Zosano Pharma Announces Notice of Allowance for a U.S. Patent Application Covering M207 as an Acute Treatment for Migraine
January 03 2018 - 8:30AM
Zosano Pharma Corp. (NASDAQ:ZSAN) (“Zosano” or the “Company”) a
clinical stage biopharmaceutical company focused on providing rapid
systemic administration of therapeutics to subjects using its
proprietary Adhesive Dermally-Applied Microarray (“ADAM”)
technology, today announced that it has received a Notice of
Allowance from the United States Patent and Trademark Office
(USPTO) for a patent application titled “Method of Rapidly
Achieving Therapeutic Concentrations of Triptans for Treatment of
Migraines”. In February 2017, Zosano reported positive
pivotal data from our Zotrip Phase 2/3 trial, in which subjects
treated with the 3.8mg dose of M207 achieved statistical
significance on the co-primary endpoints. This newly-allowed patent
application contains claims generated from formulation, preclinical
and clinical studies, and highlights the unique aspects of the
Zosano technologies and their applicability for treatment of
migraine.
“We are extremely pleased with this expansion of the patent
estate for M207,” said John Walker, Chairman and Chief Executive
Officer of Zosano. “This allowance expands the breadth of and
further validates our intellectual property portfolio for our ADAM
technology, and specifically M207. It covers method of use,
formulation, delivery system, pharmacokinetic profile and the
pharmacodynamic response.”
Zosano’s patent estate additionally includes other granted U.S.
and foreign patents and pending patent applications covering our
ADAM technology, including our microneedle technology, drug
formulations, methods of use and
applicators. About
Migraine
Migraine is the leading cause of disability among neurological
disorders in the United States according to the American Migraine
Foundation. Migraine symptoms can include moderate to severe
headache pain combined with nausea and vomiting, or abnormal
sensitivity to light and sound. According to the Migraine
Research Foundation, migraine affects 30 million men, women
and children in the United States. Most migraines last between four
and 24 hours, but some last as long as three days. According to
published studies, 63% of migraine patients experience between one
and four migraines per month. According to Decision Resources,
prescription drug sales for migraine in the top seven countries
were estimated to be $3.3 billion in 2015, and are expected to grow
to $4.4 billion in 2020. Triptans, a family of tryptamine-based
drugs first sold in the 1990s, account for almost 75% of
anti-migraine therapies prescribed at office visits.
About M207
M207 is our proprietary formulation of zolmitriptan delivered
utilizing Zosano’s proprietary Adhesive Dermally-Applied
Microarray, or ADAM technology. Zosano’s ADAM technology
consists of titanium microprojections coated with drug, and in the
case of M207, our formulation of zolmitriptan. Our ADAM
technology delivers drug by abrading the stratum corneum and
allowing drug to be absorbed into the microcapillary system of the
skin. In February 2017, the Company announced statistically
significant results from the ZOTRIP trial, which demonstrated that
the 3.8mg dose of M207 met both co-primary endpoints, achieving
pain freedom and most bothersome symptom freedom at 2
hours.
About Zosano Pharma
Zosano Pharma Corporation is a clinical stage biopharmaceutical
company focused on providing rapid systemic administration of
therapeutics to patients using our proprietary Adhesive
Dermally-Applied Microarray, or ADAM technology. The Company
recently announced positive results from our ZOTRIP study that
evaluated M207, which is our proprietary formulation of
zolmitriptan delivered via our ADAM technology, as an acute
treatment for migraine. Zosano is focused on developing
products where rapid administration of established molecules with
known safety and efficacy profiles provides an increased benefit to
patients, for markets where patients remain underserved by existing
therapies. The Company anticipates that many of its current and
future development programs may enable the Company to utilize a
regulatory pathway that would streamline clinical development and
accelerate the path towards commercialization. Learn more
at www.zosanopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding
the timing of expected clinical development milestones, sufficiency
of our capital resources and need for future funding and other
future events and expectations. 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," "unaudited,"
"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 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.. Although we
believe that the expectations reflected in these forward-looking
statements are reasonable, we 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 Contact:Georgia ErbezChief Business
Officer and Chief Financial Officer510-745-1200
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