Zosano Pharma Completes Site Qualification Batches at Contract Manufacturing Organization as it Prepares for NDA Submission o...
18 6월 2019 - 7:00PM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage
biopharmaceutical company, today announced that it has completed
manufacturing of site qualification batches at its commercial
manufacturing site for Qtrypta, the company’s investigational
treatment for migraines in late stage development. These
batches are intended to demonstrate the robustness and
reproducibility of the manufacturing process which will be included
as part of its planned submission of a New Drug Application (NDA)
for Qtrypta in the fourth quarter 2019.
"The completion of these site qualification batches forms the
basis of our commercial manufacturing process in our NDA and
illustrates the scalability of the process as we head toward
commercialization activities for Qtrypta at Thermo Fischer, in
North Carolina,” said Hayley Lewis, senior vice president,
operations at Zosano. “With the completion of our long-term safety
study, the transfer of our manufacturing process and the ongoing
completion of requisite regulatory documentation and studies, we
are on track for NDA submission by year end.”
About Qtrypta™ (M207)Qtrypta is Zosano’s
proprietary formulation of zolmitriptan delivered utilizing its
proprietary ADAM technology. Zosano's ADAM technology consists of
titanium microneedles coated with drug, and in the case of Qtrypta,
its formulation of zolmitriptan. The drug-coated microneedles
penetrate into the epidermis and dermis, where the investigational
drug is dissolved and enters into the bloodstream. In February
2017, the Company announced statistically significant results from
the ZOTRIP pivotal study, in which the 3.8mg dose of Qtrypta met
both co-primary endpoints, achieving pain freedom and most
bothersome symptom freedom at 2 hours. In November 2017, the
Company announced the initiation of its long-term safety study
evaluating Qtrypta and expects to file an NDA for Qtrypta in the
fourth quarter of 2019.
About Zosano PharmaZosano Pharma
Corporation is a clinical stage biopharmaceutical company
focused on providing administration of therapeutics to patients
using its intracutaneous delivery system, which consists of
titanium microneedles coated with drug that can enable rapid
systemic administration to patients. The company’s lead product
candidate is Qtrypta (M207), which is Zosano’s proprietary
formulation of zolmitriptan delivered via its intracutaneous
delivery technology for the treatment of migraine disease.
In February 2017, the company announced statistically
significant results from the ZOTRIP pivotal study and
in February 2019, Zosano announced the completion of the final
milestone in its long-term safety study. Learn more
at www.zosanopharma.com.
Forward-Looking StatementsThis press release
contains forward-looking statements regarding the expected timing
of a New Drug Application for Qtrypta (M207) 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 quarterly report on Form 10-Q. Although
Zosano believes 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:Greg KitchenerChief Financial
Officer 510-745-1200
PR Contacts:Sylvia Wheeler or Alexandra
Santosswheeler@wheelhouselsa.com or asantos@wheelhouselsa.com
Zosano Pharma (NASDAQ:ZSAN)
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