6-Month Exclusivity on 420mg Diltiazem Strength; First Company with Full
Line of Dosage Strengths which are AB rated to Tiazac(R)
ST. LOUIS, Sept. 12 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company
(NYSE: KVa/KVb) announced today that it has received approval from the U.S.
Food and Drug Administration to market six strengths of Diltiazem HCl ER
Capsules (AB rated to Tiazac(R) from Forest Pharmaceuticals, Inc.) through
its wholly-owned generic/non-branded subsidiary, ETHEX Corporation. ETHEX
will begin shipments of all six strengths immediately.
The launch of the six strengths of Diltiazem (120mg, 180mg, 240mg,
300mg, 360mg and 420mg) will complement ETHEX's highly regarded
cardiovascular family of products and will make KV the first generic
company that will have a full line of product AB-rated to Tiazac(R). KV
also believes it is the first generic company to receive approval of the
420mg strength dosage, and thus expects to have six months exclusivity on
this strength. However, it is also expected that the brand manufacturer may
launch an "authorized generic" version. Total market sales for this product
are approximately $160 million. Tiazac(R) is indicated for the treatment of
hypertension (high blood pressure) and angina (chest pain).
Tiazac(R) belongs to a class of drugs known as calcium channel blockers
(CCBs) that lower blood pressure by blocking calcium influx into the smooth
muscle cells of the blood vessels. CCBs may be used to treat high blood
pressure, angina and some arrhythmias. Approximately 50 million people in
the U.S. have hypertension, however, approximately 52% are not on therapy
and only 21% are on adequate control which controls their hypertension.
Hypertension is a lifelong condition and can remain asymptomatic for many
years. It is very important to reach one's blood pressure goal and maintain
that goal throughout one's life.
Marc S. Hermelin, Vice Chairman of the Board and Chief Executive
Officer stated, "We are delighted to be extending ETHEX's cardiovascular
expertise into the CCB segment with a complete line of AB-rated equivalents
to an outstanding product like Tiazac(R). The approval extends ETHEX's
line-up of quality ANDA products across multiple therapeutic categories,
with several more important opportunities in our pipeline. We are pleased
to be able to offer a full line of this important product to our customers
and patients."
About KV Pharmaceutical Company
KV Pharmaceutical Company is a fully integrated specialty
pharmaceutical company that develops, manufactures and 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 emerging
branded drug subsidiary. KV has consistently ranked as one of America's
fastest growing small companies, most recently by Forbes in its November
2004 issue.
For further information about KV Pharmaceutical Company, please visit
the Company's corporate website at http://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," "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, statements about the Company's
strategy for growth, product development, regulatory approvals, market
position, 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; (8) the
regulatory environment, including regulatory agency and judicial actions
and changes in applicable law or regulations; (9) fluctuations in operating
results; (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; and (14) the risks detailed from time to time in the Company's
filings with the Securities and Exchange Commission.
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 report.
SOURCE KV Pharmaceutical Company
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Related links:
http://www.kvpharmaceutical.com
CONTACT:
Catherine M. Biffignani, Vice President,
Investor Relations of KV Pharmaceutical Company, +1-314-645-6600
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