Zosano Pharma Completes Manufacture of M207 Registration Batches
The registration batches will be used to support Zosano’s New Drug Application (NDA) filing with the
“This is a significant milestone for Zosano in the development of our lead product candidate, M207,” said
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.
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.
Chief Executive Officer and Chairman of the Board
LifeSci Public Relations
Source: Zosano Pharma Corporation