SAN DIEGO, May 11, 2015 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that its
subsidiary, Arena Pharmaceuticals GmbH, and Roivant Sciences Ltd.,
have entered into a Development, Marketing and Supply Agreement for
nelotanserin, Arena's internally discovered inverse agonist of the
5-HT2A receptor. The agreement grants Roivant exclusive worldwide
rights to develop and commercialize nelotanserin.
Nelotanserin has been studied to date in multiple clinical
trials involving over 900 subjects. Roivant intends to initiate
additional Phase 2 clinical trials for the treatment of behavioral
and neuropsychiatric disturbances, including psychoses, in patients
with dementia and other neurological diseases. In addition, Roivant
may pursue the development of nelotanserin for other
neuropsychiatric disorders. Roivant will be responsible for funding
the development and commercialization of nelotanserin.
"Arena's prior clinical trials support nelotanserin's
tolerability, activity in the brain and potential to treat a
variety of neuropsychiatric conditions," said Jack Lief, Arena's
President and Chief Executive Officer. "Our collaboration with
Roivant enables clinical development to proceed for this novel
compound that has the potential to provide treatment in an area of
unmet medical need."
"Roivant is uniquely positioned to maximize the therapeutic and
commercial value of nelotanserin," said Vivek Ramaswamy, Founder of Roivant. "The 5-HT2A
receptor is one of the most promising targets for the treatment of
behavioral disturbances and neuropsychiatric symptoms in patients
with dementia and other neurological diseases. We applaud Arena for
discovering and advancing a potent, selective and potential
best-in-class 5-HT2A inverse agonist, and we look forward to
consummating the development and commercialization of
nelotanserin."
Under the agreement, Arena will manufacture clinical supply and
commercial product to sell to Roivant. Arena will receive a
$4.0 million upfront payment and is
eligible to receive $41.5 million in
regulatory and development milestone payments. Arena is also
eligible to receive 15% of net sales of nelotanserin in exchange
for the manufacture and supply of finished commercial drug product,
and up to a total of $60.0 million in
one-time purchase price adjustment payments tied to certain
commercial sales milestones.
About Nelotanserin
Nelotanserin is a potent and selective inverse agonist of the
5-HT2A receptor that has been implicated in the pathophysiology
underlying psychosis. Nelotanserin was discovered and developed by
Arena, and completed Phase 1 trials in healthy volunteers and Phase
2 trials in subjects with insomnia before development was
discontinued for that indication.
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.
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 rights,
obligations, activities, payments and expectations with respect to
the arrangement with Roivant; the development, therapeutic
indication, use, safety, efficacy, potency, selectivity, mechanism
of action, marketing approval, commercialization and potential of
nelotanserin; the significance of prior studies and trials for
nelotanserin, including supporting future development; Roivant's
plans and intentions for nelotanserin and its positioning;
maximizing the value of nelotanserin; the 5-HT2A receptor,
including its potential and promise as a target for treatment;
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:
nelotanserin may not be further developed, approved for marketing
or commercialized for any disease or condition; 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; 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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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.
1374
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858.717.2310
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SOURCE Arena Pharmaceuticals, Inc.