XenoPort (NASDAQ:XNPT) today reported an update on XP23289
development, including feedback from the U.S. Food and Drug
Administration (FDA) on the potential development plans, and
XenoPort’s progress on commercializing HORIZANT® (gabapentin
enacarbil) Extended-Release Tablets.
XenoPort reported today that it received feedback from the FDA
Division of Neurology Products regarding potential development
plans for XP23829 as a potential treatment for patients with
relapsing forms of multiple sclerosis (MS). Based on the feedback,
XenoPort believes that the FDA would allow XenoPort to initiate
potential Phase 3 clinical development using XP23829 doses that
produce monomethyl fumarate (MMF) exposure similar to that produced
by the approved dose of TECFIDERA (dimethyl fumarate). The FDA
encouraged the exploration of multiple doses of XP23829 to assess
the potential advantages of doses that produced either higher or
lower MMF exposure. The FDA also provided responses to the
company’s questions about its proposed development strategies to
support the potential submission of a New Drug Application (NDA) to
the FDA under Section 505(b)(2). XenoPort believes that the FDA
will require additional information on XP23829 before determining
the applicability of the Section 505(b)(2) pathway. XenoPort will
continue discussions with the FDA regarding what information could
potentially be referenced in a Section 505(b)(2) NDA.
XenoPort also indicated that its plans for 2014 include the
submission of an Investigational New Drug (IND) application to the
FDA Division of Dermatology for XP23829 as a potential treatment
for moderate-to-severe plaque psoriasis. XenoPort plans to initiate
a Phase 2 clinical trial of XP23829 in patients with
moderate-to-severe plaque psoriasis by mid-2014.
Ronald W. Barrett, PhD, chief executive officer of XenoPort,
stated, “We remain focused on advancing the development of XP23829.
We believe that the results of the planned Phase 2 psoriasis study
will guide selection of doses for potential Phase 3 trials for both
psoriasis and relapsing forms of MS. Given its unique attributes,
we intend to develop XP23829 with the objective of differentiating
XP23829 from other products for psoriasis and relapsing forms of
MS, most likely using the Section 505(b)(1) pathway.”
XenoPort also reported today its progress in the
commercialization of HORIZANT since it began its promotional
efforts on June 1, 2013. XenoPort’s efforts are focused on
physician specialists and patients within 40 U.S. geographic
territories. Based on a variety of metrics, XenoPort believes it
has made substantial progress in enhancing the value of the
HORIZANT business.
Dr. Barrett continued, “Based on our current operating plan, and
assuming continued HORIZANT sales growth comparable to what we’ve
experienced since we started commercializing HORIZANT, we believe
that net sales of HORIZANT will exceed the sum of cost of product
sold and selling, advertising and promotional expenses by the end
of 2014, and that the HORIZANT business will reach break-even and
turn profitable by the end of 2015. We believe that our recent
promotional initiatives and future efforts to enhance patient
access to HORIZANT could further increase HORIZANT sales, which
could accelerate the time to potential profitability.”
Dr. Barrett concluded, “The total cost of developing XP23829
will require additional resources regardless of whether or not our
development efforts are partnered. If our development efforts are
partnered, we believe XenoPort’s share of potential XP23829 profits
would likely depend on the degree to which we participate in the
future funding of its development. Importantly, we believe the
HORIZANT business has the potential to become a mechanism to help
fund development of XP23829. We plan to evaluate our progress
against our HORIZANT commercialization objectives and to continue
to determine the optimal approach to meet our goal of maximizing
enterprise value.”
HORIZANT Performance Highlights
Prescription Data/Prescribers
- The nationwide total HORIZANT
prescriptions and prescribed pill count for the 13 weeks ending
December 20, 2013 increased 23% and 26%, respectively, over the
previous 13 weeks.
- In the 40 territories where XenoPort is
promoting HORIZANT, total prescriptions and prescribed pills for
the 13 weeks ending December 20, 2013 increased by 36% and 40%,
respectively, over the previous 13 weeks, versus no growth in
non-promoted territories.
- From June 2013 through November 2013,
there were approximately 2,093 first-time HORIZANT
prescribers.
Patient Education Initiatives
- In October 2013, XenoPort initiated a
digital direct-to-consumer (DTC) educational program focused on
restless legs syndrome (RLS) information seekers located within the
40 territories where XenoPort is promoting HORIZANT. This DTC
initiative has resulted in over 500,000 visits to the HORIZANT
consumer education web page. The number of website visits in the
fourth quarter of 2013 increased more than 20-fold compared with
the third quarter of 2013.
Market Access
- In November 2013, approximately 70% of
HORIZANT prescriptions were from commercially insured patients and
approximately 21% of HORIZANT prescriptions were from Medicare Part
D patients. The remaining HORIZANT prescriptions were from cash,
Medicaid and other forms of reimbursement.
- In November 2013, about 67% of
commercially insured patients had unrestricted access to HORIZANT.
