~ Company now owns full global rights to late-stage program with
clinical proof-of-concept ~
LEXINGTON, Mass. and AMSTERDAM, the
Netherlands, July 31, 2017 (GLOBE NEWSWIRE) -- 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
Group
Based 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