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.
Copyright Business Wire 2015