Ther-Rx Corporation Takes Action to Further Ensure High-Risk Women Are Able to Access FDA-Approved Makena™
Announces Reduction in Price and Expansion of Patient Assistance Program for Makena™
St. Louis, April 1, 2011 – 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 (NYSE: KVa/KVb) (the "Company"), announced today important initiatives to reduce the cost of Makena™ (hydroxyprogesterone caproate injection) and encourage stakeholders to provide timely access to this important FDA-approved medication. Effective immediately, Ther-Rx has:
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
Importance of an FDA-Approved Medication
Prior to FDA approval of Makena, women who could benefit from therapy faced potential barriers to access due to the absence of a commercially-available, FDA-approved product. In a survey of 345 obstetricians/gynecologists published in the American Journal of Perinatology in March 2009, more than one in three OB/Gyns were “very concerned” about drug availability in the absence of an FDA-approved product. In a survey of over 200 obstetricians/gynecologists and maternal fetal medicine specialists conducted in 2010, the lack of FDA-approved treatment options was cited as the greatest challenge in communicating about the condition with patients.
Physicians recognize the value of prescribing an FDA-approved therapy over an unapproved compounded drug, especially for this high risk patient population. FDA has previously commented that “when pharmacy compounders both operate like drug manufacturers and engage in high-volume distribution, the risk of patient harm increases.” The process for compounding drugs does not require that the drug be made exactly the same way every time, and there are no processes in place to monitor non-FDA approved versions for patient safety. Compounders are not required to test their ingredients or to check the final product for potency or sterility. In a study conducted by the FDA five years ago, one-third of drugs made in compounding pharmacies in that study failed quality testing because the drugs were either too weak or too strong. FDA concluded that “such variability can lead to uncertainty in dosing and raises concern for patient therapy. The results of the survey suggest that problems with the quality of compounded drugs occur throughout the country.”
There are important differences between Makena – an FDA-approved and regulated medication – and individually compounded formulations that are made by hand. As an FDA-approved drug, Makena is manufactured in an FDA-regulated and FDA-compliant, sterile facility. The manufacturing process is tightly controlled to ensure quality and consistency from dose to dose. This also includes follow-up testing and reporting requirements that continue for the lifecycle of the medication.
Investment in Makena
Ther-Rx has made significant investments to advance Makena through an FDA-approval process that began in 2006 and to ensure Makena’s availability. Ther-Rx has invested or committed over a quarter of a billion dollars to-date to bring Makena to market, including more than $60 million in research and clinical trial costs associated with conducting major, multi-year follow-on health studies of Makena involving 1,700 mothers and more than 500 infants. These studies, required by FDA as a condition for Makena’s approval, are being funded by the Company, and such studies are four times larger and approximately 12 times more expensive than the initial National Institutes of Health trial submitted for FDA approval. This research will add important new medical and scientific knowledge and is critical to patients, families and society as a whole.
Because specialty injectable products like Makena are not typically carried by retail pharmacies, Ther-Rx has also made a significant investment in developing a network of specialty pharmacies, specialty distributors, and a comprehensive customer support center to facilitate access to Makena and ensure national availability.
“We reiterate our commitment to patient access to FDA-approved Makena, as exemplified by these important initiatives,” said Divis. “We remain committed to investing in clinical, scientific and product advances to create innovative products and services that will make a difference in the lives of the patients we serve.”
Because of the importance of this medication to high-risk women with a prescription for Makena, the Company will vigorously support the exclusivity of Makena.
About K-V 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 Website at www.kvpharmaceutical.com.
Cautionary Note Regarding Forward-looking Statements
This press release contains various forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 (the “PSLRA”) and that may be based on or include assumptions concerning the operations, future results and prospects of the Company. Such statements may be identified by the use of words like “plan,” “expect,” “aim,” “believe,” “project,” “anticipate,” “commit,” “intend,” “estimate,” “will,” “should,” “could,” “potential” and other expressions that indicate future events and trends.
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Such factors include (but are not limited to) the following:
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