uniQure announces closing of commercialization and license agreement with CSL Behring
May 06 2021 - 7:00AM
uniQure announces closing of commercialization and license
agreement with CSL Behring
uniQure N.V. (NASDAQ: QURE), a leading gene therapy company
advancing transformative therapies for patients with severe medical
needs, today announced that the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976 for the global
licensing agreement with CSL Behring for etranacogene dezaparvovec,
an investigational gene therapy for patients with hemophilia B,
expired on May 5, 2021, and the agreement became fully effective
today, May 6, 2021. The agreement was contingent on completion of
review under antitrust laws in the United States, Australia, and
the United Kingdom. The antitrust review process is now complete in
all three countries.
“As a global leader in hematology and
thrombosis, CSL Behring is an ideal commercial partner, and we are
excited to embark on our relationship together with a shared goal
of delivering this potentially transformative therapy to patients
around the world living with hemophilia B,” stated Matt Kapusta,
chief executive officer of uniQure. “This transaction positions
etranacogene dezaparvovec to be made available to the largest
number of hemophilia B patients as quickly as possible and provides
uniQure with significant financial resources to advance and expand
our pipeline of gene therapy candidates.”
As previously announced in June 2020, uniQure
and CSL Behring entered into a licensing agreement providing CSL
Behring with exclusive global rights to etranacogene dezaparvovec.
Under the terms of the agreement, uniQure will receive a $450
million cash payment from CSL Behring by May 13, 2021 and is
eligible to receive up to $1.6 billion in payments based on
regulatory and commercial milestones. uniQure will also be eligible
to receive tiered double-digit royalties in a range of up to a
low-twenties percentage of net product sales arising from the
collaboration.
Additionally, uniQure will be responsible for
the completion of the HOPE-B pivotal study, manufacturing process
validation, and the manufacturing supply of etranacogene
dezaparvovec until such time that these capabilities are
transferred to CSL Behring. Clinical development and regulatory
activities performed by uniQure under the agreement will be
reimbursed by CSL Behring. CSL Behring will be responsible for
regulatory submissions and commercialization of etranacogene
dezaparvovec.
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 gene therapies to treat
patients with hemophilia B, Huntington's disease, Fabry disease,
spinocerebellar ataxia Type 3 and other
diseases. www.uniQure.com
About CSL Behring
As a CSL Limited (ASX:CSL;USOTC:CSLLY) company,
CSL Behring is a global biotherapeutics leader delivering
lifesaving medicines to patients with rare and serious diseases. A
global leader in treating bleeding disorders, CSL Behring has been
delivering innovations for the hemophilia patient community for
more than 30 years. The company reported more than $1 billion in
sales of hemophilia-related medicines in 2020.
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, whether uniQure will
receive the upfront cash payment or any of the financial benefits
of the agreement; whether the collaboration will benefit Hemophilia
B patients worldwide or be made available to the largest number of
hemophilia B patients as quickly as possible, and whether uniQure
will be able to advance or expand its pipeline of innovative gene
therapies or its technology platform. uniQure’s actual results
could differ materially from those anticipated in these
forward-looking statements for many reasons, including, without
limitation, risks associated with the impact of the ongoing
COVID-19 pandemic on our Company and the wider economy and health
care system, our commercialization activities and commercialization
agreement with CSL Behring, our clinical development activities,
clinical results, potential adverse events, collaboration
arrangements, regulatory oversight, 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-K filed on March 1, 2021. Given these risks,
uncertainties and other factors, you should not place undue
reliance on these forward-looking statements, and uniQure assumes
no obligation to update these forward-looking statements, even if
new information becomes available in the future.
uniQure Contacts:
FOR
INVESTORS: |
|
FOR
MEDIA: |
|
|
|
Maria E. Cantor |
Chiara Russo |
Tom Malone |
Direct: 339-970-7536 |
Direct: 617-306-9137 |
Direct: 339-970-7558 |
Mobile: 617-680-9452 |
Mobile: 617-306-9137 |
Mobile: 339-223-8541 |
m.cantor@uniQure.com |
c.russo@uniQure.com |
t.malone@uniQure.com |
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