Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that BELVIQ(R) (lorcaserin HCl) has been nominated by the Galien Foundation and Awards Committee for the 2014 Prix Galien USA Award in the Best Pharmaceutical Agent category. BELVIQ was previously nominated for this award in 2013.
“Eisai’s commitment to patient care is the driving force behind our efforts to help address unmet medical needs,” said Frank Ciriello, Eisai’s President, Global Neurology Business Unit. “The Prix Galien USA Award recognizes the extensive research necessary to develop innovative medicines to help increase the benefits health care provides to patients and their families.”
The Prix Galien USA Award is considered one of the biomedical industry’s top accolades. It recognizes outstanding achievements in improving the human condition through the development of innovative therapies. Nominees are selected from among those medicines and devices approved by the United States Food and Drug Administration (FDA) in the previous five years.
“This nomination reflects Arena’s mission to improve health by bringing innovative medicines to patients,” said Dominic P. Behan, Ph.D., D.Sc., Arena’s Executive Vice President and Chief Scientific Officer. “We are honored to be a part of the community of those nominated for this prestigious award.”
The Prix Galien USA Award ceremony will be held in New York City on October 28, 2014.
About BELVIQ(R) (lorcaserin HCl) CIV
BELVIQ is a serotonin 2C receptor agonist approved in the United States as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m(2) or greater (obese), or BMI of 27 kg/m(2) or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes. It is not known if BELVIQ is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products, nor is it known if BELVIQ changes the risk of heart problems or stroke, or death due to heart problems or stroke.
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.
BELVIQ is approved by the FDA. Eisai markets and distributes BELVIQ in the United States, and Arena manufactures and supplies the finished commercial product from its facility in Switzerland.
For more information about BELVIQ, click here for the full FDA-approved Product Information or visit www.BELVIQ.com.
About Overweight and Obesity
Obesity has become a substantial, widespread problem with more than 2 billion people worldwide overweight or obese. Approximately two thirds of US adults are overweight or obese, and the prevalence of obesity in the United States has more than doubled in the past 30 years. Many health organizations and authorities, including the American Medical Association, Centers for Disease Control and Prevention and the National Institutes of Health, now recognize obesity as a chronic disease that needs to be treated.
Important Safety Information
— Pregnancy: Do not take BELVIQ if you are pregnant or planning to become
pregnant, as weight loss offers no potential benefit during pregnancy and
BELVIQ may harm your unborn baby.
— Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like
reactions: Before using BELVIQ, tell your doctor 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. Call your doctor
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 have had
heart valve problems. Call your doctor 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, tell your doctor if you have or have had
heart problems.
— Changes in attention or memory: BELVIQ may slow your thinking. You should
not drive a car or operate heavy equipment until you know how BELVIQ
affects you.
— Mental problems: Taking too much BELVIQ 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 doctor 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. 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, stop taking BELVIQ and call your doctor or go to the
nearest emergency room right away.
— Slow heartbeat: BELVIQ may cause your heart to beat slower.
— Decreases in blood cell count: BELVIQ may cause your red and white blood
cell counts to decrease.
— Increase in prolactin: BELVIQ may increase the amount of a hormone called
prolactin. Tell your doctor 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 in patients without diabetes: Headache,
dizziness, fatigue, nausea, dry mouth, and constipation.
— Most common side effects in patients with diabetes: Low blood sugar,
headache, back pain, cough, and fatigue.
— Nursing: BELVIQ should not be taken while breastfeeding.
— Drug interactions: Before taking BELVIQ, tell your doctor 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 is a federally controlled substance (CIV) because it may be abused or lead to drug dependence.
About Eisai Inc.
At Eisai Inc., human health care 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 help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our 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 us at http://us.eisai.com.
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.
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 has granted exclusive marketing and distribution rights for BELVIQ to Eisai Inc. and Eisai Co., Ltd., for the United States and most other territories worldwide.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of Arena Pharmaceuticals, Inc. BELVIQ(R) is a registered trademark of Arena Pharmaceuticals GmbH.
Forward-Looking Statements.
