XenoPort Awarded U.S. Patent Directed to Composition & Formulations of XP23829, a Novel Fumarate Analog for the Potential Tre...
April 04 2012 - 8:30AM
Business Wire
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 term extensions.
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.
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® (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.
Forward-Looking Statements
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.
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