XenoPort, Inc. (Nasdaq: XNPT) announced today a strategic shift to focus
on and maximize the value of its commercial product, HORIZANT®
(gabapentin enacarbil) Extended Release Tablets. As part of this shift,
XenoPort will discontinue development of XP23829 on its own and seek to
partner this and other high potential development stage assets.
In connection with the decision to focus on commercializing HORIZANT,
Ronald W. Barrett, Ph.D., has retired as Chief Executive Officer and as
a Director of XenoPort, effective immediately. Vincent J. Angotti,
Executive Vice President and Chief Operating Officer, who has
spearheaded the commercialization of HORIZANT, has been named Chief
Executive Officer and has joined XenoPort’s Board of Directors. Dr.
Barrett will continue to work with XenoPort in an advisory role, with a
primary focus on ensuring a smooth transition and advising on potential
partnering activities for the company’s development stage assets,
including XP23829.
Mr. Angotti has nearly 25 years of operations and commercialization
experience in both large and start-up specialty pharmaceutical
companies. Prior to joining XenoPort in May 2008, Mr. Angotti held
several positions with Reliant Pharmaceuticals, Inc., the most recent of
which was Senior Vice President of Sales and Marketing. In this senior
leadership role, he was responsible for launching a portfolio of
products including LOVAZA, leading to the acquisition of Reliant by
GlaxoSmithKline in 2008 for $1.7 billion. Prior to Reliant, Mr. Angotti
held several positions at Novartis Pharmaceuticals Corporation, most
recently as Executive Director, Field Operations. Mr. Angotti received a
B.S. from Cornell University and an M.B.A. from Columbia University.
XenoPort also announced that John G. Freund, M.D., has been named
Chairman of XenoPort’s Board of Directors. Dr. Freund has been a member
of XenoPort’s Board since 1999 and has served as its Lead Independent
Director since July 2008.
“On behalf of the Board,” Dr. Freund stated, “I would like to thank Ron
for his dedication and many contributions since co-founding XenoPort in
1999, including the discovery, development and approval of HORIZANT. Ron
recruited Vince to lead the commercialization of HORIZANT and, together
with the management team, they have meaningfully grown HORIZANT sales.
The Board is thrilled to welcome Vince to the role of CEO and has
confidence he will apply his operational and commercial experience to
maximize the value of HORIZANT.”
Mr. Angotti stated, “I am excited by the opportunity to lead the company
with our new strategic focus. Since XenoPort’s launch of HORIZANT in
mid-2013, we have successfully taken a staged approach to its
commercialization. With the recent expansion of our HORIZANT
Neuroscience Health Specialist team to 120 representatives in July, I
believe we are well positioned to expand our educational efforts and
increase access to HORIZANT and thereby meaningfully benefit many more
patients.”
HORIZANT Continues to Show Strong Growth
XenoPort noted that HORIZANT continues to show strong growth following
the re-launch by XenoPort after reacquisition in May 2013. HORIZANT has
achieved the following growth since the second quarter of 2013 with
substantially fewer sales representatives than deployed by its former
partner:
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2Q13
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2Q15
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% Change
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New Prescriptions*
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5,355
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14,221
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+166%
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Total Prescriptions*
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9,173
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26,271
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+186%
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Tablets*
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377,753
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1,379,341
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+265%
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Net Sales
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$1.6 million
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$8.2 million
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+413%
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*Data from National Prescription Audit from IMS
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Expense Reduction
In connection with XenoPort’s strategic shift, the company also
announced that it will be implementing a reduction in work force.
Restructuring costs, primarily related to compensation and benefit
expenses as well as severance costs related to its departing CEO, are
expected to be approximately $3.2 million and result in annual future
cash savings of approximately $6.7 million. In addition, future expenses
will be reduced due to the discontinuation of late-stage development of
XP23829. The company ended the second quarter of 2015 with $170.4
million in cash, cash equivalents and short-term investments.
