— Strengthens global leadership in serving
patients with devastating and rare diseases —
— Expands premier global metabolic rare disease
franchise with the addition of Kanuma™ (sebelipase alfa) for LAL
Deficiency (LAL-D) —
— Launches of Strensiq™ (asfotase alfa) and
Kanuma expected in 2015 —
— Creates the most robust rare disease pipeline
in biotech —
Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN) announced today that
it has successfully completed its previously announced acquisition
of Synageva BioPharma Corp. (Nasdaq:GEVA), strengthening its global
leadership in devastating and rare diseases, and creating the most
robust rare disease pipeline in the biotech industry across a range
of therapeutic modalities. The transaction was completed through a
merger of Synageva with and into a direct, wholly owned subsidiary
of Alexion.
“As we complete this acquisition, the combination of our two
companies provides us the exciting opportunity to build upon our
collective strengths and talents to firmly establish Alexion as the
global leader in serving patients with devastating and rare
diseases,” said David Hallal, Chief Executive Officer at Alexion.
“With Soliris, and the anticipated approvals of Strensiq and
Kanuma, Alexion is poised to have three innovative products serving
patients with four severe diseases in 2015 while also advancing the
deepest and broadest pipeline in our history.”
Kanuma is currently under Priority Review with the U.S. Food and
Drug Administration (FDA) and has been granted accelerated
assessment of its Marketing Authorization Application (MAA) by the
European Medicines Agency (EMA). Regulatory decisions in the U.S.
and Europe are expected in the second half of 2015. In addition, a
New Drug Application for Kanuma was submitted to Japan’s Ministry
of Health, Labour and Welfare (MHLW).
Alexion now has eight product candidates in clinical trials for
11 indications, including SBC-103, an investigational enzyme
replacement therapy in an ongoing Phase 1/2 trial for patients with
mucopolysaccharidosis IIIB (MPS IIIB), a genetic and progressive
rare metabolic disease. SBC-103 was granted Fast Track designation
by the FDA in January 2015. Additionally, the combined preclinical
pipeline includes more than 30 diverse programs across a range of
therapeutic modalities, with at least four additional programs to
enter the clinic in 2016.
Following the acquisition, Alexion has more than 2,800
employees. In addition, Dr. Felix Baker, former Chairman of the
Board of Synageva, will join the Alexion Board of Directors,
effective today.
Exchange Offer Information
The exchange offer to acquire all of the outstanding shares of
Synageva common stock expired at 12:00 a.m. Eastern Time on June
19, 2015 and was not extended. The depositary for the exchange
offer has informed Alexion that a total of 21,021,124 shares of
Synageva common stock, representing approximately 56% of Synageva’s
outstanding common stock, were validly tendered and not withdrawn
pursuant to the exchange offer. All shares that were validly
tendered and not withdrawn have been accepted for payment in
accordance with the terms of the exchange offer and applicable
law.
Synageva common stock ceased to be traded on the NASDAQ Global
Market following the close of trading on June 22, 2015.
Following its acceptance of the shares tendered in the exchange
offer, after close of the financial markets on June 22, 2015,
Alexion caused the previously agreed merger of its subsidiary with
and into Synageva, followed by a merger of Synageva with and into
another Alexion subsidiary. As a result of the completed mergers,
Synageva became a wholly owned subsidiary of Alexion. In connection
with the merger, all shares of Synageva common stock not validly
tendered into the exchange offer have been cancelled and converted
into the right to receive merger consideration in the same amounts
offered in the exchange offer.
About Soliris® (eculizumab)
Soliris is a first-in-class terminal complement inhibitor
developed from the laboratory through regulatory approval and
commercialization by Alexion. Soliris is approved in the U.S.
(2007), European Union (2007), Japan (2010) and other countries as
the first and only treatment for patients with paroxysmal nocturnal
hemoglobinuria (PNH) to reduce hemolysis. PNH is a debilitating,
ultra-rare and life-threatening blood disorder, characterized by
complement-mediated hemolysis (destruction of red blood cells).
Soliris is also approved in the U.S. (2011), European Union (2011),
Japan (2013) and other countries as the first and only treatment
for patients with atypical hemolytic uremic syndrome (aHUS) to
inhibit complement-mediated thrombotic microangiopathy, or TMA
(blood clots in small vessels). aHUS is a debilitating, ultra-rare
and life-threatening genetic disorder characterized by
complement-mediated TMA. Soliris is not indicated for the treatment
of patients with Shiga-toxin E. coli-related hemolytic uremic
syndrome (STEC-HUS). For the breakthrough medical innovation in
complement inhibition, Alexion and Soliris have received some of
the pharmaceutical industry's highest honors: the Prix Galien USA
(2008, Best Biotechnology Product) and France (2009, Rare Disease
Treatment).
More information including the full U.S. prescribing information
on Soliris is available at www.soliris.net.
