- Brings in clinical-stage anti-FcRn antibody
SYNT001 with potential to address a number of rare IgG-mediated
diseases -
- SYNT001 is first and only anti-FcRn asset
currently in clinical development for warm autoimmune hemolytic
anemia (WAIHA) -
- Conference call and webcast scheduled for
today, September 26, 2018, at 8:00 a.m. EDT -
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Syntimmune today
announced that they have entered into a definitive agreement for
Alexion to acquire Syntimmune, a clinical-stage biotechnology
company developing antibody therapeutics targeting the neonatal Fc
receptor (FcRn). SYNT001 – a humanized monoclonal antibody that
inhibits the interaction of FcRn with Immunoglobulin G (IgG) and
IgG immune complexes – has the potential to improve treatment in a
number of rare IgG-mediated diseases. SYNT001 is currently being
evaluated in Phase 1b/2a studies in patients with warm autoimmune
hemolytic anemia (WAIHA) and in patients with pemphigus vulgaris
(PV) or pemphigus foliaceus (PF) and has demonstrated proof of
mechanism showing rapid IgG reduction. Under the terms of the
agreement, Alexion will acquire Syntimmune for an upfront payment
of $400 million, with the potential for additional
milestone-dependent payments of up to $800 million, for a total
value of up to $1.2 billion.
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“Targeting FcRn holds great promise in transforming the
treatment of IgG-mediated diseases. SYNT001 has successfully
demonstrated proof of mechanism – the ability to rapidly lower IgG
levels – in early clinical studies and has the potential to treat a
number of rare IgG-mediated diseases,” said Ludwig Hantson, Ph.D.,
Chief Executive Officer of Alexion. “The acquisition of Syntimmune
represents a critical step in rebuilding Alexion’s pipeline and
further diversifying the company’s clinical-stage rare disease
portfolio. It offers a strong strategic fit with Alexion’s existing
rare disease franchises and provides the opportunity to transform
patient care in diseases like warm autoimmune hemolytic anemia,
where SYNT001 is the first, and currently the only, anti-FcRn
therapy in clinical development.”
“Since the company’s founding in 2013, the team at Syntimmune
has been focused on developing transformative therapies for
patients with autoimmune diseases. We see tremendous promise for
SYNT001, which is being evaluated in multiple IgG-mediated
autoimmune diseases in ongoing clinical trials,” said Seth
Harrison, M.D., Chairman of Syntimmune and Managing Partner of
Apple Tree Partners. “Alexion’s demonstrated rare disease expertise
and development and commercial capabilities provide an ideal
foundation for continued advancement of SYNT001 and, we believe,
will ensure its broad potential is realized.”
Terms of the Transaction
Alexion’s acquisition of Syntimmune is subject to the
satisfaction of customary closing conditions, including approval
from relevant regulatory agencies. Pending these approvals, the
transaction is expected to close in the fourth quarter of 2018.
Alexion intends to finance the acquisition through cash on
hand.
Foley Hoag LLP is serving as legal counsel to Alexion, Goodwin
Procter LLP is serving as legal counsel to Syntimmune, and Sullivan
& Cromwell LLP is serving as legal counsel for Apple Tree
Partners, which is the majority shareholder in Syntimmune.
Conference Call
Alexion will host a conference call/webcast today, September 26,
2018 at 8:00 a.m. EDT to discuss the acquisition. To participate in
this call, dial (866) 762-3111 (USA) or (210) 874-7712
(International), passcode 7449227, shortly before 8:00 a.m. EDT. A
replay of the call will be available for a limited period of time
following the call. The audio webcast can be accessed on the
Investors page of Alexion’s website at: http://ir.alexion.com.
About FcRn
Antibodies play an important role in a healthy body’s defense by
fighting infections from bacteria and other invaders. In autoimmune
diseases, however, the body mistakenly attacks itself through the
production of pathogenic (disease-causing) antibodies of the
Immunoglobulin G (IgG) subtype. Neonatal Fc receptor (FcRn) rescues
IgGs from lysosomal degradation by binding them to endosomes and
returning them to the bloodstream. This helps prolong the half-life
of IgG. In healthy individuals, this function contributes to a
normal immune response. In many autoimmune conditions, however,
FcRn prevents lysosomal degradation of pathogenic IgGs associated
with driving the disease. Therefore, blocking the FcRn-IgG
interaction has the potential to drive degradation of IgG within
cells and rapidly reduce circulating pathogenic IgG.
About WAIHA
Warm autoimmune hemolytic anemia (WAIHA) is a rare autoimmune
disorder caused by pathogenic Immunoglobulin G (IgG) antibodies
that react with and cause the premature destruction of red blood
cells at normal body temperature. The disease is often
characterized by profound, and potentially life-threatening anemia
and other acute complications, including severe and
life-threatening hemolysis, severe weakness, enlarged spleen and/or
liver, rapid heart rate (tachycardia), chest pain, heart failure
and fainting (syncope). There are approximately 65,000 patients
across the United States, France, Germany, Italy, Spain and the
United Kingdom. There are currently no approved treatments for
WAIHA.
About SYNT001
SYNT001 is an investigational humanized IgG4 monoclonal antibody
optimized to inhibit FcRn binding to IgG at both neutral and acidic
pH. Studies have shown that SYNT001 rapidly facilitates clearance
of IgG and IgG circulating immune complexes (CICs), with the
potential to block innate immune responses induced by IgG and CIC,
as well as inhibit T-cell and B-cell activation in response to CIC.
Additionally, studies suggest that SYNT001 accomplishes its effects
on IgG without destroying immune cells or impacting other types of
immunoglobulin. SYNT001 has the potential to exert a rapid
therapeutic effect in a wide range of IgG-mediated autoimmune
diseases.
