KV Pharmaceutical Launches Enhanced Formulation of PrimaCare ONE(R)
18 December 2008 - 12:00AM
PR Newswire (US)
Sets New Standard for Prescription Prenatal Vitamins ST. LOUIS,
Dec. 17 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company
(NYSE:KVa/KVb) announced today that its Ther-Rx Corporation branded
pharmaceutical subsidiary - the U.S. market leader in branded
prenatal vitamins - has enhanced the formulation of one of its most
innovative products, PrimaCare ONE(R). The enhanced PrimaCare
ONE(R) replaces the previous formulation, immediately becoming the
most comprehensive one-capsule-per day omega-3 prescription
prenatal vitamin in the market and providing unmatched prenatal and
postnatal nutritional support for mothers and babies. The new
enhanced formulation of PrimaCare ONE(R) now delivers the most
omega-3s, and includes both DHA (Docosahexaenoic acid) and EPA
(Eicosapentaenoic acid), along with 13 vitamins and minerals, folic
acid, plus a stool softener. PrimaCare ONE(R) provides all of these
benefits with the convenience of one-capsule-per day. The product
demonstrates Ther-Rx's continued leadership in marketing innovative
branded pharmaceuticals to women in their childbearing years as
part of its PreCare(R) family prescription nutritional product
line. "Ther-Rx is committed to continuously enhancing our products
based on both doctor and patient feedback," stated Greg Divis,
President of Ther-Rx Corporation. "PrimaCare ONE(R) has been a
tremendously successful contributor to our prenatal line. We are
very excited to have the opportunity to further improve PrimaCare
ONE(R) through this new enhanced formulation. We are now providing
the most omega-3s in a one-capsule-per day product to help Mom's
replace the up to 50% of essential fatty acid stores lost during
pregnancy. The National Institutes of Health (NIH), the American
Heart Association, the World Health Organization and the American
Psychiatric Association recommend supplementation with DHA and EPA
for pregnant Mothers. We believe PrimaCare ONE(R) helps address the
concerns of physicians, patients and leading health associations."
The enhanced PrimaCare ONE(R) is the newest offering in a line of
prescription prenatal nutritionals offered by Ther-Rx Corporation.
Since the strategic acquisition of a single prescription prenatal
product in 1999 (PreCare(R) Prenatal), Ther-Rx has expanded this
segment from one product and $4 million in annual revenues to more
than seven products that generated revenues of more than $82
million during fiscal 2008. This performance has been a key factor
driving Ther-Rx to its market leadership position with a 43% market
share in the U.S. branded prescription prenatal vitamin market for
fiscal year 2008, more than twice the share of the nearest
competing franchise. 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 drug subsidiary. 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",
"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, product
development, product launches, 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 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
our intellectual property rights by actual or potential competitors
or to our 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 KV's current estimates of the financial effect
of certain previously announced product recalls could prove to be
incorrect; (15) whether any product recalls or product
introductions results 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, and Form 12b-25 filed with the SEC on
November 13, 2008, 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 or at
their face value; and (19) 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 release. DATASOURCE: KV
Pharmaceutical Company CONTACT: Catherine M. Biffignani, Vice
President, Investor Relations, +1-314-645-6600 Web Site:
http://www.kvpharmaceutical.com/
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