Investigation Overview
An investigation on behalf of investors of K-V Pharmaceutical Company (NYSE:KV.A) over possible violations of Federal Securities Laws in connection with Makena was announced.
The investigation by a law firm focuses on certain statements made in connection with Makena.
Makena is a drug treatment indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
St. Louis based K-V Pharmaceuticals 12 months Total Revenue decreased from $424.31million reported on March 31, 2007 to $152.22million reported on March 31, 2010. Its Net Income over the same time frame went from $58.56million to a Net Loss of $283.61million.
Shares of K-V Pharmaceutical Company (NYSE: KV.A) traded in 2006 as low as $1.698 per share and increased during 2007 to as high as $31.02 per share. In 2008 shares fell from as high as $28.20 in January to $2.26 per share in December. During 2009 and 2010 KV.A fell to as low as $0.65, respectively $0.64 per share.
On February 4, 2011, K-V Pharmaceutical disclosed that the U.S. Food and Drug Administration (FDA) granted approval for Makena.. KV Pharmaceuticals said that Makena will be available through specialty pharmacies and distributors by prescription only and is subject to all U.S. guidelines applicable to dispensing an FDA-approved prescription product
K-V Pharmaceuticals class A shares increased from $1.53 on Feb 3 to close at $3.88 per share on February 4, 2011 and continued to increase to as high as $13.07 per share on March 8, 2011.
On March 30, 2011 the FDA announces that FDA understands that the manufacturer of Makena, KV Pharmaceuticals, has sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct.
According to a media report from the same day the news came after complaints earlier this month by two U.S. senators and an industry group about a significant price hike by K-V Pharmaceuticals for Makena.
Also on March 30, 2011, U.S. Senator Tom Harkin disclosed that K-V Pharmaceutical tried to stop pharmacists compounding the drug, advising them that it would be a violation of law to continue to compound Makena-like products.
KV.A shares fell from its closing price of $7.11 on March 29 to as low as $4 per share during March 30, 2011 and closed at closing price of $5.65 per share.