Sanofi to acquire Principia Biopharma
17 Agosto 2020 - 02:00AM
Sanofi to acquire Principia Biopharma
- Further strengthens core R&D areas of autoimmune and
allergic diseases
- Provides full control of brain-penetrant BTK inhibitor
SAR442168 in multiple sclerosis (MS), making commercialization more
efficient and eliminating future royalty payments
- Allows expansion of SAR442168 development program into other
central nervous system diseases and therapeutic areas
- Adds clinically advanced oral BTK inhibitor rilzabrutinib with
potential across a range of immunology and inflammation
indications, complementing Sanofi’s existing R&D pipeline
PARIS and SOUTH SAN FRANCISCO, Calif. –
August 17, 2020 – Sanofi and Principia Biopharma Inc.
(NASDAQ: PRNB), a late-stage biopharmaceutical company focused on
developing treatments for immune-mediated diseases, entered into a
definitive agreement under which Sanofi will acquire all of the
outstanding shares of Principia for $100 per share in cash,
which represents an aggregate equity value of approximately $3.68
billion (on a fully diluted basis). The Sanofi and Principia Boards
of Directors unanimously approved the transaction.
“This acquisition advances our ongoing R&D
transformation to accelerate development of the most promising
medicines that will address significant patient needs,” said Paul
Hudson, Sanofi Chief Executive Officer. “The addition of multiple
BTK inhibitors to our pipeline demonstrates our commitment to
strategic product acquisitions in our priority therapeutic areas.
Full ownership of our brain-penetrant BTK inhibitor ‘168 removes
complexities for this priority development program and simplifies
future commercialization.”
“The Phase 2b data in relapsing multiple
sclerosis showed the strong potential of ‘168 to address disability
and disease progression, and triggered the start of Phase 3 studies
across the full spectrum of MS. Through this acquisition, we will
be able to expand and accelerate development of BTK inhibitors
across multiple indications. Both ‘168 and rilzabrutinib, have
‘pipeline in a product’ potential, and we look forward to unlocking
their full treatment benefits across an array of diseases,” said
John Reed, M.D., Ph.D., Global Head of Research & Development
at Sanofi.
“Principia’s successful design and development
of a whole portfolio of BTK inhibitors for immunology is aimed to
transform the treatment for patients with immune-mediated diseases.
By combining with Sanofi, we will bring significant resources to
expand and accelerate the potential benefits of these therapies.
The benefit of developing several BTK inhibitors will allow us to
target specific organ systems for optimal patient benefit. The
merger will provide global resources to get these novel therapies
to patients faster,” said Martin Babler, President and CEO at
Principia Biopharma.
Principia’s Bruton tyrosine kinase (BTK)
inhibitors add to Sanofi’s efforts to accelerate and build a
portfolio of the next generation of transformative treatments for
autoimmune diseases. BTK is present in the signaling pathways of
key innate and adaptive cell types of the immune system. Being able
to block or disrupt these signaling processes can help in stopping
inflammation and tissue destruction related to autoimmune diseases
and target some of the underlying pathophysiology.
- BTK inhibitor ‘168: In a Phase 2b study in
patients with multiple sclerosis, ‘168 reduced Gd-enhancing T1
hyperintense lesions by 85% compared to placebo. In June, Sanofi
announced the first multiple sclerosis patient was enrolled in the
Phase 3 program for the BTK inhibitor, comprising four pivotal
clinical trials across the disease spectrum. The Principia
acquisition will provide an opportunity to expand the development
program to evaluate indications beyond central nervous system
diseases.
- Rilzabrutinib: This oral BTK inhibitor is
currently being evaluated in a Phase 3 program for patients with
moderate to severe pemphigus, a rare, debilitating autoimmune
disease that causes blistering of the skin and mucous membranes. A
Phase 3 program for immune thrombocytopenia, a disease that causes
high risk for bleeding events, is expected to be initiated by the
end of 2020, assuming no COVID-19 related impact. The company also
has an ongoing Phase 2 program for IgG4-related diseases, which is
driven by chronic inflammation, immune cell infiltration, and
fibrosis within organs that can lead to severe morbidity.
- PRN473 Topical: This BTK inhibitor is a
topical agent currently in Phase 1 trials and is being developed
for immune-mediated diseases that could benefit from localized
application to the skin.
The Principia BTK inhibitor franchise is based
on its proprietary Tailored Covalency® platform that has generated
potential best-in-class clinical candidates. The platform allows
the design of both reversible covalent and irreversible covalent
small molecule inhibitors that are more selective with less
off-target effects. The optimized target residence time has
potential to deliver a desired efficacy with a stronger safety
profile.
