Arena Pharmaceuticals Reports That Eisai Will Double BELVIQ® (lorcaserin HCl) CIV Sales Force by December Expansion to Approximately 400 Sales Specialists Follows Increased Coverage of BELVIQ by Health Plans and Pharmacy Benefit Managers
SAN DIEGO, Oct. 15, 2013 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today reported that Eisai Inc. will increase its BELVIQ® sales force to approximately 400 representatives by December 2013, doubling the size of the sales force from when BELVIQ became available in June 2013.
The expansion of the sales force, which has commenced and follows increases in coverage of BELVIQ by health plans and pharmacy benefit managers (PBMs) since the launch, will enable Eisai to reach approximately 65,000 physicians in the United States, including primary care providers, endocrinologists, cardiovascular specialists and gastrointestinal specialists. BELVIQ is now covered by several prominent health plans and PBMs, including, among others, Express Scripts (including its legacy Express Scripts and Medco operations), Tufts, Health Alliance Plan, Excellus BCBS, Highmark BCBS, BCBS of Michigan, BCBS of North Carolina and Healthnet (California), according to BusinessOne Technologies, Inc. While the exact coverage for BELVIQ varies by patient, this improved access means more patients will receive coverage support from their health plan or PBM.
"Eisai launched BELVIQ with a focus on educating an initial group of physicians, expanding reimbursement coverage, introducing patient support programs and increasing patient awareness," said Jack Lief, Arena's President and Chief Executive Officer. "We have seen increasing physician interest in BELVIQ as an important treatment option for chronic weight management, the payor landscape has improved and we are encouraged by the early response to the patient support programs and recently launched patient campaign. Eisai's efforts have led to month over month increases in BELVIQ prescriptions to date, and we expect that the expansion of the BELVIQ sales force will help communicate the safety and efficacy of BELVIQ to an increased number of physicians."
Lonnel Coats, Eisai Inc.'s President and Chief Executive Officer, added, "Eisai is deeply committed to launching innovative therapies with strong support from the payor community. The expansion of our sales force demonstrates the success we have gained in discussing the potential value of BELVIQ in chronic weight management within the payor community, and the subsequent agreements we have reached with many of our payor partners. We are in very active and productive discussions with other major payors and fully expect the reimbursement landscape will further improve as we head into 2014."
Eisai is responsible for the marketing and distribution of BELVIQ in the United States under its agreement with Arena.
About BELVIQ® (lorcaserin HCl) CIV
BELVIQ (pronounced BEL-VEEK) is approved by the US Food and Drug Administration for chronic weight management, and is available by prescription in the United States. BELVIQ is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. The exact mechanism of action is not known.
BELVIQ is indicated to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index 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).
Limitations of Use:
- The safety and efficacy of coadministration of BELVIQ 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 BELVIQ on cardiovascular morbidity and mortality has not been established.
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.
Arena has granted exclusive marketing and distribution rights to Eisai Inc. for most of North and South America, to Ildong Pharmaceutical Co., Ltd., for South Korea, and to CY Biotech Company Limited for Taiwan. Arena plans to enter into additional collaborations to commercialize BELVIQ outside of these territories.
About Arena Pharmaceuticals
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.
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, mechanism of action, regulatory review and approval, and potential of BELVIQ; the expansion of the BELVIQ sales force, including the number of representatives, related timing and expectations and significance; marketing activities, including with respect to product education, awareness and interest and patient support; reimbursement coverage of BELVIQ, including the improvement of the coverage; rights and obligations under the marketing and supply agreements for BELVIQ; plans to enter into additional collaborations and the commercialization of BELVIQ in additional territories; 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 drugs, including regulatory, manufacturing and supply issues and the availability and use of BELVIQ; cash and revenues generated from BELVIQ, including the impact of competition; Arena's revenues will be 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 be approved for marketing when expected or ever in combination with another drug, for another indication or using a different formulation or in any other territory for any indication; 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 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; 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.
SOURCE Arena Pharmaceuticals, Inc.