K-V Pharmaceutical Announces Updated Makena® Performance Metrics

K-V Pharmaceutical Company (the "Company" or "K-V"), today reported updated performance metrics for Makena®, the only U.S. Food & Drug Administration ("FDA") approved product indicated to reduce the risk of preterm birth in women with singleton pregnancy who have a history of a singleton spontaneous preterm birth.Makena® was launched during March of 2011. From its launch date through October 31, 2011:Approximately 7,100 vials have been shipped to Ther-Rx customers, and more than 4,700 vials have been shipped to doctors and patients;The average number of vials shipped per week to Ther-Rx customers increased 35% from the month of July to the month of October while the average number of vials shipped per week to doctors and patients increased nearly 13% during the same period;Approximately 4,300 patient referrals from over 2,700 prescribers have been made to the Makena Care Connection(TM) and the number of enrollments who have initiated treatments increased from the month of July to the month of October by nearly 16%;Approximately 2,400 patients have either initiated treatment, are in the enrollment phase or are pending insurance approval and treatment initiation;Over 200 payers, both commercial and Medicaid, have reimbursed Makena®;Contracts have been reached with four commercial insurers that cover an estimated 50 million persons;At least 17 states have reimbursed Makena® and K-V has signed Makena® rebate contracts with three states and two Managed Medicaid plans covering 5 to 6 million persons; andCurrent data indicates patient co-pays are averaging approximately $11 per injection, the same or less cost than those typically associated with compounded 17P formulations."Our commercialization efforts remain centered on communicating the important differences between FDA-approved Makena® and compounded 17P formulations," said Greg Divis, President and CEO of K-V Pharmaceutical and President of Ther-Rx. "We are actively engaging the physician and payer communities and the success of our focused outreach is evidenced by Makena®'s improving performance metrics. We believe our efforts are driving expanded access to Makena® while we are also successfully maintaining low out-of-pocket costs for patients."