R34R3

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...