Zosano Pharma Announces Completion of Pre-NDA Meetings with FDA for Qtrypta™Zosano plans to submit NDA for Qtrypta in December 2019
FREMONT, Calif., Nov. 13, 2019 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that it has received minutes from pre- New Drug Application (“NDA”) meetings with the Food and Drug Administration (“FDA”) for the acute treatment of migraine for Qtrypta. The purpose of the meetings was to confirm the completion of all requisite studies, as well as the proposed clinical, non-clinical, and chemistry, manufacturing, and controls (“CMC”) content and format of the company’s NDA submission, which the company expects to make in December 2019.
“We are encouraged by the pre-NDA minutes received from FDA after our collaborative meetings. This is an important milestone as we head into the final stages of completion of the NDA,” said Hayley Lewis, Senior Vice President, Operations. “These minutes reflect discussions made between Zosano and FDA on the format and content of the NDA to help ensure all elements of submission are met.”
The company was granted two separate pre-NDA meetings to discuss the development program. A face to face meeting was held with the FDA in September to discuss the nonclinical and clinical portions of the program. A second pre-NDA meeting request was granted to discuss CMC, and FDA recently provided its written responses to the company’s questions in lieu of holding an in-person meeting. Based on the feedback from the FDA, the company believes the information included in its planned NDA will be sufficient for the FDA to file the NDA for substantive review.
About Zosano Pharma
Zosano Pharma Corporation is a clinical stage biopharmaceutical company focused on developing products where rapid administration of established molecules with established safety and efficacy profiles may provide an increased benefit to patients, for markets where patients remain underserved by existing therapies. The company’s Adhesive Dermally-Applied Microarray (ADAM) technology consists of titanium microneedles coated with drug that is designed to enable rapid systemic administration of therapeutics to patients. Zosano’s lead product candidate is Qtrypta™ (M207), which is an investigational, proprietary formulation of zolmitriptan delivered via ADAM technology, currently in development for the acute treatment of migraine. In February 2017, the company announced positive clinical and statistically significant results from the ZOTRIP pivotal study and in February 2019, the company announced the completion of the final milestone in its long-term safety study. The company is preparing to submit a New Drug Application to the Food and Drug Administration for Qtrypta (M207). Learn more at www.zosanopharma.com.
This press release contains forward-looking statements regarding the expected New Drug Application for Qtrypta 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 NDA submission process, including that the information provided in the NDA will not be sufficient for the FDA to file and substantively review the application, 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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