Company Increases Financial Guidance
WILMINGTON, N.C., Feb. 20 /PRNewswire-FirstCall/ --
aaiPharma Inc. (Nasdaq: AAII), a science-based specialty pharmaceutical
company, today announced that the U.S. Food and Drug Administration (FDA) has
granted marketing approval for Calcitriol Injection, a liquid, injectable
vitamin D product, and the first line extension to its family of critical care
nutrition products. With this approval, the FDA has also granted shared
market exclusivity to aaiPharma, and the Company expects to launch its
Calcitriol Injection vial within the next 45 days.
"This approval is another prime example of aaiPharma delivering on its
strategy to acquire, improve and market well-known medicines," said Dr. Philip
Tabbiner, President and Chief Executive Officer of aaiPharma. "The
convenience of a vial is an important innovation in vitamin D injectable
nutrition, and we expect that this unique attribute will be a benefit for
health care professionals administering Calcitriol therapy."
This Calcitriol product will join M.V.I.-12(R), M.V.I.-Pediatric(TM),
Aquasol A(R), Aquasol E(R), Brethine(R) and Azasan(TM) as the newest product
in the Company's critical care product line. The product is used primarily to
treat chronic kidney dialysis patients with abnormally low levels of calcium
in the circulating blood. According to 2002 IMS data, annual sales for
similar injectable vitamin D nutritional products are in excess of
$300 million. Unlike other Calcitriol products, which are packaged as
ampoules, aaiPharma's product is the only Calcitriol product with final
approval for marketing in vial form, which may lead to greater ease of use in
the hospital setting.
aaiPharma is increasing its full-year 2003 revenue guidance, to between
$280 million and $290 million from between $275 million and $280 million.
Also, the Company is raising its full-year 2003 earnings per diluted share
guidance to between $1.66 and $1.75 from between $1.58 and $1.65. Following
the previously announced three for two stock split, the estimated full-year
2003 earnings per diluted share are expected to be between $1.11 and $1.17.
The record date for the split was February 19, 2003, with a distribution date
of March 10, 2003.
About Calcitriol
Calcitriol Injection is indicated in the management of hypocalcemia
(abnormally low levels of calcium in the circulating blood) in patients
undergoing chronic renal dialysis (artificial kidney function). It has also
been shown to significantly reduce elevated parathyroid hormone (PTH) levels.
Reduction of PTH levels has been shown to result in an improvement in
defective renal bone formation.
Since Calcitriol is the most potent metabolite of vitamin D available,
vitamin D and its derivatives should be withheld during treatment. Overdosage
of any form of vitamin D may be dangerous.
About aaiPharma
aaiPharma Inc. is a science-based, specialty pharmaceutical company with
more than 23 years of drug development experience. Focusing on targeted
therapeutic areas, the Company markets a growing portfolio of established
branded products and applies innovative technologies to increase the
commercial potential of these products. At the same time, aaiPharma's
research and development organization is developing an impressive pipeline of
products to position the Company for near-term and long-term growth in its
targeted therapeutic areas. In addition to developing and marketing its own
line of proprietary pharmaceutical products, aaiPharma continues to be a world
leader in providing contract pharmaceutical development services through its
AAI International division. For more information on the Company, please visit
the 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
statements pertaining to the Company's expectations as to the timing of our
product launch of calcitriol, our earnings and revenue guidance for the full
year of 2003, market and medical reaction to calcitriol in vials instead of
ampoules, and future development, 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 to the Company's ability to timely and successfully
meet manufacturing and launch plans with respect to calcitriol on an accretive
basis, and aaiPharma's ability to successfully find, acquire, finance,
develop, improve, enhance, obtain timely regulatory approval for, maximize the
value of, extend product life cycles of, conduct successful research on, renew
marketing of, and sell, on a commercially profitable basis, pharmaceutical
products, including calcitriol, without adversely affecting its client
relationships or business opportunities and without future litigation or
resulting damages or injunctive relief; 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 11, 2002, including its exhibits;
its Form 10-Q filed on August 14, 2002, including Exhibit 99.1 thereto; its
Form 10-Q filed on November 14, 2002; its Form 8-Ks; and its other periodic
filings.
SOURCE aaiPharma Inc.
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Related links:
http://www.aaipharma.com
CONTACT:
media, Andrea L. Johnston, Vice President of
Corporate Communications, +1-910-254-7340, or investors, James B.
Sloan, Jr., Senior Vice President of Corporate Finance,
+1-910-254-7690, both of aaiPharma Inc.
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