Agreement outlines commercialization and distribution execution strategy upon FDA approval
EVERSANA to provide commercial services of approximately $250 million over 5 years
FREMONT, Calif., August 6, 2020 (GLOBE NEWSWIRE) — Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced it has partnered with EVERSANA, a leading provider of commercial services to the life science industry, to commercialize and distribute Qtrypta™ in the United States. Qtrypta is Zosano’s transdermal microneedle product candidate for the acute treatment of migraine. In March, the U.S. Food and Drug Administration (FDA) accepted a New Drug Application for Qtrypta and granted a Prescription Drug User Fee Act (PDUFA) goal date of October 20, 2020. If approved, Qtrypta would be the first and only microneedle patch indicated for the acute treatment of migraine.
“We believe there is tremendous potential for Qtrypta to help patients suffering from the debilitating impact of migraine,” said Steven Lo, president and CEO of Zosano. “We are thrilled to partner with EVERSANA and look forward to leveraging EVERSANA’s established sales force, distribution networks, patient services hub and market access capabilities to support the launch and commercialization of our innovative therapeutic candidate for the acute treatment of migraine if approved by the FDA. This collaboration enables us to access a comprehensive commercial organization without the significant expense and time that would have been required to build our own infrastructure. We and EVERSANA have been working closely to ensure our commercialization strategies are aligned to provide appropriate resources to enable patients to access Qtrypta if approved.”
Zosano and EVERSANA will utilize EVERSANA’s commercial execution expertise for marketing, market access, distribution, sales force deployment, reimbursement, and patient adherence support services. To optimize performance, EVERSANA’s integrated data and analytics platform will analyze fully integrated data, predict product and patient needs, and inform commercial activities at launch of Qtrypta and thereafter.
Jim Lang, CEO of EVERSANA, added, “We’ve built comprehensive commercial services for innovators like Zosano and look forward to making Qtrypta available to the millions of migraine patients. Our partnership with Zosano puts the patient first by supporting broad market access, efficient distribution and comprehensive patient support services. We will work closely with Zosano on each stage of the product launch and roll-out.”
Under the terms of the agreement, the parties will cooperate to conduct activities over the term of the agreement pursuant to an anticipated $250 million commercialization budget for Qtrypta. Zosano maintains ownership of the Qtrypta New Drug Application as well as all legal, regulatory, and manufacturing responsibilities for the product. EVERSANA receives exclusive right to conduct agreed commercialization activities, and will utilize its internal sales organization along with its other commercial capabilities for market access, marketing, distribution and patient support services for Qtrypta. EVERSANA will receive reimbursement of certain costs and a low double digit percentage of product profits when Zosano net sales surpass certain costs incurred by the parties pursuant to the commercialization budget. Zosano and EVERSANA retain the right to terminate the agreement upon certain events, including Zosano’s right to terminate upon any change of control of Zosano. The term of the agreement is five years following the date of FDA approval.
About Qtrypta™ (M207)
Qtrypta 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 Qtrypta™, the formulation is zolmitriptan. The drug-coated microneedles are designed to penetrate the stratum corneum, where the investigational drug dissolves and easily 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 Qtrypta™ 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 Qtrypta™ (M207), which is a proprietary formulation of zolmitriptan delivered via its transdermal microneedle system technology, as an acute treatment for migraine. The company anticipates that many of its current and future development programs may enable the company to utilize a regulatory pathway that has the potential to streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com.
EVERSANA™ is the leading independent provider of global services to the life science industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product lifecycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies to advance life science solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.
This press release contains forward-looking statements regarding the partnershp with EVERSANA, the potential benefits of Qtrypta 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,” “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 Zosano’s ability to obtain additional cash resources to continue operations for the remainder of 2020, 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 Zosano’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.
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