About Strensiq™ (asfotase alfa)
Strensiq™ (asfotase alfa) is a first-in-class bone-targeted
enzyme replacement therapy designed to address the underlying cause
of HPP—deficient alkaline phosphatase (ALP). By replacing deficient
ALP, treatment with Strensiq aims to improve the elevated enzyme
substrate levels and improve the body's ability to mineralize bone,
thereby preventing serious skeletal and systemic patient morbidity
and premature death.
The FDA granted Breakthrough Therapy designation for Strensiq
and accepted Alexion’s Biologics License Application (BLA) for
Priority Review. Alexion has also submitted a Marketing
Authorization Application (MAA) for Strensiq to the EMA and has
submitted a New Drug Application for Strensiq to Japan’s Ministry
of Health, Labour and Welfare (MHLW).
About Kanuma™ (sebelipase alfa)
Kanuma™ (sebelipase alfa) is a recombinant form of the human LAL
enzyme designed to address the root cause of lysosomal acid lipase
deficiency (LAL-D). By replacing deficient LAL, treatment with
Kanuma aims to reduce substrate accumulation and improve lipid
metabolism to prevent chronic lipid accumulation, multi-systemic
organ damage and premature death.
The FDA granted Breakthrough Therapy designation for Kanuma for
LAL Deficiency presenting in infants. The FDA accepted the Kanuma
BLA for Priority Review, and the EMA validated the MAA for Kanuma
and is reviewing it under accelerated assessment. In addition, a
New Drug Application for Kanuma has been submitted to Japan’s
MHLW.
About Alexion
Alexion is a global biopharmaceutical company focused on
developing and delivering life-transforming therapies for patients
with devastating and rare disorders. Alexion developed and
commercializes Soliris® (eculizumab), the first and only approved
complement inhibitor to treat patients with paroxysmal nocturnal
hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS),
two life-threatening ultra-rare disorders. Alexion is also
establishing a premier global metabolic rare disease franchise with
the development of two late-stage therapies, Strensiq™ (asfotase
alfa) for hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) for
Lysosomal Acid Lipase Deficiency (LAL-D). In addition, Alexion is
advancing the most robust rare disease pipeline in the biotech
industry, with highly innovative product candidates in multiple
therapeutic areas. As the global leader in complement inhibition,
Alexion is strengthening and broadening its portfolio of complement
inhibitors across diverse platforms, including evaluating potential
indications for Soliris in additional severe and ultra-rare
disorders. This press release and further information about Alexion
can be found at: www.alexion.com.
[ALXN-G]
Forward-Looking
Statements
This communication includes statements that may be
forward-looking statements. The words “believe,” “expect,”
“anticipate,” “project” and similar expressions, among others,
generally identify forward-looking statements. Alexion cautions
that these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, realization of
the expected benefits of the transaction, challenges to
intellectual property, competition from other products,
difficulties inherent in the research and development process,
adverse litigation or government action and changes to laws and
regulations applicable to our industry, status of our ongoing
clinical trials, commencement dates for new clinical trials,
clinical trial results, decisions and the timing of decisions of
regulatory authorities regarding marketing approval or material
limitations on the marketing of our approved products or any future
approved products, delays or interruptions in manufacturing or
commercial operations including due to actions of regulatory
authorities or otherwise, the possibility that results of clinical
trials in approved and investigational indications are not
predictive of safety and efficacy in broader patient populations,
the adequacy of our pharmacovigilance and drug safety reporting
processes, the risk that acquisitions will not result in the
anticipated clinical milestones or long-term commercial results,
the risk that initial results of commercialization in approved
indications are not predictive of future performance, risks
involving the ability to license necessary intellectual property on
reasonable terms or at all, the risk that third party payors,
public or private, will not reimburse for the use of Soliris,
Strensiq (asfotase alfa) or Kanuma (sebelipase alfa), or any future
products at acceptable rates or at all, risks regarding estimates
of the ultimate size of various patient populations, risks relating
to foreign currency fluctuations, exposures to additional tax
liabilities, and a variety of other risks. Additional information
about the economic, competitive, governmental, technological and
other factors that may affect Alexion's operations is set forth, in
the case of Alexion, in Item 1.A, “Risk Factors,” in Alexion’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2015,
and in the Quarterly Report on Form 10-Q for the quarter ended
March 31, 2015 of Alexion’s subsidiary, formerly known as Synageva
Biopharma Corp., each of which has been filed with the Securities
and Exchange Commission (the “SEC”). Alexion undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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Alexion Pharmaceuticals, Inc.MediaIrving Adler, 203-271-8210Vice
President, Corporate CommunicationsorKim Diamond,
203-439-9600Executive Director, Corporate
CommunicationsorInvestorsElena Ridloff, CFA, 203-699-7722Executive
Director, Investor Relations
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