Vistagen Announces Issuance of U.S. Patent for PH80 Nasal Spray for Treatment of Migraine
March 01 2023 - 8:30AM
Business Wire
PH80 patent portfolio now includes U.S. patents
for treatment of both hot flashes and migraine
Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical
company aiming to transform the treatment landscape for individuals
living with anxiety, depression, and other central nervous system
(CNS) disorders, today announced that the U.S. Patent and Trademark
Office (USPTO) has granted a U.S. patent for Vistagen’s PH80 nasal
spray for treatment of migraine. The newly issued patent will be in
effect until at least 2040.
PH80 is an investigational pherine nasal spray designed with a
potential rapid-onset mechanism of action that is fundamentally
differentiated from all currently approved treatments for migraine.
PH80 does not require systemic exposure to produce an effect,
providing a significant potential therapeutic advantage over
traditional pharmaceuticals targeted at the CNS. PH80 nasal spray
initiates neural impulses in the olfactory bulb transmitted by
pathways that rapidly affect brain function, including the amygdala
and hypothalamus, which have been linked to the pathology of
migraine.
Migraine affects about 40 million adults in the U.S. each year,
and while approved treatments are available, many individuals could
benefit from safer and more efficacious treatment options. PH80 has
the potential to be a safe, fast-acting, easy to use nasal spray
for the treatment of migraine.
Vistagen’s recently completed acquisition of Pherin
Pharmaceuticals resulted in the full ownership of intellectual
property rights worldwide to five pherine drug candidates,
including, the newly issued PH80 patent for the treatment of
migraine (U.S. Patent 11,419,881), among others.
About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage
biopharmaceutical company aiming to transform the treatment
landscape for individuals living with anxiety, depression and other
CNS disorders. The Company is advancing therapeutics with the
potential to be faster-acting, and with fewer side effects and
safety concerns, than those that are currently available for
treatment of anxiety and depression and other CNS disorders.
Several of Vistagen’s product candidates belong to a new class of
drugs known as pherines, which are designed with a novel
rapid-onset mechanism of action that activates chemosensory neurons
in the nasal passages and can impact key neural circuits without
systemic uptake or direct activity on CNS neurons in the brain.
Vistagen is passionate about transforming mental health care and
redefining what is possible in the treatment of anxiety and
depression. Connect at www.Vistagen.com.
Forward Looking Statements
This press release contains certain forward-looking statements
within the meaning of the federal securities laws. These
forward-looking statements involve known and unknown risks that are
difficult to predict and include all matters that are not
historical facts. In some cases, you can identify forward-looking
statements by the use of words such as “may,” “could,” “expect,”
“project,” “outlook,” “strategy,” “intend,” “plan,” “seek,”
“anticipate,” “believe,” “estimate,” “predict,” “potential,”
“strive,” “goal,” “continue,” “likely,” “will,” “would” and
variations of these terms and similar expressions, or the negative
of these terms or similar expressions. Such forward-looking
statements are necessarily based upon estimates and assumptions
that, while considered reasonable by Vistagen and its management,
are inherently uncertain. As with all pharmaceutical products,
there are substantial risks and uncertainties in the process of
development and commercialization and actual results or
developments may differ materially from those projected or implied
in these forward-looking statements. Among other things, there can
be no guarantee that the scope of protection provided by the U.S.
patents issued for any of the Company’s drug candidates, including
PH80, PH94B, PH10 or any other pherine drug candidate, will be
sufficient to deter competition; any of Vistagen’s drug candidates
will successfully complete ongoing or future clinical trials,
receive regulatory approval or be commercially successful;
Vistagen’s ability to realize the anticipated benefits of the
acquisition of Pherin, including the possibility that the expected
benefits will not be realized or will not be realized within the
expected time period; or unknown liabilities that may or may not be
within Vistagen’s control. Certain of these risks are more fully
discussed in the section entitled "Risk Factors" in the Company’s
most recent Annual Report on Form 10-K for the fiscal year ended
March 31, 2022 and in the Company’s most recent Quarterly Report on
Form 10-Q for the quarter ended December 31, 2022, as well as
discussions of potential risks, uncertainties, and other important
factors in our other filings with the U.S. Securities and Exchange
Commission (SEC). The Company’s SEC filings are available on the
SEC’s website at www.sec.gov. You should not place undue reliance
on these forward-looking statements, which apply only as of the
date of this press release and should not be relied upon as
representing the Company’s views as of any subsequent date. The
Company explicitly disclaims any obligation to update any
forward-looking statements, other than as may be required by law.
If the Company does update one or more forward-looking statements,
no inference should be made that the Company will make additional
updates with respect to those or other forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20230301005495/en/
Investors Mark Flather Vice President, Investor Relations (650)
577-3617 mflather@vistagen.com
Media Nate Hitchings SKDK nhitchings@skdknick.com
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