The Company has refined its strategy for the resubmission of the M207 (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) following the Company’s receipt of top-line results from the pharmacokinetic study.
Pending the receipt of Type C written responses from the FDA, which the Company expects to receive by mid-December, the Company plans to submit bioavailability data comparing Zomig® nasal spray and patches produced on only one piece of manufacturing equipment. The Company’s long-term safety study, which used patches produced on this equipment, also collected open-label efficacy data, which the Company believes may provide supportive safety and efficacy evidence for M207. In contrast, the Company’s initial NDA submission relied on the data and results from multiple pieces of manufacturing equipment that supported both its published pivotal Phase 2 clinical efficacy study and the long-term safety study.
If FDA approval is received, the Company expects that commercialization of M207 would initially occur using drug product produced in the Fremont, California facility, on a timeline yet to be determined.
Forward-Looking Statements
This current report on Form 8-K contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the Company’s strategy for the resubmission of a 505(b)(2) NDA, the data that may be required to support the 505(b)(2) NDA resubmission, the anticipated timing of resubmission and other future events and expectations described in this report. 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,” “scheduled,” “goal,” “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 Company’s ability to obtain additional cash resources to continue operations, 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 and quarterly reports on Form 10-Q. Although Zosano believes that the expectations reflected in these forward-looking statements are reasonable, Zosano 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.