WILMINGTON, N.C., Sept. 11 /PRNewswire-FirstCall/ -- aaiPharma Inc.
(Nasdaq: AAII) announced that it received confirmation today of U.S. Food and
Drug Administration (FDA) approval of Darvocet A500(TM) (propoxyphene
napsylate and acetaminophen) for the treatment of mild to moderate pain.
Darvocet A500(TM) is the only propoxyphene napsylate/acetaminophen combination
product currently FDA approved that contains a lower (500 mg) dose of
acetaminophen combined with 100 mg of propoxyphene napsylate, the same dose of
propoxyphene napsylate found in Darvocet-N(R) 100. This new product will
provide patients a unique Darvocet(TM) formulation with the safety benefits of
less acetaminophen and the full power of propoxyphene.
"Darvocet A500(TM) will provide an important alternative for health care
providers concerned about high acetaminophen intake in patients suffering from
mild-to-moderate pain," commented Dr. Philip S. Tabbiner, President and CEO of
aaiPharma. "Because the FDA has established a 4,000 mg maximum daily dose of
acetaminophen for adults and physicians are concerned about patients who self
medicate using over-the-counter products, we believe there is a significant
market opportunity for this dose combination which contains less acetaminophen
while retaining the full power of propoxyphene napsylate. This product is a
clear illustration of our strategy to bring to market line extensions that
make established products safer for patients and patient management easier for
physicians."
As previously announced, aaiPharma acquired the product from Athlon
Pharmaceuticals. The Company is preparing for an immediate launch to the
trade followed by a national launch of Darvocet A500(TM) in October.
Darvocet A500(TM) contains 100 mg of propoxyphene napsylate and 500 mg of
acetaminophen compared to the Darvocet-N(R) 100 presentation, which contains
100 mg of propoxyphene and 650 mg of acetaminophen. The Darvocet-N(R) 100
presentation, branded and generic, currently accounts for 95% of the more than
$500 million total propoxyphene market, according to Verispan data.
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, critical care and
gastroenterology. 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 Development Services. 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, and
the market opportunity for, the approved Darvocet A500(TM) product, the
uniqueness of the product and its dose combination, the future use of
aaiPharma's sales force to promote the 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. 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 timely and successfully develop, improve,
obtain timely regulatory approval for, and profitably sell pharmaceutical
products (including Darvocet-A500(TM)); to obtain, use, enforce, defend and
license valid and commercially valuable patents; to obtain and enforce
existing and future contracts with major pharmaceutical companies for
significant royalties and other consideration; 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 Exhibit 99.1
and other exhibits; its Forms 10-Q filed on May 15, 2003 and August 14, 2003,
its Form 8-Ks; and its other periodic filings.
Darvocet(TM) is a trademark and Darvocet-N(R) and Darvon(R) are registered
trademarks owned by aaiPharma Inc.
SOURCE aaiPharma Inc.
 back to top
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.
|
