uniQure to Acquire Corlieve Therapeutics and Advance its Gene
Therapy Program to Treat Temporal Lobe Epilepsy (TLE)
uniQure N.V. (NASDAQ: QURE), a leading gene therapy company
advancing transformative therapies for patients with severe medical
needs, today announced it has entered into a definitive agreement
to acquire Corlieve Therapeutics and its lead program, which will
be known as AMT-260, to treat temporal lobe epilepsy, the most
common form of focal epilepsy.
Corlieve’s lead gene therapy program employs
miRNA silencing technology to target suppression of aberrantly
expressed kainate receptors in the hippocampus of patients with
temporal lobe epilepsy (TLE). TLE affects approximately 1.3 million
people in the U.S. and Europe alone, of which approximately 800,000
patients are unable to adequately control acute seizures with
currently approved anti-epileptic therapies. Patients with
refractory TLE experience increased morbidity, excess mortality,
and poor quality of life.
AMT-260 was originally developed by Corlieve in
collaboration with Christophe Mulle, Ph.D., CNRS Research Director,
at the Interdisciplinary Institute of Neurosciences, CNRS,
University of Bordeaux, Valerie Crepel, Ph.D., Inserm Research
Director at the Institut de Neurobiologie de la Méditerranée,
INSERM, Aix-Marseille University, and REGENXBIO Inc. Drs. Mulle and
Crepel will continue their collaborations with uniQure.
“The acquisition of Corlieve provides an
extraordinary opportunity to transform the lives of hundreds of
thousands of patients around the world suffering from epilepsy and
aligns with our vision of pursuing unmet medical needs for
disorders that impact large populations and can be addressed with
gene therapies directed to the CNS and liver,” stated Matt Kapusta,
Chief Executive Officer of uniQure. “The groundbreaking work of the
Corlieve team, in collaboration with Drs. Mulle and Crepel, has led
to compelling preclinical results in temporal lobe epilepsy that we
believe can strategically leverage uniQure’s leading position in
developing and delivering gene therapies that employ miRNA
silencing technology. We look forward to welcoming the Corlieve
team into the uniQure family as we join forces to advance this
important and potentially transformative therapy into clinical
studies.”
“I am very proud of what Corlieve has achieved
in such a short amount of time. With the dedication and focus of
our team and our collaboration partners, we have taken a promising
therapeutic approach discovered by our scientific founders and
created a potential transformative therapeutic opportunity for
patients with refractory TLE,” said Richard Porter, Ph.D., founder
and Chief Executive Officer of Corlieve. “As leaders in the field
for miRNA gene therapy for neurological conditions, uniQure is the
ideal long-term partner for us, and we look forward to working
together to advance our program rapidly to the clinic for the
benefit of the patients we serve.”
Upon the closing of the transaction, Dr. Porter
will assume the role at uniQure of General Manager of the Corlieve
subsidiary.
“As a founding investor, we are delighted to see
that the translational work conducted by Corlieve is recognized by
uniQure, further reinforcing our commitment to company creation
based on partnering with the industry,” said Vanessa Malier,
Managing Partner at Kurma Partners and Chairman of Corlieve.
Transaction Details
Under the terms of the agreement, uniQure will
pay €46.3 million in an upfront payment of cash to acquire
Corlieve.
Corlieve shareholders are eligible to receive
the following additional payments of which up to 25% will be
payable in uniQure ordinary shares at uniQure’s election: up to
€43.7 million in development milestones through Phase I/II and €160
million in milestones associated with Phase III development and the
approvals of AMT-260 in the U.S and European Union.
Corlieve has an established license and
collaboration agreement with REGENXBIO that includes an exclusive
license to AAV9 for the specific genetic target of AMT-260. Under
the license and collaboration agreement, REGENXBIO received equity
in Corlieve and is eligible to receive milestone payments and
royalties on net sales of AMT-260.
The transaction has been approved by the Boards
of both companies and does not require uniQure shareholder
approval. The transaction is subject to customary closing
conditions as well as review by the French Ministry of Economy,
Finance and Recovery (Ministère de l’Economie, des Finances et de
la Relance) pursuant to articles L.151-3 and R.151-1 and seq. of
the French Code Monétaire et Financier. Currently, the transaction
is anticipated to be completed early in the third quarter of
2021.
SVB Leerink LLC is acting as sole financial
advisor and Morgan Lewis is acting as legal advisor to
uniQure. McDermott Will & Emery is acting as legal advisor to
Corlieve.
About Corlieve
TherapeuticsCorlieve Therapeutics is a biotechnology
company focused on bringing novel therapeutic options to patients
with severe neurological disorders. The lead project is targeting
aberrantly expressed kainate receptors in the hippocampus of
patients with refractory TLE using a gene therapy approach.
Corlieve was founded by Kurma Partners 4Q2019 on the basis of a
partnership with REGENXBIO Inc., SATT Aquitaine Science Transfert,
and Inserm Transfert. Corlieve is supported by its investors and
partners Kurma Partners, Eurazeo, Pureos Bioventures, SATT
Aquitaine Science Transfert, Inserm Transfert, Inserm CNRS, and
REGENXBIO. For more information, please
visit www.corlieve.com.
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
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 or
Corlieve will advance the AMT-260 program to the clinic rapidly or
at all, and whether the transaction is completed early in the third
quarter of 2021 or ever. 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 risks
associated with the integration of Corlieve and the execution of
the AMT-260 development efforts, regulatory review of the
transaction, our clinical development activities, clinical results,
collaboration arrangements, 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 10, 2021. 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.
Corlieve Contacts:
Amy ConradJuniper
Point858-366-3243amy@juniper-point.comOr
contact@corlieve.com
uniQure Contacts:
FOR INVESTORS: |
|
FOR MEDIA: |
|
|
|
Maria E. CantorDirect: 339-970-7536Mobile:
617-680-9452m.cantor@uniQure.com |
Chiara RussoDirect:
617-306-9137 Mobile:
617-306-9137c.russo@uniQure.com |
Tom MaloneDirect:
339-970-7558Mobile:339-223-8541t.malone@uniQure.com |
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