SAN DIEGO and WOODCLIFF LAKE, N.J., April 7, 2015 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc., announced
today that the US Patent and Trademark Office granted Arena US
Patent No. 8,999,970, which describes a method for selecting
appropriate patients based on renal function for BELVIQ®
(lorcaserin HCl), a serotonin 2C receptor agonist approved for
weight management.
"Seeking strong intellectual property protection has always been
a key component of Arena's business model," said Jack Lief, Arena's
President and Chief Executive Officer. "We expect this new patent
to extend exclusivity for BELVIQ until 2033."
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.
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.
BELVIQ is approved for weight management by the US Food and Drug
Administration (FDA) and the Ministry of Food and Drug Substances
(MFDS) 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.
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 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® is a registered
trademark of Arena Pharmaceuticals GmbH.
About Eisai Inc.
At Eisai Inc., human health care is our goal. Eisai gives its
first thoughts to patients and their families, and helping to
increase the benefits health care provides. As the US
pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., Eisai has a
passionate commitment to patient care that is the driving force
behind Eisai's efforts to help address unmet medical needs. Eisai
is 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.
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; patent coverage for BELVIQ, including its
significance, patent term, exclusivity period and possible
extension; seeking strong intellectual property protection; 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: 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; Arena's and third parties' intellectual property
rights; 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; 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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www.eisai.com/US
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www.arenapharm.com
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SOURCE Arena Pharmaceuticals, Inc.