May 12 Biogen Idec Inc and partner
Swedish Orphan Biovitrum AB on Monday said they will
donate hemophilia drugs for use in developing nations in
quantities large enough to treat tens of thousands of patients
over the next decade.
The potentially life-saving clotting factor medicines would
be intended for use in Africa, Asia and elsewhere, where three
quarters of the world's 400,000 hemophilia sufferers have
limited or no access to such drugs, and where most fail to live
into adulthood as a result.
Biogen and Sobi announced their intention to donate one
billion international units of clotting factor drugs over 10
years at the World Federation of Hemophilia (WFH) meeting in
"WFH do their work in countries that consume less than 1 iu
per capita. That's a level below which people are dying, where
they don't even have enough to treat the life-threatening
bleeds," Paula Cobb, Biogen's head of hematology, said in a
Hemophilia, an inherited disorder in which the blood does
not clot properly, is a new therapeutic area for Biogen. The
companies last month received U.S. approval for Alprolix, which
treats the more rare hemophilia B.
The success of the humanitarian effort will hinge on Food
and Drug Administration approval of Eloctate for hemophilia A,
which would account for at least 85 percent of the donated
product. That approval is expected later this year.
Biogen, based in Weston, Massachusetts and Stockholm-based
Sobi initially committed to donate up to 500 million units to
WFH over five years. The remaining 500 million units will be
made available for future distribution.
The drugs would primarily be used for emergency treatments
rather than preventive care as is common in the developed world,
where a year of treatment can cost upwards of $300,000.
The quantity of donated product would enable doctors to
treat more than 75,000 joint bleeding episodes, more than 2,000
life-threatening bleeds and to perform thousands of surgical
procedures that would not be possible without access to clotting
drugs, the companies said.
"We wanted to do something significant that would change and
really shift the way donation programs in that field will work,"
said John Cox, Biogen's head of manufacturing and supply. He
added that he hopes other companies would be prompted follow
It was not possible to put a commercial value on the
donation as Biogen has yet to set a price for Eloctate. Alprolix
was priced at $2.85 per unit. "It is tens of millions of dollars
in terms of internal manufacturing supply and cost," Cox said.
Drugmakers, under pressure from the international community
over the high prices of their medicines, have sought to burnish
their images by offering HIV drugs and other medicines at
drastically reduced cost in Africa and poor nations in other
regions. Biogen officials said they were responding to a plea
for help from the WFH.
"Trying to price this for the developing world was not part
of the conversation. When we sat down with the executive team,
it was not a public relations discussion," Cox said.
(Reporting by Bill Berkrot in New York; Editing by Eric Walsh)