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Exhibit 99.2
FOR IMMEDIATE RELEASE
NASDAQ: AAII
APPLIED ANALYTICAL INDUSTRIES RECAPS
ITS PRODUCT DEVELOPMENT PIPELINE IN
THIRD QUARTER CONFERENCE CALL
WILMINGTON, NC, NOVEMBER 7, 2000 - Applied Analytical Industries, Inc.
(NASDAQ: AAII), reported several advances in its pharmaceutical product
development pipeline during its November 1 conference call and corresponding
Webcast with analysts and investors discussing the Company's financial results
for the third quarter and nine months ended September 30, 2000, and in an
additional webcasted interview on November 3, 2000.
Dr. Fred Sancilio, Chairman and Chief Executive Officer, noted the
following developments in the Company's product pipeline in the conference call
and Webcasts:
o A third clinical trial is in the process of being completed in
the fourth quarter of 2000 testing the resilience of the
Company's once-a-day formulation of
fexofenadine/pseudo-ephedrine to food effects. The Company is
in negotiations with a multinational drug company for this
product and is seeking fair value for it, in light of its
positive clinical data during the development and negotiation
process to date. The Company believes that these negotiations
will reach a conclusion within the next three quarters.
o Late in the third quarter of 2000, the Company completed a
Phase II clinical trial for its ProSorb-D(TM) pain management
product. In these studies, AAI's ProSorb-D(TM) statistically
outperformed both placebo and Novartis's Cataflam(R) product
in time to onset of relief from pain, with onset of pain
relief occurring one-third faster than Cataflam(R).
ProSorb-D(TM) also substantially outperformed both placebo and
Cataflam(R) in duration of relief of pain associated with the
trauma. The Company plans to meet with FDA and European
regulatory agencies and finalize the design of trials for this
product for worldwide introduction.
o AAI is not presently seeking a partner for its ProSorb-D(TM)
pain management product, but rather will wait for further
value maximization before deciding how to commercialize the
product. The Company may decide to license this product
outside the United States while performing Phase III clinical
trials prior to seeking regulatory approval to sell the
product in the United States.
o Progress continues in clinical and nonclinical research in
certain targeted areas of interest to the Company's client
base. The Company is nearing completion of a glipizide core
using osmotic applications and with combinations of glipizide,
to improve patient compliance in the treatment of diabetes.
The Company is also evaluating use of the
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osmotic pseudoephedrine 24-hour core in combination with
products other than with fexofenadine.
o In immunosuppression, the Company is in late stage development
of products to better treat rheumatoid arthritis and kidney
rejection and is in preclinical development of specific dosage
forms to treat lupus. The Company is also beginning early
stage development using a metabolite of azathioprine to treat
other immunosuppressive disorders such as inflammatory bowel
disease (IBD) and Crohn's disease. AAI is beginning to
leverage this work into new regulatory approvals for such
immunosuppression products and establishing proprietary
intellectual property positions through unique dosage forms
and delivery systems.
o The Company is planning to introduce direct sales of its
branded azathioprine product in the first quarter of 2001 and
to conduct investigations of new uses for this drug. The
Company believes that sales of this drug will grow at a
moderate rate during 2001.
o The Company has continued to make significant progress in its
"proton pump inhibitor" research projects. AAI has filed
several additional U.S. and international patents around
proton pump inhibitors that should publish early in 2001 and
could issue within the next two years.
Dr. Sancilio further noted the Company's plan by year-end to have
completed the segmentation of AAI's businesses into distinct fee-for-service,
product development and direct pharmaceutical sales businesses.
About AAI
AAI is a specialty pharmaceutical and product development company with
comprehensive drug development capabilities in the United States, Europe and
Asia. Since 1979, AAI has partnered with pharmaceutical companies on both a
fee-for-service and royalty and milestone payment basis, providing the expertise
and knowledge to create quality health care products. The Company has earned a
reputation for solving complex pharmaceutical challenges utilizing analytical
testing and formulations development techniques, as well as validation and
regulatory affairs support services. Its stock is listed on Nasdaq (AAII). For
more information about AAI, visit the Company's website at www.aaiintl.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 in this
press release pertaining to potential outcomes and commercial implications with
respect to clinical trials; negotiations to out-license products under
development and the related timeframes and geographic areas; plans to meet with
regulatory agencies to seek product approvals; work on, and potential sales or
out-licensing of, new potential products and the timing thereof; potential
issuance of patents and related timing; the Company's revenues and growth
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rates; products in the Company's development and regulatory approval pipelines
and the status thereof, including products for the treatment of lupus, IBD,
rheumatoid arthritis, kidney rejection and Crohn's disease; and the Company's
future goals. These statements 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 successfully enhance its
ability to provide strategic product development solutions to its clients while
developing and profitably selling its own products, in each case with timely
regulatory approvals; apply its technologies to develop and commercialize new
and improved products which receive timely regulatory approvals and are
commercially successful; and to scientific, competitive and other developments
and factors in the Company's chosen fields of direct pharmaceutical sales,
pharmaceutical product development and out-licensing, and fee-for-service drug
development research. Additional factors that may cause the actual results to
differ materially are discussed in the Company's recent filings with the
Securities and Exchange Commission, including, but not limited to, its
registration statement, as amended, its Annual Report on Form 10-K filed with
the SEC on March 30, 2000, its Quarterly Reports on Form 10-Q filed with the SEC
on May 15, 2000 and August 14, 2000, including the exhibits thereof, its Form
8-Ks and its other periodic filings.
