uniQure Reacquires Development and Commercialization Rights for its Gene Therapy Candidate in Hemophilia B
July 31 2017 - 7:00AM
uniQure N.V. (NASDAQ:QURE), a leading gene therapy company
advancing transformative therapies for patients with severe medical
needs, today announced that it has entered into an agreement with
Chiesi Group to reacquire the rights to co-develop and
commercialize its hemophilia B gene therapy in Europe and other
select territories and to terminate their co-development and
license agreement.
“We are very pleased to reach an agreement with Chiesi to
acquire back European and other territorial rights to our lead gene
therapy program in hemophilia B,” stated Matthew Kapusta, Chief
Executive Officer of uniQure. “By regaining unencumbered,
global rights to a late-stage program that has demonstrated
significant clinical benefit for patients with hemophilia B, we
believe uniQure is better positioned to accelerate the global
clinical development plan, maximize shareholder return on our
pipeline and take advantage of new potential opportunities related
to the program. We are grateful for the substantial investments
that Chiesi has made in AMT-060, and we have been fortunate to have
them as a collaboration partner over the years.”
“As we recently announced, we have made significant progress in
preparing for a late-stage clinical program in hemophilia B and
look forward to providing additional updates this fall,” added Mr.
Kapusta.
“Chiesi’s decision was driven by recent changes in our strategic
priorities,” stated Ugo Di Francesco, Chief Executive Officer of
Chiesi. “We greatly appreciate the advances uniQure has made
in the development of AMT-060 over the years and sincerely wish
them the best as they advance this potentially exciting gene
therapy to patients. We will continue to support the
transition and expect it will be relatively quick and
seamless.”
In 2013, uniQure and Chiesi entered into an agreement for the
co-development and commercialization of a hemophilia B gene therapy
in Europe and other select territories, including an equal sharing
of all development related costs. Under the terms of the
agreement announced today, uniQure will be responsible for all
future development costs related to its hemophilia B program,
including approximately $3 million of expenses in 2017 that would
have otherwise been shared with Chiesi. The Company does not
expect the transaction will impact its previous cash guidance, and
continues to anticipate cash on hand will be sufficient to fund
operations into 2019.
As a result of the transaction, uniQure expects to recognize in
the third quarter of 2017 the remaining deferred revenue of
approximately $14 million from non-refundable payments received
from Chiesi in 2013.
About uniQure
uniQure is delivering on the promise of gene
therapy – single treatments with potentially curative results. We
are leveraging our modular and validated technology platform to
rapidly advance a pipeline of proprietary and partnered gene
therapies to treat patients with hemophilia, Huntington’s disease
and cardiovascular diseases. www.uniQure.com
About Chiesi GroupBased in
Parma, Italy, Chiesi Farmaceutici is an international
research-focused Healthcare Group, with over 80 years of experience
in the pharmaceutical industry, present in 26 countries. Chiesi
researches, develops and markets innovative drugs in the
respiratory therapeutics, specialist medicine and rare disease
areas. Its R&D organization is headquartered in Parma (Italy),
and integrated with 6 other key R&D groups in France, the USA,
the UK, Sweden and Denmark to advance Chiesi's pre-clinical,
clinical and registration programmes. Chiesi employs nearly 5,000
people.
uniQure Forward-Looking
Statements
This press release contains forward-looking statements. All
statements other than statements of historical fact are
forward-looking statements, which are often indicated by terms such
as "anticipate," "believe," "could," "estimate," "expect," "goal,"
"intend," "look forward to," "may," "plan," "potential," "predict,"
"project," "should," "will," "would" and similar expressions.
Forward-looking statements are based on management's beliefs and
assumptions and on information available to management only as of
the date of this press release. These forward-looking statements
include, but are not limited to, statements regarding the future
development of our hemophilia B program, the transition of
development efforts from Chiesi and the risk of cessation, delay or
lack of success of any of our ongoing or planned clinical studies
and/or development of our product candidates. Our actual results
could differ materially from those anticipated in these
forward-looking statements for many reasons, including, without
limitation, risks associated with corporate reorganizations and
strategic shifts, collaboration arrangements, our and our
collaborators’ clinical development activities, regulatory
oversight, product commercialization and intellectual property
claims, as well as the risks, uncertainties and other factors
described under the heading "Risk Factors" in uniQure’s Quarterly
Report on Form 10-Q filed on May 9, 2017. Given these risks,
uncertainties and other factors, you should not place undue
reliance on these forward-looking statements, and we assume no
obligation to update these forward-looking statements, even if new
information becomes available in the future.
uniQure Contacts
For Investors:
Maria E. Cantor
Direct: 339-970-7536
Mobile: 617-680-9452
m.cantor@uniqure.com
Eva M. Mulder
Direct: +31 20 240 6103
Mobile: +31 6 52 33 15 79
e.mulder@uniQure.com
For Media:
Tom Malone
Direct: 339-970-7558
Mobile: 339-223-8541
t.malone@uniQure.com
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