XenoPort (NASDAQ:XNPT) today reported an update on prescription trends
and further development of HORIZANT® (gabapentin enacarbil)
Extended-Release Tablets, including feedback from the U.S. Food and Drug
Administration (FDA) on development for treatment of alcohol use
disorder (AUD).
HORIZANT prescription trend highlights include:
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The number of nation-wide prescribed tablets for the 13 weeks ending
December 19, 2014 was 1,256,082, an increase of 18% compared to the
prior 13 weeks ending September 19, 2014 and an increase of 95% over
the 13-week period ending December 20, 2013.*
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The rolling four-week average of prescribed tablets for the week
ending December 19, 2014 was 100,742.* The current wholesale
acquisition cost (WAC) price is $7.69 per tablet.
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During the third quarter of 2014, XenoPort increased its field sales
force of NeuroHealth Sales (NHS) Specialists from approximately 40 to
65 representatives. The number of prescribed tablets for the 13 weeks
ending December 19, 2014 in the territories occupied by the new NHS
Specialists was 227,897, an increase of 46% compared to the 13 weeks
ending June 27, 2014, which was prior to the addition of the new NHS
Specialists.*
Vincent J. Angotti, XenoPort’s chief operating officer, stated, “Our
efforts to educate doctors and patients about HORIZANT are clearly
having an impact. With the addition of the new NHS Specialists who were
deployed during the third quarter of 2014, we believe that prescriptions
will continue to experience strong growth in 2015. Given HORIZANT’s
demonstrated promotional sensitivity and the fact that we believe the
healthcare providers we are currently calling on represent a small
percentage of the prescription market potential of HORIZANT, we plan to
continue to explore means to expand our promotional efforts.”
XenoPort also today provided the following update on the development of
HORIZANT as a potential treatment for AUD:
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In the fourth quarter of 2014, representatives from XenoPort and the
National Institutes for Alcohol Abuse and Alcoholism (NIAAA) conducted
a pre-investigational new drug (IND) meeting with the FDA. Based on
the meeting, XenoPort believes that the FDA has accepted the NIAAA’s
design of the proposed pivotal clinical trial of HORIZANT as a
potential treatment for AUD. In addition, XenoPort believes that it
may be possible for this clinical trial to support a potential
supplemental new drug application (sNDA) for HORIZANT if the results
from the trial are robust and compelling and if there is additional
confirmatory evidence from the literature or other sources to support
the findings.
-
The NIAAA submitted an IND for HORIZANT as a potential treatment for
AUD in December 2014 and has indicated that, upon clearance of the
IND, the NIAAA’s proposed pivotal clinical trial will begin in the
first half of 2015 and that the results may be available by the end of
2016.
Ronald W. Barrett, PhD, chief executive officer of XenoPort, stated,
“HORIZANT sales are growing, and we believe that we have just begun to
unlock the potential value of this product for our stockholders. We have
also consummated agreements with Reckitt Benckiser Pharmaceuticals, Inc.
(now Indivior PLC) for arbaclofen placarbil (AP) and with the NIAAA for
HORIZANT that we believe could lead to important use of
XenoPort-discovered compounds to treat AUD - a serious disorder that
deserves better treatment options.”
Dr. Barrett continued, “We also continue to make good progress on the
development of XP23829. XenoPort believes that XP23829 could potentially
be a best-in-class fumaric acid ester compound with a potentially better
tolerability profile than other drugs in this class. We remain on track
and continue to expect to obtain the top-line results of our Phase 2
XP23829 moderate-to-severe chronic plaque-type psoriasis study in the
third quarter of this year. We believe the study will provide key data
on the effect of dose and dosing regimen on efficacy and tolerability.
In advance of the results, we are focused on preparing to advance
XP23829 into Phase 3 development by mid-2016 in psoriasis and/or
relapsing forms of multiple sclerosis (MS).”
About HORIZANT
HORIZANT, discovered and developed by XenoPort, was approved in the
United States in July 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. XenoPort assumed
responsibility for commercialization of HORIZANT in the United States in
May 2013 after return of all product rights from its former partner. 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.
HORIZANT is protected by a composition-of-matter patent that runs to
2022, with potential patent term extension likely into 2025.
About Alcohol Use Disorder (AUD)
AUD affects about 17 million people in the United States and has an
estimated societal cost of approximately $225 billion each year,
primarily from lost productivity, but also from healthcare and property
damage costs.
