WILMINGTON, N.C., June 25 /PRNewswire-FirstCall/ --
aaiPharma Inc. (Nasdaq: AAII) announced today it has filed a supplemental
new drug application (SNDA) for Brethine(R) Ampuls with the U.S. Food and Drug
Administration (FDA).
"With this SNDA, we are seeking approval for a new and safer vial
presentation of injectable Brethine(R) to replace the current ampul
presentation," stated Dr. Philip S. Tabbiner, President and CEO of aaiPharma.
"In addition, we are seeking certification of our sterile manufacturing
facility in Charleston, South Carolina, as an alternate production site for
the product."
Brethine(R) is indicated for the prevention and reversal of bronchospasm
in patients 12 years of age and older with asthma and reversible bronchospasm
associated with bronchitis and emphysema. The drug is currently supplied in
ampuls, each containing 1 mg of Brethine(R) per 1mL of solution for
subcutaneous injection.
Dr. Tabbiner added, "This filing is the direct result of development work
conducted in aaiPharma labs and underscores our commitment to improving
existing products to make them safer, more effective or convenient for health
care providers and their patients."
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 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 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 Brethine(R)). 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.
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.
Brethine(R) is a registered trademark 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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