ST. LOUIS, Jan. 12, 2011 /PRNewswire/ -- K-V Pharmaceutical
Company (NYSE: KVa/KVb) today issued an update on the status
of the U.S. Food and Drug Administration's review of Hologic,
Inc.'s (Hologic) New Drug Application (NDA) for Gestiva™
(hydroxyprogesterone caproate injection) as a treatment for the
prevention of preterm birth in women with a singleton pregnancy who
have a history of singleton spontaneous preterm birth.
Following the July 2010
resubmission of the NDA by Hologic, the FDA assigned a Prescription
Drug User Fee Act ("PDUFA") action date of January 13, 2011. Hologic advised the
Company that the FDA had recently requested additional information
with respect to the Gestiva™ application. The requested
information was provided to the FDA on January 10, 2011.
In order to provide for additional time to review the
information that was solicited by the FDA and provided by Hologic,
the FDA has extended the PDUFA date to April
13, 2011. Based on the information provided, the
Company remains confident in the approval of Gestiva™ and believes
a positive action by the FDA is likely on or before the new PDUFA
date.
In light of this new information, the Company further stated
that it is evaluating its liquidity outlook. When the Company
completes its evaluation, it intends to furnish an update as
appropriate.
About Preterm Birth
According to the March of Dimes, preterm birth, or the birth of
a baby prior to 37 completed weeks of pregnancy, affects one in
eight babies born in the United
States. Preterm birth is the leading cause for infant
mortality and morbidity. Babies born preterm tend to grow
more slowly, have more problems with their eyes, ears, breathing
and nervous system, and experience more learning and behavioral
problems. Preterm birth has been estimated to cost
the United States more than
$26 billion a year.
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 Web site at
www.kvpharmaceutical.com.
Cautionary Note Regarding Forward-looking Statements
This press releases 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:
(1) the ability to continue as a going concern;
(2) the terms of our recently executed secured loan
agreement with U.S. Healthcare I, L.L.C. and U.S. Healthcare II,
L.L.C. (together, the "Lenders"), as more fully described in Item
1— "Business—(b) Significant Recent Developments—Financing" in the
Company's Annual Report on Form 10-K for the year ended
March 31, 2010 (the "Form 10-K"),
could have an adverse effect on us if we are not able to refinance
it or repay it at maturity on March 20,
2013, or earlier in accordance with its terms or if we
experience an event of default and such terms contain numerous
affirmative and negative covenants and conditions that must be met
in order to avoid default and/or to qualify for additional loan
tranches, and there are substantial risks of triggering defaults
with respect to such covenants and/or the occurrence or
non-occurrence of conditions that would preclude the Company from
being able to draw down additional loan tranches, which could
materially adversely impact the Company, lead to foreclosure on the
Company assets acting as collateral for the loan agreement, and
adversely affect the Company's ability to operate;
(3) the possibility of not obtaining FDA approvals or
delay in obtaining FDA approvals, including with respect to the
drug originally submitted under the trade name Gestiva™
("Gestiva™")
(4) new product development and launch, including the
possibility that any product launch may be delayed or unsuccessful,
including with respect to Gestiva™;
(5) acceptance of and demand for the Company's new
pharmaceutical products, including Gestiva™, and for our current
products upon their return to the marketplace, as well as the
number of preterm births for which Gestiva™ may be prescribed and
its safety profile and side effects profile;
(6) the possibility that any period of exclusivity may not
be realized, including with respect to Gestiva™, a designated
Orphan Drug;
(7) the satisfaction or waiver of the terms and conditions
for the acquisition of the full U.S. and worldwide rights to
Gestiva™ set forth in the previously disclosed Gestiva™ acquisition
agreement, as amended;
(8) the consent decree between the Company and the U.S.
Food and Drug Administration ("FDA") and the Company's suspension
of the production and shipment of all of the products that it
manufactures (other than the Potassium Chloride ER 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
1—"Business—(b) Significant Recent Developments—Discontinuation of
Manufacturing and Distribution; Product Recalls; and the FDA
Consent Decree" in the Form 10-K for fiscal 2010;
(9) 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 15—"Commitments and
Contingencies—Litigation and Governmental Inquiries" of the Notes
to the Consolidated Financial Statements included in the Form 10-K
for fiscal 2010;
(10) 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 Item 1—"Business—(b) Significant Recent
Developments—Plea Agreement with the U.S. Department of Justice" in
the Form 10-K for fiscal 2010;
(11) changes in the current and future business
environment, including interest rates and capital and consumer
spending;
(12) the availability of raw materials and/or products
manufactured for the Company under contract manufacturing
agreements with third parties;
(13) the regulatory environment, including regulatory
agency and judicial actions and changes in applicable laws or
regulations, including the risk of obtaining necessary state
licenses in a timely manner;
(14) fluctuations in revenues;
(15) the difficulty of predicting the pattern of inventory
movements by the Company's customers;
(16) he impact of competitive response to the Company's
sales, marketing and strategic efforts, including introduction or
potential introduction of generic or competing products against
products sold by the Company and its subsidiaries, including
Gestiva™, and including competitive pricing changes;
(17) 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 15 – "Commitments and Contingencies" of the Notes to the
Consolidated Financial Statements in the Form 10-K, and that any
adverse judgments or settlements of such litigation, including
product liability lawsuits, may be material to the Company;
(18) the possibility that our current estimates of the
financial effect of certain announced product recalls could prove
to be incorrect;
(19) whether any product recalls or product introductions result
in litigation, agency action or material damages;
(20) failure to supply claims by certain of the Company's
customers, including CVS Pharmacy, Inc., 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;
(21) 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 15 –
"Commitments and Contingencies – Litigation and Governmental
Inquiries" of the Notes to the Consolidated Financial Statements in
the Form 10-K for fiscal 2010;
(22) 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;
(23) the informal inquiries initiated by the SEC and any
related or additional government investigation or enforcement
proceedings as more fully described in Note 15 – "Commitments and
Contingencies – Litigation and Government Inquiries," of the Notes
to the Consolidated Financial Statements in the Form 10-K for
fiscal 2010;
(24) the possibility that the pending investigation by the
Office of Inspector General of the Department of Health and Human
Services into potential false claims under the Title 42 of the U.S.
Code as more fully described in Note 15 – "Commitments and
Contingencies – Litigation and Government Inquiries" of the Notes
to the Consolidated Financial Statements in the Form 10-K for
fiscal 2010 could result in significant civil fines or penalties,
including exclusion from participation in federal healthcare
programs such as Medicare and Medicaid;
(25) 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;
(26) the ability to sell or license certain assets, and the
purchase prices, milestones, terms and conditions of such
transactions;
(27) the possibility that default on one type or class of
the Company's indebtedness, or in certain contracts or agreements
referenced in our recently executed secured loan agreement with the
Lenders, could result in cross default under, and the acceleration
of, its other indebtedness or such secured loan agreement;
(28) the risks that present or future changes in the Board
of Directors or management may lead to an acceleration of the
Company's bonds or to adverse actions by government agencies, our
lenders or our auditors;
(29) 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 have recently again begun satisfying 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; and
(30) 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
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 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