WOODCLIFF LAKE, N.J. and
SAN DIEGO, Calif., April 10, 2015 /PRNewswire/ -- Eisai Inc.
and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced the
completion of two Phase 1 registrational clinical trials that Eisai
and Arena believe demonstrate bioequivalence of an investigational
once-daily extended release formulation of lorcaserin, as compared
to the twice-daily immediate release formulation approved by the US
Food and Drug Administration (FDA) and marketed as BELVIQ®. If
approved, the extended release formulation is expected to be
marketed as BELVIQ XR, which is the brand name conditionally
approved by the FDA.
"This extended release formulation has the potential to offer
once-daily dosing," said Jack Lief, Arena's President and Chief
Executive Officer. "We expect the results from these trials will
allow us to submit a New Drug Application with the FDA for the
treatment of weight management later this year and may also support
our efforts to further pursue additional opportunities within our
lorcaserin lifecycle management portfolio."
Each of the two randomized, crossover trials evaluated the
safety, tolerability, pharmacokinetics and bioavailability of an
extended release formulation of lorcaserin in 36 healthy adult
subjects. Patients in each trial were divided into two treatment
groups and received both doses in a two-way crossover sequence.
Patients in the first study were dosed under fasted conditions
either 10 mg twice-daily (BID) immediate release or 20 mg
once-daily (QD) extended release. Patients in the second study were
dosed either 20 mg QD extended release in the fasted state or 20 mg
QD extended release in the fed state.
The most common treatment-emergent adverse events were similar
to those seen in the Phase 3 clinical trials of BELVIQ, and
included mild or moderate headache, constipation, dizziness and
nausea. There were no discontinuations for adverse events, and no
serious adverse events were observed.
Lorcaserin extended release formulation is investigational and
not approved by any regulatory agency.
About BELVIQ® (lorcaserin HCl) CIV
Immediate-release lorcaserin is approved under the brand name
BELVIQ for weight management by the FDA and the Ministry of Food
and Drug Substances in South
Korea. Eisai Inc. and Ildong Pharmaceutical Co., Ltd.,
market and distribute BELVIQ in the
United States and South
Korea, respectively, and Arena manufactures and supplies the
finished commercial product from its facility in Switzerland.
BELVIQ is a serotonin 2C receptor agonist indicated in
the United States 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. 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.
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 (eg, cabergoline).
In clinical trials, 2.4% of patients taking BELVIQ and 2.0% of
patients taking placebo developed valvular regurgitation: none of
these patients were 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 (eg, sickle cell anemia, multiple
myeloma, or leukemia), or in men with anatomical deformation of the
penis (eg, 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 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 that may lead
to abuse or dependence.
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 help address unmet medical needs. We are a
fully integrated pharmaceutical business with discovery, clinical,
manufacturing and marketing capabilities. Our key areas of
commercial focus include oncology and specialty care (Alzheimer's
disease, epilepsy and metabolic disorders). To learn more about
Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product
creation organization that includes R&D facilities in
Massachusetts, New Jersey, North
Carolina and Pennsylvania,
as well as a global demand chain organization that includes
manufacturing facilities in Maryland and North
Carolina. Eisai's global areas of R&D focus include
neuroscience; oncology; metabolic disorders; vascular, inflammatory
and immunological reaction; and antibody-based programs.
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 focus is discovering, developing and
commercializing drugs to address unmet medical needs, and BELVIQ®
(lorcaserin HCl) is Arena's first internally discovered drug
approved for marketing. 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® and BELVIQ
XR® 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 therapeutic
indication, use, safety, efficacy and potential of BELVIQ and
BELVIQ XR, including the potential of BELVIQ XR to offer once-daily
dosing; submission of a New Drug Application for BELVIQ XR,
including related timing; the potential approval and marketing of
the extended release formulation of lorcaserin, including under the
brand name BELVIQ XR; the results of the registrational trials of
BELVIQ XR, including their significance, demonstrating
bioequivalence, allowing the submission of a New Drug Application
with the FDA and supporting efforts to pursue additional
opportunities; pursuing additional opportunities within the
lorcaserin lifecycle management portfolio; the collaborations with
Eisai and Ildong and related activities and expectations; 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: we may
determine not to submit a regulatory application for BELVIQ XR or
the FDA (or any other regulatory agency) may not accept any such
application, agree that bioequivalence has been established or ever
approve any such application; 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; 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 BELVIQ may not be
approved for marketing 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.
Contacts: Eisai
Inc.
|
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Investor
Inquiries:
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Media
Inquiries:
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Alex Scott
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Laurie
Landau
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alex_scott@eisai.com
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Laurie_Landau@eisai.com
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201.746.2177
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201.746.2510
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Contact: Arena
Pharmaceuticals, Inc.
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Media Contact: Russo
Partners
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Scott A.
Rieger
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David
Schull
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Senior Director,
Investor Relations
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President
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srieger@arenapharm.com
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david.schull@russopartnersllc.com
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858.453.7200, ext.
1347
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858.717.2310
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SOURCE Arena Pharmaceuticals, Inc.