting more than 4 hours while on BELVIQ or BELVIQ XR, stop taking BELVIQ or BELVIQ XR and call your healthcare provider or go to the nearest emergency room right away.
Slow heartbeat: Both BELVIQ or BELVIQ XR may cause your heart to beat slower.
Decreases in blood cell count: BELVIQ or BELVIQ XR may cause your red and white blood cell counts to decrease.
Increase in prolactin: BELVIQ or BELVIQ XR may increase the amount of a hormone called prolactin. Tell your healthcare provider if your breasts begin to make milk or a milky fluid, or if you are a male and your breasts increase in size.
Most common side effects of BELVIQ or BELVIQ XR: Headache, dizziness, fatigue, nausea, dry mouth, constipation, cough, low blood sugar (hypoglycemia) in patients with diabetes, and back pain.
Nursing: BELVIQ or BELVIQ XR should not be taken while breastfeeding.
Drug interactions: Before taking BELVIQ or BELVIQ XR, tell your healthcare provider if you take medicines for depression, migraines, or other medical conditions, such as: triptans; medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or antipsychotics; cabergoline; linezolid (an antibiotic); tramadol; dextromethorphan (an over-the-counter (OTC) common cold/cough medicine); OTC supplements such as tryptophan or St. John's Wort; or erectile dysfunction medicines.
BELVIQ and BELVIQ XR are federally controlled substances (CIV) because they may be abused or lead to drug dependence.
For more information about BELVIQ or BELVIQ XR talk to your healthcare provider and see the full Product Information for BELVIQ or BELVIQ XR.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Co. Ltd.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including oncology and neurology. For more information about Eisai Co., Ltd., please visit www.eisai.com.
SOURCE Eisai Inc.