Technical Transfer of manufacturing process to CMO signals commencement of commercial readiness activities
NDA planned for Q4 2019
FREMONT, Calif. (GLOBE NEWSWIRE) -- 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.
This 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.
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