FDA and CMS Issue Important Updates on Makena®

ST. LOUIS, June 18, 2012 /PRNewswire/ -- K-V Pharmaceutical Company ("the Company") (NYSE: KV.A/KV.B) announced today that the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) both issued updated statements on Makena® that affirm the importance of the only FDA-approved drug for treatment of women with a history of preterm birth.  Prior statements by both agencies had been cited by some payers as the basis for denying patients' access to FDA-approved Makena in favor of unapproved compounded hydroxyprogesterone caproate (17P) formulations. 

FDA's June 15, 2012 update highlights:

• In a reversal of its March 30, 2011 statement, the "FDA emphasizes that it is applying its normal enforcement policies for compounded drugs to compounded hydroxyprogesterone caproate."
• "The compounding of any drug, including hydroxyprogesterone caproate, should not exceed the scope of traditional pharmacy compounding."
• "Compounding large volumes of drugs that are copies of FDA-approved drugs circumvents important public health requirements, including the Federal Food, Drug, and Cosmetic Act's drug approval provisions."
• "…one factor that the agency considers in determining whether a drug may be compounded is whether the prescribing practitioner has determined that a compounded product is necessary for the particular patient and would provide a significant difference for the patient as compared to the FDA-approved commercially available drug product."
• "The drugs that pharmacists compound (including compounded hydroxyprogesterone caproate) are not FDA approved, which means they do not undergo premarket review nor do they have an FDA finding of safety and efficacy."
• For at least the third time in the past 15 months, FDA has reiterated that "…approved drug products, such as Makena, provide a greater assurance of safety and effectiveness than do compounded products."

For more information about FDA and Pharmacy Compounding, please see the following links:

• http://www.youtube.com/watch?v=kif_rmtIQb0
• http://www.fda.gov/OHRMS/DOCKETS/98fr/02D-0242_gdl0001.pdf

FDA's statement also summarized the results of its investigation of a limited number of samples of compounded hydroxyprogesterone caproate API and finished 17P, including the following:

• 100% (16 of 16) of the API samples procured and tested by FDA failed Makena's standards for unidentified impurities.  According to FDA requirements, API of this quality is unsuitable for use in Makena®. 
• FDA also found potency and unidentified impurity issues in compounded 17P finished goods samples.  According to FDA requirements, if Makena® were to have these deficiencies, it would be considered adulterated. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070287.pdf
• FDA's testing of the compounded 17P samples provided by the Company also confirmed variability in potency and purity.

In addition, the Company's previously reported research found: 

• That the primary source of hydroxyprogesterone caproate is unregistered and/or uninspected manufacturing facilities in China
• That one of seven samples of API from the original Chinese manufacturers was not hydroxyprogesterone caproate, but was instead glucose

More recently, the Company has identified and provided information to the FDA relating to multiple instances of intentionally mislabeled hydroxyprogesterone caproate API sourced from multiple Chinese suppliers. 

CMS's June 15, 2012 update:

In a related statement, CMS also issued an update, which reiterated FDA's comments that approved drug products, such as Makena, provide a greater assurance of safety and effectiveness compared to compounded products, and also that the compounding of any drug, including hydroxyprogesterone caproate, should not exceed the scope of traditional pharmacy compounding.  Additionally, in its June 15 update, CMS:

• Reminded States of their "…responsibility to cover FDA-approved products, such as Makena, that qualify as covered outpatient drugs under the Medicaid drug rebate program."
• Pointed out with regard to drug coverage policies for their insured beneficiaries that …"Any prior authorization procedures for such drugs must be administered in accordance with Section 1927(d) of the Social Security Act, without imposing unreasonable conditions."

The Company has identified and informed CMS of certain States that are acting contrary to these established policies by imposing unreasonable conditions, including so-called "prior authorization" procedures that have effectively denied Medicaid participants' access to Makena.  Based on the updated CMS statement of June 15, 2012, we look forward to these States promptly removing these unreasonable conditions and providing unimpeded coverage for FDA approved Makena.    

"This is an important day for pregnant women who can benefit from Makena," said Greg Divis, President and CEO. "Healthcare providers have advocated for unencumbered access to FDA-approved Makena.  We believe the announcements from these two key agencies are a clear signal that the compounding of hydroxyprogesterone caproate should not exceed the scope of traditional pharmacy compounding and that payers who have made access to Makena difficult should remove roadblocks that have prevented patients from receiving the only FDA-approved drug for their condition."

As part of its commitment to patients and healthcare providers, the Company has made substantial efforts to work with payers to facilitate insurance coverage of Makena®.  The Company's significantly reduced pricing to both commercial and Medicaid payers make the cost of a full course of therapy a small fraction of the cost of the average preterm birth.  Further, patient co-pays are averaging approximately $8 per injection (often less than the cost to patients for compounded 17P formulations).  The Company provides Makena at no out-of-pocket cost to uninsured women through its financial assistance programs.  

The Company has entered into agreements with a number of States that provide unencumbered access to Makena for eligible patients.  With the support of the June 15th statement by CMS, the Company looks forward to working with all payers to help ensure patient access to Makena, especially Medicaid payers, because low-income pregnant women are known to be at higher risk for premature birth.

"As a high-risk pregnancy specialist caring for women who are at risk of preterm birth, I need to be able to prescribe medications that have been tested and proven effective," said Sean C. Blackwell, MD, Interim Chair, Department of Obstetrics, Gynecology and Reproductive Sciences at the University of Texas Health Science Center in Houston, Texas.  "Pregnant women deserve to have access to FDA-approved medications.  I am hopeful that the policy modification from CMS will help to remove obstacles that have prevented some Medicaid participants from getting the same 17P formulation that was utilized in the NICHD Maternal Fetal Medicine Units Network clinical trial and was compliant with Good Manufacturing Practices."

The full FDA and CMS updates can be found here.

FDA Update

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm308546.htm

CMS Update

http://www.medicaid.gov/Federal-Policy-Guidance/Downloads/CIB-2-06-15-12.pdf

New Global Report Says U.S. Lags Behind 130 other Nations in Preterm Birth Rate

The report, containing the first-ever estimates of preterm birth rates by country, was published in May 2012 by The March of Dimes Foundation, The Partnership for Maternal, Newborn & Child Health, Save the Children, and The World Health Organization, and represents almost 50 United Nations agencies, universities, and organizations.

Preterm babies are born at a higher rate in the United States than in 130 other countries of the world, including many poorer nations, according to the just-released report Born Too Soon: The Global Action Report on Preterm Birth. The report ranks the U.S. 131^st in the world in terms of its preterm birth rate of 12.0 per 100 live births.  Nearly half a million babies are born too soon in the U.S. each year.

About Makena® (hydroxyprogesterone caproate injection)

Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered

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