Submitted by: Submitted by poyanwong
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Words: 1188
Pages: 5
Category: Business and Industry
Date Submitted: 08/28/2015 05:29 AM
The Betaseron Decision
T
he United States Food and Drug Adminis
(A)
system to transmit nerve impulses to and from the
tration's (FDA) approval of interferon beta
brain becomes impaired. With MS, there are scle
lb (brand name Betaseron), made it the first
rosed (i.e., scarred or hardened) areas in multiple
(MS) treatment to get FDA
parts of the brain and spinal cord when the im
approval in 25 years. Betaseron was developed
multiple sclerosis
mune system mistakenly attacks the myelin sheath.
by Berlex Laboratories, a U.S. unit of Schering AG,
the German pharmaceutical company. Berlex
handled the clinical development, trials, and
marketing of the drug, while Chiron Corporation,
a biotechnology firm based in California, manu
factured it. The groundbreaking approval of
Betaseron represented not only a great opportu
nity for Berlex but a dilemma. Supplies were
insufficient to meet initial demand, and shortages
were forecast for three years. With insufficient
supplies and staggering development costs, how
would Berlex allocate and price the drug?
THE CHALLENGE OF MULTIPLE
SCLEROSIS
MS is a disease of the central nervous system that
The Impact of MS.
The symptoms of MS
depend to some extent on the location and size of
the sclerosis. Symptoms may include numbness,
slurred speech, blurred vision, poor coordination,
muscle weakness, bladder dysfunction, extreme
fatigue, and paralysis. There is no way to know
how the disease will progress for any individual,
because the nature of the disease can change. Some
people will have a relatively benign course of MS
with only one or two mild attacks, nearly complete
remission, and no permanent disability. Others
will have a chronic progressive course resulting in
severe disability. A third group displays the most
typical pattern, which is periods of exacerbations,
when
the
disease is active,
and
periods of
remission, when the symptoms...