July 13, 2010, St. Louis, MO. - K-V Pharmaceutical Company (NYSE: KVa/KVb) (the "Company"), a specialty pharmaceutical company, announced today that it has been informed by Hologic, Inc. (NASDAQ: HOLX) that a resubmission to the FDA's Complete Response action letter received in January 2009 has been submitted for GestivaTM (hydroxyprogesterone caproate injection), 250 mg/mL. If approved, Gestiva, commonly referred to as "17P," would be the first and only FDA-approved drug for the prevention of preterm birth in women who are pregnant with a single baby and have spontaneously delivered a single baby preterm in the past.
Greg Divis, President of Ther-Rx Corporation, the Company's branded subsidiary and Interim President and Chief Executive Officer of the Company, stated, "We believe this latest submission meets all the outstanding FDA requirements and marks an important milestone in the progression toward the potential approval and marketing of this product."
As previously announced, K-V has an agreement with Hologic, Inc. to secure the rights of GestivaTM upon FDA approval.
About Preterm Birth
According to the March of Dimes, preterm birth, or the birth of a baby prior to 37 completed weeks of pregnancy, affects one in eight babies born in the United States1. Additionally, the rate of preterm birth has increased more than 35 percent in the last 25 years2, and is the leading cause for infant mortality and morbidity. Preterm birth is currently the number one cause of neonatal mortality, and babies born preterm tend to grow more slowly, have more problems with their eyes, ears, breathing and nervous system, and experience more learning and behavioral problems3,4. Preterm birth has been estimated to cost the United States more than $26 billion a year5.
About KV Pharmaceutical Company
K-V Pharmaceutical Company is a fully-integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technology-distinguished branded prescription pharmaceutical products. The company markets its technology-distinguished products through Ther-Rx Corporation, its branded drug subsidiary.
For further information about K-V Pharmaceutical Company, please visit the company's corporate Web site at www.kvpharmaceutical.com