– WTX101 is in Phase 3 Development as a Novel
Treatment for Wilson Disease, a Rare, Genetic, and Chronic
Copper-Mediated Liver Disorder –
– Conference Call and Webcast Scheduled for
Today, April 11, 2018 at 8:30 a.m. EDT –
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Wilson
Therapeutics AB (publ) announced today that Alexion has made a
recommended public cash offer to the shareholders in Wilson
Therapeutics to acquire all outstanding shares in Wilson
Therapeutics by way of a tender offer, through a wholly-owned
subsidiary. Wilson Therapeutics is a biopharmaceutical company,
based in Stockholm, Sweden, that develops novel therapies for
patients with rare copper-mediated disorders. Wilson Therapeutics’
product, WTX101, is in Phase 3 development as a treatment for
Wilson disease, a rare genetic disorder with devastating hepatic
and neurological consequences for patients. WTX101 is a
first-in-class oral copper-binding agent with a unique mechanism of
action and ability to access and bind copper from serum and promote
its removal from the liver. WTX101 has received Fast Track
designation in the U.S. and Orphan Drug Designation for the
treatment of Wilson disease in the U.S. and EU.
“Wilson disease is a rare disorder that can lead to severe liver
disease, including cirrhosis and acute liver failure, as well as
debilitating neurological morbidities such as impaired movement,
gait, speech, swallowing, and psychiatric disorders. WTX101 is an
innovative product that addresses the underlying cause of the
disease and has the potential to define a new standard of care in
treating Wilson disease, an area that has not had a new treatment
in over two decades,” said Ludwig Hantson, Chief Executive Officer
of Alexion. “The acquisition of Wilson Therapeutics is a strong
strategic fit for Alexion given the overlap with our current
clinical and commercial focus on metabolic and neurologic
disorders, and is an important first step in rebuilding our
clinical pipeline.”
“Alexion is a global leader in rare diseases with a proven
record of developing and commercializing therapies for patients
with rare diseases, making them a great partner to make WTX101
available to Wilson disease patients worldwide,” said Jonas
Hansson, CEO of Wilson Therapeutics.
The Transaction
Alexion will acquire Wilson Therapeutics through a tender offer
that was launched this morning at 7:00 a.m. CET/1:00 a.m. EDT
whereby Alexion, through a wholly owned subsidiary, has offered SEK
232 in cash for each outstanding share of Wilson Therapeutics. The
total equity value of the transaction amounts to SEK 7,100 million,
based on outstanding shares on a fully diluted basis, or
approximately $855 million. The Independent Committee of the Board
of Directors of Wilson Therapeutics has unanimously recommended
Wilson Therapeutics shareholders accept the offer and Alexion’s
Board of Directors also unanimously approved the offer. Alexion has
obtained shareholder support agreements from the four largest
shareholders accounting for 57.4% of Wilson Therapeutics’
outstanding shares and two additional shareholders accounting for
8.7% for a total of 66.1% of Wilson Therapeutics’ outstanding
shares, to the effect that these shareholders have undertaken to
accept the offer on certain terms. In addition, Polar Capital,
holding 7.3% of Wilson Therapeutics’ outstanding shares, has
expressed its support for, and intends to accept, the Offer, for a
total support of 73.4%. The acquisition of Wilson Therapeutics
requires approval of relevant regulatory authorities, and Alexion
expects to obtain such approvals prior to the end of the acceptance
period. The tender offer is expected to complete and the
transaction is expected to close in the second quarter of 2018.
Alexion intends to finance the acquisition through cash on
hand.
BofA Merrill Lynch is acting as Alexion’s lead financial
advisor. Deutsche Bank is also serving as a financial advisor, and
DNB Markets is acting as Nordic financial advisor and Settlement
Agent. Advokatfirman Cederquist is acting as Alexion’s legal
advisor as to Swedish law, and Ropes & Gray LLP is acting as
legal advisor as to U.S. law in connection with the Offer. Lazard
is acting as exclusive financial adviser to Wilson Therapeutics,
and Vinge is serving as legal counsel to Wilson Therapeutics.
For additional details on the transaction, please visit
http://ir.alexion.com/acquisitions.cfm.
Conference Call
Alexion will host a conference call/webcast today, April 11,
2018 at 8:30 a.m. EDT to discuss the acquisition. To participate in
this call, dial (866) 762-3111 (USA) or (210) 874-7712
(International), passcode 8294207, shortly before 8:30 a.m. EDT. A
replay of the call will be available for a limited period of time
following the call. The replay number is (855) 859-2056 (USA) or
(404) 537-3406 (International), passcode 8294207. The audio webcast
can be accessed on the Investors page of Alexion’s website at:
http://ir.alexion.com.
About Wilson Disease
Wilson disease is a rare, chronic, genetic and potentially
life-threatening liver disorder of impaired copper transport.
