Acquisition Complements and Strengthens
Merck’s Cardiovascular Pipeline
Sotatercept is a Potentially First-In-Class
Therapy in Phase 3 Development for the Treatment of Pulmonary
Arterial Hypertension
REBLOZYL® (luspatercept-aamt)
is a First-In-Class Erythroid Maturation Recombinant Fusion Protein
Approved for the Treatment of Anemia in Certain Rare Blood
Disorders
Merck to Host Investor Call at 8 a.m. ET
Today
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, and Acceleron Pharma Inc. (Nasdaq: XLRN), a publicly traded
biopharmaceutical company, today announced that the companies have
entered into a definitive agreement under which Merck, through a
subsidiary, will acquire Acceleron for $180 per share in cash for
an approximate total equity value of $11.5 billion.
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the full release here:
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Acceleron is focused on harnessing the power of the transforming
growth factor (TGF)-beta superfamily of proteins that is known to
play a central role in the regulation of cell growth,
differentiation and repair. Acceleron’s lead therapeutic candidate,
sotatercept, has a novel mechanism of action with the potential to
improve short-term and/or long-term clinical outcomes in patients
with pulmonary arterial hypertension (PAH), a progressive and
life-threatening blood vessel disorder. Sotatercept is in Phase 3
trials as add-on to current standard of care for the treatment of
PAH.
“Strategic business development is a top priority for Merck as
we look to drive sustainable growth and further bolster and balance
our pipeline with breakthrough science,” said Rob Davis, chief
executive officer and president, Merck. “Acceleron’s innovative
research has yielded an exciting late-stage candidate that
complements and strengthens our growing cardiovascular portfolio
and pipeline and holds the potential to build upon Merck’s proud
legacy in cardiovascular disease.”
In addition to sotatercept, Acceleron’s portfolio includes
REBLOZYL® (luspatercept-aamt), a first-in-class erythroid
maturation recombinant fusion protein approved in the United
States, Europe, Canada and Australia for the treatment of anemia in
certain rare blood disorders. REBLOZYL is being developed and
commercialized through a global collaboration with Bristol Myers
Squibb.
“This agreement with Merck represents the culmination of decades
of work by Acceleron researchers successfully leveraging our
company’s deep scientific expertise in the biology of the TGF-beta
superfamily and driven by an unwavering dedication to delivering
life-changing medicines for patients,” said Habib Dable, chief
executive officer and president, Acceleron. “We believe Merck is
well-positioned to apply its industry-leading clinical and
commercial capabilities to harness the potential of sotatercept as
we join together to help make an impact on cardiopulmonary disease
for the benefit of patients.”
Under the terms of the acquisition agreement, Merck, through a
subsidiary, will initiate a tender offer to acquire all outstanding
shares of Acceleron. The closing of the tender offer will be
subject to certain conditions, including the tender of shares
representing at least a majority of the total number of Acceleron’s
outstanding shares, receipt of applicable regulatory approvals, and
other customary conditions. Upon the successful completion of the
tender offer, Merck’s acquisition subsidiary will be merged into
Acceleron, and any remaining shares of common stock of Acceleron
will be canceled and converted into the right to receive the same
$180 per share price payable in the tender offer. The transaction
is expected to close in the fourth quarter of 2021.
Merck Investor Call
Investors, journalists and the general public may access a live
audio webcast of the call today at 8:00 a.m. EDT on Merck’s website
at
https://investors.merck.com/events-and-presentations/default.aspx.
Institutional investors and analysts can participate in the call by
dialing (833) 353-0277 or (469) 886-1947 and using ID code number
8698516. Members of the media are invited to monitor the call by
dialing (833) 353-0277 or (469) 886-1947 and using ID code number
8698516. Journalists who wish to ask questions are requested to
contact a member of Merck’s Media Relations team at the conclusion
of the call.
About Sotatercept
Sotatercept is an investigational reverse-remodeling agent
proposed to rebalance TGF-beta superfamily signaling. In
preclinical models of PAH, sotatercept reversed pulmonary arterial
wall and right ventricular remodeling that are hallmarks of the
disease. A Phase 2 trial (PULSAR) evaluating sotatercept in
combination with approved PAH-specific medicines in patients with
PAH met its primary endpoint of improvement in pulmonary vascular
resistance. The study results were published in the New England
Journal of Medicine. Sotatercept is being studied in multiple Phase
3 trials for the treatment of certain patients with PAH as well as
a Phase 2 trial in patients with combined post- and pre-capillary
pulmonary hypertension in heart failure with preserved ejection
fraction.
