— 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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