KV's ETHEX Subsidiary to Market AB-rated Equivalent to Rythmol(R)
In All Three Dosage Strengths
ST. LOUIS, Feb. 19 /PRNewswire-FirstCall/ -- KV Pharmaceutical announced
today that it has received approval from the Food and Drug Administration
(FDA) of its ANDA for Propafenone Hydrochloride (HCl) Tablets in all three
dosage strengths -- 150 mg., 225 mg. and 300 mg.
Propafenone is a cardiovascular prescription drug specifically indicated
for the treatment of heart rhythm abnormalities (antiarrhythmic agent), and is
an AB-rated equivalent to Rythmol(R) (Abbott Labs). In addition to ETHEX's
Propafenone, there are only two other products in the category with ANDA's for
one or more dosage strengths. Total Propafenone sales for the last 12 months
were approximately $100 million.
Marc S. Hermelin, Vice Chairman and CEO of KV stated, "This Propafenone
approval represents our first ANDA approval announcement of 2002. It's also
the quickest such approval in the history of our Company, coming only 8 months
after submission to the Agency, a tribute to our talented R&D and regulatory
teams. We continue to pursue development of additional products for which we
anticipate further ANDA filings."
ETHEX Corporation has established a strong track record of developing and
marketing quality generic pharmaceuticals. ETHEX's vision is to leverage KV's
array of drug delivery technologies in a way that addresses efficacy of
patient use and the cost-consciousness of the pharmacy and patient
communities.
About KV Pharmaceutical Company
KV Pharmaceutical Company is a fully integrated specialty pharmaceutical
company that develops, acquires, manufactures and markets controlled release
and tastemasked pharmaceutical products using proprietary drug delivery and
tastemasking technologies. 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 emerging branded
drug subsidiary. KV has consistently ranked as one of America's fastest
growing small companies, most recently by Forbes in its October 2001 issue.
For further information about KV Pharmaceutical Company, please visit the
Company's corporate website at http://www.kvpharmaceutical.com.
About ETHEX Corporation
ETHEX Corporation provides technology distinguished, high quality, and
competitively priced products. ETHEX Corporation markets and sells to most
classes of trade with representation at drug wholesalers, retail and hospital
levels.
For further information about ETHEX Corporation, please visit the
Company's corporate website at http://www.ETHEX.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," "anticipate," "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, market position, expenditures and 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 the 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;
(3) acceptance and demand for new pharmaceutical products; (4) the impact of
competitive products and pricing; (5) new product development and launch; (6)
reliance on key strategic alliances; (7) the availability of raw materials;
(8) the regulatory environment; (9) fluctuations in operating results; (10)
the difficulty of predicting the pattern of inventory movements by the
Company's customers; (11) the impact of competitive response to the Company's
efforts to leverage its brand power with product innovation, promotional
programs, and new advertising; and, (12) the risks detailed from time to time
in the Company's filings with the Securities and Exchange Commission.
This discussion of uncertainties is by no means exhaustive, but is
designed to highlight important factors that may impact the Company's outlook.
SOURCE KV Pharmaceutical Company
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Related links:
http://www.kvpharmaceutical.com
http://www.ETHEX.com
CONTACT:
Catherine M. Biffignani, Director of Investor
Relations of KV Pharmaceutical Company, +1-314-645-6600
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