Zosano Pharma Announces Issuance of U.S. Patent for Method of Rapidly Achieving Therapeutic Levels with M207 for the Acute Tr...
July 20 2021 - 8:30AM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage
biopharmaceutical company, today announced that it has been granted
an additional patent covering method of use of M207 with the
issuance of U.S. Patent No. 11,058,630 titled Method of Rapidly
Achieving Therapeutic Concentrations of Triptans for the Treatment
of Migraines.
“As we continue to execute on completing the pharmacokinetic
study for the potential resubmission of our NDA for M207, we are
very pleased to strengthen our patent portfolio for our innovative
product candidate,” said Steven Lo, president and chief executive
officer of Zosano. “We believe M207, if approved, may represent an
attractive therapeutic option for patients with debilitating
migraines and look forward to further discussions with the FDA as
we continue to seek approval.”
The newly issued patent covers methods for the release of active
drug from Zosano’s microneedle system in about one minute and
reaching potentially therapeutic levels as quickly as 30 minutes
upon application. This latest patent adds to Zosano’s M207 patent
portfolio, which now includes two U.S. patents with claims covering
composition of matter and method of use for M207 with expirations
in 2037.
About M207 M207 is Zosano’s proprietary
investigational formulation of zolmitriptan delivered utilizing its
proprietary transdermal microneedle system (the “System”) in
development for the acute treatment of migraine. The System
consists of titanium microneedles coated with drug, and in the case
of M207, the formulation is zolmitriptan. The drug-coated
microneedles are designed to penetrate the stratum corneum, where
the investigational drug potentially dissolves and enters into the
bloodstream. In February 2017, the company announced
statistically significant results from the ZOTRIP pivotal study, in
which the 3.8 mg dose of M207 met both co-primary endpoints,
achieving pain freedom and most bothersome symptom freedom at 2
hours.
About MigraineMigraine is a highly prevalent
neurological disease impacting 12% of the US population and 1 in 4
households. Patients impacted by migraine experience significant
disability, with 90% unable to function normally. Migraine
attacks are estimated to lead to lost productivity costs as high
as $36 billion annually in the United States,
including both direct and indirect costs. Zosano believes there is
a significant need for new acute treatment options since 74% of
migraine patients experience inadequate treatment response.
About Zosano PharmaZosano Pharma Corporation is
a clinical-stage biopharmaceutical company focused on developing
products where rapid administration of approved molecules with
established safety and efficacy profiles may provide substantial
benefit to patients, in markets where patients remain underserved
by existing therapies. The company’s transdermal microneedle system
technology consists of titanium microneedles coated with drug that
are designed to enable rapid systemic administration of
therapeutics to patients. Zosano’s lead product candidate is M207,
which is a proprietary formulation of zolmitriptan designed to be
delivered via its transdermal microneedle system technology, as an
acute treatment for migraine. Learn more at
www.zosanopharma.com.
Forward-Looking StatementsThis press release
contains forward-looking statements. All statements other than
statements of historical facts contained herein are forward-looking
statements reflecting the current beliefs and expectations of
management made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, including, but
not limited to, statements regarding the company’s ongoing
pharmacokinetic study and its potential resubmission of the NDA for
M207, the potential benefits and availability of M207 for patients
and other future events and expectations described in this press
release. Readers are urged to consider statements that include the
words "may," "will," "would," "could," "should," "might,"
"believes," "estimates," "projects," "potential," "expects,"
"plans," "anticipates," "intends," "continues," "forecast,"
"designed," "goal," "approximately" or the negative of those words
or other comparable words to be uncertain and forward-looking.
These statements are subject to risks and uncertainties that are
difficult to predict, and actual outcomes may differ materially.
These include risks and uncertainties, without limitation,
associated with the company’s ability to obtain additional cash
resources to continue operations, the process of discovering,
developing and commercializing products that are safe and effective
for use as human therapeutics, risks inherent in the effort to
build a business around such products and other risks and
uncertainties described under the heading "Risk Factors" in the
company's most recent annual report on Form 10-K and quarterly
reports on Form 10-Q. Although Zosano believes that the
expectations reflected in these forward-looking statements are
reasonable, Zosano cannot in any way guarantee that the future
results, level of activity, performance or events and circumstances
reflected in forward-looking statements will be achieved or occur.
All forward-looking statements are based on information currently
available to Zosano and Zosano assumes no obligation to update any
such forward-looking statements.
Zosano Contacts:Christine MatthewsChief
Financial Officer510-745-1200
Zosano PR:Sylvia Wheeler or Alexandra
Santosswheeler@wheelhouselsa.com or asantos@wheelhouselsa.com
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