K-V Pharma seeks Chapter 11 bankruptcy protection

The St. Louis company's shares have been suspended from the New York Stock Exchange. K-V said Monday that it will not fight the suspension and its shares will trade over-the-counter. Class A shares of K-V last traded at 32 cents.

K-V filed for bankruptcy protection in New York on Saturday so it could restructure its financial obligations. The company said it will continue to operate.

K-V said it has been unable to realize the value of Makena because the FDA is not enforcing the marketing exclusivity that was awarded to Makena. The company also owes a milestone payment to Hologic Inc., which developed the drug. It has not been able to renegotiate that payment. K-V said restrictions related to 2008 and 2009 manufacturing problems are also hurting its business.

Makena is intended to prevent preterm birth in women who've already had one premature birth and are pregnant again. The drug is a synthetic version of the hormone progesterone. Makena was approved in February 2011 and costs $690 per weekly injection. That price has been a source of controversy even after K-V lowered the cost from $1,500 per injection and announced a patient assistance program designed to help uninsured and low-income women get the drug at little or no cost.

Specialty pharmacies can make a generic version of progesterone that costs $10 to $20 a dose, which has hurt K-V's sales. After approving Makena, the FDA said it would not stop specialty pharmacies from making the generic version. K-V announced the price cut after the FDA made that decision.