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Ther-Rx Takes Steps to Improve Access, Reduce Cost of Makena

As part of its ongoing efforts to ensure that high-risk women have access to FDA-approved Makena instead of unapproved, unregulated compounded drugs, Ther-Rx Corporation, a subsidiary of K-V Pharmaceutical Company announced April 1, 2011, that it has taken several steps to reduce the cost of Makena™ (hydroxyprogesterone caproate injection) and encourage stakeholders to provide timely access to this medication. Effective immediately, Ther-Rx has:

· Reduced the list price of Makena by nearly 55%, to $690 per injection;

· Will offer supplemental rebates that, in conjunction with the list price reduction and the standard Medicaid rebate of 23.1%, will result in a substantially reduced cost per injection for state Medicaid agencies compared to list price. This will help ensure that every woman who is prescribed Makena – regardless of her ability to pay – has the comfort of knowing a medication that has been rigorously reviewed by FDA for safety and efficacy is available to her;

· Capped the costs for a full course of therapy to a maximum of three vials (15 injections) for contracted health insurance plans and state Medicaid agencies; and

· Expanded the Company’s patient assistance program for patients who are prescribed this important medication by removing income caps to qualify for financial assistance. 85 percent of patients will pay $20 or less per injection for FDA-approved Makena, and patients whose financial need is greatest would receive FDA-approved Makena at no out-of-pocket cost.

Under the new pricing structure, the Company believes that the use of Makena by eligible patients will deliver net cost savings to Medicaid programs and private insurance plans in year one, based on third-party economic modeling of costs associated with the condition.

“Ensuring access to an FDA-approved sterile, injectable medication, manufactured under mandatory strict quality controls, is in the best interests of all high-risk women,” said Greg Divis, Chief Executive Officer, K-V Pharmaceutical Company and President, Ther-Rx Corporation. “We understand the concerns that key stakeholders raised under our original pricing structure. We also recognize the current budget challenges facing state Medicaid programs and other payers. In conjunction with our substantial reduction in price, it is our sincere hope that all committed stakeholders will take appropriate action to provide timely access to this important FDA-approved medication.”

The FDA granted Makena orphan drug status and approved the drug on February 3, 2011.

For further information about K-V Pharmaceutical Company, please visit the Company’s corporate Website at www.kvpharmaceutical.com.

While these steps represent important steps forward, ACNM will continue to monitor the pricing structure and accessibility of Makena for midwifery clients and encourages members to keep us informed regarding their experiences.  ACNM has been invited to participate in a meeting with Ther-Rx in June 2011 to review the first quarter of experience.