THOUSAND OAKS, Calif. and
NEWARK, Calif., July 27, 2021 /PRNewswire/ -- Amgen (NASDAQ:
AMGN) and Teneobio today announced an agreement under which Amgen
will acquire Teneobio, a privately held, clinical stage
biotechnology company developing a new class of biologics called
Human Heavy-Chain Antibodies. Under the terms of the
agreement, Amgen will acquire all outstanding shares of Teneobio at
closing in exchange for a $900
million upfront cash payment, as well as future contingent
milestone payments to Teneobio equity holders potentially worth up
to an additional $1.6 billion in
cash.
The acquisition includes Teneobio's proprietary bispecific and
multispecific antibody technologies, which will enable significant
acceleration and efficiency in the discovery and development of new
molecules that have the potential to treat a wide range of
important diseases across Amgen's core therapeutic areas. These
platforms complement Amgen's existing antibody capabilities with
the addition of a heavy-chain only platform that allows a
streamlined, sequence-based discovery approach for target binders,
as well as Teneobio's novel T-cell engager platform, which expands
on Amgen's existing leadership position in bispecific T-cell
engagers by providing a differentiated, but complementary, approach
to Amgen's current BiTE® platform.
"The acquisition of Teneobio will strengthen our ability to
develop innovative medicines to treat patients with serious
illnesses and to bring to market best-in-class products,
particularly with respect to multispecific and bispecific medicines
directed against targets in a wide range of diseases across our
core therapeutic areas," said David M.
Reese, M.D., executive vice president of Research and
Development at Amgen. "Teneobio's antibody platform
complements our existing capabilities and could potentially give us
a more diverse set of building blocks that can be developed into
new multispecific therapeutics. In addition, the availability
of Teneobio's CD3 engager technology will allow us to broaden our
capabilities in generating bispecifics, and with our own
technology, enable customization of the T cell engaging domain of
the molecules depending on the disease and target."
The acquisition will also add TNB-585, a Phase 1 bispecific T
cell-engager for the treatment of metastatic castrate-resistant
prostate cancer (mCRPC), and several preclinical oncology pipeline
assets with the potential for near-term IND filings. TNB-585
complements Amgen's existing prostate cancer portfolio, which
includes acapatamab (formerly AMG 160) and AMG 509, both in Phase
1. Each of these three investigational therapies uses a
different approach to treat a highly prevalent disease for which
new treatment options are very much needed.
"The Teneobio team is enthusiastic about joining forces with
Amgen, a pioneer of biotherapeutics. Amgen's R&D
resources and its extensive clinical experience in immuno-oncology
are ideally suited to applying and advancing Teneobio's
differentiated technologies and multispecific antibodies to deliver
transformative medicines," said Roland
Buelow, Ph.D., chief executive officer of Teneobio.
"Over the last five years, Teneobio developed leading-edge
expertise in efficiently engineering differentiated multispecific
and bispecific therapeutics for numerous indications with
potentially better safety, efficacy and pharmacokinetic profiles
than the first generation of T-cell engagers. Together, we
share a focused commitment to rapidly discover, develop and deliver
novel and meaningful disease-modifying multispecific antibodies to
patients in need."
In June 2021, AbbVie Inc.
exercised its right to acquire TeneoOne, Inc. (a Teneobio
affiliate), which includes TNB-383B, an anti-CD3/BCMA bispecific
for the treatment of relapsed or refractory multiple myeloma.
Further details of this transaction, including conditions to
closing, can be found here. Prior to close of the Amgen
acquisition, three Teneobio affiliates will be spun-off to
Teneobio's existing equity holders: TeneoTwo, Inc. (anti-CD19/CD3),
TeneoFour, Inc. (anti-CD38 enzyme inhibitor) and TeneoTen, Inc.
(anti-HBV/CD3).
The acquisition is subject to customary closing conditions,
including applicable regulatory approvals and is expected to close
in the second half of 2021. Goldman Sachs & Co. LLC acted
as financial advisor to Amgen and Latham & Watkins LLP as its
legal advisor. Gunderson Dettmer Stough
Villeneuve Franklin & Hachigian, LLP acted as legal
advisor to TeneoBio.
About Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer
since 1980, Amgen has grown to be one of the world's leading
independent biotechnology companies, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
About Teneobio
Teneobio, Inc. is a clinical stage biotechnology company developing
a new class of biologics, Human Heavy-Chain Antibodies (UniAb®),
for the treatments of cancer, autoimmunity, and infectious
diseases. Teneobio's discovery platform, TeneoSeek, comprises
genetically engineered animals (UniRat® and OmniFlic®),
next-generation sequencing, bioinformatics and high-throughput
vector assembly technologies. TeneoSeek rapidly identifies large
numbers of unique binding molecules specific for therapeutic
targets of interest. Versatile antibody variable domains (UniDab®)
derived from UniAb® can be assembled into multi-specific and
multivalent therapeutic proteins, surpassing limitations of
conventional antibody therapeutics. Teneobio's "plug-and-play"
T-cell engaging platform includes a diverse set of anti-CD3
antibodies for therapeutics with optimal efficacy and reduced
toxicity.
