In the news release, K-V Pharmaceutical Comments on ACOG and
SMFM Information Update Regarding Hydroxyprogesterone Caproate -
FDA-Approved Makena™ and Compounded 17P, issued Oct. 13, 2011 by K-V Pharmaceutical Company over
PR Newswire, we are advised by a representative of the company that
there have been updates to the release. Please disregard the
original transmission. The complete, updated release follows:
K-V Pharmaceutical Comments on ACOG and SMFM Information Update
Regarding 17-Alpha Hydroxyprogesterone Caproate - FDA-Approved
Makena™ and Compounded 17P
ST. LOUIS, Oct. 13, 2011 /PRNewswire/ -- K-V Pharmaceutical
Company (the "Company") (NYSE: KV.A/KV.B) appreciates that the
American College of Obstetricians and Gynecologists (ACOG) and
Society for Maternal-Fetal Medicine (SMFM) have issued an
information update that ensures healthcare providers, patients, and
the payer community have the facts regarding FDA-approved Makena™.
The information update emphasizes that previous ACOG and SMFM
statements regarding Makena were not intended to be used by private
or public payers as a basis for interfering with the medical
judgment of healthcare providers or denying patient access to
Makena. It also states that physicians should understand the
inherent differences between an FDA-approved manufactured product
and a compounded preparation, and that ACOG and SMFM's previous
statements were not meant to suggest that Makena and compounded 17P
are identical products.
Healthcare providers understand that evidence-based medicine is
the foundation of clinical practice. Evidence from the NICHD
MFMU Network study (Meis, et al.) supporting the use of
hydroxyprogesterone caproate (17P) was based on drug manufactured
under FDA's Good Manufacturing Practices (GMP) conditions, and not
on drug made using compounding processes or obtained from
compounding pharmacies. The drug used in the NICHD study is
available today as FDA-approved Makena.
Access to FDA-approved Makena for clinically-indicated patients
is an important public health priority. Certain payer
coverage policies have been influenced by a belief that unapproved
compounded 17P formulations are the same as Makena. These
policies should be modified to ensure that clinically-indicated
patients have unencumbered access to FDA-approved Makena,
consistent with their healthcare provider's medical judgment.
As part of our commitment to patients, we have made substantial
efforts to work with the payer community, and patient co-pays for
Makena are averaging approximately $12 per injection.
For details regarding the Makena financial assistance program
for clinically-eligible patients, please visit www.makena.com.
The full text of the ACOG and SMFM information update is
available at www.acog.org.
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 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.
All statements that address expectations or projections about
the future, including without limitation, statements about product
development, product launches, regulatory approvals, governmental
and regulatory actions and proceedings, market position,
acquisitions, sale of assets, revenues, expenditures, resumption of
manufacturing and distribution of products and the impact of the
recall and suspension of shipments on revenues, 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, the Company
provides 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:
- our ability to continue as a going concern;
- 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, to the
Company's sales, marketing, product pricing, product access and
strategic efforts with respect to Makena™, and its other products,
including introduction or potential introduction of generic or
competing products, or competition from unapproved therapies or
compounded drugs, against products sold by the Company and its
subsidiaries, including Makena™, and including competitive or
responsive pricing changes;
- the possibility of not obtaining the U.S. Food and Drug
Administration (the "FDA") approvals or delay in obtaining FDA
approvals;
- the impact of: (i) the FDA's decision to decline to take
enforcement action with regards to compounded alternatives to the
Company's Makena ™ product despite the Company's orphan drug
exclusivity; (ii) CMS policy permitting Medicaid program
reimbursement of such products; and (iii) resulting coverage
decisions by various state Medicaid and commercial payors, on the
Company's sales revenues for Makena ™ and the resulting impact on
the Company's operations and financial results, including, without
limitation, its ability to continue as a going concern;
- new product development and launch, including the possibility
that any product launch may be delayed or unsuccessful, including
with respect to Makena™;
- acceptance of and demand for the Company's new pharmaceutical
products, including Makena™, and for our current products upon
their return to the marketplace, as well as the number of preterm
births for which Makena™ may be prescribed and its safety profile
and side effects profile and acceptance of the degree of patient
access to, and pricing for, Makena™;
- the possibility that any period of exclusivity may not be
realized, including with respect to Makena™, a designated Orphan
Drug;
- the satisfaction or waiver of the terms and conditions for the
continued ownership of the full U.S. and worldwide rights to
Makena™ set forth in the previously disclosed Makena™ acquisition
agreement, as amended;
- the consent decree between the Company and the FDA and the
Company's suspension of the production and shipment of all of the
products that it manufactures (other than the Potassium Chloride
Extended Release Capsule products that are the subject of the FDA
letter received September 8, 2010 allowing the return of those
products to the marketplace) and the related nationwide recall
affecting all of the other products that it manufactures, as well
as the related material adverse effect on its revenue, assets and
liquidity and capital resources, as more fully described in 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" in this
Report;
- the two agreements between the Company and the Office of
Inspector General of the U.S. Department of Health and Human
Services ("HHS OIG") pertaining to the exclusion of our former
