SAN DIEGO and WOODCLIFF LAKE, N.J., Oct. 27, 2015 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today
that the US Patent and Trademark Office granted Arena US Patent No.
9,169,213, entitled "Method of Weight Management," covering
BELVIQ® (lorcaserin HCl) for chronic weight
management.
"This patent is based on the discovery that achieving 5% weight
loss with BELVIQ by Week 12 is a strong predictor of responses in
weight loss at Week 52 of treatment," said Harry F. Hixson, Jr., Arena's interim Chief
Executive Officer. "We expect that this method-of-treatment patent
will provide additional support for exclusivity in the US until
2032, further strengthening our intellectual property position for
BELVIQ."
In addition to this method-of-treatment patent,
composition-of-matter patents for BELVIQ are issued in major
jurisdictions globally that, in most cases, are capable of
continuing into 2023. Arena has filed applications for patent term
extension on patents directed to composition of matter in
the United States, which, if
granted, would extend the composition-of-matter patent term for
BELVIQ into 2026 or potentially 2027. In addition, the US Patent
and Trademark Office previously granted Arena a method-of-treatment
patent, US Patent No. 8,999,970, which describes a method for
selecting appropriate patients based on renal function for BELVIQ
and may extend exclusivity for BELVIQ in the US until 2033.
About BELVIQ® (lorcaserin HCl) CIV
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.
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.
Response to therapy should be evaluated by Week 12. If a patient
has not lost at least 5% of baseline body weight, discontinue
BELVIQ as it is unlikely that the patient will achieve and sustain
clinically meaningful weight loss with continued treatment.
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 (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, and Pennsylvania, as well as a global demand chain
organization that includes 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 embraces 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 has US operations
located in San Diego, California, and operations outside of the
United States, including its
commercial manufacturing facility, 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 therapeutic
indication, use, safety, efficacy, mechanism of action and
potential of BELVIQ or lorcaserin; patent coverage for BELVIQ,
including the importance of individual patents and its
significance, strength, patent term, exclusivity period and
possible extension; the Eisai collaboration 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: the extent, term and significance of
patent coverage are uncertain, and any patent may not effectively
provide exclusivity against competition or increase the commercial
value of a drug; risks related to commercializing drugs, including
regulatory, manufacturing, supply and marketing issues and the
availability and use of BELVIQ or lorcaserin; 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 lorcaserin 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 and related strategy and decisions; 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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Craig M. Audet,
Ph.D., Senior Vice President,
Operations & Head of Global Regulatory Affairs
caudet@arenapharm.com
858.453.7200, ext. 1612
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visit:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-issued-additional-patent-covering-belviq-lorcaserin-hcl-by-united-states-patent-and-trademark-office-300166484.html
SOURCE Arena Pharmaceuticals, Inc.; Eisai Inc.