SAN DIEGO, Oct. 27, 2015 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced plans to
improve efficiencies and reduce costs as it focuses on the
advancement of its research and development priorities.
Arena intends to focus on its key strengths by concentrating
near-term activities and resources primarily on:
- advancing its APD334 program, including the ongoing Phase 2
clinical trial for ulcerative colitis, and potentially exploring
additional indications beyond inflammatory bowel disease through
small pilot studies;
- advancing its ralinepag (formerly known as APD811) program,
including its ongoing Phase 2 clinical trial for pulmonary arterial
hypertension (PAH), and potentially exploring enhanced efficacy
with other classes of PAH agents;
- advancing its APD371 program through a Phase 1
multiple-ascending dose clinical trial;
- supporting Eisai to advance the MACE, diabetes conversion, MACE
plus and other endpoints of the ongoing BELVIQ®
(lorcaserin HCl) cardiovascular outcomes trial (CVOT), also known
as the CAMELLIA study, and seeking potential regulatory approval
for BELVIQ XR®, a once-daily formulation of BELVIQ;
- maintaining its core research function to discover and advance
drug candidates;
- assessing strategic collaboration opportunities for certain
clinical- and earlier-stage programs; and
- meeting manufacturing obligations to collaborators and others,
while reducing commercial manufacturing overhead to achieve
potential savings.
As part of this initiative, Arena will reduce its US workforce
by approximately 80 employees or 35%, which Arena estimates will
reduce annualized cash expenditures for personnel by approximately
$11.0 million. Arena plans to
implement additional cost control measures to further reduce its
expenditures, including reductions at its Swiss manufacturing
facility, Arena Pharmaceuticals GmbH.
"This initiative supports our strong desire to create a more
streamlined and efficient organization focused on key priorities
designed to add both near- and long-term value to the
organization," said Harry F. Hixson,
Jr., Arena's interim Chief Executive Officer. "We believe
our clinical-stage pipeline, including the MACE plus portion of the
CAMELLIA study, offer tremendous promise, and we are committed to
generating clinical data supporting meaningful differentiation of
our compounds from currently available therapies. We thank all of
our employees who were affected by today's announcement for their
contributions to Arena."
As a result of the US workforce reduction, which is planned to
be completed by December 31, 2015,
Arena estimates it will incur restructuring charges, primarily in
the fourth quarter of 2015, of approximately $3.3 million in connection with one-time employee
termination costs, including severance and other benefits.
As part of this initiative, Arena does not intend to currently
advance certain lifecycle management programs for lorcaserin,
including evaluating lorcaserin in combination with phentermine and
for smoking cessation. Feedback from the US Food and Drug
Administration regarding a lorcaserin and phentermine combination
for weight management indicated that a full development program
would be required, including a factorial design Phase 2 study and
two, 1-year Phase 3 studies. In addition, with respect to
lorcaserin's potential for smoking cessation, there are
market-specific challenges that might limit the potential return on
the investment required to advance a development program for this
indication.
Arena expects to discuss its new strategic focus and cost
reduction plan during its upcoming quarterly conference call.
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® and BELVIQ XR® are registered
trademarks 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 reduction
of Arena's workforce, including the expected size, timing, related
charges and benefits, and other expected impact of such reduction;
Arena's focus, plans and strategy, including with respect to
research, development, regulatory, and collaborations, and related
activities, benefits, outcome and expectations; the advancement and
potential of Arena's research and development programs; seeking
potential regulatory approval of BELVIQ XR; activities with Eisai;
assessing strategic collaboration opportunities; meeting
manufacturing obligations; implementing additional cost control
measures; reducing expenditures and achieving savings; 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 risk
that the cost and other negative effects related to the reduction
of Arena's workforce may be greater than anticipated; the risk that
Arena may not realize the benefits expected from the workforce
reduction or other cost control measures; 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.
Contact: Arena Pharmaceuticals, Inc.
Craig M. Audet, Ph.D., Senior
Vice President,
Operations & Head of Global Regulatory Affairs
caudet@arenapharm.com
858.453.7200, ext. 1612
www.arenapharm.com
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SOURCE Arena Pharmaceuticals, Inc.