XenoPort Provides Updates on XP23829 Development and HORIZANT Performance
SANTA CLARA, Calif. -- January 12, 2014
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
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
*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.
*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
*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
*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
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
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
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.
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.
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.
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.
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.
Jackie Cossmon, 408-616-7220
Press spacebar to pause and continue. Press esc to stop.