About Syntimmune
Syntimmune is a clinical-stage biotechnology company developing
differentiated drug candidates in a wide range of autoimmune
diseases. Drawing on the pioneering research of its scientific
founders, the company is advancing novel therapies based on its
deep expertise in the biology of the neonatal Fc receptor (FcRn)
and its complex role in the pathogenesis of IgG-mediated autoimmune
diseases. Syntimmune’s lead candidate, SYNT001, is a monoclonal
antibody that specifically blocks FcRn-IgG interactions and is
being studied in multiple Phase 1b/2a trials for the treatment of
IgG-mediated autoimmune diseases. Syntimmune is headquartered in
Boston, Mass., and was founded in 2013 by Richard Blumberg, M.D.,
and Laurence Blumberg, M.D. Syntimmune has raised $78 million in
private financing from lead investor Apple Tree Partners, with
participation from additional investors Partners Innovation Fund,
FMB Research and AFB Fund. For more information on Syntimmune,
please visit the company’s website at www.syntimmune.com.
About Alexion
Alexion is a global biopharmaceutical company focused on serving
patients and families affected by rare diseases through the
discovery, development and commercialization of life-changing
therapies. As the global leader in complement biology and
inhibition for more than 20 years, Alexion has developed and
commercializes the first and only approved complement inhibitor to
treat patients with paroxysmal nocturnal hemoglobinuria (PNH),
atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine
receptor (AchR) antibody-positive generalized myasthenia gravis
(gMG). Alexion also has two highly innovative enzyme replacement
therapies for patients with life-threatening and ultra-rare
metabolic disorders, hypophosphatasia (HPP) and lysosomal acid
lipase deficiency (LAL-D). In addition, the company is developing
two late-stage therapies, including a second complement inhibitor
and a copper-binding agent for Wilson disease. Alexion focuses its
research efforts on novel molecules and targets in the complement
cascade and its development efforts on the core therapeutic areas
of hematology, nephrology, neurology, and metabolic disorders.
Alexion has been named to the Forbes list of the World’s Most
Innovative Companies seven years in a row and is headquartered in
Boston, Massachusetts’ Innovation District. The company also has
offices around the globe and serves patients in more than 50
countries. This press release and further information about Alexion
can be found at: www.alexion.com.
[ALXN-G]
Forward-Looking Statement
This press release contains forward-looking statements for
purposes of the Private Securities Litigation Reform Act of 1995,
including statements related to: the benefits of SYNT001, the
potential of SYNT001 to improve the treatment paradigm in a number
of rare IgG-mediated diseases, targeting FcRn holds great promise
in transforming the IgG treatment landscape, SYNT001 has the
potential to treat a number of rare IgG-mediated diseases, the
planned acquisition of Syntimmune is a critical step in rebuilding
Alexion’s pipeline and further diversifying the company’s
clinical-stage rare disease portfolio, Syntimmune provides the
opportunity to transform patient care in diseases like WAIHA, all
necessary approvals necessary to complete the acquisition of
Syntimmune will be obtained and obtained in a timely manner
(including the necessary regulatory approvals), the acquisition of
Syntimmune is expected to close in the fourth quarter of 2018,
SYNT001 has the potential to exert a rapid therapeutic effect in a
wide range of IgG-mediated autoimmune diseases, and the potential
benefits of the transaction. Forward-looking statements are subject
to factors that may cause Alexion's results and plans to differ
materially from those forward-looking statements, including for
example, the technology acquired from Syntimmune may not confer the
expected therapeutic benefits (particularly with respect to
treatment of IgG-mediated diseases), future clinical trials of
SYNT001 may not prove that the therapy is safe and effective to the
level required by regulators, delay by regulatory authorities to
approve transaction (or a decision not to approve the transaction),
the closing conditions to complete the acquisition may not be
satisfied, decisions of regulatory authorities regarding the
adequacy of our and Syntimmune’s research and clinical tests,
marketing approval or material limitations on the marketing of
products, delays, failure of product candidates to obtain
regulatory approval, delays or the inability to launch product
candidates due to regulatory restrictions, anticipated expense or
other matters, interruptions or failures in the manufacture and
supply of our products and our product candidates, failure to
satisfactorily address matters raised by the FDA and other
regulatory agencies, the possibility that results of clinical
trials are not predictive of safety and efficacy results of
products in broader patient populations, the possibility that
clinical trials of our product candidates could be delayed or
terminated prior to completion, the adequacy of our
pharmacovigilance and drug safety reporting processes, delay of
collection or reduction in reimbursement due to adverse economic
conditions or changes in government and private insurer regulations
and approaches to reimbursement, uncertainties surrounding legal
proceedings, company investigations and government investigations,
including investigations of Alexion by the U.S. Securities and
Exchange Commission (SEC) and U.S. Department of Justice, the risk
that anticipated regulatory filings are delayed, the risk that
estimates regarding the number of patients with PNH, aHUS, gMG,
HPP, IgG-mediated autoimmune diseases (including WAIHA) and LAL-D
are inaccurate, risks related to the acquisition of Syntimmune and
other acquisitions and co-development efforts, and a variety of
other risks set forth from time to time in Alexion's filings with
the SEC, including but not limited to the risks discussed in
Alexion's Quarterly Report on Form 10-Q for the period ended June
30, 2018 and in our other filings with the SEC. Alexion disclaims
any obligation to update any of these forward-looking statements to
reflect events or circumstances after the date hereof, except when
a duty arises under law.
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AlexionMediaMegan Goulart, 857-338-8634Senior
Director, Corporate CommunicationsorInvestorsSusan
Altschuller, Ph.D., 857-338-8788Vice President, Investor
Relations
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