The United States Food and Drug Administration (FDA) has granted
Orphan Drug and Breakthrough Therapy designations and the European
Commission and European Medicines Agency (EMA) have granted Orphan
and Priority Medicines (PRIME) designations, respectively, for
sotatercept for the treatment of PAH.
About REBLOZYL
Acceleron’s REBLOZYL (luspatercept-aamt) is the first and only
erythroid maturation agent approved in the United States, Europe,
Canada and Australia for the treatment of anemia in certain rare
blood disorders. REBLOZYL is being developed as part of a global
collaboration with Bristol Myers Squibb. Ongoing Phase 3 trials are
evaluating luspatercept for the treatment of anemia in patient
populations of myelodysplastic syndromes, beta-thalassemia, and
myelofibrosis.
Credit Suisse Securities (USA) LLC and Goldman Sachs & Co.
LLC acted as financial advisors to Merck in this transaction and
Covington & Burling LLP and Gibson, Dunn & Crutcher LLP as
its legal advisors. Centerview Partners LLC and J.P. Morgan
Securities LLC were financial advisors to Acceleron and Ropes &
Gray LLP its legal advisor.
About Merck
For over 130 years, Merck, known as MSD outside of the United
States and Canada, has been inventing for life, bringing forward
medicines and vaccines for many of the world’s most challenging
diseases in pursuit of our mission to save and improve lives. We
demonstrate our commitment to patients and population health by
increasing access to health care through far-reaching policies,
programs and partnerships. Today, Merck continues to be at the
forefront of research to prevent and treat diseases that threaten
people and animals – including cancer, infectious diseases such as
HIV and Ebola, and emerging animal diseases – as we aspire to be
the premier research-intensive biopharmaceutical company in the
world. For more information, visit www.merck.com and connect with
us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
About Acceleron
Acceleron is a biopharmaceutical company dedicated to the
discovery, development, and commercialization of therapeutics to
treat serious and rare diseases. Acceleron’s leadership in the
understanding of TGF-beta superfamily biology and protein
engineering generates innovative compounds that engage the body's
ability to regulate cellular growth and repair. Acceleron focuses
its research, development, and commercialization efforts in
pulmonary and hematologic diseases. In pulmonary, Acceleron is
developing sotatercept for the treatment of pulmonary hypertension
(PH). Following positive PULSAR Phase 2 results, Acceleron is
executing on its Phase 3 development plan to support its long-term
vision of establishing sotatercept as a backbone key therapy for
patients with PAH as an add-on to the current standard of care.
Acceleron is also expanding the development of sotatercept into
Group 2 PH, with the CADENCE Phase 2 trial expected to initiate
this year. Acceleron has expanded its rare pulmonary disease
pipeline and is investigating the potential of ACE-1334 in a Phase
1b/Phase 2 trial in systemic sclerosis-associated interstitial lung
disease (SSc-ILD).
In hematology, REBLOZYL (luspatercept-aamt) is the first and
only erythroid maturation agent approved in the United States,
Europe, Canada and Australia for the treatment of anemia in certain
blood disorders. REBLOZYL is part of a global collaboration
partnership with Bristol Myers Squibb. The Companies co-promote
REBLOZYL in the United States and are also developing luspatercept
for the treatment of anemia in patient populations of
myelodysplastic syndromes, beta-thalassemia and myelofibrosis.
For more information, please visit www.acceleronpharma.com.
Follow Acceleron on Social Media: @AcceleronPharma and
LinkedIn.
Important Information About the Tender Offer
The tender offer described in this press release has not yet
commenced. This press release is for informational purposes only
and is neither an offer to purchase nor a solicitation of an offer
to sell any shares of the common stock of Acceleron Pharma Inc.
(Acceleron) or any other securities, nor is it a substitute for the
tender offer materials described herein. At the time the planned
tender offer is commenced, a tender offer statement on Schedule
(TO), including an offer to purchase, a letter of transmittal and
related documents, will be filed by Merck Sharp & Dohme Corp.
