SAN DIEGO, Sept. 2, 2014 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that the US
Food and Drug Administration (FDA) has granted orphan drug status
to APD811 for the treatment of pulmonary arterial hypertension.
"The FDA Office of Orphan Products Development (OOPD) evaluates
scientific and clinical data submissions from sponsors to identify
and designate drug candidates that could potentially treat rare
diseases to help advance the evaluation and development of such
products," said Craig M. Audet,
Ph.D., Arena's Senior Vice President, Operations & Head of
Global Regulatory Affairs. "We are pleased with the OOPD's
designation of orphan drug status for the active moiety of APD811,
and we look forward to advancing this drug candidate into a Phase 2
clinical trial program later this year."
About Orphan Drug Status
Under the Orphan Drug Act, the FDA may grant orphan drug
designation to drug candidates intended to treat a rare disease or
condition that generally affects fewer than 200,000 individuals in
the United States. Orphan drug designation qualifies the
sponsor of the drug candidate for various development incentives,
which may include tax credits for qualified clinical testing, an
exemption from fees under the Prescription Drug User Fee Act
(PDUFA), and a seven-year marketing exclusivity period following
approval. Orphan drug status applies specifically to the active
moiety and the indication for which it is granted, and is not
applicable to other indications for that moiety.
About Pulmonary Arterial Hypertension (PAH)
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 APD811
APD811, an orally available agonist of the prostacyclin (IP)
receptor, is an investigational drug candidate internally
discovered and developed by Arena and intended for the treatment of
vasospastic diseases, such as 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 APD811; the significance and
potential benefits of APD811's designation as an orphan drug; the
advancement of APD811 into a Phase 2 clinical trial program and
related timing; 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: potential benefits relating to APD811's
designation as an orphan drug depend on whether the drug candidate
is developed and approved for marketing for PAH, and APD811 may not
be developed or approved for marketing for PAH or 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; 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.
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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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SOURCE Arena Pharmaceuticals, Inc.