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Independent Laboratory Testing Demonstrates Important Quality Differences Between FDA-Approved Makena® and Compounded 17P Formulations
FDA Issues Statement on Makena® on November 8, 2011
St. Louis, MO - November 8, 2011 - Recent testing conducted by independent laboratories, commissioned by Ther-Rx Corporation, a subsidiary of K-V Pharmaceutical Company (the "Company") (NYSE: KV.A/KV.B), shows that multiple samples of both compounded 17P drug formulations and active pharmaceutical ingredient (API) that may be used in compounded 17P failed to meet certain established standards for potency and purity. These findings, which have been submitted to the U.S. Food and Drug Administration (FDA), demonstrate important quality differences in these compounded 17P formulations when compared to FDA-approved Makena® (hydroxyprogesterone caproate injection).
"We commissioned this research because moms and healthcare providers deserve to know whether medications prescribed during pregnancy meet FDA's quality standards," said Greg Divis, President and CEO of K-V Pharmaceutical Company. "This research demonstrates important differences in product quality between FDA-approved Makena® and these compounded 17P formulations. Healthcare providers and patients have no practical way of ensuring that compounded 17P formulations meet FDA's quality standards. Now that FDA-approved Makena® is available, America's high-risk moms deserve a product that consistently meets FDA's standards."
On Nov. 8, 2011, the FDA issued a statement on Makena® acknowledging it has received information from the Company regarding the potency and purity of samples of bulk hydroxyprogesterone caproate APIs and compounded hydroxyprogesterone caproate products. FDA stated, "According to the analysis of this information provided by K-V, there is variability in the purity and potency of both the bulk APIs and compounded hydroxyprogesterone caproate products that were tested." The Agency has begun its own sampling and analysis of compounded hydroxyprogesterone products and the bulk APIs used to make them. In FDA's statement, the agency "reminds healthcare providers and patients that before approving the Makena® new drug application, FDA reviewed manufacturing information, such as the source of the API used by the manufacturer, proposed manufacturing processes and the firm's adherence to current good manufacturing practice. Therefore, as with other approved drugs, greater assurance of safety and effectiveness is generally provided by the approved product than by a compounded product."
The full text of the FDA statement is available at :
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm279098.htm
Overview of Research
The active pharmaceutical ingredient in FDA-approved
Makena®, hydroxyprogesterone caproate, is sourced
exclusively from the same FDA-registered and
FDA-inspected manufacturer that supplied the API used
in the NICHD study that served as part of the basis
for FDA approval of Makena®. To the Company's
knowledge, this is the only manufacturer of
hydroxyprogesterone caproate known to have an active
Drug Master File with the FDA.
The independent laboratories measured the quality of each API sample and compounded 17P vial against certain quality standards required by FDA for Makena®. The samples also were evaluated by these labs against certain U.S. Pharmacopeia (USP) standards for hydroxyprogesterone caproate and hydroxyprogesterone caproate injection, because some compounding pharmacies claim that their compounded formulations meet USP criteria. The laboratories analyzed the API and compounded 17P drug formulations to assess potency, chemical impurities and drug identity. |
Key Laboratory Testing Findings
Active Pharmaceutical Ingredient (API)
|
Compounded 17P Formulations
-
27 percent (8 of 30) of the compounded 17P vials tested
failed to meet the USP standard for potency. The potency
values of the compounded 17P vials ranged from just over
half to a level more than 2.5 times the labeled potency.
If these vials were administered to patients, some
patients would not have received the dose of 17P that was
reviewed and subsequently approved by FDA for safety and
efficacy in this patient population. This variability in
potency was comparable to those found in FDA's limited
survey of compounded drug products conducted in 2006,
which is available at:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
PharmacyCompounding/ucm204237.htm -
53 percent (16 of 30) of the vials of compounded 17P had
levels of unknown impurities that exceeded at least one
standard required by the FDA for Makena®. The potential
toxic effects of these unidentified compounds in the
intended patient population are unknown.
-
Taken together, two-thirds (20 of 30) of the compounded
17P vials failed to meet at least one USP requirement (a
standard used by some compounding pharmacies) or at least
one FDA quality standard required of Makena® for potency
and/or purity levels. Information was not obtained
regarding the sterility of, or potential presence of
endotoxins in, the compounded 17P vials.
-
FDA-approved Makena® must meet FDA's quality standards
before release for patient use.
About K-V Pharmaceutical Company
K-V Pharmaceutical Company is a specialty branded pharmaceutical company with a primary focus in the area of women's healthcare. As such, we are committed to advancing the health of women across all the stages of their lives.
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 release contains various forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 (the "PSLRA") and which may be based on or include assumptions concerning our operations, future results and prospects. 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.
All statements that address expectations or projections about the future, including, without limitation, statements about product launches, governmental and regulatory actions and proceedings, market position, revenues, expenditures and the impact of the recall and suspension of shipments on revenues, adjustments to the financial statements, the filing of amended SEC filings, and other financial results, are forward-looking statements.