chief executive officer from participation in federal healthcare
programs and pertaining to the dissolution of our ETHEX subsidiary,
in order to resolve the risk of potential exclusion of our Company,
as more fully described in Note 1—"Description of Business—Changes
in Management" in the Notes to the Consolidated Financial
Statements included in Part I of this Report;
- the plea agreement between the Company and the U.S. Department
of Justice and the Company's obligations therewith, as well as the
related material adverse effect, if any, on its revenue, assets and
liquidity and capital resources, as more fully described in Note
1—"Description of Business—Plea Agreement with the U.S. Department
of Justice" in the Notes to the Consolidated Financial Statements
included in Part I of this Report;
- changes in the current and future business environment,
including interest rates and capital and consumer spending;
- the availability of raw materials and/or products, including
Makena™ and Evamist ® , manufactured for the Company under contract
manufacturing agreements with third parties;
- the regulatory environment, including legislative, government
or regulatory agency and judicial actions and changes in applicable
laws or regulations, including the risk of obtaining necessary
state licenses in a timely manner;
- fluctuations in revenues;
- the difficulty of predicting the pattern of inventory movements
by the Company's customers;
- risks that the Company may not ultimately prevail in
litigation, including product liability lawsuits and challenges to
its intellectual property rights by actual or potential competitors
or to its ability to market generic products due to brand company
patents and challenges to other companies' introduction or
potential introduction of generic or competing products by third
parties against products sold by the Company or its subsidiaries
including without limitation the litigation and claims referred to
in Note 16—"Commitments and Contingencies" of the Notes to the
Consolidated Financial Statements in Part I of this Report, and
that any adverse judgments or settlements of such litigation,
including product liability lawsuits, may be material to the
Company;
- the possibility that our current estimates of the financial
effect of certain announced product recalls could prove to be
incorrect;
- whether any product recalls or product introductions result in
litigation, agency action or material damages;
- the possibility of our loss of failure to supply claims by
certain of the Company's customers that, despite the formal
discontinuation action by the Company of its products, the Company
should compensate such customers for any additional costs they
allegedly incurred for procuring products the Company did not
supply;
- the series of putative class action lawsuits alleging
violations of the federal securities laws by the Company and
certain individuals, as more fully described in Note
16—"Commitments and Contingencies—Litigation and Governmental
Inquiries" of the Notes to the Consolidated Financial Statements in
Part I of this Report;
- the possibility that insurance proceeds are insufficient to
cover potential losses that may arise from litigation, including
with respect to product liability or securities litigation;
- the informal inquiries initiated by the Securities and Exchange
Commission (the "SEC") and any related or additional government
investigation or enforcement proceedings as more fully described in
Note 16—"Commitments and Contingencies—Litigation and Governmental
Inquiries" of the Notes to the Consolidated Financial Statements in
Part I of this Report;
- the possibility that the pending investigation by HHS OIG into
potential false claims under the Title 42 of the U.S. Code as more
fully described in Note 16—"Commitments and
Contingencies—Litigation and Governmental Inquiries" of the Notes
to the Consolidated Financial Statements in Part I of this Report
could result in significant civil fines or penalties, including
exclusion from participation in federal healthcare programs such as
Medicare and Medicaid;
- delays in returning, or failure to return, certain or many of
the Company's approved products to market, including loss of market
share as a result of the suspension of shipments, and related
costs;
- the ability to sell or license certain assets, and the purchase
prices, milestones, terms and conditions of such transactions;
- 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;
- the risks that present or future changes in the Board of
Directors or management may lead to an acceleration of the
Company's debt or to adverse actions by government agencies or our
auditors;
- the risk that even though the price and 30-day average price of
the Company's Class A Common Stock and Class B Common Stock
currently satisfy the quantitative listing standards of the New
York Stock Exchange, including with respect to minimum share price
and public float, the Company can provide no assurance that they
will remain at such levels thereafter;
- compliance with debt covenants; and
- 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 the Company's forward-looking
statements. Because the factors referred to above, as well as the
statements included under the captions Part I, Item 1A—"Risk
Factors," Part II, Item 7—"Management's Discussion and Analysis of
Financial Condition and Results of Operations" and elsewhere in the
Company's 2011 Form 10-K, could cause actual results or outcomes to
differ materially from those expressed in any forward-looking
statements made by the Company or on the Company's behalf, you
should not place undue reliance on any forward-looking
statements.
All forward-looking statements attributable to the Company 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 – "Risks
Factors" in the Company's 2011 Form 10-K, as supplemented by the
Company's subsequent SEC filings. Further, any forward-looking
statement speaks only as of the date on which it is made and the
Company is 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
the Company to predict which factors will arise, when they will
arise and/or their effects. In addition, the Company cannot assess
the impact of each factor on its 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.
SOURCE K-V Pharmaceutical Company