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

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.

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 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:

1. Advancing our proprietary clinical programs:
   1. 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
   2. Ralinepag (APD811) – an agonist of the prostacyclin receptor – in an ongoing Phase 2 clinical trial for pulmonary arterial hypertension (PAH)
   3. 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
2. Supporting our collaborations:
   1. Eisai Inc. and Eisai Co., Ltd. and others – in their efforts with respect to the approved product BELVIQ for weight management
   2. Axovant Sciences Ltd. – in Phase 2 clinical trials for nelotanserin, an inverse agonist of the serotonin 2A receptor for central nervous system disorders
   3. Ildong Pharmaceuticals Co., Ltd. – in a Phase 1 clinical trial for temanogrel, an inverse agonist of the serotonin 2A receptor for thrombotic diseases
   4. 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 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.

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SOURCE Eisai Inc.

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