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are
based on the current expectations and beliefs of Amgen. All
statements, other than statements of historical fact, are
statements that could be deemed forward-looking statements,
including any statements on the outcome or benefits of acquisitions
or collaborations with any other company, including the Teneobio
acquisition, as well as regulatory or clinical results or
practices, and other such estimates and results. Forward-looking
statements involve significant risks and uncertainties, including
those discussed below and more fully described in the Securities
and Exchange Commission reports filed by Amgen, including its most
recent annual report on Form 10-K and any subsequent periodic
reports on Form 10-Q and current reports on Form 8-K. Unless
otherwise noted, Amgen is providing this information as of the date
of this news release and does not undertake any obligation to
update any forward-looking statements contained in this document as
a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in
humans. The complexity of the human body cannot be perfectly, or
sometimes, even adequately modeled by computer or cell culture
systems or animal models. The length of time that it takes for us
to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar
variability in the future. Even when clinical trials are
successful, regulatory authorities may question the sufficiency for
approval of the trial endpoints we have selected. We develop
product candidates internally and through licensing collaborations,
partnerships and joint ventures. Product candidates that are
derived from relationships may be subject to disputes between the
parties or may prove to be not as effective or as safe as we may
have believed at the time of entering into such relationship. Also,
we or others could identify safety, side effects or manufacturing
problems with our products, including our devices, after they are
on the market.
Our results may be affected by our ability to successfully
market both new and existing products domestically and
internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing our products and global
economic conditions. In addition, sales of our products are
affected by pricing pressure, political and public scrutiny and
reimbursement policies imposed by third-party payers, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment. Furthermore, our research, testing,
pricing, marketing and other operations are subject to extensive
regulation by domestic and foreign government regulatory
authorities. Our business may be impacted by government
investigations, litigation and product liability claims. In
addition, our business may be impacted by the adoption of new tax
legislation or exposure to additional tax liabilities. If we fail
to meet the compliance obligations in the corporate integrity
agreement between us and the U.S. government, we could become
subject to significant sanctions. Further, while we routinely
obtain patents for our products and technology, the protection
offered by our patents and patent applications may be challenged,
invalidated or circumvented by our competitors, or we may fail to
prevail in present and future intellectual property litigation. We
perform a substantial amount of our commercial manufacturing
activities at a few key facilities, including in Puerto Rico, and also depend on third parties
for a portion of our manufacturing activities, and limits on supply
may constrain sales of certain of our current products and product
candidate development. An outbreak of disease or similar public
health threat, such as COVID-19, and the public and governmental
effort to mitigate against the spread of such disease, could have a
significant adverse effect on the supply of materials for our
manufacturing activities, the distribution of our products, the
commercialization of our product candidates, and our clinical trial
operations, and any such events may have a material adverse effect
on our product development, product sales, business and results of
operations. We rely on collaborations with third parties for the
development of some of our product candidates and for the
commercialization and sales of some of our commercial products. In
addition, we compete with other companies with respect to many of
our marketed products as well as for the discovery and development
of new products. Further, some raw materials, medical devices and
component parts for our products are supplied by sole third-party
suppliers. Certain of our distributors, customers and payers have
substantial purchasing leverage in their dealings with us. The
discovery of significant problems with a product similar to one of
our products that implicate an entire class of products could have
a material adverse effect on sales of the affected products and on
our business and results of operations. Our efforts to collaborate
with or acquire other companies, products or technology, and to
integrate the operations of companies or to support the products or
technology we have acquired, may not be successful. A breakdown,
cyberattack or information security breach could compromise the
confidentiality, integrity and availability of our systems and our
data. Our stock price is volatile and may be affected by a number
of events. Global economic conditions may magnify certain risks
that affect our business. Our business performance could affect or
limit the ability of our Board of Directors to declare a dividend
or our ability to pay a dividend or repurchase our common stock. We
may not be able to access the capital and credit markets on terms
that are favorable to us, or at all.
The scientific information discussed in this news release
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and Drug
Administration, and no conclusions can or should be drawn regarding
the safety or effectiveness of the product candidates.
CONTACT: Amgen, Thousand Oaks
Megan Fox, 805-447-1423 (media)
Trish Rowland,
805-447-5631(media)
Arvind Sood, 805-447-1060
(investors)
CONTACT: Teneobio, Newark
Omid Vafa, Chief Business
Officer
ovafa@teneobio.com
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SOURCE Amgen