KV Pharmaceutical Company, Purdue Pharma L.P. Settle OxyContin(R) Dispute
June 09 2009 - 7:22PM
PR Newswire (US)
KV acknowledges validity of Purdue patents; Receives limited
license rights to all strengths of oxycodone controlled-release
tablets ST. LOUIS, June 9 /PRNewswire-FirstCall/ -- KV
Pharmaceutical Company (NYSE: KVa; KVb) of St. Louis, MO., today
announced it has entered into a settlement agreement with Purdue
Pharma L.P. of Stamford, Conn., in regard to the patent
infringement lawsuit between the two companies. Under the terms of
the settlement agreement, KV Pharmaceutical Company acknowledges
that Purdue Pharma's OxyContin(R) patents are valid and enforceable
and infringed. In exchange, Purdue will grant KV Pharmaceutical
Company certain limited non-exclusive, royalty-bearing,
non-transferable rights to sell in the United States generic
versions of the drug OxyContin(R) (oxycodone HCl
controlled-release) for a limited period of time. The Companies
have agreed to continue to discuss the final location for the
manufacturing of this product. About KV Pharmaceutical Company KV
Pharmaceutical Company is a fully integrated specialty
pharmaceutical company that develops, manufactures, markets, and
acquires technology-distinguished branded and generic/non-branded
prescription pharmaceutical products. The Company markets its
technology distinguished products through ETHEX Corporation, a
subsidiary that competes with branded products, and Ther-Rx
Corporation, the company's branded drug subsidiary. For further
information about KV Pharmaceutical Company, please visit the
Company's corporate Web site at http://www.kvpharmaceutical.com/.
About Purdue Pharma L.P. Purdue Pharma L.P. and its associated U.S.
companies are privately-held pharmaceutical companies known for
pioneering research on persistent pain. Purdue is engaged in the
research, development, production, and distribution of both
prescription and over-the-counter medicines and hospital products.
Additional information about Purdue can be found at
http://www.purduepharma.com/. The professional product labeling for
OxyContin(R) Tablets contains the following boxed warning: WARNING:
OxyContin(R) is an opioid agonist and a Schedule II controlled
substance with an abuse liability similar to morphine. Oxycodone
can be abused in a manner similar to other opioid agonists, legal
or illicit. This should be considered when prescribing or
dispensing OxyContin(R) in situations where the physician or
pharmacist is concerned about an increased risk of misuse, abuse,
or diversion. OxyContin(R) Tablets are a controlled-release oral
formulation of oxycodone hydrochloride indicated for the management
of moderate to severe pain when a continuous, around-the-clock
analgesic is needed for an extended period of time. OxyContin(R)
Tablets are NOT intended for use as a prn analgesic. OxyContin(R)
60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40
mg, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. A single dose
greater than 40 mg, or total daily doses greater than 80 mg, may
cause fatal respiratory depression when administered to patients
who are not tolerant to the respiratory depressant effects of
opioids. OxyContin(R) TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT
TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED
OxyContin(R) TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A
POTENTIALLY FATAL DOSE OF OXYCODONE. Cautionary Note Regarding
Forward-looking Statements The information in this press release
may contain various forward-looking statements within the meaning
of the United States Private Securities Litigation Reform Act of
1995 ("PSLRA") and which may be based on or include assumptions
concerning the operations, future results and prospects of KV
Pharmaceutical company (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" and other expressions that indicate
future events and trends. All statements that address expectations
or projections about the future, including without limitation,
product development, product launches, regulatory approvals, market
position, acquisitions, 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 "safe harbor"
provisions, the Company provides the following cautionary
statements identifying important economic, political and
technological factors, which among others, 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)
changes in the current and future business environment, including
interest rates and capital and consumer spending; (2) the
difficulty of predicting FDA approvals, including timing, and that
any period of exclusivity may not be realized; (3) acceptance and
demand for new pharmaceutical products; (4) the introduction and
impact of competitive products and pricing, including as a result
of so-called authorized-generic drugs; (5) new product development
and launch, including the possibility that any product launch may
be delayed or that product acceptance may be less than anticipated;
(6) reliance on key strategic alliances; (7) the availability of
raw materials and/or products manufactured for the Company under
contract manufacturing arrangements with third parties; (8) the
regulatory environment, including regulatory agency and judicial
actions and changes in applicable law or regulations; (9)
fluctuations in revenues; (10) the difficulty of predicting
international regulatory approval, including timing; (11) the
difficulty of predicting the pattern of inventory movements by the
Company's customers; (12) the impact of competitive response to the
Company's sales, marketing and strategic efforts, including the
introduction or potential introduction of generic or competing
products against products sold by the Company and its subsidiaries;
(13) risks that the Company may not ultimately prevail in
litigation, including challenges to the Company's intellectual
property rights by actual or potential competitors or to the
Company's 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 of the Notes to the Consolidated Financial Statements in
the Company's Form 10-Q for the quarter ended June 30, 2008; (14)
the possibility that the Company's current estimates of the
financial effect of certain announced product recalls could prove
to be incorrect; (15) whether any product recalls or product
introductions result in litigation, agency action or material
damages; (16) the possibility that the findings of the Audit
Committee inquiry referenced in the Company's Form 10-Q for the
quarter ended June 30, 2008, Form 12b-25 filed with the U.S.
Securities and Exchange Commission (the "SEC") on November 13,
2008, Form 12b-25 filed with the SEC on February 2, 2009, as well
as certain other of the Company's SEC filings, could have a
material impact on the Company's financial results; (17) the
satisfaction or waiver of the other closing conditions in the
previously disclosed Gestiva(TM) acquisition agreement; (18) the
possibility that the auction rate securities held by the Company
may not return to liquidity at their face value or at all; (19) the
Company's voluntary suspension of the production and shipment of
substantially all of the products that the Company manufactures and
the related nationwide recall affecting substantially all of the
products that the Company manufactures, as well as the expected
material adverse effect on the Company's revenue, assets and
liquidity and capital resources, all as more fully described in the
Company's Form 8-K filed with the SEC on January 26, 2009 and the
Company's Form 8-K filed with the SEC on February 26, 2009; (20)
the series of putative class action lawsuits alleging violations of
the federal securities laws by the Company and certain individuals,
and the initiation of lawsuits alleging violations under the
Employee Retirement Income Security Act (ERISA), all as more fully
described in the Company's Form 8-K filed with the SEC on January
26, 2009, as well as certain other of the Company's SEC filings;
(21) the informal inquiry initiated by the SEC and any related or
additional governmental investigative or enforcement proceedings,
including actions by the FDA and the U.S. Department of Justice,
all as more fully described in the Company's Form 8-K filed with
the SEC on January 26, 2009; (22) delays in returning the Company's
products to market, including loss of market share as a result of
the suspension of shipments, and related costs; and (23) 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. The Company is under no obligation to update any of the
forward-looking statements after the date of this press release.
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 the heading "Item 1A--Risk
Factors" in the Company's Annual Report on Form 10-K for the year
ended March 31, 2008, as supplemented by the Company's subsequent
SEC filings. DATASOURCE: KV Pharmaceutical Company CONTACT: Michael
Anderson, KV Pharmaceutical Company, +1-314-645-6600 Web Site:
http://www.kvpharmaceutical.com/
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