Approximately 75% of HORIZANT prescriptions written for
commercially insured patients were successfully filled.
- In November 2013, about 9% of Medicare
Part D covered patients had unrestricted access to HORIZANT.
Approximately 61% of HORIZANT prescriptions written for Medicare
Part D patients were successfully filled.
- In June 2013, XenoPort introduced a
HORIZANT co-pay assistance card directed at commercially insured
patients with high co-pay insurance coverage. From June through
November 2013, the HORIZANT co-pay assistance cards were used to
fill approximately 10% of total commercial prescriptions.
Vince Angotti, chief operating officer of XenoPort, stated,
“Since re-acquiring HORIZANT rights, we believe we have made
progress in demonstrating that the prior commercial performance of
HORIZANT was not representative of its market potential. Despite a
product stock-out immediately prior to XenoPort’s launch of
HORIZANT, both the total number and the trajectory of growth of
prescribed tablets have achieved all-time highs. This was
accomplished within six months with substantially fewer resources
applied by XenoPort than were provided by the preceding marketer.
We believe that the data to date indicate a positive response to
our promotional efforts. Our objective for 2014 is to continue to
grow HORIZANT sales, enhance patient access and manage costs. We
plan to closely monitor our progress against these objectives.”
HORIZANT Updates and Initiatives for 2014
In January 2014, HORIZANT 300 mg tablets will be available to
pharmacies. HORIZANT 300 mg tablets are indicated for use in the
dosing of adults with impaired renal function who are taking
HORIZANT. The wholesale acquisition cost (WAC) for a bottle of 30
tablets of 300 mg or 600 mg of HORIZANT is currently $162.07.
In January 2014, XenoPort initiated a program to assist
healthcare providers with reimbursement matters and will continue
its co-pay assistance program. It also plans to contract where
appropriate to enhance patient access.
In the first quarter of 2014, XenoPort expects to announce the
top-line results of an FDA-required, post-marketing study of low
doses of HORIZANT for the treatment of moderate-to-severe primary
RLS in adults. The study is being conducted by GlaxoSmithKline.
XenoPort expects that HORIZANT cost of product sold will benefit
for the next several years from the gabapentin enacarbil inventory
that was acquired as part of the termination agreement with its
previous partner.
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 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.
XenoPort initiated personal promotion to healthcare providers in
June 2013 after resolving the product stock-out experienced by its
former partner. XenoPort’s commercial efforts are focused on RLS
and PHN prescribing specialists and patients within 40
territories.
HORIZANT is protected by a composition-of-matter patent that
runs to 2022, with patent term extension likely into 2025.
About XP23829
XP23829, an experimental drug discovered and currently under
development by XenoPort, is a fumaric acid ester compound that is a
prodrug of 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 (U.S.
Patent Number 8,148,414) 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 psoriasis and/or
relapsing forms of MS. REGNITE® (gabapentin enacarbil)
Extended-Release Tablets is being marketed in Japan by Astellas
Pharma Inc. XenoPort's pipeline of product candidates also includes
potential treatments for patients with spasticity related to spinal
cord injury and 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 and value proposition for HORZIANT; the
XP23829 clinical development program, including the initiation or
conduct of planned or potential future clinical trials and the
timing thereof; the potential submission of an NDA to the FDA for
XP23829 and related potential NDA pathways; the potential
submission of an IND to the FDA for XP23829 for moderate-to-severe
plaque psoriasis; the potential suitability of XP23829 as a
treatment for moderate-to-severe plaque psoriasis and/or relapsing
forms MS; the expected cost and financial resources required to
develop XP23829 and related potential partnering efforts; the
potential for HORIZANT to help fund development of XP23829;
projections and estimates regarding future financial performance
and HORIZANT growth potential, including the potential for the
HORIZANT business to reach break-even and become profitable by the
end of 2015, future potential HORIZANT sales growth, net sales and
expense projections, and planned promotional efforts; the potential
for HORIZANT patent term extension; XenoPort’s expectations
regarding the announcement of the results of the HORIZANT
post-marketing study; and other statements that are not historical
facts. 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 “achieve,” “believe,” “believes,”
“could,” “encouraged,” “intend,” “initiate,” “likely,” “plan,”
“potential,” “preparing,” “proposed,” “should,” “will,” “would” 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 lack of commercialization experience and its ability to
successfully market and sell HORIZANT, including XenoPort’s ability
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; 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 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 uncertainty of the FDA’s
review process and other regulatory requirements; XenoPort’s
dependence on future collaborative partners; XenoPort’s need for
and the availability of resources to develop XP23829 and support
XenoPort’s operations; the uncertain therapeutic and commercial
value of HORIZANT and XP23829; as well as risks related to future
opportunities and plans, including the uncertainty of projected
future financial performance and results. 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, 2013, filed with the Securities and Exchange
Commission on November 8, 2013. 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
XenoPortJackie Cossmon, 408-616-7220ir@XenoPort.com
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