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:
- 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.*
- 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.
- 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:
- 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
XenoPort, Inc.Jackie Cossmon, 408-616-7220ir@XenoPort.com
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