- Celgene accelerates its immuno-oncology
strategy in solid tumors with acquisition of worldwide rights, rest
of world outside Asia, to BeiGene’s PD-1 inhibitor BGB-A317;
Pivotal BGB-A317 solid tumor studies planned for 2018
- Collaboration maximizes potential for
best-in-class PD-1-based immuno-oncology combinations in solid
tumors by leveraging BGB-A317’s differentiated profile and
Celgene’s novel pipeline assets and global oncology expertise
- BeiGene to acquire Celgene’s commercial
operations in China and exclusive license to Celgene’s China cancer
commercial portfolio (ABRAXANE®, REVLIMID®, VIDAZA®)
- BeiGene to receive $263 million in
upfront license fees and $150 million equity investment
Celgene Corporation (NASDAQ:CELG) and BeiGene,
Ltd. (NASDAQ:BGNE) entered into a strategic collaboration to
develop and commercialize BeiGene’s investigational anti-programmed
cell death protein 1 (PD-1) inhibitor, BGB-A317, for patients with
solid tumor cancers in the United States, Europe, Japan and rest of
world outside Asia. BeiGene will retain exclusive rights for the
development and commercialization of BGB-A317 for hematological
malignancies globally and for solid tumors in Asia (with the
exception of Japan). BeiGene will acquire Celgene’s commercial
operations in China and gain an exclusive license to commercialize
Celgene’s approved therapies in China – ABRAXANE®, REVLIMID® and
VIDAZA®.
BGB-A317 is an advanced clinical-stage investigational PD-1
inhibitor, which has been dosed in over 500 patients. Initial
clinical data suggest that BGB-A317 is well tolerated and exhibits
anti-tumor activity across a range of solid tumor types. BGB-A317
has high affinity and specificity for PD-1 and may be
differentiated from the currently approved PD-1 antibodies through
an engineered Fc region, potentially minimizing interactions with
other immune cells that may exert a negative impact on effector
T-cell function. BGB-A317 is being developed as a monotherapy and
in combination with other therapies for the treatment of solid
tumor cancers. It is currently in two pivotal trials in China, and
global pivotal studies of BGB-A317 are planned for initiation in
2018. Celgene and BeiGene will collaborate in the global
development of BGB-A317. In addition, BeiGene retains the right to
develop BGB-A317 in hematology and in combination with its other
portfolio compounds.
“The acquisition of BGB-A317 significantly accelerates and
expands our opportunity to develop and deliver novel T-cell
checkpoint inhibitor-based therapies in solid tumor cancers to
patients worldwide and adds to our ongoing PD-L1 FUSION™ program in
hematological malignancies,” said Mark J. Alles, Chief Executive
Officer of Celgene. “China is an important market for Celgene, and
our collaboration with BeiGene positions us exceptionally well to
optimize research, manufacturing, and the long-term commercial
potential of our portfolio in China.”
“This strategic partnership with Celgene is a transformational
event for BeiGene, transitioning us into a commercial-stage company
and preparing us well for the future potential launch of our
internally developed compounds, some of which are already in
pivotal trials in China,” said John V. Oyler, Co-founder, CEO, and
Chairman of BeiGene. “Aligned in our mission and therapeutic focus,
we believe that we have forged a promising alliance with Celgene
that will help both companies fulfill their ultimate commitments of
bringing new, life-altering treatments to patients in China and
worldwide.”
BeiGene will acquire Celgene’s operations in China. BeiGene will
also license and assume commercial responsibility for Celgene’s
approved therapies in China, consisting of ABRAXANE® (paclitaxel
protein-bound particles for injectable suspension) (albumin-bound),
REVLIMID® (lenalidomide) and VIDAZA® (azacitidine). In addition,
BeiGene is granted licensing rights in China to CC-122, under the
same terms and conditions as the approved commercial products.
CC-122 is a next generation CelMOD currently in development by
Celgene for lymphoma and hepatocellular carcinoma. BeiGene plans to
expand manufacturing and commercial operations in China in
preparation for the potential approvals of BGB-A317 and future
innovative therapies developed by BeiGene in greater China.
Celgene will maintain a strategic and R&D presence in China
dedicated to long-term commercial activities, regulatory affairs
and clinical development of new therapies in the country. Celgene
will also continue supporting BeiGene with management of the
REVLIMID® Risk Minimization Program.
Upon closing, BeiGene will receive upfront licensing fees
totaling $263 million, and in addition Celgene will acquire an
equity stake in BeiGene by purchasing 32.7 million, or 5.9 percent,
of BeiGene’s ordinary shares at $4.58 per share, or $59.55 per
BeiGene’s American Depositary Shares (ADS), representing a 35%
premium to an 11-day volume-weighted average price of BeiGene’s
ADS. BeiGene is eligible to receive up to $980 million in
development, regulatory and sales milestone payments and royalties
on future sales of BGB-A317.
The transactions have been approved by the boards of directors
of Celgene and BeiGene. Both companies expect to complete the
transaction during the third quarter of 2017, subject to the
expiration or termination of applicable waiting periods under all
applicable antitrust laws and satisfaction of other usual and
customary closing conditions.
BGB-A317 is not approved in any country for any indication.
About BGB-A317
BGB-A317 is an investigational humanized monoclonal antibody
that belongs to a class of immuno-oncology agents known as immune
checkpoint inhibitors. It is designed to bind to PD-1, a cell
surface receptor that plays an important role in downregulating the
immune system by preventing the activation of T-cells. BGB-A317 has
high affinity and specificity for PD-1. It is believed to be
differentiated from the currently approved PD-1 antibodies, as the
engineering of its Fc region is believed to minimize potentially
negative interactions with other immune cells. BGB-A317 is being
developed as a monotherapy and in combination with other therapies
for the treatment of various cancers.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com. Follow Celgene
on social media: @Celgene, Pinterest, LinkedIn, Facebook and
YouTube.
About BeiGene
BeiGene is a global, clinical-stage, research-based
biotechnology company focused on molecularly targeted and
immuno-oncology cancer therapeutics. With a team of over 400
employees in China, the United States, and Australia, BeiGene is
advancing a pipeline consisting of novel oral small molecules and
monoclonal antibodies for the treatment of cancer. BeiGene is
working to create combination solutions aimed at having both a
meaningful and lasting impact on cancer patients.
Forward-Looking Statements
This press release contains forward-looking statements, which
are generally statements that are not historical facts.
Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," "outlook" and similar expressions. Forward-looking
statements are based on management's current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. Celgene and BeiGene undertake no obligation to update any
forward-looking statement in light of new information or future
events, except as otherwise required by law. Forward-looking
statements involve inherent risks and uncertainties, most of which
are difficult to predict and are generally beyond our control.
Actual results or outcomes may differ materially from those implied
by the forward-looking statements as a result of the impact of a
number of factors, many of which are discussed in more detail in
Celgene's Annual Report on Form 10-K and other reports filed with
the Securities and Exchange Commission, with respect to Celgene’s
forward-looking statements, and BeiGene’s Annual Report on Form
10-K and other reports filed with the Securities and Exchange
Commission, with respect to BeiGene’s forward-looking
statements.
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