Alexion gets EU approval
for drug acquired in Synageva deal
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[September 02, 2015] By
Bill Berkrot
NEW YORK (Reuters) - Ten weeks after
closing its $8.4 billion purchase of Synageva BioPharma Corp, Alexion
Pharmaceuticals Inc on Tuesday announced European approval for the key
drug acquired through the deal, an enzyme-replacement therapy for an
ultra-rare, life threatening disease.
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European health regulators approved Kanuma for patients with
lysosomal acid lipase deficiency (LAL-D). They also approved
Strensiq for patients with pediatric-onset hypophosphatasia (HPP), a
drug Alexion had previously acquired. The treatments are awaiting
U.S. approval decisions after receiving breakthrough therapy
designations from the Food and Drug Administration.
"This is sort of a momentous year for us," Alexion Chief Executive
David Hallal said in an interview. "We're moving from a one-drug
company to a three-drug company, eight, nine years after the launch
of our first drug."
LAL-D is a progressive metabolic disease that often leads to liver
failure, multi-organ damage and premature death. HPP is a
progressive metabolic disease that can lead to deformity of bones,
fractures and other skeletal abnormalities, as well as muscle
weakness, seizures, pain, and respiratory failure, causing death in
infants and children.
Both are ultra-rare diseases defined as occurring in fewer than 20
patients per one million in the general population.
Hallal said he expects Kanuma to eventually generate more than $1
billion in annual sales. He declined to provide a sales forecast for
Strensiq.
He sees a slow sales uptake for the drugs as raising awareness of
the diseases and identifying patients is one of the biggest
challenges facing the company.
"It takes time to reach the patients and the physicians," Hallal
said. "When we launch, it's usually one patient at a time."
Hallal said Alexion aims for similar pricing for the new drugs in
the United States and elsewhere. "The U.S. should not have to
underwrite the cost," he said.
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The price Alexion paid for Synageva, which was more than twice its
market value, drew criticism on Wall Street. But it transforms
Alexion into a multi-product company with a larger developmental
pipeline.
Alexion said the Synageva deal will add to profits beginning in
2018.
Alexion sells Soliris for two rare diseases at a cost of around
$500,000 a year. It had sales of $2.23 billion in 2014.
It is in late stage testing of Soliris for three other rare
conditions, and expects early stage data on another enzyme
replacement therapy this year.
In addition, "we added another 12 preclinical programs from Synageva
to our pipeline," Hallal said.
Alexion shares fell $1.32 to close at $170.87 on Nasdaq.
(Reporting by Bill Berkrot and Caroline Humer; Editing by Andrew Hay
and Frances Kerry)
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