(“Merck”) and Astros Merger Sub, Inc., a wholly-owned subsidiary of
Merck, with the Securities and Exchange Commission (the “SEC”), and
a solicitation/recommendation statement on Schedule 14D-9 will be
filed by Acceleron with the SEC.
INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE
TENDER OFFER MATERIALS CAREFULLY (INCLUDING AN OFFER TO PURCHASE, A
RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER
DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON
SCHEDULE 14D-9 REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM
TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD
CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR
SECURITIES.
Investors and security holders may obtain a free copy of the
Offer to Purchase, the related Letter of Transmittal, certain other
tender offer documents and the Solicitation/Recommendation
Statement (when available) and other documents filed with the SEC
at the website maintained by the SEC at www.sec.gov or by directing
such requests to the Information Agent for the Offer, which will be
named in the tender offer statement. In addition, Merck and
Acceleron file annual, quarterly and current reports and other
information with the SEC, which are available to the public from
commercial document-retrieval services and at the SEC’s website at
www.sec.gov. Copies of the documents filed with the SEC by Merck
may be obtained at no charge on Merck’s internet website at
www.merck.com or by contacting Merck at 2000 Galloping Hill Road,
Kenilworth, N.J. 07033 or (908) 423-1000. Copies of the documents
filed with the SEC by Acceleron may be obtained at no charge on
Acceleron’s internet website at www.acceleronpharma.com or by
contacting Acceleron at 128 Sidney Street, Cambridge, MA 02139 or
(617) 649-9200.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes statements that are not statements of
historical fact, or “forward-looking statements,” including with
respect to the company’s proposed acquisition of Acceleron. Such
forward-looking statements include, but are not limited to, the
ability of the company and Acceleron to complete the transactions
contemplated by the merger agreement, including the parties’
ability to satisfy the conditions to the consummation of the offer
contemplated thereby and the other conditions set forth in the
merger agreement, statements about the expected timetable for
completing the transaction, the company’s and Acceleron’s beliefs
and expectations and statements about the benefits sought to be
achieved in the company’s proposed acquisition of Acceleron, the
potential effects of the acquisition on both the company and
Acceleron, the possibility of any termination of the merger
agreement, as well as the expected benefits and success of
Acceleron’s product candidates. These statements are based upon the
current beliefs and expectations of the company’s management and
are subject to significant risks and uncertainties. There can be no
guarantees that the conditions to the closing of the proposed
transaction will be satisfied on the expected timetable or at all,
with respect to pipeline products that the products will receive
the necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate
or risks or uncertainties materialize, actual results may differ
materially from those set forth in the forward-looking
statements.
Risks and uncertainties include but are not limited to,
uncertainties as to the timing of the offer and the subsequent
merger; uncertainties as to how many of Acceleron’s stockholders
will tender their shares in the offer; the risk that competing
offers or acquisition proposals will be made; the possibility that
various conditions to the consummation of the merger and the offer
contemplated thereby may not be satisfied or waived; the effects of
disruption from the transactions contemplated by the merger
agreement and the impact of the announcement and pendency of the
transactions on Acceleron’s business; the risk that stockholder
litigation in connection with the offer or the merger may result in
significant costs of defense, indemnification and liability;
general industry conditions and competition; general economic
factors, including interest rate and currency exchange rate
fluctuations; the impact of the global outbreak of novel
coronavirus disease (COVID-19); the impact of pharmaceutical
industry regulation and health care legislation in the United
States and internationally; global trends toward health care cost
containment; technological advances, new products and patents
attained by competitors; challenges inherent in new product
development, including obtaining regulatory approval; the company’s
ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; dependence on the
effectiveness of the company’s patents and other protections for
innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise, except to the extent required by law.
Additional factors that could cause results to differ materially
from those described in the forward-looking statements can be found
in the company’s 2020 Annual Report on Form 10-K and the company’s
other filings with the Securities and Exchange Commission (SEC)
available at the SEC’s Internet site (www.sec.gov).
