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Exhibit 99.1
AAI and PDC Form Pharmaceutical Development Alliance
Agreement enhances drug development efforts
in biotechnology-based products
WILMINGTON, NORTH CAROLINA, JUNE 1, 2000 -- Applied Analytical Industries
(NASDAQ: AAII) has entered into a formal alliance with Pharmaceutical
Development Center (PDC), to provide sterile drug manufacturing services, in
support of AAI's expanding drug research, development, formulation and
manufacturing capabilities.
Fred Sancilio, Ph.D., CEO and chairman of AAI commented, "This relationship will
allow products developed in our state-of-the-art biotechnology laboratory to be
scaled-up to commercial size for eventual market introduction. This alliance
continues to position AAI as a specialty pharmaceutical company focused on
solving challenging scientific problems and enabling the company to capture more
of the upside opportunity in drug development through royalty sharing,
production charges or direct marketing of products in targeted niche therapeutic
areas. We are pleased to conclude this alliance in what already looks to be a
strong second quarter performance, substantially better than last year's
results."
"We are happy to be associated with AAI," said Terry W. Osborn, Ph.D., MBA,
president and chief executive officer of PDC. "We share a common goal to develop
drugs, rather than just providing pharmaceutical testing. Both PDC and AAI
believe that our sterile manufacturing facilities are an essential part of the
future of new drug development."
PDC is privately held and headquartered in Charleston, South Carolina. The
company, founded in 1979, provides an array of scientific products and services.
PDC will be providing AAI with sterile processing capabilities including
producing solutions for injection, lyophilization, and sterile powders.
Non-sterile processing capabilities being provided include the manufacturing of
solid dosage forms, liquids and semi-solids.
"Today, important new drugs are being developed through biotechnology," said
Bill Blank, executive vice president for sales & marketing for AAI. "These drugs
are generally in the form of large molecules. Currently, large molecule drugs
are most practically administered by injection, which requires sterile
manufacturing. We believe that PDC's sterile processing capabilities are an
excellent match with AAI's formulations, product licensing, and other drug
development activities."
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
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services. Its stock is listed on Nasdaq (AAII). For more information about AAI,
visit the company's website at www.aaiintl.com.
ABOUT PDC
PDC is built on two decades of client service and the highest level of academic
scholarship in research. The Pharmaceutical Development Center located in
Charleston, South Carolina has become a recognized leader in providing superior
development and consulting services for a wide variety of dosage forms. PDC's
new state of the art cGMP facility affords the highest quality levels for
development and manufacturing of all sterile and non-sterile dosage forms. PDC's
core competency is in the area of sterile processing including aseptic filling,
terminal sterilization and lyophilization. The company has extensive experience
with small molecules as well as proteins, peptides and polynucleic acids. PDC
also offers development and manufacturing services for tablets, capsules,
liquids, powders, topicals, semi-solids and DEA controlled substances. For more
information about PDC, please call Gerald J. Vardzel Vice President Business
Development at (843) 746-2508 or visit the company's website at www.pdclabs.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 by Dr. Sancilio
in the second paragraph of this press release. 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 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 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 10-Q filed with the
SEC on May 15, 2000, including the exhibits thereof, its Form 8-Ks and its other
periodic filings.
