SAN DIEGO, Calif., Feb. 10, 2014 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today reported that Eisai has
secured improved patient access of BELVIQ® (lorcaserin
HCl) with two leading healthcare benefit companies, and that the
estimated number of insured commercial lives in the United States that have coverage for
BELVIQ now exceeds 50 percent.
CVS Caremark customers (employers and health plans) have
broadened the coverage of BELVIQ, and eligible CVS Caremark members
may have access to BELVIQ in either a preferred or non-preferred
brand position depending on the design of the employer benefit or
health plan. In addition, Aetna recently announced that it would
offer BELVIQ as a preferred brand to eligible patients as part of
its pilot program to self-insured plan sponsors nationwide. The
Aetna program, which offers access to lifestyle management programs
and surgical options, will also measure improvements in health
outcomes, productivity and medical costs.
"Securing broad reimbursement coverage for patients is an
important part of the foundation for the long-term success of
BELVIQ in the United States, and
Eisai has continued to demonstrate its expertise in this area,"
said Jack Lief, Arena's President and Chief Executive Officer.
"Over 50 percent of insured commercial lives with coverage
for BELVIQ represents a significant increase from the approximately
30 percent of insured commercial lives that were estimated to have
coverage at launch in June 2013."
Lonnel Coats, President and Chief
Executive Officer of Eisai Inc., added, "We are committed to
ensuring that patients have access to BELVIQ. Given how many people
are struggling with their weight, it's important to provide
treatment options to those who have not been able to sustain
long-term weight loss with diet and exercise alone."
A patient's individual coverage for BELVIQ will vary, and
may depend on the design of the patient's employer benefit or
health plan. The estimated number of insured commercial lives is
derived from Fingertip Formulary data, which is generally based on
enrollment reported by health plans and pharmacy benefit
managers.
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 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.
Indications
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/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
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.
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.
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;
reimbursement coverage of BELVIQ, including the improvement and
importance of coverage; CVS Caremark's coverage, the Aetna program
and related activities and expectations; the long-term success of
BELVIQ; Eisai's commitment to patient access and expertise with
respect to reimbursement coverage; the importance of providing
treatment options; regulatory review and approval and marketing and
distributing of BELVIQ; 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 we 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
|
|
|
Cindy McGee, Vice President,
|
David Schull,
President
|
Investor Relations & Alliance Management
|
david.schull@russopartnersllc.com
|
cmcgee@arenapharm.com
858.453.7200, ext. 1479
www.arenapharm.com
|
858.717.2310
|
SOURCE Arena Pharmaceuticals, Inc.