Zosano Pharma Confirms NDA Resubmission Strategy Following Type A Meeting Minutes from FDA
February 22 2021 - 8:30AM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage
biopharmaceutical company, today announced that the company has
received the official Type A meeting minutes from the U.S. Food and
Drug Administration (“FDA") Division of Neurology II (the
“Division”) regarding the requirements for resubmission of the
Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2)
New Drug Application (“NDA”) following the Complete Response Letter
received on October 20, 2020.
The Type A meeting minutes were generally consistent with the
company’s expectations, and the company maintains its plans to
conduct an additional pharmacokinetic (“PK”) study for inclusion in
an NDA resubmission package. In a post-meeting comment, the FDA
recommended a skin assessment on patients in the planned PK study
to generate additional safety information. This assessment is
included in the proposed study protocol, which has been submitted
to FDA. The Division indicated willingness to review the study
protocol and provide comments prior to the initiation of the study.
The company’s plans for resubmitting the NDA are based on the
discussions between the company and the FDA and may be subject to
change upon receipt of the FDA’s comments to the proposed study
protocol.
“Upon receiving feedback from the FDA on our proposed protocol,
we look forward to initiating and completing the PK study and
ultimately resubmitting our NDA for Qtrypta,” said Steven Lo,
President and CEO of Zosano. “We believe in the potential of
Qtrypta, if approved, to be an attractive alternative treatment for
patients with debilitating migraines and look forward to addressing
the remaining steps to meet regulatory requirements to gain
approval.”
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
Qtrypta™ (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 plans to conduct
an additional PK study, the Division’s willingness to review the
study protocol and provide comments prior to the initiation of the
study, plans for resubmission of the company’s Qtrypta NDA to the
FDA, the potential benefits of Qtrypta 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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