STAINES-UPON-THAMES, United
Kingdom and LONDON,
July 18, 2019 /PRNewswire/ --
Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company,
and Silence Therapeutics plc (LON: SLN), a leader in the discovery,
development and delivery of novel RNA2 interference
(RNAi) therapeutics for the treatment of serious diseases, today
announced a collaboration that will allow the companies to develop
and commercialize RNAi drug targets designed to inhibit or
'silence' the complement cascade, a group of proteins that are
involved in the immune system and that play a role in the
development of inflammation. These proteins are known to contribute
to the pathogenesis of many diseases, including autoimmune
diseases.
Under the terms of the agreement, Mallinckrodt will obtain an
exclusive worldwide license to Silence's C33 complement
asset, SLN500, with options to license up to two additional
complement-targeted assets in Silence's preclinical
complement-directed RNAi development program. Silence will be
responsible for preclinical activities, and for executing the
development program of each asset until the end of Phase 1, after
which Mallinckrodt will assume clinical development and
responsibility for global commercialization.
Mallinckrodt has agreed to provide Silence with an upfront
payment of $20 million. Silence is
also eligible to receive up to $10
million in research milestones for SLN500 and for each
optioned asset, in addition to funding for Phase 1 clinical
development including GMP4 manufacturing. Silence will
fund all other preclinical activities. The collaboration provides
for potential added clinical and regulatory milestone payments of
up to $100 million for SLN500, as
well as commercial milestone payments of up to $563 million for SLN500. Should Mallinckrodt opt
to license one or two additional assets, Silence could receive up
to $703 million in similar clinical,
regulatory, and commercial milestone payments per asset. Silence
would also receive tiered, low double-digit to high-teen royalties
on net sales for SLN500 and each optioned asset.
"We are very excited by the significant potential offered by
Silence's RNAi technology to meet the needs of underserved patients
in a number of serious and critical conditions, and we look forward
to collaborating with them to advance development of
complement-targeted assets as new therapeutic options," said
Steven Romano, M.D., Chief
Scientific Officer and Executive Vice President of
Mallinckrodt.
"This license provides Mallinckrodt with an expansion of
early development opportunities and the value of applying RNA
technology therapeutically to target a range of rare diseases as
well as conditions of immune dysregulation," adds Ulrich H. von Andrian, M.D., Edward Mallinckrodt Jr. Professor of
Immunopathology, Microbiology and Immunobiology, Harvard Medical School and Member of the
Mallinckrodt Pharmaceuticals Scientific Advisory Council.
"This collaboration combines Silence Therapeutics' knowledge and
world-class research and development in the field of RNAi with
Mallinckrodt's expertise and resources as a global
biopharmaceutical company with years of experience solving complex
challenges," said Dr. David Horn
Solomon, President and Chief Executive Officer of Silence
Therapeutics. "The increasing number of clinical conditions and
pathologies that involve the complement system has generated
significant interest in the development of therapeutic options to
inhibit complement activation, which holds great promise in
treating a range of diseases. We look forward to working closely
with Mallinckrodt to extend our capabilities with RNAi therapies
that have the potential to transform patients'
lives."
The companies will work together to develop and commercialize
this RNAi therapeutic target, with the possibility of additional
assets, and will form a Joint Steering Committee to guide the
asset's development program. Silence's proprietary technology is a
highly specific and modular platform designed to inhibit or
'silence' the expression of disease-causing genes. The technology
is appropriate to target any number of genes; however, the
collaboration focuses on the complement cascade, which is
implicated in a number of autoimmune diseases.
Silence Call with Investors
Dr. David Horn Solomon, Chief Executive Officer of
Silence Therapeutics, will host a conference call accompanied by a
live presentation for analysts and investors today at 13.00pm BST (8.00am
EDT). Link to the live webcast:
https://edge.media-server.com/mmc/p/d4noa4jd. Dial-in details are:
Participant UK dial-in: +44 (0) 2071 928000; Participant; US
Dial-in: +1 631 510 7495 Conference ID: 1576453. A
presentation to accompany the call will be made available to
download from
https://www.silence-therapeutics.com/investors/results-reports-presentations.
ABOUT SILENCE
Silence Therapeutics is developing a new
generation of medicines by harnessing the body's natural mechanism
of RNA interference, or RNAi, within its cells. Its proprietary
technology can selectively inhibit any gene in the genome,
specifically silencing the production of disease-causing proteins.
