Xenoport, Inc. (MM) (NASDAQ:XNPT)
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2 Years : From Mar 2012 to Mar 2014
XenoPort, Inc. (Nasdaq: XNPT) announced today that it was awarded U.S.
Patent 8,148,414 for “Prodrugs of Methyl Hydrogen Fumarate,
Pharmaceutical Compositions Thereof, and Methods of Use.” The term of
the patent extends until 2029, subject to potential Hatch-Waxman patent
The patent is directed to the XP23829 compound, analogs thereof and
formulations thereof. A related U.S. patent application directed to
therapeutic uses of XP23829 is now pending.
XP23829 is a prodrug of methyl hydrogen fumarate, also known as
monomethyl fumarate (MMF). In cell- and animal-based models, MMF has
been shown to exhibit immuno-modulatory properties and inhibit damage
from oxidative stress.
In XenoPort’s preclinical animal studies that compared molar equivalent
doses of XP23829 to dimethyl fumarate (DMF), another prodrug of MMF,
XP23829 demonstrated a greater degree of efficacy in animal models of
both multiple sclerosis (MS) and psoriasis. Toxicology studies conducted
in two species showed that XP23829 caused less stomach irritation
compared to DMF.
XenoPort intends to file an Investigational New Drug Application (IND)
for XP23829 for the treatment of relapsing remitting MS with the U.S.
Food and Drug Administration (FDA) in the second quarter of 2012 and
expects to initiate human clinical trials later this year.
XenoPort owns all rights to XP23829.
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®
(gabapentin enacarbil) Extended-Release Tablets is XenoPort’s first
FDA-approved product. GlaxoSmithKline holds commercialization rights and
certain development rights for Horizant in the United States. Regnite®
(gabapentin enacarbil) is approved for the treatment of
moderate-to-severe primary restless legs syndrome in Japan. Astellas
Pharma Inc. holds all development and commercialization rights for Regnite
in Japan and five Asian countries. XenoPort holds all other world-wide
rights and has co-promotion and certain development rights to gabapentin
enacarbil in the United States. XenoPort’s pipeline of product
candidates includes potential treatments for patients with postherpetic
neuralgia, spasticity and Parkinson’s disease.
To learn more about XenoPort, please visit the company Website at www.XenoPort.com.
This press release contains “forward-looking” statements, including,
without limitation, all statements related to patent coverage for
XP23829; potential future actions by the FDA related to the IND for
XP23829 and the timing thereof; XenoPort’s future clinical development
program for XP23829 and the timing thereof; the therapeutic and
commercial potential of XP23829; and the suitability of XP23829 as a
treatment for MS and/or psoriasis. 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 “expects,” “intends,”
“potential” 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 the uncertainty of
the FDA IND clearance process and other regulatory requirements; the
uncertain results and timing of clinical trials; XenoPort’s ability to
successfully conduct clinical trials in the anticipated timeframes, or
at all; XenoPort’s dependence on its current and additional
collaborative partners; 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 Annual Report
on Form 10-K for the year ended December 31, 2011, filed with the
Securities and Exchange Commission on February 29, 2012. 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 is a registered trademark of XenoPort, Inc.
Horizant is a registered trademark of GlaxoSmithKline.
Regnite is a registered trademark of Astellas Pharma Inc.