Arena Pharmaceuticals Reports that Eisai Plans to Further Increase its Sales Force for BELVIQ(R) (lorcaserin HCl) CIV by 50%
-- Expansion to Approximately 600 Sales Specialists Follows Initiation of National Television Advertising Campaign --
-- Access to Reimbursement Coverage Now Exceeds 60% --
SAN DIEGO, May 9, 2014 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today reported that Eisai plans to add more than 200 new contract sales representatives to its Metabolic Business Unit, increasing the sales force for BELVIQ(R) by 50% to approximately 600, triple the size from the commercial launch of BELVIQ in June 2013. Eisai expects this expansion of the sales force will become effective on July 1, 2014, and enable them to reach approximately 90,000 physicians in the United States.
"This second expansion in field support will nearly quadruple physician coverage since launch, and follows Eisai's initiation of a national television advertising campaign for BELVIQ," said Jack Lief, Arena's President and Chief Executive Officer. "With 600 representatives soon to be in the field and increased outreach to consumers about the availability of this treatment option, BELVIQ is well positioned to continue the upward trend in physician and patient adoption."
In addition to creating greater awareness among physicians and patients, Eisai has announced that its continued work to expand reimbursement has resulted in additional insurance coverage for BELVIQ. According to Fingertip Formulary, the number of insured commercial lives in the United States with access to BELVIQ is now estimated to exceed 60%. While the exact coverage for BELVIQ varies by each patient's insurance plan, this improved access means more patients will receive coverage support from their health plan or pharmacy benefit manager.
Michael O'Brien, Eisai Inc.'s Vice President of Americas Metabolic Business Unit, added, "Eisai's human health care mission means we regard patients and their families as the most important participants in the healthcare process. We believe the expanded insurance coverage for BELVIQ is important for patient access, and our television campaign is designed to facilitate an open discussion between patients and physicians about weight and health, making healthy food choices, being more active, and the potential value of BELVIQ in their treatment paradigm."
Eisai is responsible for the marketing and distribution of BELVIQ in the United States under its agreement with Arena.
About BELVIQ(R) (lorcaserin HCl) CIV
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 US Food and Drug Administration. Eisai markets and distributes BELVIQ in the United States, and Arena manufactures and supplies the finished commercial product from its facility in Switzerland. Eisai and Arena's BELVIQ marketing and supply agreement covers most territories worldwide. For more information about BELVIQ, click here for the full US FDA-approved Product Information or visit www.BELVIQ.com.
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 Clinical Trials
-- 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 US FDA-approved Product Information or visit www.BELVIQ.com.
About Arena Pharmaceuticals
Arena is embracing the challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. BELVIQ(R) (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(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
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, use, safety, efficacy, mechanism of action and potential of BELVIQ or lorcaserin; the sales force for BELVIQ and its expansion, including the number of representatives, timing, significance, physician coverage and other expectations; marketing activities, including outreach, education and awareness, facilitating discussions and other expectations; the positioning of BELVIQ and physician and patient adoption; reimbursement coverage for BELVIQ, including efforts to improve coverage, improved coverage, patient access and significance; regulatory review and approval and commercialization of BELVIQ; 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 drugs, including regulatory, manufacturing, supply and marketing 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 (or Arena or a collaborator may not pursue) 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.
Contact: Arena Pharmaceuticals, Inc. Media Contact: Russo Partners
Craig Audet, Senior Vice President, David Schull, President
Operations and Head of Global Regulatory [email protected]
Affairs
[email protected] 858.717.2310
858.453.7200, ext. 1612
www.arenapharm.com
SOURCE Arena Pharmaceuticals, Inc.