Zosano Pharma Completes Manufacture of M207 Registration Batches
September 19 2018 - 8:30AM
Zosano Pharma Corporation (NASDAQ:ZSAN) (“Zosano” or the
“Company”), a clinical-stage biopharmaceutical company focused on
providing rapid systemic administration of therapeutics to patients
using its proprietary Adhesive Dermally-Applied Microneedle
(“ADAM™”) technology, today announced the release of three
registration batches of M207, the Company’s lead development
candidate.
The registration batches will be used to support Zosano’s New
Drug Application (NDA) filing with the U.S. Food and Drug
Administration (FDA). Twelve months of room temperature stability
for a product candidate are typically required in order for the FDA
to assess manufacturability and stability of a drug product.
Zosano’s batches have been placed on stability per regulatory
requirements and will complete the 12-month timepoint in September
of 2019.
“This is a significant milestone for Zosano in the development
of our lead product candidate, M207,” said Hayley Lewis, senior
vice president, operations at Zosano Pharma. “Our process
development and manufacturing teams have successfully established a
robust process to scale up for commercial manufacturing of M207. We
can now confidently say we have completed an important requirement
in anticipation of our filing in Q4 2019, which is a monumental and
very encouraging accomplishment.”
About M207
M207 is our proprietary formulation of zolmitriptan delivered
utilizing Zosano's proprietary ADAM technology. Zosano's ADAM
technology consists of titanium microprojections (microneedles)
coated with drug, and in the case of M207, our formulation of
zolmitriptan. The drug-coated microneedles penetrate into the
epidermis and dermis, where the drug is dissolved and enters into
the bloodstream. In February 2017, the Company announced
statistically significant results from the ZOTRIP pivotal study,
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. In November 2017, the Company announced
the initiation of its long-term safety study evaluating M207 and
expects to file an NDA for M207 in the fourth quarter of 2019.
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: John Walker Chief Executive
Officer and Chairman of the Board 510-745-1200
Media Contact:Sara ZelkovicLifeSci Public
Relationssara@lifescipublicrelations.com(646)
876-4933
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