Replies to post #22098 on Arena Pharmaceuticals, Inc. (ARNA)

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Eisai and Arena Pharmaceuticals Announce Completion of Enrollment in BELVIQ® (lorcaserin HCI) CAMELLIA-TIMI 61 Study

Long-Term, Large-Scale Outcomes Study Assesses Cardiovascular and Metabolic Effects of BELVIQ in Overweight and Obese Patients

WOODCLIFF LAKE, N.J. and SAN DIEGO, Dec. 1, 2015 /PRNewswire/ -- Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that the CAMELLIA-TIMI 61 study has reached its target enrollment of 12,000 patients at more than 470 sites in eight countries. The CAMELLIA-TIMI 61 outcomes study is designed to evaluate the impact of long-term treatment with BELVIQ® (lorcaserin HCl) CIV on the incidence of major adverse cardiovascular events and conversion to type 2 diabetes mellitus in obese and overweight patients with cardiovascular disease and/or multiple cardiovascular risk factors.

"We are pleased to see full enrollment in this important study, which will advance scientific understanding of the long-term safety and efficacy of BELVIQ in overweight and obese patients," said Andrew Satlin, MD, Executive Vice President, Neuroscience and General Medicine PCU, Eisai Inc. "As a company focused on human health care, we are committed to increasing our knowledge of the effects of BELVIQ on cardiovascular health."

The five-year study, conducted in partnership with the Thrombolysis in Myocardial Infarction (TIMI) Study Group, will address the post-marketing requirement from the U.S. Food and Drug Administration to evaluate the long-term cardiovascular safety of BELVIQ. In addition, the study includes two primary efficacy endpoints: (1) to assess the effect of BELVIQ on cardiovascular event risk reduction and (2) to assess the effect of BELVIQ on the conversion to type 2 diabetes mellitus among patients without diabetes at baseline.

"We are very excited that CAMELLIA-TIMI 61 has completed enrollment in such a timely fashion," said Benjamin M. Scirica, MD, MPH, Senior Investigator, TIMI Study Group and Associate Professor of Medicine, Harvard Medical School and Co-Primary Investigator of the CAMELLIA-TIMI 61 Trial. "The enthusiasm and speed of enrollment highlights the commitment to evaluate the efficacy and safety of pharmacotherapy in obese and overweight patients who have cardiovascular disease or are at risk of cardiovascular complications. As the largest ongoing outcomes trial in obesity, CAMELLIA-TIMI 61 will provide invaluable information about this traditionally difficult to treat population."

BELVIQ is used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 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 promote satiety and decrease food consumption by selectively activating serotonin 2C receptors in the brain. The exact mechanism of action of BELVIQ is not known.

"We commend Eisai on the progress they have made in advancing CAMELLIA and on reaching this significant milestone," said Harry F. Hixson, Jr., Arena's interim Chief Executive Officer. "Data from this cardiovascular outcomes trial will provide a better understanding of the potential of long-term treatment with BELVIQ, and we look forward to the study results."

About the Study

The CAMELLIA (Cardiovascular And Metabolic Effects of Lorcaserin In Overweight And Obese Patients) TIMI 61 study is the largest ongoing double-blind, placebo-controlled, parallel-group Phase IIIB/IV study among weight loss medications. The primary safety objective is to evaluate the incidence of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction or stroke. If the primary safety objective is met, the co-primary efficacy objectives are to evaluate the impact of BELVIQ on the incidence of: (1) MACE+, defined as MACE or hospitalization due to unstable angina or heart failure, or any coronary revascularization, and (2) conversion to type 2 diabetes mellitus for subjects without diabetes at baseline. In addition, the study will evaluate the efficacy of BELVIQ with respect to glycemic control in patients with type 2 diabetes mellitus.

IMPORTANT SAFETY INFORMATION

Contraindication

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%).
Nursing Mothers

BELVIQ should not be taken by women who are nursing.
BELVIQ is a federally controlled substance (CIV) because it may be abused or lead to dependence.

