WILMINGTON, N.C., Jan. 15 /PRNewswire-FirstCall/ -- aaiPharma Inc.,
(Nasdaq: AAII) today confirmed Aventis' submission of a new drug application
(NDA) to the FDA for Aventis' Allegra-D 24 hour tablets (fexofenadine HCl 180
mg/pseudoephedrine HCl 240 mg), a formulation developed with aaiPharma using a
patented extended release drug delivery technology, ProSlo II(TM), developed
by Osmotica. Aventis is seeking approval for a once-daily formulation for the
treatment of seasonal allergy symptoms with nasal congestion in adults and
children 12 years of age and older. Aventis currently markets twice-daily
Allegra-D (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg) extended release
tablets.
The once-daily technology platform used in the Allegra-D NDA submission
was developed by aaiPharma's collaborative partner, Osmotica. aaiPharma and
Osmotica collaborate around the use of patented osmotic technology for drug
development.
"The submission of an NDA for a product as important as Allegra-D using
aaiPharma development expertise reinforces our unique drug development
capabilities," said Dr. Vijay Aggarwal, President, Research and Development
for aaiPharma. "The submission also confirms aaiPharma's strategy to utilize
our significant development capabilities to benefit not only our own
pharmaceutical pipeline, but also the product development needs of our
pharmaceutical partners."
About Allegra-D
Side effects with Allegra-D (fexofenadine HCl 60 mg/pseudoephedrine HCl
120 mg) extended release tablets were similar to Allegra alone and may include
headache, insomnia, and nausea. Due to the decongestant (pseudoephedrine)
component in Allegra-D, this product must not be used if you: are taking an
MAO inhibitor (a medication for depression) or have stopped taking an MAO
inhibitor within 14 days; retain urine; have narrow-angle glaucoma; have
severe high blood pressure or severe heart disease.
You should also tell your doctor if you have high blood pressure,
diabetes, heart disease, glaucoma, thyroid disease, impaired kidney function,
or symptoms of an enlarged prostate such as difficulty urinating.
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 and a proven sales and
marketing track record, 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 .
About Osmotica
Osmotica is a pharmaceutical research and development company, with more
than 15 years of leadership experience in the area of controlled release
formulations with operations in both North and South America. Osmotica
currently provides to its marketing partners, for registration or sale, more
than five different products in 15 countries around the world. Osmotica
offers innovative osmotic tablet technology to the international
pharmaceutical industry for the improvement of product profiles and extension
of their life cycle. For more information about Osmotica, please visit our
website at http://www.osmoticausa.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 statements by Dr. Aggarwal. 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 use its development capabilities to timely and
successfully develop, improve, obtain timely regulatory approval for, and
profitably sell pharmaceutical products and services. 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.
SOURCE aaiPharma Inc.
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Related links:
http://www.aaipharma.com
http://www.osmoticausa.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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