ARENA PHARMACEUTICALS, INC. SAN DIEGO, Jan. 9, 2015 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today reported on Eisai Inc.'s updated BELVIQ® marketing program with targeted new initiatives to address payers, patients and physicians.
Encouraged by the increasing number of payers who have made the decision to provide formulary coverage for BELVIQ, Eisai will continue to focus on expanding managed care and employer coverage in the year ahead. For patients who do not have health insurance coverage for BELVIQ, Eisai plans on launching a new program next week to help improve access and affordability. Additionally, Eisai plans to expand its consumer outreach efforts, and the BELVIQ sales force will consist of 450 representatives strategically focused on health care providers who may prescribe pharmacotherapy for weight management.
"At the time of FDA approval, BELVIQ was the first new prescription drug for weight management in over a decade, and since then approximately 275,000 patients have initiated therapy," said Jack Lief, Arena's President and Chief Executive Officer. "Eisai's updated sales and marketing initiatives, including its plans to increase the access and affordability of BELVIQ for a greater number of patients, as well as the strategic focus of its sales force, are being launched at a time of year when we historically see a renewed interest by patients and physicians to address weight management."
BELVIQ is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m(2) or greater (obese), or 27 kg/m(2) or greater (overweight) in the presence of at least one weight-related, comorbid condition (e.g., hypertension, dyslipidemia, 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, and the effect of BELVIQ on cardiovascular morbidity and mortality has not been established.
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 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 marketing and supply agreement for BELVIQ 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. Arena's internally discovered drug, BELVIQ(®) (lorcaserin HCl), is approved in the United States, and 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 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 the advancement, therapeutic indication, use, safety, efficacy, mechanism of action, and potential of BELVIQ; Eisai's new sales and marketing initiatives, including with respect to scope, BELVIQ access and affordability, outreach, timing and other expectations; the BELVIQ sales force, including size and focus; coverage for BELVIQ, including Eisai's focus and expanding such coverage; health care providers prescribing pharmacotherapy for weight management; seasonal focus on weight loss and renewed interest in addressing weight management; rights, obligations and activities under the marketing and supply agreement among Arena and Eisai; 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 effectiveness of Eisai's sales and marketing initiatives and related efforts, and whether and how such initiatives and efforts may change in the future; 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 and third parties' intellectual property rights; 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 M. Audet, Ph.D., Senior Vice President, David Schull, President
Operations & Head of Global Regulatory Affairs david.schull@russopartnersllc.com
caudet@arenapharm.com 858.717.2310
858.453.7200, ext. 1612
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SOURCE Arena Pharmaceuticals, Inc.
