Zosano Pharma Announces Partnership Agreement with EVERSANA to Support the Launch and Commercialization of Qtrypta™
August 06 2020 - 5:00PM
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.
About Migraine 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.
About EVERSANA™ 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.
Forward-Looking Statements This press release
contains forward-looking statements regarding the partnership 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.
Zosano Contacts:Corporate
Christine MatthewsChief Financial Officer(510) 745-1200
Investors and Press Sylvia Wheeler or Alexandra
Santosswheeler@wheelhouselsa.com or asantos@wheelhouselsa.com
EVERSANA Contact:Sarah
Zwickysarah.zwicky@eversana.com+1 (414) 434-4691
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