SAN DIEGO, Nov. 25, 2014 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that the US
Patent and Trademark Office granted Arena U.S. Patent No.
8,895,776, entitled "Modulators of the Prostacyclin (PGI2) Receptor
Useful for the Treatment of Disorders Related Thereto," covering
ralinepag (formerly APD811), an orally available agonist of the
prostacyclin (IP) receptor. Ralinepag is an investigational drug
candidate being developed by Arena for the treatment of vasospastic
diseases such as pulmonary arterial hypertension (PAH).
"We believe that ralinepag, a lead development compound
discovered and developed at Arena, could provide physicians and
patients an improved treatment option for PAH compared to currently
available therapy," said Jack Lief, Arena's President and Chief
Executive Officer. "The issuance of this patent increases the value
of this important asset by providing duration of coverage in
the United States to at least
August 2031. The FDA recently granted
ralinepag orphan drug status for the treatment of PAH, and we plan
to initiate a Phase 2 trial with the compound before the end of
this year."
Arena owns patents and pending patent applications covering
compositions of matter for ralinepag and related compounds, as well
as methods of treatment utilizing ralinepag and related compounds.
Patent applications for ralinepag have been filed in 19
jurisdictions, including the United
States, Europe,
Japan and China.
About Pulmonary Arterial Hypertension
PAH is a progressive, life-threatening disorder characterized by
increased pressure in the arteries that carry blood from the heart
to the lungs. The increased pressure strains the heart, which can
limit physical activity, result in heart failure and reduce life
expectancy. Based on data from the Registry to EValuate Early And
Long-term PAH disease management (REVEAL) of patients in
the United States, there is an
estimated five-year survival rate of 57% from diagnosis.
About Ralinepag
Ralinepag, an orally available agonist of the IP receptor, is an
investigational drug candidate internally discovered and developed
by Arena and intended for the treatment of vasospastic diseases,
including PAH. In Phase 1 trials, ralinepag showed an approximate
25-hour half-life, indicating that the compound could be dosed
orally, once or twice daily. Arena believes that an orally
available, non-prostanoid IP receptor agonist that provides
clinical benefits similar to currently available IP receptor
agonists has the potential to improve treatment for patients with
PAH.
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 ralinepag; patents, patent
applications and patent protection, including their significance,
coverage, duration and exclusivity provided thereby; the increase
in value and importance of ralinepag; providing an improved
treatment option for PAH; initiation of a Phase 2 trial of
ralinepag, including related timing; potential of an orally
available, non-prostanoid IP receptor agonist that provides
clinical benefits similar to available IP receptor agonists to
improve the standard of care for PAH; 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: Arena's patent protection
and ability to obtain and defend patents; ralinepag may not be
developed or approved for marketing for any disease or condition;
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; 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.
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Media Contact: Russo
Partners
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Craig M. Audet,
Ph.D., Senior Vice President,
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David Schull,
President
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Operations & Head
of Global Regulatory Affairs
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david.schull@russopartnersllc.com
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caudet@arenapharm.com
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858.717.2310
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858.453.7200, ext.
1612
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www.arenapharm.com
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visit:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-issued-composition-of-matter-patent-by-united-states-patent-and-trademark-office-for-ralinepag-and-related-compounds-300000865.html
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SOURCE Arena Pharmaceuticals, Inc.