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Exhibit 99.1
APPLIED ANALYTICAL INDUSTRIES PRESENTS DRUG DEVELOPMENT UPDATE AT GOLDMAN SACHS
21st ANNUAL PHARMACEUTICALS CONFERENCE
WILMINGTON, NC, JUNE 14, 2000 - Applied Analytical Industries, Inc. (NASDAQ:
AAII), an international provider of specialty pharmaceutical products and
services to pharmaceutical, biotechnology and medical device clients, presented
at the Goldman Sachs 21st Annual Healthcare Conference held in Laguna Nigel,
California.
Fred Sancilio, Ph.D., the Company's Chief Executive Officer, discussed the
opportunities in the drug development market and the Company's key growth
strategies. Throughout the presentation, Dr. Sancilio emphasized the Company's
increased focus on the development of complete drug products to supplement
fee-for-service revenue from the Company's wide range of research services used
by its customers to develop their products.
Dr. Sancilio highlighted the Company's extensive capabilities in product
development and its strong relationships with leading pharmaceutical companies.
In addition, Dr. Sancilio explained that the Company has made a significant
investment in a state-of-the art research and development infrastructure,
doubling the square footage of laboratory and production space, and now has over
400,000 square feet of prime product development facilities worldwide, which
include manufacturing facilities and laboratories regularly inspected by FDA and
MCA, and Level IV facilities for manufacturing high-toxicity active ingredients
into safe drug products. In addition, the Company employs over 600 scientists
and pharmaceutical specialists among its 1,100 personnel.
The Company currently has 6 drug products marketed by AAI partners, 4 more
products in review with the FDA, and more than 20 filings in development. So far
in 2000, it has received two U.S. FDA drug approvals (including one tentative
approval) for products to be marketed by its partners. The Company expects both
products to be launched later in 2000.
Dr. Sancilio presented additional approved or pending products in the
hyperthyroid and
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hypertensive areas, and its current pipeline for products that are at the FDA to
treat hypertension, Parkinson's disease, and cancer. In addition, Dr. Sancilio
discussed some early-stage projects, including AAI's formulations of ProSorb(R)
diclofenac for migraine and acute pain, which are both in Phase II trials
expected to be completed sometime in August, and two development projects
featuring AAI's ProCore(TM) technology--a formulation for an existing allergy
product and a generic controlled release formulation for an existing diabetes
product.
In addition, Dr. Sancilio announced for the first time that the Company has a
strategy in place to manufacture, sell and market a line of its own branded
products. The Company will continue its long-term strategy of providing niche
products that are non-competitive with its clients.
Dr. Sancilio commented, "We are transitioning from a 'pure' service company to a
product and service company. In addition to our recently approved formulations,
we have an extensive pipeline of early- and mid-stage projects in development,
targeted on selective, high margin yielding products." He continued, "Both our
current pipeline and early-stage products can take advantage of our extensive
patent portfolio of 14 patents and patents pending."
Dr. Sancilio also expanded upon the Company's technologies in the drug delivery
area, and discussed its drug delivery formulation capabilities. These include
AAI's Pro-Teen(TM) oral protein delivery technology for site release;
Pro-Taste(TM) technology, a patented formulation for taste masking (used, e.g.,
for Allegra(R) Pediatric); patented ProSorb(R) rapid and enhanced release system
for quick dissolution (used, e.g., for diclofenac); and ProCore(TM) technology,
a patented controlled release osmotic system for oral delayed release (used,
e.g., for allergy and hypertension drugs).
Dr. Sancilio concluded, "AAI is beginning to experience the anticipated benefits
of the important investments we have made in people, technology, research, and
service
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capabilities. We remain excited about our projects in development and the value
of our drug pipeline."
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 with its
pharmaceutical product development expertise. 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 statements made by Dr. Sancilio with respect to the
Company's expectations and goals pertaining to product launches,
AAI's product development pipeline, targeted therapeutic uses and
markets, niche marketing of non-conflicting products, product
profitability, and the anticipated benefits of the Company's
investments. 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 apply the Company's technologies to new products, the
Company's ability to successfully develop and focus direct selling
efforts in identified niche products while successfully partnering
with major pharmaceutical companies in other product areas,
successfully and timely complete product development projects in
its product pipeline and scale up the resulting products to
commercial production, enter into additional beneficial agreements
with respect to its products with pharmaceutical companies, and
obtain timely regulatory approvals of the Company's developed
products. 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 Report on Form 10Q filed with the SEC on May 15, 2000,
including the exhibits thereof, its Form 8-Ks and its other
periodic filings.
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