EXPM:ZSANQ - Post by User
Post by
Humaniston Jun 18, 2019 8:44am
62 Views
Post# 29834953
ZOSANO PREPARES FOR NDA SUBMISSION OF QTRYPTA DRUG
ZOSANO PREPARES FOR NDA SUBMISSION OF QTRYPTA DRUGZosano Pharma Completes Site Qualification Batches at Contract Manufacturing Organization as it Prepares for NDA Submission of Qtrypta™ - Technical Transfer of manufacturing process to CMO signals commencement of commercial readiness activities
NDA planned for Q4 2019 FREMONT, Calif., June 18, 2019/6:00 am (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.
About Zosano Pharma
Zosano 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.