XenoPort Reports Top-Line Results of Phase 3 Trial of Arbaclofen Placarbil for Spasticity in Multiple Sclerosis Patients

  XenoPort Reports Top-Line Results of Phase 3 Trial of Arbaclofen Placarbil
  for Spasticity in Multiple Sclerosis Patients

Business Wire

SANTA CLARA, Calif. -- May 20, 2013

XenoPort, Inc. (Nasdaq: XNPT) announced today top-line results from its
pivotal Phase 3 clinical trial of arbaclofen placarbil (AP) for the treatment
of patients with spasticity due to multiple sclerosis (MS). The trial was
unsuccessful in demonstrating that AP provided statistically significant
improvement relative to placebo in the co-primary endpoints of the study.

Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, “We are
obviously disappointed that the co-primary efficacy endpoints were not met.
Based on the results of the study, we have decided to terminate further
investment in this program. We will be working diligently to shut down all
activities related to AP development, and plan to provide an update in the
future on the impact of these expected savings on our cash burn guidance. We
remain committed to allocating our resources to build value through the
focused commercialization of Horizant and advancing the development of our
novel fumarate product candidate, XP23829.”

About the Trial

The trial was a 13-week, multicenter, randomized, double-blind,
placebo-controlled study that enrolled 228 subjects in 30 sites in the United
States. There was a one-week placebo run-in period, two weeks of up-titration,
eight weeks at the maintenance dose and two weeks of down-titration. Eligible
subjects were randomized to one of four arms: 15 mg, 30 mg or 45 mg of AP or
placebo dosed twice a day (BID) with food.

The first of the co-primary endpoints for the study was the time-matched
change from baseline in Maximum Ashworth score (six hours post-dose time
point) at the end of the maintenance dose period. The muscle group in the
lower limbs with the highest Ashworth score at baseline was followed
throughout the trial. Subjects entering the trial were required to have a
Maximum Ashworth score of two or greater prior to entering the study and at
the end of the placebo run-in period, which served as baseline. The second
co-primary endpoint was the score on the 7-point Patient Global Impression of
Change scale at the end of the maintenance period. The co-primary endpoint
analysis plan examined the differences of the 30 and 45 mg BID groups from the
placebo group. The co-primary endpoints and dose groups were analyzed
independently. Comparison of the AP groups to the placebo group did not reach
statistical significance on either of the co-primary endpoints for either of
the AP doses.

The most commonly reported adverse event was somnolence (2%, 7%, 16% and 21%
for placebo, 15, 30 and 45 mg AP BID, respectively). There were seven subjects
with treatment emergent serious adverse events, none of which were deemed to
be related to treatment.

Conference Call

XenoPort will host a conference call at 8:30 am Eastern Time today to discuss
its AP Phase 3 clinical trial results and business updates. To access the
conference call via the Internet, go to www.XenoPort.com. To access the live
conference call via phone, dial 1-888-275-3514. International callers may
access the live call by dialing 1-706-679-1417.

The replay of the conference call may be accessed after 11:30 am Eastern Time
today via the Internet, at www.XenoPort.com, or via phone at 1-855-859-2056
for domestic callers or 1-404-537-3406 for international callers. The
reference number to enter the call and the replay of the call is 74912690.

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. Horizant, XenoPort’s
internally discovered drug, is approved and being marketed by XenoPort in the
United States. 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 Parkinson's disease, relapsing-remitting multiple
sclerosis and psoriasis.

Forward-Looking Statements

This press release contains “forward-looking” statements, including, without
limitation, all statements related to the shutdown of activities related to AP
development, and the timing thereof; future impact on cash burn guidance and
resource allocation; building value through the focused commercialization of
Horizant and advancing the development of XP23829; 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 “expected,” “plan,”
“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;
XenoPort’s lack of commercialization experience and its ability to
successfully market and sell Horizant, including its ability to obtain
uninterrupted drug supply and appropriate pricing and reimbursement for
Horizant in an increasingly challenging environment; 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; the
uncertain results and timing of clinical trials and other studies; XenoPort’s
ability to successfully initiate, conduct and complete clinical trials in the
anticipated timeframes, or at all; 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
Securities and Exchange Commissionfilings and reports, including in its
Quarterly Report on Form 10-Q for the quarter endedMarch 31, 2013, filed with
the Securities and Exchange Commission on April 24, 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 trademarks of XenoPort, Inc.

XNPT2C

Contact:

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