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XenoPort Provides Update on Its Introduction of Horizant



  XenoPort Provides Update on Its Introduction of Horizant

Business Wire

SANTA CLARA, Calif. -- April 12, 2013

XenoPort, Inc. (Nasdaq: XNPT) reported today that GlaxoSmithKline (GSK), who
holds commercialization rights to Horizant^® (gabapentin enacarbil)
Extended-Release Tablets in the United States during a transition period
ending on April 30, 2013, has experienced manufacturing delays that have
resulted in a stockout of Horizant. GSK continues to have sole responsibility
for the manufacture and supply of Horizant during this transition period and
is working to resolve the manufacturing issues with its contract manufacturer.
Although the timing is not yet certain, XenoPort is hopeful that new inventory
of Horizant will be available in pharmacies in June.

In accordance with the November 8, 2012 Termination and Transition Agreement
between XenoPort and Glaxo Group Limited, XenoPort will assume
responsibilities for further development, manufacturing and commercialization
of Horizant in the United States on May 1, 2013. As part of this agreement,
GSK agreed to continue to supply Horizant to XenoPort until October 30, 2013.
XenoPort is in the process of completing preparations to assume all other
responsibilities for Horizant, including the deployment of its contract sales
force and other commercialization efforts to fully support Horizant product
sales in the United States. However, as a result of the manufacturing delays,
XenoPort anticipates that its full commercial introduction of Horizant will
not commence until a sufficient supply of Horizant is available.

Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, “We are
obviously disappointed by this news, particularly since we have received
inquiries from patients who have been unable to get their Horizant
prescriptions filled. We are working with GSK and its contract manufacturer to
expedite the next Horizant manufacturing campaign, and we are also advancing
our plans to work directly with the contract manufacturer as soon as
possible.”

Dr. Barrett continued, “We are evaluating the impact, if any, this will have
on our financial expectations for Horizant. We believe we will gain clarity on
this as we address backorders, fill the supply chain and work to ensure an
uninterrupted supply of Horizant in the future.”

About XenoPort

XenoPort is a biopharmaceutical company focused on developing and
commercializing a portfolio of internally discovered product candidates for
the potential treatment of neurological disorders. Horizant is our first
approved product in the United States. GlaxoSmithKline holds commercialization
rights for Horizant in the United States during a transition period ending on
April 30, 2013, following which XenoPort will be responsible for the further
development, manufacturing and commercialization of Horizant. Regnite^®
(gabapentin enacarbil) Extended-Release Tablets is approved and is being
marketed in Japan. Astellas Pharma Inc. holds all development and
commercialization rights for Regnite in Japan and five other Asian countries.
XenoPort holds all other world-wide rights to gabapentin enacarbil. XenoPort's
pipeline of product candidates includes potential treatments for patients with
spasticity, Parkinson's disease, relapsing-remitting multiple sclerosis and
psoriasis. 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 GSK’s future activities during the
transition period with respect to their sole oversight over all aspects of the
manufacturing relating to Horizant; XenoPort’s future development,
manufacturing and commercialization activities with respect to Horizant
following such transition period, and the timing thereof; expected timing for,
and the future sufficiency of, drug supply; XenoPort’s anticipated timing for
the full commercialization of Horizant; the impact, if any, on XenoPort’s
financial expectations for Horizant; and XenoPort’s future activities with
respect to addressing backorders, filling the supply chain and working to
ensure an uninterrupted supply of Horizant. 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 “anticipates,” “believes,”
“expectations,” “hopeful,” “plans,” “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
lack of commercialization experience and its ability to establish, or contract
with third parties to establish, sales, marketing, distribution,
manufacturing, supply chain and other sufficient capabilities to assume
responsibility for, and to market and sell, Horizant following the transition
period; XenoPort’s ability to successfully market and sell Horizant following
the transition period, including its ability to obtain uninterrupted drug
supply and appropriate pricing and reimbursement for Horizant in an
increasingly challenging environment, and whether any such sales will be
sufficient to outweigh the costs of establishing and maintaining sales,
marketing, distribution, supply chain and other capabilities; XenoPort’s
ability to comply with applicable regulatory guidelines and requirements with
respect to the marketing and manufacturing of Horizant or with Horizant
post-marketing commitments or requirements mandated by the U.S. Food and Drug
Administration (FDA); XenoPort’s need for additional funding and the risk that
XenoPort could utilize its available capital resources sooner than it expects;
the uncertainty of the FDA approval process and other regulatory requirements;
and risks related to future opportunities and plans, including the uncertainty
of expected future financial performance and results. These and other risk
factors are discussed under the heading “Risk Factors” in XenoPort’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2012, filed with
the Securities and Exchange Commission on March 14, 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.

XENOPORT, Horizant and Regnite are registered trademarks of XenoPort, Inc.

XNPT2G

Contact:

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