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
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
SUMMIT, N.J. & BEIJING--(BUSINESS WIRE)--
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
"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
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.
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.
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,
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.
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170705006141/en/
Lucy Li, Ph.D., +1 781-801-1800
Source: Celgene Corporation and BeiGene, Ltd.
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