Using its enabling delivery systems, it has achieved an additional
level of specificity by delivering its therapeutic RNA molecules
exclusively to target cells. Silence's proprietary RNA chemistries
and delivery systems are designed to improve the stability of our
molecules and enhance effective delivery to target cells, providing
a powerful modular technology well suited to tackle
life-threatening diseases. Silence Therapeutics remains focused and
is determined to be responsive to creating shareholder value as
well as the appropriate growth and development of its business.
Silence Therapeutics continues to assess a number of options in
addition to its organic plan which it believes would be additive to
the Company's future growth prospects and shareholder value, which
may include equity fundraisings as well as other strategic
licensing and collaboration opportunities. For more information,
please visit https://www.silence-therapeutics.com/.
ABOUT MALLINCKRODT
Mallinckrodt is a global business
consisting of multiple wholly owned subsidiaries that develop,
manufacture, market and distribute specialty pharmaceutical
products and therapies. The company's Specialty Brands reportable
segment's areas of focus include autoimmune and rare diseases in
specialty areas like neurology, rheumatology, nephrology,
pulmonology and ophthalmology; immunotherapy and neonatal
respiratory critical care therapies; analgesics and
gastrointestinal products. Its Specialty Generics reportable
segment includes specialty generic drugs and active pharmaceutical
ingredients. To learn more about Mallinckrodt, visit
www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of
important company information, such as press releases, investor
presentations and other financial information. It also uses its
website to expedite public access to time-critical information
regarding the company in advance of or in lieu of distributing a
press release or a filing with the U.S. Securities and Exchange
Commission (SEC) disclosing the same information. Therefore,
investors should look to the Investor Relations page of the website
for important and time-critical information. Visitors to the
website can also register to receive automatic e-mail and other
notifications alerting them when new information is made available
on the Investor Relations page of the website.
Cautionary Statements Related to Forward-Looking
Statements
Mallinckrodt
This release includes
forward-looking statements concerning Mallinckrodt's collaboration
with Silence, including expectations regarding future research and
development plans, potential milestone payments and commercial
arrangements and the potential impact on patients. The statements
are based on assumptions about many important factors, including
the following, which could cause actual results to differ
materially from those in the forward-looking statements:
uncertainties inherent in research and development, including
clinical trial results; satisfaction of regulatory and other
requirements; actions of regulatory bodies and other governmental
authorities; changes in laws and regulations; issues with product
quality, manufacturing or supply, or patient safety issues; and
other risks identified and described in more detail in the "Risk
Factors" section of Mallinckrodt's most recent Annual Report on
Form 10-K and other filings with the SEC, all of which are
available on its website. The forward-looking statements made
herein speak only as of the date hereof and Mallinckrodt does not
assume any obligation to update or revise any forward-looking
statement, whether as a result of new information, future events
and developments or otherwise, except as required by law.
Silence
The information contained within this
announcement is deemed by the Silence Therapeutics plc to
constitute inside information as stipulated under the Market Abuse
Regulation (EU) No. 596/2014. Upon the publication of this
announcement via the Regulatory Information Service, this inside
information is now considered to be in the public domain.
CONTACTS
MALLINCKRODT
Investor Relations
Daniel J. Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@mnk.com
Media
Daniel Yunger
Kekst CNC
212-521-4879
mallinckrodt@kekstcnc.com
SILENCE THERAPEUTICS
Dr. David Horn Solomon, Chief Executive Officer
Mr. Iain Ross, Non-Executive
Chairman
+44 (0) 20 3457 6900
Peel Hunt/LLP (Nominated Adviser and Broker)
James Steel/Oliver Jackson
+44 (0) 20 7418 8900
European IR
Consilium Strategic Communications
Mary-Jane Elliott/Chris Welsh/Angela
Gary
silencetherapeutics@consilium-comms.com
+44 (0) 20 3709 5700
US IR
Westwicke Partners
Peter Vozzo
Peter.vozzo@westwicke.com
442-213-0505
Mallinckrodt, the "M" brand mark and the Mallinckrodt
Pharmaceuticals logo are trademarks of a Mallinckrodt company.
Other brands are trademarks of a Mallinckrodt company or their
respective owners. © 2019 Mallinckrodt. 7/19
1 British Summer Time
2 Ribonucleic acid
3 The C3 protein is part of the complement system.
There are nine major complement proteins, labeled C1 through C9.
https://medlineplus.gov/ency/article/003539.htm Accessed
June 27, 2019.
4 Good manufacturing practices
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SOURCE Mallinckrodt plc