Bristol-Myers Squibb Company (NYSE:BMY) and uniQure N.V.
(NASDAQ:QURE) announced today an agreement that provides
Bristol-Myers Squibb with exclusive access to uniQure’s gene
therapy technology platform for multiple targets in cardiovascular
diseases. The collaboration includes uniQure’s proprietary gene
therapy program for congestive heart failure that is intended to
restore the heart’s ability to synthesize S100A1, a calcium sensor
and master regulator of heart function, and thereby improve
clinical outcomes for patients with reduced ejection fraction.
Beyond cardiovascular diseases, the agreement also includes the
potential for target-exclusive collaboration in other disease
areas. In total, the companies may collaborate on ten targets,
including S100A1.
uniQure will lead discovery efforts and be responsible for
manufacturing of clinical and commercial supplies using its vector
technologies and its industrial, proprietary insect-cell based
manufacturing platform. Bristol-Myers Squibb will lead development
and regulatory activities across all programs and be responsible
for all research and development costs. Bristol-Myers Squibb will
be solely responsible for commercialization of all products from
the collaboration.
“Bristol-Myers Squibb has an excellent and long-standing track
record of success in discovering and developing treatments for
cardiovascular diseases and in embracing advancing technologies for
the treatment of human diseases,” said Carl Decicco, Ph.D., Head of
Discovery, R&D, Bristol-Myers Squibb. “Collaborating with
uniQure, a clear leader in the field with an innovative and
validated gene therapy platform, further strengthens our capability
to bring forward transformational new therapeutics for
difficult-to-treat diseases, including cardiovascular diseases such
as heart failure.”
“Bristol-Myers Squibb’s strength in the cardiovascular area and
its commitment to gene therapy will allow them to leverage the full
breadth and capacity of our platform for cardiovascular diseases,”
said Joern Aldag, Chief Executive Officer of uniQure. “This
collaboration will accelerate the application of gene therapy for
large patient populations suffering from heart diseases and will
complement the further development of uniQure’s internal pipeline
in two focus areas: liver diseases, including hemophilia, and CNS,
including lysosomal storage diseases.”
Under the terms of the agreement, Bristol-Myers Squibb will make
near-term payments of approximately $100 million, including an
upfront payment of $50 million to be made at the closing of the
transaction, a $15 million payment for the selection of three
collaboration targets, in addition to S100A1, to be made within
three months of the closing and an initial equity investment in
uniQure for a number of shares that will equal 4.9% of the total
number of shares outstanding following such issuance, at a purchase
price of $33.84 per share, or at least $32 million in total.
Bristol-Myers-Squibb will acquire an additional 5.0% ownership
before December 31, 2015, at a 10% premium, and will be granted two
warrants to acquire up to an additional 10% equity interest, at a
premium, based on additional targets being introduced into the
collaboration. The parties have also agreed to enter into a supply
contract, under which uniQure will undertake manufacturing of all
gene therapy products under the collaboration.
uniQure will be eligible to receive research, development and
regulatory milestone payments, including up to $254 million for the
lead S100A1 therapeutic and up to $217 million for each other gene
therapy product potentially developed under the collaboration.
uniQure is also eligible to receive net sales based milestone
payments and tiered single to double-digit royalties on product
sales.
“It is immensely exciting to see the potential of our initial
discoveries recognized first by uniQure and then advanced to a
stage where we can build a portfolio of gene therapies to treat
cardiovascular disease in partnership with Bristol-Myers Squibb,”
added Prof. Dr. Patrick Most, Managing Director of uniQure Germany
(formerly known as InoCard). “I would like to thank my colleagues
in Heidelberg, Amsterdam and Lexington, Massachusetts for the
teamwork that has contributed to bringing the lead S100A1
therapeutic closer to helping patients.”
uniQure and Bristol-Myers Squibb anticipate the collaboration to
be effective during the second quarter of 2015. The effectiveness
of the transaction is subject to customary closing conditions,
including clearance under the Hart-Scott-Rodino Antitrust
Improvements Act. The initial issuance by uniQure of equity to
Bristol-Myers Squibb also is anticipated to close in the second
quarter of 2015 and is subject to the approval by the shareholders
of uniQure.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information, please visit www.bms.com or follow us on Twitter at
http://twitter.com/bmsnews.
About uniQure
uniQure is delivering on the promise of gene therapy through
single treatments with potentially curative results. We have
developed a modular platform to rapidly bring new disease-modifying
therapies to patients with severe disorders. We are engaged in
multiple partnerships and have obtained regulatory approval of our
lead product, Glybera, in the European Union for a subset of
patients with LPLD. www.uniQure.com
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among other risks, there can be no guarantee
that any of the investigational gene therapy programs described in
this release will be successful. Forward-looking statements in this
press release should be evaluated together with the many
uncertainties that affect Bristol-Myers Squibb's business,
particularly those identified in the cautionary factors discussion
in Bristol-Myers Squibb's Annual Report on Form 10-K for the year
ended December 31, 2014 in our Quarterly Reports on Form 10-Q and
our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no
obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or
otherwise.
uniQure Forward-Looking Statement
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
development of gene therapies for cardiovascular disease, the
success of our collaboration with Bristol-Myers Squibb, the
election by Bristol-Myers Squibb to extend the range of target
indications covered by our collaboration, 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 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 2013 Annual Report on Form 20-F filed with the Securities
and Exchange Commission on April 25, 2014 and its 2014 Annual
Report on Form 20-F to be filed with the Securities and Exchange
Commission. 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.
Media:Bristol-Myers SquibbSarah Koenig,
609-252-4145sarah.koenig@bms.comorMacDougall Biomedical
CommunicationsGretchen SchweitzerDirect: +49 172 861 8540Main: +49
89 2424 3494 or +1 781 235
3060gschweitzer@macbiocom.comorInvestor
Relations:Bristol-Myers SquibbRanya Dajani,
609-252-5330ranya.dajani@bms.comoruniQureAicha DibaDirect : +31 20
240 6100Main: +31 20 240 6000a.diba@uniQure.com
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