About XP23829
XP23829, an experimental drug discovered and currently under development
by XenoPort, is a fumaric acid ester compound that is a prodrug of
monomethyl fumarate (MMF). Fumaric acid ester compounds have shown
immuno-modulatory and neuroprotective effects in cell-based systems and
preclinical models of disease. XenoPort has completed a single-dose, a
multiple-ascending dose and single-dose radiolabeled metabolism and
disposition trials of XP23829 in healthy subjects. It has also completed
13-week toxicology studies in three species. XP23829 is in the fumaric
acid ester class of compounds that include TECFIDERA, which was approved
in March 2013 by the FDA for the treatment of patients with relapsing
forms of MS, and FUMADERM, which is approved in Germany and widely used
for the treatment of patients with psoriasis.
XP23829 is protected by a composition-of-matter patent that currently
has an expiration date of 2029.
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on developing and
commercializing a portfolio of internally discovered product candidates
for the potential treatment of neurological disorders. XenoPort is
currently commercializing HORIZANT in the United States and developing
its novel fumaric acid ester product candidate, XP23829, as a potential
treatment for patients with moderate-to-severe chronic plaque-type
psoriasis and/or relapsing forms of MS. REGNITE® (gabapentin
enacarbil) Extended-Release Tablets is being marketed in Japan by
Astellas Pharma Inc. XenoPort granted exclusive world-wide rights for
the development and commercialization of its clinical-stage oral product
candidate, arbaclofen placarbil, to Reckitt Benckiser Pharmaceuticals,
Inc. (now Indivior PLC) for all indications. XenoPort's pipeline of
product candidates also includes a potential treatment for patients with
Parkinson's disease.
To learn more about XenoPort, please visit the Website at www.XenoPort.com.
Forward-Looking Statements
This press release contains “forward-looking” statements, including,
without limitation, all statements related to the commercial
opportunity, planned promotional efforts, anticipated 2015 prescription
growth and the value proposition for HORIZANT; the potential clinical
development of HORIZANT by the NIAAA, including the initiation, conduct
and results of the NIAAA’s proposed pivotal clinical trial and the
timing thereof; the suitability of HORIZANT as a potential treatment for
AUD; XenoPort’s beliefs regarding the design of NIAAA’s proposed pivotal
clinical trial and its potential to support a potential sNDA for
HORIZANT as a potential treatment for AUD; the potential clinical
development of AP by Reckitt (now Indivior PLC); the suitability of AP
as a potential treatment for AUD; the XP23829 clinical development
program, including XenoPort’s expectations to obtain top-line Phase 2
XP23829 study results in the third quarter of 2015 and to advance
XP23829 into Phase 3 development by mid-2016; the suitability of XP23829
as a potential treatment for moderate-to-severe plaque psoriasis and/or
relapsing forms of MS; the potential that XP23829 could potentially be a
best-in-class fumaric acid ester compound with a potentially better
tolerability profile than other drugs; the potential for HORIZANT patent
term extension; and the therapeutic and commercial potential of
XenoPort’s product candidates. 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,” “could,” “expect,”
“likely,” “may,” “plan,” “possible,” “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 internal and
third-party 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;
the difficulty and uncertainty of pharmaceutical product development and
the uncertain results and timing of clinical trials and other studies,
including the risk that success in preclinical testing and early
clinical trials does not ensure that later clinical trials will be
successful, and that the results of clinical trials by other parties may
not be indicative of the results in trials that XenoPort or its partners
may conduct; XenoPort’s ability to successfully advance XP23829
development and to conduct or initiate clinical trials in the
anticipated timeframes, or at all; the NIAAA’s ability to successfully
conduct the proposed clinical trial of HORIZANT in the anticipated
timeframe, or at all; the risk that the initiation or completion of
clinical trials for XP23829, HORIZANT or AP may be delayed or terminated
as a result of many factors, including delays in patient enrollment; the
risk that XP23829 will require significant additional clinical testing
prior to any possible regulatory approvals and failure could occur at
any stage of its development; the risk that XenoPort and/or the NIAAA
may be required to conduct significant additional clinical testing of
HORIZANT prior to any HORIZANT label expansion to include the AUD
indication; the uncertainty of the FDA’s review process and other
regulatory requirements; the risk that even if HORIZANT is approved for
the treatment of AUD, XenoPort may be unable to, or may otherwise be
unsuccessful in, expanding the commercial opportunity for HORIZANT;
XenoPort’s dependence on collaborative partners; the availability of
resources to develop XenoPort’s product candidates and support
XenoPort’s operations; and the uncertain therapeutic and commercial
value of XenoPort’s product candidates. 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 September 30, 2014, filed with
the Securities and Exchange Commission on November 5, 2014. 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.
*Data Source: Symphony Health Solutions, PrescriberSource Weekly,
09/01/2013 through 12/19/2014.
XNPT2G
Copyright Business Wire 2015