Zosano Pharma Resumes Development of Weekly ZP-PTH Treatment for Severe Osteoporosis
29 9월 2015 - 5:05AM
Company Announces Discontinuation of Development
of Daily ZP-PTH and Terminates Collaboration With Eli Lilly and
Company
Zosano to Host Webcast and Conference Call Today
at 5:00 p.m. ET
Zosano Pharma Corporation (NASDAQ:ZSAN) announced today that the
company has decided to discontinue development of its Daily ZP-PTH
treatment for severe osteoporosis and to resume development of its
Weekly ZP-PTH product.
Zosano's decision to discontinue development of Daily ZP-PTH is
driven by recent feedback from Japanese regulatory authorities,
which would have required additional studies that would have likely
delayed commercialization in Japan by approximately one year, as
well as an overall assessment and prioritization of company
resources towards the most promising commercial opportunities.
After discussions with Lilly, the companies agreed to terminate the
collaboration agreement that they signed in 2014.
Zosano will resume its efforts to develop a Weekly ZP-PTH
product, as the company had been doing prior to its collaboration
with Lilly. In early 2014, Zosano completed a Phase 1 clinical
trial of Weekly ZP-PTH in Australia and in July 2014 held a pre-IND
meeting with the U.S. Food and Drug Administration (FDA) to discuss
the clinical trial design for a planned Phase 2 and Phase 3 trial
of Weekly ZP-PTH. Zosano is now planning to initiate a Phase 2
trial of Weekly ZP-PTH in the first half of 2016.
"While we have received positive feedback from the FDA and were
on track to initiate a Phase 3 trial of Daily ZP-PTH in the U.S.,
we believe that committing significant capital and other resources
to development of Daily ZP-PTH is not a prudent investment given
the recent feedback received from Japanese regulatory authorities
and the significant milestone payments associated with approval in
Japan. Although we have made the decision to terminate our contract
with Lilly due to business reasons, we are extremely thankful for
their support and collaboration," said Vikram Lamba, Zosano's Chief
Executive Officer. "Our Weekly ZP-PTH patch has strong clinical
data and is well-differentiated compared to competitive products.
As we finalize our plans for further development of Weekly ZP-PTH,
we look forward to announcing results from a Phase 2 trial of our
ZP-Glucagon product within the next few weeks and results from a
Phase 1 trial of our ZP-Triptan product before the end of
2015."
Webcast and Conference Call
Zosano management will host a webcast and conference call to
discuss this announcement at 5:00 p.m. ET today. The live call may
be accessed by dialing 1-866-410-5537 for domestic callers and
1-704-908-0329 for international callers. The conference ID is
49587251. A live webcast of the call will be available from the
investor relations section of the company's website at
ir.zosanopharma.com, and will be archived there for 30 days.
About Zosano Pharma
Zosano Pharma Corporation is a clinical-stage specialty
pharmaceutical company that has developed a proprietary transdermal
microneedle patch system to deliver drug formulations through the
skin for the treatment of a variety of indications. Zosano's
microneedle patch system offers rapid onset, consistent drug
delivery, improved ease of use and room-temperature stability,
benefits that the company believes often are unavailable using oral
formulations or injections. Zosano's microneedle patch system has
the potential to deliver numerous medications for a wide variety of
indications in commercially attractive markets. It has been tested
in more than 400 patients with over 30,000 patches successfully
applied to humans in Phase 1 and Phase 2 clinical studies. Learn
more at www.zosanopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding
the timing of expected clinical development milestones, sufficiency
of Zosano Pharma's 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 Annual Report on Form 10-K for the year ended December
31, 2014 filed with Securities and Exchange Commission on March 26,
2015. Although the company believes that the expectations reflected
in these forward-looking statements are reasonable, it 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.
CONTACT: Zosano Contact:
Vikram Lamba
Chief Executive Officer
510-745-1200
Investor Contact:
Patti Bank
Westwicke Partners
415-513-1284
patti.bank@westwicke.com
Media Contact:
Jamie Lacey-Moreira
PressComm PR, LLC
410-299-3310
jamielacey@presscommpr.com
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