Copper balance is normally maintained in the body by hepatic
excretion of excessive copper in the bile. In patients with Wilson
disease, a genetic mutation disables this biliary excretion pathway
and excess copper accumulates over time in the liver cells. The
accumulation of copper eventually overwhelms safe storage capacity
and cellular injury occurs. When the liver’s capacity for copper
storage is exceeded, and when liver cells are injured, copper is
released into the circulation and may accumulate in other organs,
including the central nervous system. Untreated, Wilson disease
leads to various combinations and severity of hepatic, neurologic
and psychiatric symptoms, and can be fatal.1,2
Wilson disease affects approximately one in every 30,000 people
worldwide.3 The average age of diagnosis is 15-20 years,3 with the
majority of patients presenting between the ages of 10 and 30.4
Current standard of care includes metal chelators to remove serum
copper, followed by maintenance with zinc to prevent
re-accumulation.1,2 There have been no new treatment options
approved in over two decades and a significant unmet need still
exists for patients.
About WTX101
WTX101 (bis-choline tetrathiomolybdate) is a first-in-class
copper-binding agent with a unique mechanism of action, under
investigation as a novel therapy for Wilson disease. In contrast to
current treatments, WTX101 provides an alternative copper-protein
binding mechanism by forming a tripartite complex with copper and
albumin. WTX101 thereby detoxifies excess copper in both the liver
and blood, and promotes copper clearance through biliary excretion
(the body’s natural route of elimination). WTX101 has a 10,000-fold
higher affinity for copper than other chelators and addresses the
underlying cause of the disease.
A Phase 2 study evaluating the efficacy and safety of WTX101 in
patients with Wilson disease has been completed successfully.5 In
addition, the active moiety of WTX101, tetrathiomolybdate, has been
tested in several previous clinical studies in Wilson disease
patients. The data from these studies suggest that WTX101 can
reduce and control free copper levels and improve symptoms and
associated disabilities. The data also suggest that WTX101 is
generally well tolerated with a low risk of drug-induced
neurological worsening. WTX101 has received Fast Track designation
in the U.S. and Orphan Drug Designation for the treatment of Wilson
disease in the U.S. and EU.
About Wilson Therapeutics
Wilson Therapeutics is a biopharmaceutical company, based in
Stockholm, Sweden, that develops novel therapies for patients with
rare copper-mediated disorders. Wilson Therapeutics’ product,
WTX101, is in Phase 3 development as a novel treatment for Wilson
disease. Wilson Therapeutics is listed in the Mid Cap segment on
Nasdaq Stockholm with the stock ticker WTX. For more information
please visit www.wilsontherapeutics.com.
About Alexion
Alexion is a global biopharmaceutical company focused on serving
patients and families affected by rare diseases through the
innovation, development, and commercialization of life-changing
therapies. Alexion is the global leader in complement inhibition
and 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). In addition, Alexion 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). As the leader in complement biology for over 20 years,
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. 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,
including statements related to the status of and plans for
clinical trials for WTX101, the potential benefits of WTX101 for
the treatment of Wilson disease, and the potential benefits of the
transaction. Forward-looking statements are subject to factors that
may cause Alexion's results and plans to differ from those
expected, including for example, decisions of regulatory
authorities regarding the adequacy of our research, marketing
approval or material limitations on the marketing of our products,
delays, interruptions or failures in the manufacture and supply of
our products and our product candidates, failure to satisfactorily
address matters raised by the U.S. Food and Drug Administration and
other regulatory agencies, the possibility that results of clinical
trials are not predictive of safety and efficacy results of our
products in broader patient populations, the possibility that
clinical trials of our product candidates could be delayed, the
adequacy of our pharmacovigilance and drug safety reporting
processes, 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 Wilson disease are
inaccurate, the risks of changing foreign exchange rates, risks
relating to the potential effects of the Company's restructuring
and relocation of its corporate headquarters, 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 Annual Report on Form 10-K for the period ended December
31, 2017 and in our other filings with the SEC. Alexion does not
intend to update any of these forward-looking statements to reflect
events or circumstances after the date hereof, except when a duty
arises under law.
References
1 Roberts, E. and M.L. Schilsky (2008). “Diagnosis and Treatment
of Wilson Disease: An Update.” Hepatology 47(6): 2089-2111.
2 European Association for the Study of the Liver (2012). “EASL
clinical practice guidelines: Wilson’s Disease.” J Hepatol 6(53):
671-685.
3 Merle, U. et al., (2007). “Clinical presentation, diagnosis
and long-term outcome of Wilson’s disease: a cohort study.” Gut 56:
115-120.
4 Beinhardt, S. et al., (2014). “Long-term outcomes of patients
with Wilson disease in a large Austrian cohort.” Clin Gastroenterol
Hepatol 12: 683-689.
5 Weiss, K.H. et al., (2017). “Bis-choline tetrathiomolybdate in
patients with Wilson’s disease: an open-label, multicentre, phase 2
study.” Lancet Gastroenterol Hepatol 2(12): 869-876.
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version on businesswire.com: https://www.businesswire.com/news/home/20180410006794/en/
AlexionMediaKim Diamond,
475-230-3775kim.diamond@alexion.comOrInvestorsSusan Altschuller,
PhD, 475-230-3534susan.altschuller@alexion.com
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