March of Dimes cuts ties with KV Pharma

The March of Dimes has severed ties with KV Pharmaceuticals and its subsidiary Ther-Rx Corp. in protest over the company's pricing for Makena (hydroxyprogesterone caproate injection), a drug to prevent preterm birth that won US Food and Drug Administration (FDA) approval in February.

The group, which is the leading US non-profit organisation for pregnancy and baby health, believes the pricing is exorbitant and will be a barrier for women who need the treatment.

K-V has provided about $1m in financial support for March of Dimes fundraising events and family support projects over the past several years. "However, under the current circumstances, we feel that it is in the best interests of the Foundation to step away from our corporate relationship," the March of Dimes said in a letter to the company. "We are, therefore, exercising our option to terminate our agreement with Ther-Rx Corporation."

The group has asked the company to immediately stop using the March of Dimes name or logo on any of its materials.

Makena, which was formerly known as Gestiva, was developed by Hologic but is marketed by K-V through Ther-Rx. It was approved by the FDA in February.

The company launched the drug at a price of $1,500 per dose, meaning that a full course of treatment would cost about $30,000. The pricing was disputed and led the FDA to say that it would not take enforcement action against pharmacies that continued to compound versions of the drug that had not been officially approved and that could be purchased for about $20 a dose.

Following that announcement, Ther-Rx agreed to reduce the list price of Makena to $690 per dose and to expand its existing patient financial assistance program, which the March of Dimes called "steps in the right direction."

"Nevertheless, the March of Dimes has decided to exercise our right to terminate our current contract and sever all professional relationships with Ther-Rx," the group said in a press statement. "The company's handling of the launch of Makena, and the initial list price, were highly unsatisfactory and unacceptable to the March of Dimes and the families we represent."