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KV Pharmaceutical Company Announces Approval for the 50 mg Strength of Generic Version of Toprol-XL(R)
KV Pharmaceutical Company Announces Approval for the 50 mg Strength of Generic Version of Toprol-XL(R)
ST. LOUIS, May 15 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company
(NYSE: KVa/KVb), a fully integrated specialty pharmaceutical company that
develops, manufactures, acquires and markets technology-differentiated branded
products and generic/non-branded prescription pharmaceuticals, announced today
that it has received final approval from the U.S. Food and Drug Administration
(FDA) of its Abbreviated New Drug Application (ANDA) to market its 50 mg
strength of metoprolol succinate extended-release tablets. The Company expects
to begin shipping immediately. This product is a generic version of
AstraZeneca's branded product, Toprol-XL(R) and the 50 mg strength recorded
total branded and generic dollar volume in 2007 of $585 million according to
IMS America. The 50 mg strength is the largest of the four strengths in both
units sold and dollar volume.
As a result of the 50 mg approval, KV is now offering the complete line of
all four dosage strengths of metoprolol succinate extended-release tablets --
200 mg, 100 mg, 50 mg and 25 mg. KV currently has a 77.8% and 77.4% market
share for the 200 mg and 100 mg strengths, respectively. Based on the
Company's first-to-file status on its ANDA for these two strengths, KV was
accorded the benefit of a 180-day generic exclusivity period for the marketing
of these two dosage strengths. Even though KV was not granted an exclusivity
period for the 50 mg or 25 mg dosage strengths, the Company currently has a
23.5% market share for the 25 mg strength which was only approved by the FDA
on March 20, 2008.
Marc S. Hermelin, Vice Chairman and Chief Executive Officer of KV
Pharmaceutical stated, "Following today's approval, KV is now able to offer
all four dosage strengths of metoprolol succinate extended-release tablets. We
have achieved remarkable results marketing the 100 mg and 200 mg strengths of
metoprolol succinate extended-release tablets and have demonstrated success
marketing the 25 mg strength since we began shipping in March. With the 50 mg
dosage strength now available, we expect the complete product line to continue
to be a solid contributor to our growth in fiscal 2009 and beyond."
Metoprolol succinate extended-release tablets are indicated for the
treatment of hypertension used alone or in combination with other
antihypertensive agents, for the long-term treatment of angina pectoris and
for the treatment of stable, symptomatic (NYHA Class II or III) heart failure
of ischemic, hypertensive, or cardiomyopathic origin.
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 national leader in pharmaceuticals that
compete with branded products, and Ther-Rx Corporation, its branded
prescription pharmaceutical subsidiary.
For further information about KV Pharmaceutical Company, please visit the
Company's corporate website at www.kvpharmaceutical.com .
Safe Harbor
The information in this 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 KV's operations, future results and prospects. Such
statements may be identified by the use of words like "plans", "expect",
"aim", "believe", "projects", "anticipates", "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, statements about the Company's strategy for
growth, product development, product launches, regulatory approvals, market
position, market share increases, acquisitions, revenues, expenditures 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, KV provides the following cautionary statements identifying
important economic, political and technology 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 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; (13) risks that the
Company may not ultimately prevail in litigation; (14) completion of the
Company's financial statements for the first, second and third quarters of
fiscal 2008 and for the full fiscal year ended March 31, 2008; (15) actions by
the Securities and Exchange Commission and the Internal Revenue Service with
respect to the Company's stock option grants and accounting practices; and
(16) the risks detailed from time-to-time in the Company's filings with the
Securities and Exchange Commission; (17) actions by the NYSE Regulation, Inc.
with respect to the continued listing of the Company's stock on the New York
Stock Exchange; and (18) the impact on the magnitude of the market opportunity
for the 50 mg strength of metoprolol succinate extended-release tablets by our
and other generic entry.
This discussion is by no means exhaustive, but is designed to highlight
important factors that may impact the Company's outlook. We are under no
obligation to update any of the forward-looking statements after the date of
this release.
SOURCE KV Pharmaceutical Company
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