In 2017, Sanofi formed a collaboration with
Principia under which Principia granted Sanofi an exclusive,
worldwide license to develop and commercialize BTK inhibitor ‘168
in multiple sclerosis and other central nervous system
diseases.
Transaction Terms
Under the terms of the merger agreement, Sanofi
will commence a cash tender offer to acquire all outstanding shares
of Principia common stock for $100 per share in cash for a total
enterprise value of approximately $3.36 billion.
The consummation of the tender offer is subject
to customary closing conditions, including the tender of at least a
majority of the outstanding shares of Principia common stock, the
expiration or termination of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other
customary conditions. Following the successful completion of the
tender offer, a wholly owned subsidiary of Sanofi will merge with
Principia and the outstanding Principia shares not tendered in the
tender offer will be converted into the right to receive the same
$100 per share in cash paid in the tender offer. The tender offer
is expected to commence later this month. Sanofi plans to finance
the transaction with cash on hand. Subject to the satisfaction or
waiver of customary closing conditions, Sanofi expects to complete
the acquisition in the fourth quarter of 2020.
Evercore is acting as financial advisor to
Sanofi and Weil, Gotshal & Manges LLP is acting as its legal
counsel. Centerview Partners LLC and BofA Securities are acting as
financial advisors to Principia and Cooley LLP is acting as its
legal counsel.
Investor Relations Call
Sanofi will host an audio webcast live and
conference call at 3:00 pm CET / 9:00 am ET on Monday, August 17,
2020. The webcast, conference call details, and full presentation
will be made available on Sanofi’s Investor Relations webpage.
About Principia
BiopharmaPrincipia is a late-stage biopharmaceutical
company dedicated to bringing transformative therapies to patients
with significant unmet medical needs in immune-mediated diseases.
Through Principia’s proprietary Tailored Covalency® platform, our
strategy is to build and advance a pipeline of best-in-class drug
candidates with significant therapeutic benefits, limit unintended
side effects, improve quality of life and over time modify the
course of disease. This highly reproducible approach enables the
company to pursue multiple programs efficiently, having discovered
three drug candidates. Rilzabrutinib, a reversible covalent BTK
inhibitor, is being evaluated in a global Phase 3 clinical trial in
participants with pemphigus, a Phase 1/2 clinical trial in
participants with immune thrombocytopenia (ITP), and the company
plans to initiate a Phase 2 clinical trial in participants with
IgG4-Related Diseases and a Phase 3 trial in ITP. PRN2246/SAR442168
is a covalent BTK inhibitor which crosses the blood-brain barrier
and is licensed to Sanofi. Sanofi has announced that
SAR442168 will be evaluated in four Phase 3 clinical trials in
participants with relapsing and progressive forms of multiple
sclerosis. PRN473 Topical, a topical reversible covalent BTK
inhibitor designed for immune-mediated diseases that could benefit
from localized application to the skin, is being evaluated in Phase
1 trials. For more information, please visit
www.principiabio.com.
About Sanofi Sanofi is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe. Sanofi, Empowering Life |
Sanofi Media Relations Contact Ashleigh Koss Tel.:
+1 908 205 2572 Ashleigh.Koss@sanofi.com Nicolas KressmannTel: +1
732 532 5318Nicolas.Kressmann@sanofi.com
|
Sanofi
Investor Relations Contacts Paris Eva Schaefer-Jansen
Arnaud DelepineYvonne Naughton Sanofi Investor
Relations Contacts North America Felix LauscherFara
BerkowitzSuzanne Greco IR main line:Tel.: +33 (0)1 53 77 45
45 ir@sanofi.com |
Principia Media Relations ContactPaul
Laland, VP of Corporate CommunicationsTel: +1 415
519-6610paul.laland@principiabio.com |
Principia Investor Relations ContactChristopher
Chai, CFOir@principiabio.com |
Sanofi and Principia Forward-Looking
Statements This communication contains
forward-looking statements. Forward-looking statements are
statements that are not historical facts and may include
projections and estimates and their underlying assumptions,
statements regarding plans, objectives, intentions and expectations
with respect to future financial results, events, operations,
services, product development and potential, and statements
regarding future performance. Forward-looking statements are
generally identified by the words “expects”, “anticipates”,
“believes”, “intends”, “estimates”, “plans”, “will be” and similar
expressions. Although Sanofi’s and Principia ’s management each
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
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi and Principia, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, risks related to Sanofi’s and Principia’s
ability to complete the acquisition on the proposed terms or on the
proposed timeline, including the receipt of required regulatory
approvals, the possibility that competing offers will be made,
other 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, risks
related to 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, the market price of Sanofi’s
