Zosano Pharma Engages Contract Manufacturer as Part of the Commercialization Strategy for M207
FREMONT, Calif., Oct. 03, 2018 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN) (“Zosano” or the “Company”), a clinical-stage biopharmaceutical company developing and commercializing therapies that deliver rapid systemic absorption by leveraging its novel and proprietary technology, Adhesive Dermally-Applied Microneedle System (“ADAM™”), today announced a manufacturing and supply agreement for M207 with a leading global contract development and manufacturing organization, which serves more than 400 clients in the pharmaceutical and biotechnology sectors.
Under the terms of the agreement, Zosano will transfer its proprietary technology for the coating of zolmitriptan onto the ADAM delivery system. Additionally Zosano has entered into a long-term manufacturing and supply agreement.
“This agreement represents another step in our overall strategy to commercialize M207, when and if approved by the Food and Drug Administration,” said John Walker, chief executive officer and chairman of the board of Zosano Pharma. “The decision to contract with an outside manufacturer enables Zosano to focus its current manufacturing capability for the supply of clinical trial material for future development programs. We believe this will result in our conservation of capital, improved cost of goods and ensured availability of supply once M207 is launched.”
Additional details for the agreement are available in the Zosano 8-K filed with the SEC, which is available in the IR section of the Company’s website (click here).
M207 is Zosano’s proprietary formulation of zolmitriptan delivered utilizing its proprietary ADAM technology. Zosano's ADAM technology consists of titanium microprojections (microneedles) coated with drug, and in the case of M207, its 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 a New Drug Application 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
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