For more information about BELVIQ, click here for the full Product Information or visit http://www.BELVIQ.com.

About Obesity

Obesity is a serious and growing public health issue. The prevalence of obesity in the U.S. has more than doubled among adults in the past 30 years. Approximately 69 percent of American adults over the age of 20 are affected by obesity and overweight. This dramatic rise in obesity has also had a major impact on other diseases.

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://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 and Pennsylvania, as well as a global demand chain organization that includes 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. 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 embraces the challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. Arena's focus is discovering, developing and commercializing drugs to address unmet medical needs, and BELVIQ® (lorcaserin HCl) is Arena's first internally discovered drug approved for marketing. Arena has US operations located in San Diego, California, and operations outside of the United States, including its commercial manufacturing facility, located in Zofingen, Switzerland. For more information, visit Arena's website at http://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 the TIMI Study Group

The TIMI Study Group is an Academic Research Organization based at Brigham and Women's Hospital that has been leading practice-changing cardiovascular clinical trials for 30 years. Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 3.5 million annual patient visits, is the largest birthing center in New England and employs nearly 15,000 people.

Forward-Looking Statements

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 therapeutic indication, use, safety, efficacy, mechanism of action and potential of BELVIQ or lorcaserin; the cardiovascular outcomes study of BELVIQ, including the protocol, design, scope, enrollment, importance, significance, advancing understanding related to BELVIQ, providing invaluable information, addressing post-marketing requirements and other expectations; 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: the cardiovascular outcomes study of BELVIQ may not proceed at all or in the manner or time expected, and the results of the study may not satisfy post-marketing requirements or otherwise be as expected; risks related to commercializing drugs, including regulatory, manufacturing, supply and marketing issues and the availability and use of BELVIQ or lorcaserin; cash and revenues generated from BELVIQ; the risk that Arena's revenues are 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 lorcaserin may not receive any additional marketing approvals; 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 and third parties' intellectual property rights; the timing, success and cost of Arena's research and development and related strategy and decisions; 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.



Contacts: Eisai Inc.


Investor Inquiries:

Media Inquiries:

Alex Scott

Laurie Landau

[e-mail]

[e-mail]

201.746.2177

201.746.2510



Contact: Arena Pharmaceuticals, Inc.


Craig M. Audet, Ph.D., Senior Vice President,


Operations & Head of Global Regulatory Affairs


[e-mail]


858.453.7200, ext. 1612

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Arena Pharmaceuticals to Present at the 34th Annual J.P. Morgan Healthcare Conference

SAN DIEGO, Jan. 7, 2016 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that the company is scheduled to present a corporate overview and update at the 34th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2016, at 9:00 a.m. Pacific Time (12:00 p.m. Eastern Time), at The Westin St. Francis Hotel in San Francisco, California.

A live audio webcast of the presentation will be available under the investor relations section of Arena's website at www.arenapharm.com. A replay of the presentation will be available for 30 days following the event. Please connect to Arena's website several minutes prior to the start of the webcast to ensure adequate time for any software download that may be necessary.

About Arena Pharmaceuticals

Arena embraces the challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. Arena's focus is discovering, developing and commercializing drugs to address unmet medical needs, and BELVIQ® (lorcaserin HCl) is Arena's first internally discovered drug approved for marketing. Arena has US operations located in San Diego, California, and operations outside of the United States, including its commercial manufacturing facility, located in Zofingen, Switzerland. For more information, visit Arena's website at http://www.arenapharm.com.

Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc. BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.

Forward-Looking Statements

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 Arena's presentation at a conference; 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: risks related to commercializing BELVIQ or any future drug, including regulatory, manufacturing, supply and marketing issues and their availability and use; having adequate funds and other assets and their effective use; the risk that Arena's revenues are 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 lorcaserin may not receive any additional marketing approvals; 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; the timing, success and cost of Arena's research and development and related strategy and decisions; 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; 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 and third parties' intellectual property rights; and satisfactory resolution of litigation or other disagreements. 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.


