WILMINGTON, N.C., May 22 /PRNewswire-FirstCall/ --
aaiPharma Inc. (Nasdaq: AAII) announced today that the Company has filed a
"Supplement - Changes Being Effected in 30 days" (CBE-30) filing with the U.S.
Food and Drug Administration (FDA) for Darvon(R) Compound (propoxyphene
hydrochloride, aspirin and caffeine), the first of two line extensions
aaiPharma is planning to launch to the Darvon(R)/Darvocet-N(R) brand family of
pain products in 2003. This type of filing is associated with a 30-day
response from the FDA.
Upon approval, Darvon(R) Compound will offer a lower dose (i.e., 32 mg of
propoxyphene) alternative to Darvon(R) Compound 65 (i.e., 65 mg of
propoxyphene), providing physicians with increased titration flexibility to
aid in the management of headache pain. This product will expand aaiPharma's
current portfolio of exclusive and semi-exclusive Darvon(R) branded products.
Darvon(R) Compound, coupled with the second new line extension planned for
later this year, will help pave the way for the significant, exclusive line
extensions planned for 2004.
"We are very pleased to announce our filing of the first of the Darvon(R)
line extensions we committed to developing when we acquired these products
last year," commented Dr. Philip Tabbiner, President and CEO of aaiPharma.
"Darvon(R) Compound will not only be the first addition to the pain management
options offered by the Darvon(R) brand family, but will, upon FDA approval,
mark the first Darvon(R) product to be manufactured exclusively by aaiPharma."
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 and
attractiveness of the newly-filed product, the expected timeline for FDA
response, and the future development, regulatory approval, commercialization
and growth of products in the Company's pipeline and its product portfolio
(including Darvon(R) Compound and other Darvon(R) and Darvocet-N(R) products
and line extensions). 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 Darvon(R)
Compound). 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 Exhibit 99.1 and other exhibits;
its Form 10-Q filed on May 15, 2003, its Form 8-Ks; and its other periodic
filings.
Darvon(R) and Darvocet-N(R) are registered trademarks owned by aaiPharma
Inc.
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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