XenoPort Announces 2009 Milestones and Provides Financial Guidance

* Reuters is not responsible for the content in this press release.

Mon Jan 12, 2009 8:30am EST

SANTA CLARA, Calif.--(Business Wire)--
XenoPort, Inc. (Nasdaq:XNPT) announced today its milestones for 2009 and
elaborated on actions that are expected to extend the company`s cash reserves
into the second quarter of 2011. 

2009 Milestones and Clinical Activities

In 2009, XenoPort or its collaborators expect to advance the development of
XenoPort`s product candidates as follows:

* GSK submitted a new drug application, or NDA, with the Food and Drug
Administration, or FDA, for Solzira (known as XP13512 outside the United States)
as a potential treatment for moderate-to-severe primary restless legs syndrome,
or RLS, on January 9. XenoPort expects to receive milestone payments of $23
million in the aggregate from GSK and Astellas Pharma Inc., which are associated
with the acceptance by the FDA of the NDA. 
* GSK has previously disclosed that it expects results from the following trials
in 2009:

* A Phase 2 clinical trial of Solzira in patients with painful diabetic
neuropathy. 
* Two Phase 2 clinical trials of Solzira in patients with post-herpetic
neuralgia.

* GSK is conducting a Phase 2 clinical trial of Solzira as a potential
prophylactic treatment for migraine headaches that was initiated in August 2008,
and a polysomnography clinical trial of Solzira in RLS patients that was
initiated in October 2008. 
* Astellas is conducting a Phase 2 clinical trial of XP13512 in RLS patients in
Japan that completed enrollment in October 2008. 
* XenoPort expects to report results from a Phase 2 clinical trial of XP19986 in
spinal cord injury patients with spasticity by mid-year. 
* XenoPort expects to complete an exploratory safety study of XP19986 in
patients with acute back spasms of neuromuscular origin by year end. The first
subject was enrolled in this trial in December 2008. 
* XenoPort expects to commence in the second half of this year a Phase 2
clinical trial of XP19986 as a potential treatment for subjects with
gastroesophageal reflux disease, or GERD, who are incomplete responders to
proton pump inhibitors. 
* XenoPort expects to complete a Phase 1 clinical trial in healthy subjects
designed to assess the pharmacokinetics and safety/tolerability of two new
formulations of XP21279 compared to oral L-dopa in the first quarter. 
* XenoPort expects to commence a multiple-dose clinical trial exploring the
safety, tolerability and pharmacokinetics of XP21279 in Parkinson`s disease
patients.

Separately, Xanodyne Pharmaceuticals, Inc. expects to file an NDA with the FDA
on XP12B, its modified-release tranexamic acid product candidate for the
reduction of menstrual blood loss in women with menorrhagia, or excessive
menstrual bleeding. Pursuant to the terms of its exclusive licensing agreement
with Xanodyne, XenoPort would be eligible to receive escalating single-digit
royalties on any sales of XP12B. 

Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, "2009
will be an important year for XenoPort. We were pleased to announce that GSK
re-filed the Solzira NDA and we look forward to working with GSK to provide this
promising product candidate to patients who are suffering from RLS. We believe
additional data that will become available in 2009 will reveal the potential of
Solzira in other indications. Coupled with $40 million in proceeds from our
recent registered direct financing, we believe our existing cash plus expected
milestones will take us well into 2011. With a possible regulatory action from
the FDA for the Solzira NDA and multiple Phase 2 trials in new indications
reading out for both Solzira and XP19986 by the end of 2009, we believe that the
company is poised for an exciting year." 

Financial Guidance

XenoPort announced that it expects the net use of cash for 2009 to be in the
range of $55 million to $65 million (net use of cash is the difference between
the balances of cash and cash equivalents plus short-term investments at
12/31/09 and 12/31/08). This guidance includes expected milestones under its
existing collaboration agreements with GSK, Astellas and Xanodyne. The 2009 net
use of cash guidance further assumes the suspension of the preclinical
development program on XP20925, its Transported Prodrug of propofol, and certain
other preclinical activities. 

XenoPort also announced a provision from its agreement with GSK that has the
effect of reducing the expenditure of cash in 2009 if XenoPort exercises its
option to co-promote Solzira and participate in a profit-share arrangement.
During the period after the co-promotion option is exercised and prior to the
launch of Solzira, the cash payments to GSK representing XenoPort`s share of any
loss would be deferred and would be repayable following the launch of Solzira.
As a result, the foregoing net use of cash guidance for 2009 is not expected to
change if XenoPort elects to exercise the co-promotion option under the GSK
agreement. 

About XenoPort

XenoPort, Inc. is a biopharmaceutical company focused on developing a portfolio
of internally discovered product candidates that utilize the body`s natural
nutrient transport mechanisms to improve the therapeutic benefits of existing
drugs. XenoPort is developing its lead product candidate in partnership with
Astellas Pharma Inc. and GSK. GSK has filed with the FDA an NDA for Solzira for
the treatment of RLS. XenoPort`s product candidates are also being studied for
the potential treatment of GERD, migraine headaches, neuropathic pain,
spasticity related to spinal cord injury, acute back spasms and Parkinson`s
disease. 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 XenoPort`s and its partners` future
clinical development of XP13512 (Solzira) and the timing thereof; XenoPort`s
future clinical development programs for XP19986 and XP21279 and timing thereof;
the release of additional clinical data and the timing thereof; the therapeutic
and commercial potential of XenoPort`s product candidates; the suitability of
XP13512 as a treatment for neuropathic pain and migraine prophylaxis; the
suitability of XP19986 as a treatment for GERD, spasticity and acute back
spasms; the suitability of XP21279 as a treatment for Parkinson`s disease;
XenoPort`s and its partners` future clinical trials; the regulatory process and
the timing of regulatory submissions; milestone payments and the timing thereof;
and sufficiency of XenoPort`s existing cash and other financial guidance. 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," "expects," "may," "potential," "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, the uncertain results and timing of clinical
trials; XenoPort`s or its partners` ability to successfully conduct clinical
trials in the anticipated timeframes, or at all; the uncertainty of the FDA`s
NDA acceptance and approval process and other regulatory requirements;
XenoPort`s dependence on its current and additional collaborative partners; and
the uncertain therapeutic and commercial value of XenoPort`s and its licensees`
compounds. These and other risk factors are discussed under the heading "Risk
Factors" in XenoPort`s prospectus supplement filed with the Securities and
Exchange Commission under Rule 424(b)(5) on December 30, 2008. 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. 

XNPT2G 

XenoPort is a registered trademark 

Transported Prodrug is a trademark of XenoPort 

Solzira is a trademark of GSK 





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



Copyright Business Wire 2009

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