About HORIZANT
HORIZANT, discovered and developed by XenoPort, was approved in the
United States in April 2011 for the treatment of moderate-to-severe
primary restless legs syndrome (RLS) in adults and in June 2012 for the
management of postherpetic neuralgia (PHN) in adults. The most common
adverse reactions for adult patients with moderate-to-severe primary RLS
receiving HORIZANT were somnolence/sedation, dizziness, headache, nausea
and fatigue. The most common adverse reactions for adult patients with
PHN taking HORIZANT were dizziness, somnolence/sedation, headache,
nausea and fatigue. In addition, the National Institute on Alcohol Abuse
and Alcoholism (NIAAA) is currently funding and conducting a trial of
HORIZANT in patients with alcohol use disorder (AUD). XenoPort is
supplying the clinical trial material for this trial. If successful, it
could lead to a new potential option for the treatment of patients with
AUD.
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on commercializing
HORIZANT in the United States. XenoPort has entered into a clinical
trial agreement with the NIAAA under which the NIAAA has initiated a
clinical trial evaluating gabapentin enacarbil as a potential treatment
for AUD. REGNITE® (gabapentin enacarbil) Extended-Release
Tablets is being marketed in Japan by Astellas Pharma Inc. XenoPort has
granted exclusive world-wide rights for the development and
commercialization of its clinical-stage oral product candidate,
arbaclofen placarbil, to Indivior PLC for all indications. XenoPort’s
other product candidates include XP23829, a novel fumaric acid ester
prodrug that is a potential treatment for patients with
moderate-to-severe chronic plaque-type psoriasis and potentially for
patients with relapsing forms of multiple sclerosis, and XP21279, a
prodrug of levodopa that is a potential treatment for patients with
idiopathic Parkinson's disease.
To learn more about XenoPort, please visit the Web site at www.XenoPort.com.
Forward-Looking Statements
This press release contains "forward-looking" statements, including,
without limitation, all statements related to: the anticipated benefits
and effects related to XenoPort’s announced restructuring and executive
leadership transition; the promotional efforts and value proposition for
HORIZANT, including all statements related to the anticipated impact of
XenoPort’s recent sales force expansion and anticipated future HORIZANT
sales growth; the possible approval of HORIZANT for the treatment of
patients with AUD; and the value of XenoPort’s development stage assets
and the ability to partner XP23829 and other development stage assets.
Any statements contained in this press release that are not statements
of historical fact may be deemed to be forward-looking statements. Words
such as "believe," "can," "could," "plan," "potential," "will" and
similar expressions are intended to identify forward-looking statements.
These forward-looking statements are based upon XenoPort's current
expectations. Forward-looking statements involve risks and
uncertainties. XenoPort's actual results and the timing of events could
differ materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which include,
without limitation, risks related to: XenoPort's relative lack of
commercialization experience and its ability to successfully market and
sell HORIZANT, including XenoPort's ability to maintain a sales force
comprised of both XenoPort-employed sales representatives and contract
sales representatives, and XenoPort's reliance on its contract sales
organization to maintain sales, marketing, distribution, supply chain
and other sufficient capabilities to sell HORIZANT; XenoPort's
dependence on the success of its strategies for HORIZANT
commercialization, promotion and distribution, as well as its ability to
successfully execute on these activities and to comply with applicable
laws, regulations and regulatory requirements; the competitive
environment for and the degree of market acceptance of HORIZANT;
obtaining appropriate pricing and reimbursement for HORIZANT in an
increasingly challenging environment; risks related to future
opportunities and plans, including the uncertainties of future financial
results and XenoPort’s ability to attain profitability; risks related to
the impact of the XenoPort’s announced restructuring and reduction in
workforce on XenoPort’s business, including the risk that such changes
could negatively affect XenoPort’s ability to attract or retain the
personnel necessary to enable XenoPort to successfully commercialize
HORIZANT; risks related to executive leadership transitions, including
that fact that such transitions inherently create uncertainty and can
negatively affect business strategy and execution; XenoPort’s potential
inability to partner XP23829 and its other development stage assets with
third parties on acceptable terms, or at all, including the risk that
XenoPort may fail to realize any return on its investments in such
assets. Many of these and other risk factors are discussed under the
heading "Risk Factors" in XenoPort's Quarterly Report on Form 10-Q for
the quarter ended June 30, 2015 filed with the Securities and Exchange
Commission on August 6, 2015. XenoPort expressly disclaims any
obligation or undertaking to release publicly any updates or revisions
to any forward-looking statements contained herein to reflect any change
in the company's expectations with regard thereto or any change in
events, conditions or circumstances on which any such statements are
based.
HORIZANT, REGNITE and XENOPORT are registered trademarks of XenoPort,
Inc.
XNPT2G
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