K-V sued over marketing of Makena drug

* Company had "orphan" status on pregnancy drug

* Company sued over alleged misleading statements

* Senators had complained about price hikes

Oct 19 (Reuters) - KV Pharmaceutical (KVa.N) was sued on Wednesday by an investor claiming he lost money when the drugmaker made misleading statements about the marketing of its pregnancy drug Makena.

K-V misled investors about the extent of expanded patient access to Makena, according to the lawsuit. Makena is a hormone medicine that reduces the risk of a pre-term delivery in women who have delivered prematurely in the past.

"Contrary to their statements, K-V's marketing of Makena would restrict, not increase, patient access to the drug," according to the lawsuit, which was filed in federal court in St. Louis.

K-V was granted so-called orphan status for Makena, a designation that meant it had seven years of marketing exclusivity. A version of the drug had previously been available. K-V got the rights to the drug from Hologic Inc (HOLX.O).

The company began selling Makena in February 2011, and at the time "touted" expanded access to Makena for pregnant women, investor Frank Julianello said in the lawsuit.

In March, two U.S. Senators and an industry group complained about price hikes for Makena. The price of the drug per injection spiked to $1,500 from $10 to $20. After the complaints, the stock dropped, according to the lawsuit.

The Food and Drug Administration on March 30 said it would take no action against pharmacies that made a cheaper version of Makena, causing K-V's shares to fall from $7.11 to $5.65, according to the lawsuit.

A message left on K-V's media relations line wasn't immediately returned.

The lawsuit seeks class action status on behalf of investors who held the stock from February 14 to April 4.

The case is Frank Julianello v. K-V Pharmaceutical, No. 11-cv-01816, U.S. District Court, Eastern District of Missouri. (Reporting by Carlyn Kolker; editing by Carol Bishopric)