Craig M. Audet, Ph.D., Senior Vice President,Operations & Head of Global Regulatory [e-mail] 858.453.7200, ext. 1612


http://www.arenapharm.com



To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-to-present-at-the-34th-annual-jp-morgan-healthcare-conference-300200329.html

SOURCE Arena Pharmaceuticals, Inc.

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Eisai and Arena Pharmaceuticals Announce Regulatory Approval of VENESPRI® (lorcaserin HCl) in Mexico

First Country in Latin America to Approve lorcaserin

WOODCLIFF LAKE, N.J. and SAN DIEGO, July 14, 2016 /PRNewswire/ -- Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) has granted regulatory approval of the chronic weight management agent VENESPRI® (lorcaserin HCl: U.S. brand name: BELVIQ®) for commercialization by Eisai Laboratorios, S. de R.L. de C.V. (Eisai Mexico) in Mexico.

http://photos.prnewswire.com/prnvar/20160613/378839LOGO
VENESPRI is now approved in Mexico as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with a body mass index (BMI) of 30 kg/m2 or greater (obese). Patients with a BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes, are also eligible to be treated with VENESPRI. The product is expected to become available later this year. In connection with the approval Arena will receive a $1 million milestone payment.

"Currently more than 70 percent of the Mexican population is either overweight or obese," said Shaji Procida, President and Chief Operating Officer, Eisai Inc. "Without intervention, these numbers are projected to increase. Eisai remains committed to help address the health care needs of this patient population."

In addition to Mexico, lorcaserin HCl is also approved for weight management in the United States and in South Korea, where it is marketed under the name BELVIQ®. Eisai and Ildong Pharmaceutical Co., Ltd., market and distribute BELVIQ in the United States and South Korea, respectively. Arena manufactures and supplies the finished commercial product from its facility in Switzerland.

"We are pleased that the Mexican health authority has approved VENESPRI as an option for patients who find it difficult to lose weight through diet and exercise alone," said Craig M. Audet, Ph.D., Senior Vice President of Operations & Head of Global Regulatory Affairs, Arena Pharmaceuticals, Inc.

About VENESPRI (lorcaserin HCl) BELVIQ CIV (in the United States)) for Chronic Weight Management
VENESPRI is a serotonin 2C receptor agonist approved 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/m2 or greater (obese), or BMI of 27 kg/m2 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 VENESPRI is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products, nor is it known if VENESPRI changes the risk of heart problems or stroke, or death due to heart problems or stroke. The safety and efficacy of coadministration of VENESPRI with other products intended for weight loss, including prescription drugs (e.g., phentermine), over-the-counter drugs and herbal preparations have not been established. The effect of VENESPRI on cardiovascular morbidity and mortality has not been established.

For more information about VENESPRI and BELVIQ in the United States, click here for the full Product Information or visit www.BELVIQ.com.

Important Safety Information for VENESPRI® (marketed as BELVIQ® in U.S.)

Pregnancy: Do not take VENESPRI if you are pregnant or planning to become pregnant, as weight loss offers no potential benefit during pregnancy and VENESPRI may harm your unborn baby.
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions: Before using VENESPRI, 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 VENESPRI. 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 VENESPRI 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 VENESPRI, tell your doctor if you have or have had heart problems.
Changes in attention or memory: VENESPRI may slow your thinking. You should not drive a car or operate heavy equipment until you know how VENESPRI affects you.
Mental problems: Taking too much VENESPRI 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 VENESPRI. 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 VENESPRI, stop taking VENESPRI and call your doctor or go to the nearest emergency room right away.
Slow heartbeat: VENESPRI may cause your heart to beat slower.
Decreases in blood cell count: VENESPRI may cause your red and white blood cell counts to decrease.
Increase in prolactin: VENESPRI 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: VENESPRI should not be taken while breastfeeding.
Drug interactions: Before taking VENESPRI, 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.
About Eisai Laboratorios S. de R.L. de C.V. (Eisai Mexico)
Eisai established Eisai Laboratorios, S. de R.L. de C.V. (Eisai Mexico) in August 2011 in Mexico City as a direct subsidiary of Eisai's U.S. subsidiary Eisai Inc. Mexico is ranked as the fifth largest pharmaceutical market in the Americas behind the United States, Canada, Brazil and Venezuela and the 16th largest in the world.

