WILMINGTON, N.C., March 12 /PRNewswire-FirstCall/ --
aaiPharma Inc. (Nasdaq: AAII) announced today that a New Drug Application
has been submitted to the U.S. Food and Drug Administration for M.V.I.
Adult(TM). M.V.I. Adult(TM) is a reformulation of M.V.I.-12(R) in which
concentrations of vitamins B1, B6, C, and folic acid are increased and vitamin
K is added.
"We are very pleased that we have achieved another milestone in the
development of our pipeline with the submission of this NDA," commented Dr.
Philip S. Tabbiner, President and CEO of aaiPharma. "M.V.I. Adult(TM) will be
an important addition to our portfolio of injectable nutrition products, and
will provide critically ill patients on intravenous vitamin therapy with the
added nutritional elements they may need from the M.V.I.(R) brand."
aaiPharma is a leader in the critical care vitamin therapy market with its
M.V.I.(R) and Aquasol(R) brands. The Company currently markets M.V.I.-12(R)
and M.V.I. Pediatric(TM) injectable multi-vitamin nutrition products as well
as Aquasol A(R), an injectable form of vitamin A, and Aquasol E(R) Drops, an
orally administered form of vitamin E. In addition, the Company recently
received FDA approval for Calcitriol Injection, an injectable vitamin D
product used primarily to treat chronic kidney dialysis patients with
abnormally low levels of calcium in their circulating blood.
About aaiPharma
aaiPharma Inc. is a leading, science-based specialty pharmaceutical
company with corporate headquarters in Wilmington, North Carolina. With more
than 23 years of drug development expertise and a proven sales and marketing
track record, the Company is focused on acquiring, improving and marketing
well-known, branded medicines in pain management, gastroenterology and
critical care. In addition to its branded product portfolio and robust
pipeline, aaiPharma continues to offer comprehensive drug development services
to the pharmaceutical, biotechnology, generic and device industries through
its services division, AAI International. For more information, please visit
aaiPharma's website at http://www.aaipharma.com.
Forward Looking Statements
Information in this press release contains certain "forward-looking
statements" within the meaning of Section 27A of the Securities Act of 1933
and Section 21E of the Securities and Exchange Act of 1934, including
statements concerning the future medical and commercial significance of the
newly-filed product and the future development (including through the use of
our research and drug development capabilities), regulatory approval,
commercialization and growth of products in the Company's pipeline and of its
product portfolio (including M.V.I. Adult(TM)). The "forward-looking
statements" herein involve risks and uncertainties that could cause actual
results to differ materially, including, without limitation, risks and
uncertainties pertaining aaiPharma's ability to successfully develop, improve,
obtain timely regulatory approval for, and profitably sell pharmaceutical
products (including M.V.I. Adult(TM)). Additional factors that may cause the
actual results to differ materially are discussed in aaiPharma's recent
filings with the Securities and Exchange Commission, including, but not
limited to, its Annual Report on Form 10-K filed on March 11, 2002, including
its exhibits; its Form 10-Q filed on August 14, 2002, including Exhibit 99.1
thereto; its Form 10-Q filed on November 14, 2002; its Form 8-Ks; and its
other periodic filings.
M.V.I. Adult(TM) and M.V.I. Pediatric(TM) are trademarks, and M.V.I.(R),
M.V.I.-12(R), Aquasol(R), Aquasol A(R) and Aquasol E(R) are registered
trademarks, owned by aaiPharma Inc.
SOURCE aaiPharma Inc.
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Related links:
http://www.aaipharma.com
CONTACT:
Andrea L. Johnston, Vice President of
Corporate Communications, +1-910-254-7340, or James B. Sloan,
Jr., Senior Vice President of Corporate Finance, +1-910-254-7690,
both of aaiPharma Inc.
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