Zosano Pharma Announces NDA Resubmission Plans Following Type A Meeting with FDA
February 01 2021 - 8:00AM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage
biopharmaceutical company, today announced that the company
completed its Type A meeting with 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.
Based on feedback from the Type A meeting held with the
Division, the company plans to conduct an additional
pharmacokinetic (“PK”) study for inclusion in an NDA resubmission
package. During the meeting, the Division did not request that the
company conduct any further clinical efficacy studies to support
the resubmission. Prior to initiating the PK study, the company
plans to submit the study protocol to the Division for additional
comment and review. 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 Division during the
Type A meeting and may be subject to change upon receipt of the
FDA’s official meeting minutes from the Type A meeting.
“We appreciate the FDA’s willingness to discuss our application,
and the Division providing confirmation that an additional PK study
will be necessary to resubmit the NDA for Qtrypta,” said Steven Lo,
President and CEO of Zosano. “We are working to have a protocol for
the PK study finalized this quarter. We look forward to initiating
and completing the study, and ultimately resubmitting our NDA
application. Qtrypta leverages our proprietary microneedle
technology that has been supported by data from five trials in 774
subjects, and we are encouraged by its potential to treat patients
with debilitating migraines.”
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 outcomes of the Type A Meeting as will
be reflected in the FDA’s forthcoming official meeting minutes,
including the feedback from the FDA suggesting that an additional
PK study will be necessary to resubmit the NDA for Qtrypta and the
lack of any request for additional clinical efficacy studies,
timing of protocol finalization, initiation, and completion of the
PK 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 related to any differences
between the company’s understanding of the FDA’s feedback during
the Type A meeting and the official meeting minutes from the
meeting and other 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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