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 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, manufacturing 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 http://www.eisai.com/US.

About Arena Pharmaceuticals
We are a biopharmaceutical company focused on discovering and developing novel, small molecule drugs. We are currently directing our activities and resources primarily on the following activities:

Advancing our proprietary clinical programs: Etrasimod (APD334) – a next generation, highly specific modulator of Sphingosine 1-Phosphate Subtype 1 (S1P1) receptor – in an ongoing Phase 2 clinical trial for ulcerative colitis, and potentially exploring additional indications, including beyond inflammatory bowel disease Ralinepag (APD811) – an agonist of the prostacyclin receptor – in an ongoing Phase 2 clinical trial for pulmonary arterial hypertension (PAH) APD371 – an agonist of the cannabinoid-2 (CB2) receptor – most recently completed a Phase 1 multiple-ascending dose clinical trial with favorable results, and is under evaluation for pain indications
Supporting our collaborations: Eisai Inc. and Eisai Co., Ltd. and others – in their efforts with respect to the approved product BELVIQ for weight management Axovant Sciences Ltd. – in Phase 2 clinical trials for nelotanserin, an inverse agonist of the serotonin 2A receptor for central nervous system disorders Ildong Pharmaceuticals Co., Ltd. – in a Phase 1 clinical trial for temanogrel, an inverse agonist of the serotonin 2A receptor for thrombotic diseases Boehringer Ingelheim International GmbH – in preclinical development of drug candidates targeting a central nervous system (CNS) receptor for psychiatric diseases
Our US operations are located in San Diego, California, and our operations outside of the United States, including our commercial manufacturing facility, are located in Zofingen, Switzerland. For more information, visit Arena's website at http://www.arenapharm.com.

Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc. VENESPRI® and BELVIQ® are registered trademarks of Arena Pharmaceuticals GmbH.

Forward-Looking Statements
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 expected commercialization of VENESPRI; the achievement of a milestone; Eisai's commitment; Arena's focus, plans and strategy; the advancement and potential of Arena's clinical programs and collaborations; and activities with Eisai and other collaborators. 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 and developing drugs; the risk that we may need additional funds to advance all of our programs, and you and others may not agree with the manner we allocate our resources; cash and revenues generated from BELVIQ, including the impact of competition; the risk that Arena's revenues are 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 lorcaserin may not be approved for marketing in a different formulation or in any other territory; 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 and third parties' intellectual property rights; the timing, success and cost of Arena's research and development and related strategy and decisions; 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.

Contacts: Eisai Inc.


Investor Inquiries:

Media Inquiries:

Ivor Macleod

Laurie Landau

[e-mail]

[e-mail]

201-746-2660

201-746-2510


Contact: Arena Pharmaceuticals, Inc.


Kevin R. Lind, Chief Financial Officer


[e-mail]


858-453-7200, ext. 1716

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Eisai and Arena Pharmaceuticals Announce Presentation of BELVIQ® (lorcaserin HCl) Data at 2016 Annual Obesity Week Meeting

WOODCLIFF LAKE, N.J. and SAN DIEGO, Nov. 3, 2016 /PRNewswire/ -- Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the presentation of one oral presentation and one poster at Obesity Week(SM) regarding new data on BELVIQ® (lorcaserin HCl) CIV. Hosted by The Obesity Society and the American Society for Metabolic and Bariatric Surgery, the meeting is taking place from October 31-November 4, 2016, in New Orleans, Louisiana at the Morial Convention Center.

https://photos.prnewswire.com/prnvar/20120413/MM87168LOGO
Presentations of note include:

Effects of Lorcaserin on Lipid Parameters in Patients With Overweight or Obesity and Dyslipidemia

Oral Presentation Number: T-OR-2070
Session: Energy Balance: Causes and Consequences
Presentation: 11/3/16; 3:45 pm – 5:15 pm
Location: Ernest N. Morial Convention Center; Room 206-207
A post-hoc analysis that evaluated triglycerides (TG) and non-high-density lipoprotein cholesterol (non-HDL-C) after treatment with lorcaserin in a subset of patients without T2DM and with dyslipidemia at baseline (defined as: Fasting TG ≥200 mg/dL and/or non-HDL-C ≥160 mg/dL)

Health-Related Quality of Life in Randomized Controlled Trials of lorcaserin for Obesity Management: What Mediates Improvement?

