Bristol-Myers Squibb Signs Exclusive Agreement with Bavarian Nordic for PROSTVAC®, a Prostate-Specific Antigen-Targeting Cancer Immunotherapy
(Thomson Reuters ONE) -
* Bavarian Nordic to receive up to $975 million, inclusive of $60 million
upfront and potential exercise payment; potential development, regulatory
and commercialization milestone payments; additional tiered double-digit
royalties on future sales
KVISTGAARD, Denmark and NEW YORK, March 4, 2015 - Bavarian Nordic (OMX: BAVA,
OTC: BVNRY) and Bristol-Myers Squibb Company (NYSE: BMY) announced today an
agreement that provides Bristol-Myers Squibb an exclusive option to license and
commercialize PROSTVAC®, Bavarian Nordic's investigational Phase 3 prostate-
specific antigen (PSA)-targeting cancer immunotherapy in development for the
treatment of asymptomatic or minimally symptomatic metastatic castration-
resistant prostate cancer (mCRPC).
Under terms of the agreement, Bavarian Nordic will receive an upfront payment of
$60 million. Bristol-Myers Squibb can exercise the option in its sole discretion
within a designated time after data is available from the ongoing Phase 3 trial.
Bavarian Nordic would be entitled to a payment of $80 million upon exercise of
the option plus additional incremental payments starting at $50 million, but
with a potential to exceed $230 million should the median overall survival
benefit of PROSTVAC exceed the efficacy seen in Phase 2 results. Furthermore,
Bavarian Nordic could receive regulatory milestone payments of $110 million, up
to $495 million in sales milestones as well as tiered double-digit royalties on
future sales of PROSTVAC. The parties have also agreed to enter into a supply
contract, under which Bavarian Nordic will undertake the future commercial
manufacturing of PROSTVAC.
An investigator sponsored Phase 2 study is currently in the planning stages to
investigate the combination of Bristol-Myers Squibb's YERVOY (ipilimumab) and
PROSTVAC. The companies have also entered into an agreement by which they may
conduct one or more exploratory combination studies of PROSTVAC and agents from
Bristol-Myers Squibb's immuno-oncology portfolio.
"While additional treatment options have become available, metastatic
castration-resistant prostate cancer remains largely incurable," said Michael
Giordano, Head of Development, Oncology, Bristol-Myers Squibb. "Our agreement
with Bavarian Nordic reflects our commitment to following the emerging science
in immuno-oncology and supports our strategy to transform the treatment of
cancer across multiple tumor types, lines of therapy and stages of disease."
Bristol-Myers Squibb has an ongoing Phase 3 program for YERVOY in prostate
cancer, and scientific rationale exists to evaluate PROSTVAC in combination with
YERVOY, and other agents from Bristol-Myers Squibb's immuno-oncology portfolio.
"We are proud to partner with Bristol-Myers Squibb whose excellence and
leadership in immuno-oncology provides a strong foundation for advancing
PROSTVAC, which has the potential to become an essential component in the
treatment of prostate cancer," said Paul Chaplin, Ph.D. and Chief Executive
Officer of Bavarian Nordic. "Leveraging the capabilities of Bristol-Myers
Squibb's science, we look forward to exploring the full potential of PROSTVAC in
the future treatment paradigm of prostate cancer."
About PROSTVAC
PROSTVAC is a ready to use immuno-oncology agent that stimulates an immune
response that attacks prostate cancer cells. Administered subcutaneously,
PROSTVAC employs Bavarian Nordic's active immunotherapy (vaccinia-
fowlpox/TRICOM) technology platform. When PSA-TRICOM is presented to the immune
system in the PROSTVAC regimen, cytotoxic T lymphocytes (CTLs) are generated
that may recognize and kill PSA-expressing cancer cells and trigger an immune
response to other tumor antigens. PROSTVAC is currently being evaluated in a
global, randomized, double-blind, placebo-controlled phase 3 study (PROSPECT),
that has fully enrolled at 1,298 patients with asymptomatic or minimally
symptomatic metastatic castration-resistant prostate cancer (mCRPC). Previous
clinical studies of PROSTVAC, either as single-agent therapy or in combination
with anti-androgen therapies, radiation therapies or immune checkpoint
inhibitors have indicated possible therapeutic synergies for these treatment
combinations and PROSTVAC has been generally well-tolerated.
About Prostate Cancer
Prostate cancer is the second most frequently diagnosed cancer and the sixth
most deadly cancer in men. Most deaths will be caused by metastatic castration-
resistant prostate cancer, which occurs when the cancer becomes resistant to
standard hormonal treatment and spreads from the prostate to other organs in the
body.
About Bavarian Nordic
Bavarian Nordic is an international biotechnology company developing and
manufacturing novel cancer immunotherapies and vaccines for infectious diseases.
Lead product candidates are PROSTVAC®, an immunotherapy product candidate for
advanced prostate cancer that is the subject of an ongoing pivotal Phase 3
clinical trial, and IMVAMUNE®, a non-replicating smallpox vaccine candidate in
Phase 3 development, which is being developed and supplied for emergency use to
the U.S. Strategic National Stockpile under a contract with the U.S. Government.
The vaccine is approved in Canada under the trade name IMVAMUNE and in the
European Union under the trade name IMVANEX. For more information, please visit
www.bavarian-nordic.com or follow us on Twitter at
http://twitter.com/bavariannordic.
Bavarian Nordic Forward-Looking Statement
This announcement includes forward-looking statements that involve risks,
uncertainties and other factors, many of which are outside of our control that
could cause actual results to differ materially from the results discussed in
the forward-looking statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events, performance and/or other
information that is not historical information. We undertake no obligation to
publicly update or revise forward-looking statements to reflect subsequent
events or circumstances after the date made, except as required by law.
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.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" relating to the option
and licensing agreement between Bavarian Nordic and Bristol-Myers Squibb and the
discovery, development and commercialization of Bavarian Nordic's
investigational immunotherapy. 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 BMS will exercise its option to license and commercialize
PROSTVAC. In addition, PROSTVAC is subject to all the risks inherent in the
drug development process, and there can be no assurance that its development
will be successful. Forward-looking statements in the 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, its Quarterly Reports on Form 10-Q, and 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.
Contacts
Bavarian Nordic
Rolf Sass Sørensen, Vice President Investor Relations (EU). Phone
+45 61 77 47 43
Seth Lewis, Vice President Investor Relations (US). Phone + 1 978-341-5271
Bristol-Myers Squibb
Media:
Ken Dominski, 609-252-5251, ken.dominski(at)bms.com
Sarah Koenig, 609-252-4145, sarah.koenig(at)bms.com
Investors:
Ranya Dajani, 609-252-5330, ranya.dajani(at)bms.com
201504uk:
http://hugin.info/100065/R/1899275/674710.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Bavarian Nordic A/S via GlobeNewswire
[HUG#1899275]
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