Zosano Pharma Announces Issuance of U.S. Patent for Method of Rapidly Achieving Therapeutic Levels with M207 for the Acute Treatment of Migraine
FREMONT, Calif., July 20, 2021 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that it has been granted an additional patent covering method of use of M207 with the issuance of U.S. Patent No. 11,058,630 titled Method of Rapidly Achieving Therapeutic Concentrations of Triptans for the Treatment of Migraines.
“As we continue to execute on completing the pharmacokinetic study for the potential resubmission of our NDA for M207, we are very pleased to strengthen our patent portfolio for our innovative product candidate,” said Steven Lo, president and chief executive officer of Zosano. “We believe M207, if approved, may represent an attractive therapeutic option for patients with debilitating migraines and look forward to further discussions with the FDA as we continue to seek approval.”
The newly issued patent covers methods for the release of active drug from Zosano’s microneedle system in about one minute and reaching potentially therapeutic levels as quickly as 30 minutes upon application. This latest patent adds to Zosano’s M207 patent portfolio, which now includes two U.S. patents with claims covering composition of matter and method of use for M207 with expirations in 2037.
M207 is Zosano’s proprietary investigational formulation of zolmitriptan delivered utilizing its proprietary transdermal microneedle system (the “System”) in development for the acute treatment of migraine. The System consists of titanium microneedles coated with drug, and in the case of M207, the formulation is zolmitriptan. The drug-coated microneedles are designed to penetrate the stratum corneum, where the investigational drug potentially dissolves and enters into the bloodstream. In February 2017, the company announced statistically significant results from the ZOTRIP pivotal study, in which the 3.8 mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours.
Migraine is a highly prevalent neurological disease impacting 12% of the US population and 1 in 4 households. Patients impacted by migraine experience significant disability, with 90% unable to function normally. Migraine attacks are estimated to lead to lost productivity costs as high as $36 billion annually in the United States, including both direct and indirect costs. Zosano believes there is a significant need for new acute treatment options since 74% of migraine patients experience inadequate treatment response.
About Zosano Pharma
Zosano Pharma Corporation is a clinical-stage biopharmaceutical company focused on developing products where rapid administration of approved molecules with established safety and efficacy profiles may provide substantial benefit to patients, in markets where patients remain underserved by existing therapies. The company’s transdermal microneedle system technology consists of titanium microneedles coated with drug that are designed to enable rapid systemic administration of therapeutics to patients. Zosano’s lead product candidate is M207, which is a proprietary formulation of zolmitriptan designed to be delivered via its transdermal microneedle system technology, as an acute treatment for migraine. Learn more at www.zosanopharma.com.
This press release 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 ongoing pharmacokinetic study and its potential resubmission of the NDA for M207, the potential benefits and availability of M207 for patients and other future events and expectations described in this press release. 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," "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.
Chief Financial Officer
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