shares could decline, as well as other risks related Sanofi’s and
Principia’s respective businesses, including the ability to grow
sales and revenues from existing products and to develop,
commercialize or market new products, competition, including
potential generic competition, the uncertainties inherent in
research and development, including future clinical data and
analysis, regulatory obligations and oversight by regulatory
authorities, such as the FDA or the EMA, 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, the absence of a guarantee that any
product candidates, if approved, will be commercially successful,
the future approval and commercial success of therapeutic
alternatives, Sanofi’s ability to benefit from external growth
opportunities and to complete related transactions and/or obtain
regulatory clearances, risks associated with Sanofi’s and
Principia’s intellectual property and any related pending or future
litigation and the ultimate outcome of such litigation,
trends in exchange rates and prevailing interest rates, volatile
economic and market conditions, cost containment initiatives and
subsequent changes thereto, and the impact that COVID-19 will have
on Sanofi and Principia and their respective customers, suppliers,
vendors, and other business partners, and the financial condition
of any one of them, as well as on Sanofi’s and Principia’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 Sanofi and Principia. This situation is changing rapidly and
additional impacts may arise of which Sanofi and Principia are 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 companies’ consolidated financial condition or results of
operations. The foregoing factors should be read in conjunction
with the risks and cautionary statements discussed or identified in
the public filings with the U.S. Securities and Exchange Commission
(the “SEC”) and the AMF made by Sanofi, including those listed
under “Risk Factors” and “Cautionary Statement Regarding
Forward-Looking Statements” in Sanofi’s annual report on Form 20-F
for the year ended December 31, 2019, and the current reports on
Form 8-K, quarterly reports on Form 10-Q and annual reports on Form
10-K filed by Principia with the SEC. The forward-looking
statements speak only as of the date hereof and, other than as
required by applicable law, Sanofi and Principia do not undertake
any obligation to update or revise any forward-looking information
or statements. Additional Information for US
shareholders The tender offer for the outstanding
shares of Principia common stock referenced 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 securities, nor is it a substitute
for the tender offer materials that Sanofi and its acquisition
subsidiary will file with the SEC, upon the commencement of the
tender offer. At the time the tender offer is commenced, Sanofi and
its acquisition subsidiary will file a tender offer statement on
Schedule TO and thereafter Principia will file a
Solicitation/Recommendation Statement on Schedule 14D-9 with the
SEC with respect to the tender offer. THE TENDER OFFER MATERIALS
(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 WILL
CONTAIN IMPORTANT INFORMATION. PRINCIPIASTOCKHOLDERS ARE URGED TO
READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE (AS EACH
MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY WILL
CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF PRINCIPIA SECURITIES
SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING
THEIR SECURITIES. The Offer to Purchase, the related Letter of
Transmittal and certain other tender offer documents, as well as
the Solicitation/Recommendation Statement, will be made available
to all holders of Principia stock at no expense to them. The tender
offer materials and the Solicitation/Recommendation Statement will
be made available for free at the SEC’s website at www.sec.gov.
Additional copies may be obtained for free by contacting Sanofi or
Principia. Copies of the documents filed with the SEC by Principia
will be available free of charge on Principia’s internet website at
https://ir.principiabio.com or by contacting Principia’s Investor
Relations Department at ir@principiabio.com. Copies of the
documents filed with the SEC by Sanofi will be available free of
charge on Sanofi’s internet website at
https://en.sanofi.com/investors or by contacting Sanofi’s Investor
Relations Department at ir@sanofi.com. In addition to the
Offer to Purchase, the related Letter of Transmittal and certain
other tender offer documents, as well as the
Solicitation/Recommendation Statement, Sanofi files annual and
special reports and other information with the SEC and Principia
files annual, quarterly and special reports and other information
with the SEC. You may read and copy any reports or other
information filed by Sanofi and Principia at the SEC public
reference room at 100 F. Street, N.E., Washington D.C. 20549.
Please call the Commission at 1-800-SEC-0330 for further
information on the public reference room. Sanofi’s and Principia’s
filings with the SEC are also available to the public from
commercial document-retrieval services and at the website
maintained by the SEC at www.sec.gov |
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