Poster Number: T-P3478
Session: Pharmacological and Surgical Treatment of Obesity and Others
Presentation: 11/4/16; 12:00 pm – 1:30 pm
Location: Ernest N. Morial Convention Center; Exhibit Hall
A pooled analysis from three lorcaserin Phase 3 trials (BLOOM, BLOSSOM and BLOOM DM) to determine whether lorcaserin is associated with greater improvements in health-related quality of life and whether these improvements are solely attributable to weight loss.

This release discusses an investigational use for an FDA-approved product. It is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain FDA approval.

INDICATION FOR BELVIQ® (lorcaserin HCl) CIV

BELVIQ is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults 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 (eg, hypertension, dyslipidemia, type 2 diabetes).
Limitations of Use

The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss, including prescription drugs (eg, phentermine), over-the-counter drugs, and herbal preparations, have not been established.
The effect of BELVIQ on cardiovascular morbidity and mortality has not been established.
IMPORTANT SAFETY INFORMATION

Contraindication

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 (eg, cabergoline). In clinical trials, 2.4% of patients taking BELVIQ and 2.0% of patients taking placebo developed valvular regurgitation: none of these patients were 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 (eg, sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (eg, 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 (>5% and more common than placebo)

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%).
Nursing Mothers

BELVIQ should not be taken by women who are nursing.
BELVIQ is a federally controlled substance (CIV) because it may be abused or lead to dependence.

For more information about BELVIQ, see full Prescribing Information.

About Eisai Inc.

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.

About Arena Pharmaceuticals

We are a biopharmaceutical company focused on developing novel, small molecule drugs across a range of therapeutic areas. We have three primary proprietary investigational clinical programs: etrasimod (APD334) in Phase 2 evaluation for ulcerative colitis, APD371 entering Phase 2 evaluation for the treatment of pain associated with Crohn's disease, and ralinepag (APD811) in Phase 2 evaluation for pulmonary arterial hypertension (PAH). Additionally, we have collaborations with the following pharmaceutical companies: Eisai Co., Ltd. and Eisai Inc. (commercial stage), Axovant Sciences Ltd. (Phase 2 candidate), and Boehringer Ingelheim International GmbH (preclinical candidate).

Our US operations are located in San Diego, California. Our primary clinical operations are located in Zug, Switzerland, and our commercial manufacturing for BELVIQ is located in Zofingen, Switzerland.

Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc.

BELVIQ® is a registered trademarks of Arena Pharmaceuticals GmbH.

Forward-Looking Statements

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 therapeutic potential of BELVIQ; the need to address obesity; Eisai's commitment; and Arena's focus, plans, goals, strategy, expectations, research and development programs, and ability to 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, supply and marketing issues and the availability and use of BELVIQ; cash and revenues generated from BELVIQ; Arena may need additional funds to advance all of its programs, and you may not agree with the manner Arena allocates its resources; the risk that Arena's revenues are 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 receive any additional marketing approvals; 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 and third parties' intellectual property rights; the timing, success and cost of Arena's research and development and related strategy and decisions; 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; 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.

Contacts: Eisai Inc.

Media Inquiries

Investor Inquiries

Laurie Landau

Ivor Macleod

Eisai Inc.

Eisai Inc.

201-746-2510

201-746-2660



Contact: Arena Pharmaceuticals, Inc.


Kevin R. Lind, Chief Financial Officer


[e-mail]


858-453-7200, ext. 1716


http://www.eisai.com/US


http://www.arenapharm.com