All forward-looking statements are based on current expectations and are subject to risk and uncertainties. In connection with the PSLRA's "safe harbor" provisions, we provide the following cautionary statements identifying important economic, competitive, political, regulatory and technological factors, among others, that could cause actual results or events to differ materially from those set forth or implied by the forward-looking statements and related assumptions. Such factors include (but are not limited to) the following:
(1) our ability to continue as a going concern, as discussed
in Note 3-"Going Concern and Liquidity Considerations" in the
Notes to the Consolidated Financial Statements included in
Part I, Item 1 of our Quarterly Report on Form 10-Q for the
fiscal quarter ended June 30, 2011;
(2) risks associated with the introduction and growth strategy related to the Company's Makena® product, including:
- (a) the impact of competitive, commercial payor, governmental (including Medicaid program), physician, patient, public or political responses and reactions, and responses and reactions by medical professional associations and advocacy groups, on the Company's sales, marketing, product pricing, product access and strategic efforts;
- (b) the possibility that the benefit of any period of exclusivity resulting from the designation of Makena® as an orphan drug may not be realized as a result of U.S. Food and Drug Administration (the "FDA")'s decision to decline to take enforcement action with regards to compounded alternatives;
- (c) the Center for Medicare and Medicaid Services' ("CMS") policy regarding Medicaid reimbursement for Makena®, and the resulting coverage decisions for Makena® by various state Medicaid and commercial payors;
- (d) the satisfaction or waiver of the terms and conditions for our continued ownership of the full U.S. and worldwide rights to Makena® set forth in the previously disclosed Makena® acquisition agreement, as amended, including a $107.5 million scheduled payment by us for those rights; and
- (e) the number of preterm births for which Makena® may be prescribed, its safety and side effects profiles and acceptance of pricing;
(3) the possibility of delay or inability to obtain FDA
approvals of Clindesse® and Gynazole-1® and the possibility
that any product relaunch may be delayed or unsuccessful;
(4) risks related to compliance with various agreements and settlements with governmental entities which are discussed in Part I, Item 2- "Management's Discussion and Analysis of Financial Condition and Results of Operations-Discontinuation of Manufacturing and Distribution; Product Recalls; and the FDA Consent Decree" of our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2011, including:
- (a) the consent decree between the Company and the FDA and the Company's suspension in 2008 and 2009 of the production and shipment and the nationwide recall of all of the products that it formerly manufactured, as well as the related material adverse effect on our revenue, assets and liquidity and capital resources;
- (b) the agreement between the Company and the Office of Inspector General of the U.S. Department of Health and Human Services ("HHS OIG") to resolve the risk of potential exclusion of the Company from participation in federal healthcare programs; and
- (c) our ability to comply with the plea agreement between a now-dissolved subsidiary of the Company and the U.S. Department of Justice;
(5) the availability of raw materials and/or products
manufactured for the Company under contract manufacturing
agreements with third parties;
(6) risks that the Company may not ultimately prevail in, or that insurance proceeds, if any, will be insufficient to cover potential losses that may arise from, litigation discussed in Note 16-"Commitments and Contingencies-Litigation and Governmental Inquiries" of the Notes to the Consolidated Financial Statements included in Part I, Item 1 of our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2011, including:
- (a) the series of putative class action lawsuits alleging violations of the federal securities laws by the Company and certain individuals;
- (b) product liability lawsuits;
- (c) lawsuits pertaining to indemnification and employment agreement obligations involving the Company and its former Chief Executive Officer;
- (d) the possibility that the pending lawsuits and investigation by HHS OIG regarding potential false claims under Title 42 of the U.S. Code could result in significant civil fines or penalties, including exclusion from participation in federal healthcare programs such as Medicare and Medicaid and the possibility; and
- (e) challenges to our intellectual property rights by actual or potential competitors and challenges to other companies' introduction or potential introduction of generic or competing products by third parties against products sold by the Company;
(7) the possibility that our current estimates of the
financial effect of previously announced product recalls
could prove to be incorrect;
(8) risks related to the Company's highly leveraged capital structure discussed in Part I, Item 2- "Management's Discussion and Analysis of Financial Condition and Results of Operations-Liquidity and Capital Resources" of our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2011, including:
- (a) the risk that the maturities of our debt obligations may be accelerated due to our inability to comply with covenants and restrictions contained in our loan agreements, including as a result of unanticipated delays in filing restated financial statements and related reports;
- (b) restrictions on the ability to increase our revenues through certain transactions, including the acquisition or in-licensing of products; and
- (c) risks that present or future changes in the Board of Directors may lead to an acceleration of the maturities of the Company's debt;
(9) the risks of unexpected delays in our ability to file
restated financial statements and related reports;
(10) the risk that we may not be able to satisfy the
quantitative listing standards of the New York Stock
Exchange, including with respect to minimum share price and
public float;
(11) the possibility that default on one type or class of the
Company's indebtedness could result in cross default under,
and the acceleration of, its other indebtedness; and
(12) the risks detailed from time to time in the Company's
filings with the SEC. This discussion is not exhaustive, but
is designed to highlight important factors that may impact
our forward-looking statements.
Because the factors referred to above, as well as the
statements included in Part I, Item 1A-"Risk Factors," of our
Annual Report on Form 10-K for the fiscal year ended March
31, 2011, and Part II, Item 1A-"Risk Factors," and Part I,
Item 2-"Management's Discussion and Analysis of Financial
Condition and Results of Operations" of our Quarterly Report
on Form 10-Q for the fiscal quarter ended June 30, 2011,
could cause actual results or outcomes to differ materially
from those expressed in any forward-looking statements made
by us or on our behalf, you should not place undue reliance
on any forward-looking statements. All forward-looking
statements attributable to us are expressly qualified in
their entirety by the cautionary statements in this
"Cautionary Note Regarding Forward-Looking Statements" and
the risk factors that are included under Part I, Item 1A of
our Annual Report on Form 10-K for the fiscal year ended
March 31, 2011, and Part II, Item 1A under our Quarterly
Report on Form 10-Q for the fiscal quarter ended June 30,
2011, as supplemented by our subsequent SEC filings. Further,
any forward-looking statement speaks only as of the date on
which it is made and we are under no obligation to update any
of the forward-looking statements after the date of this
release. New factors emerge from time to time, and it is not
possible for us to predict which factors will arise, when
they will arise and/or their effects. In addition, we cannot
assess the impact of each factor on our future business or
financial condition or the extent to which any factor, or
combination of factors, may cause actual results to differ
materially from those contained in any forward-looking
statements.