Forward-Looking Statement for Acceleron
This press release contains forward-looking statements about
Acceleron Pharma Inc.’s (Acceleron) financial results. The words
"anticipate," "believe," "could," "estimate," "expect," "goal,"
"intend," "may," "plan," "potential," "project," "should,"
"target," "will," "would," and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Though
Acceleron’s management believes that the expectations reflected in
such forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are
subject to various risk and uncertainties, many of which are
difficult to predict and go beyond the control of Acceleron, that
could cause actual results to differ materially from those included
in the forward-looking statements due to various factors, risks and
uncertainties, including, but not limited to, risks related to (a)
Acceleron’s and Merck’s inability to complete the acquisition on
the proposed terms and the proposed timeline, due to factors such
as regulatory approvals, the possibility that competing offers will
be made and risks associated with executing business combination
transactions, such as the risk that the businesses will not be
integrated successfully, that such integration may be more
difficult, time-consuming or costly than expected or that the
expected benefits of the acquisition will not be realized, (b)
future opportunities and plans for the combined company, including
uncertainty of the expected financial performance and results of
the combined company following completion of the proposed
acquisition, disruption from the proposed acquisition making it
more difficult to conduct business as usual or to maintain
relationships with customers, employees, manufacturers, suppliers
or patient groups, and the possibility that, if the combined
company does not achieve the perceived benefits of the proposed
acquisition as rapidly or to the extent anticipated by financial
analysts or investors, that the market price of Merck’s shares
could decline, (c) the ability to grow sales and revenues from
existing products and to develop, commercialize or market new
products, (d) competition, (e) the uncertainties inherent in
research and development, including future clinical data and
analysis, regulatory obligations and oversight by regulatory
authorities, such as the U.S. Food and Drug Administration,
including decisions of such authorities regarding whether and when
to approve any drug, device or biological application that may be
filed for any product candidates as well as decisions regarding
labelling and other matters that could affect the availability or
commercial potential of any product candidates, (f) the absence of
a guarantee that any product candidates, if approved, will be
commercially successful, (g) the future approval and commercial
success of therapeutic alternatives, (h) Acceleron’s intellectual
property and any related pending or future litigation and the
ultimate outcome of such litigation, (i) trends in exchange rates
and prevailing interest rates, (j) volatile economic and market
conditions, (k) preclinical testing of Acceleron’s compounds and
data from clinical trials, including the risk that they may not be
predictive of the results or success of other clinical trials, (l)
regulatory approval of Acceleron’s compounds, and the risk that
approval in one indication or country may not be predictive of
approval in another indication or country, (m) the development of
Acceleron’s compounds, and the risk that it may take longer and/or
cost more than planned or accelerate faster than currently
expected, (n) Acceleron’s or its collaboration partner, Bristol
Myers Squibb’s (“BMS”), inability to successfully complete the
clinical development of Acceleron’s compounds, or that Acceleron or
BMS may be delayed in initiating, enrolling or completing any
clinical trials, and that Acceleron’s compounds may not receive
regulatory approval or become commercially successful products and
(o) the impact that COVID-19 will have on Acceleron and its
respective customers, suppliers, vendors, and other business
partners, and the financial condition of any one of them, as well
as on Acceleron’s employees and on the global economy as a whole.
Any material effect of COVID-19 on any of the foregoing could also
adversely impact Acceleron. This situation is changing rapidly and
additional impacts may arise of which Acceleron is not currently
aware and may exacerbate other previously identified risks. While
the list of factors presented here is representative, no list
should be considered a statement of all potential risks,
uncertainties or assumptions that could have a material adverse
effect on the companies’ consolidated financial condition or
results of operations. The foregoing factors should be read in
conjunction with the risks and uncertainties identified under the
heading “Risk Factors” included in Acceleron’s most recent Annual
Report on Form 10-K for the fiscal year ended December 31, 2020,
quarterly reports on Form 10-Q, current reports on Form 8-K and
other filings that Acceleron has made and may make with the SEC in
the future. The forward-looking statements contained in this press
release are based on management's current views, plans, estimates,
assumptions, and projections with respect to future events, and
Acceleron does not undertake and specifically disclaims any
obligation to update any forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20210930005314/en/
Merck Media Contacts:
Patrick Ryan (973) 275-7075
Melissa Moody (215) 407-3536
Acceleron Media Contact:
Matt Fearer (617) 301-9557
Merck Investor Contacts:
Peter Dannenbaum (908) 740-1037
Steven Graziano (908) 740-6582
Acceleron Investor Contacts:
Todd James (617) 649-9393
Jamie Bernard, IRC (617) 301-9650
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