Page 397 - The Case Lab Book

of getting approval from the Food and Drug Administration (F.D.A.) by
showing that its drug is equivalent to Daraprim. This is difficult, because

Shkreli’s company, Turing Pharmaceuticals, tightly controls its distribution,
making it hard to get the samples to do testing. Only about 15 percent of
drugs that begin clinical trials are ever approved by the F.D.A.

On October 22, 2015, San Diego-based Imprimis Pharmaceuticals Inc.,
which mixes approved drug ingredients to fill individual patient
prescriptions, said it would begin selling a very similar, but not identical

drug to Daraprim , for $1 per pill (a 100-capsule bottle for $99)

"This is not the first time a sole supply generic drug — especially one that
has been approved for use as long as Daraprim — has had its price

increased suddenly and to a level that may make it unaffordable," Imprimis
CEO Mark Baum said.

Unlike Daraprim, Imprimis's formulation in itself is not FDA approved, and
can only be used when prescribed by a doctor for a particular patient.

“An undated presentation highlighted Mr. Shkreli’s experience with other
prescription drug price increases, including Daraprim, Chenodal, and
Thiola. The presentation stated: “increased Chenodal price 5x with no

pushback from payors ... Licensing of Thiola … Increased price 21x with no
pushback from payors … Acquisition of Daraprim … Increased price 43x

with no pushback from payors.” (4)

Turing, in late November, said it would cut the price of Daraprim by up to
50% for some patients.

Acquisition: KaloBios Acquired