WILMINGTON, N.C., Feb. 19 /PRNewswire-FirstCall/ -- aaiPharma Inc.
(Nasdaq: AAII) announced today that the Company has received approval by the
U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for
M.V.I. Adult(TM) (Multi-Vitamin Infusion), Pharmacy Bulk Package. (The
Company previously reported the FDA's approval of a related NDA, regarding the
single-dose and univial presentations of M.V.I. Adult(TM), on January 30,
2004.)
"We are very pleased with the approval of both NDAs for M.V.I. Adult(TM).
With these product approvals, aaiPharma will now be able to offer the most
comprehensive, reformulated, low aluminum, infusion multivitamin product line
to the market," commented Dr. Philip S. Tabbiner, President and CEO of
aaiPharma. "With this approval, the conditions for the contingent payment due
to AstraZeneca have been met and, as previously guided in the event that these
conditions were met, the Company will make a third quarter payment of $31.5
million as the remainder of the purchase price for M.V.I.(R)."
About aaiPharma
aaiPharma Inc. is a leading, science-based pharmaceutical company focused
on pain management, with corporate headquarters in Wilmington, North Carolina.
With more than 24 years of drug development expertise, the Company is focused
on developing, acquiring, and marketing well-known, branded medicines in its
targeted therapeutic areas. aaiPharma's development efforts are focused on
developing improved medicines from established molecules through its
significant research and development capabilities. For more information on the
Company, including its product development organization AAI Development
Services, 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 the
quoted statement by Dr. Tabbiner with respect to future payments and product
line offerings. The "forward-looking statements" herein involve risks and
uncertainties that could cause actual results to differ materially, including,
without limitation, risks and uncertainties pertaining the commercial and
medical attractiveness of the Company's present and planned products
(including, without limitation, the presentations of M.V.I. Adult(TM)) in
light of sales of competitive or generic products; regulatory decisions by the
FDA and other agencies regulating the Company; and the Company's ability to
successfully acquire, finance, conduct successful research on, develop,
improve, obtain timely regulatory approval for, launch, extend product life
cycles of, and sell, on a commercially profitable basis, pharmaceutical
products; to obtain, use, enforce, defend and license valid and commercially
valuable patents, including, without limitation, in the Company's patent
litigation; to obtain and enforce existing and future contracts; to defend
against pending and future litigation claims, including, without limitation,
securities class action litigation claims; and on the commercial success of
the contemplated products. 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 28, 2003, including its exhibits;
its Forms 10-Q filed on May 15, 2003, August 14, 2003 (including its Exhibit
99.1) and November 14, 2003, its Form 8-Ks; and its other periodic filings.
M.V.I. Adult(TM) is a trademark, and M.V.I.(R) is a registered trademark,
of aaiPharma LLC
SOURCE aaiPharma Inc.
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Related links:
http://www.aaipharma.com
CONTACT:
Media, Andrea L. Johnston, Vice President,
Corporate Communications, +1-910-254-7340, or Investors, James B.
Sloan, Jr., Senior Vice President, Corporate Finance,
+1-910-254-7690, both of aaiPharma Inc.
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