(Updates with comment from company, FDA, background)
By Toni Clarke
WASHINGTON, June 6 The U.S. Food and Drug
Administration said on Friday it approved Biogen Idec Inc's
long-lasting hemophilia A drug, Eloctate, adding
another product to the company's nascent portfolio of drugs for
non-malignant blood disorders.
Hemophilia A is a rare, inherited blood-clotting disorder
that can lead to prolonged bleeding, bruising and joint and
tissue damage. It is caused by deficient levels in the body of
factor VIII, a protein needed to clot the blood.
The FDA's ruling followed its approval in March of Biogen's
hemophilia B treatment, Alprolix. Biogen developed both drugs
with Swedish Orphan Biovitrum AB, or Sobi, and
expects the products to form the basis of a new non-malignant
blood disorder portfolio.
"We see Alprolix and Eloctate as the anchor tenants in a
growing franchise," said Douglas Williams, Biogen's head of
research and development. "We're in this space to stay."
Biogen's biggest products are currently the multiple
sclerosis drugs Avonex, Tecfidera and Tysabri.
Eloctate is expected to generate annual sales of $1.5
billion by 2019, according to the average estimate of six
analysts polled by Thomson Reuters. Sales of Alprolix are
expected to generate annual sales of $286 million over the same
Current treatments for hemophilia B generate about $1
billion a year, according to Biogen, while the market for
hemophilia A therapies is worth about $6 billion.
Hemophilia A is the more common form of the disease,
affecting about 16,000 people in the United States, Biogen said.
Hemophilia B affected about 4,000 people.
Hemophilia drugs must be infused two to three times a week
to prevent bleeding episodes. Eloctate cuts the number of doses
needed per week to between three and five days.
Biogen has not set a price for the drug, but Tony Kingsley,
head of commercial operations, said the cost for patients who
switch from a short-acting product to Biogen's longer-acting
product should be roughly the same, even though they will be
dosing themselves less frequently.
Last month, Weston, Massachusetts-based Biogen and
Stockholm-based Sobi said they would donate hemophilia drugs for
use in developing nations in quantities large enough to treat
tens of thousands of patients over the next decade.
The drugs will primarily be used in those nations for
emergency treatments rather than preventative care.
(Reporting by Toni Clarke; Editing by Sandra Maler and Peter