K-V Pharma renegotiates Makena deal in survival struggle

Troubled US generic drugmaker K-V Pharmaceutical has renegotiated the terms of its licensing deal
with Hologic for Makena, its only commercial product, as it fights for financial survival.

K-V Pharma filed for voluntary bankruptcy protection in August as it struggled to maintain sales of
Makena (hydroxyprogesterone caproate), an injectable drug used to prevent premature birth that
was approved as an orphan drug by the US Food and Drug Administration (FDA) in 2011 (The Pharma
Letter February 7, 2011).

Sales of Makena have been adversely affected by the availability of unapproved, compounded
versions of the product which sell for a fraction of the branded product's price - currently
somewhere between $300 and $600 a dose.