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DUSA PHARMACEUTICALS, INC.
FOR RELEASE AT 8:30 AM SEPTEMBER 20, 2000
DUSA PHARMACEUTICALS REPORTS
RECEIPT OF FDA "APPROVABLE" LETTER
RE: COMMERCIAL BLU-U(TM) DEVICE SUPPLEMENT
WILMINGTON, MA, SEPTEMBER 20, 2000 - DUSA Pharmaceuticals, Inc. (NASDAQ NMS:
DUSA) reports that it has received an "approvable" letter from the FDA for the
commercial version of its BLU-U(TM) brand light source. The Company is now
awaiting receipt of the final FDA approval letter, which is expected at any
time.
The "approvable" letter states that final approval is dependent only upon the
FDA finding that DUSA's facilities, and those of its' BLU-U(TM) manufacturer,
meet all current Good Manufacturing Practices. As previously announced, the FDA
completed its inspections of these facilities in August, and reported no
deficiencies to DUSA.
Dr. Geoffrey Shulman, DUSA's President and CEO, stated "DUSA has been in regular
communication with the FDA, and we are pleased to have received the approvable
letter. Once the inspection process was successfully completed, as previously
announced, DUSA believed it had no further conditions to meet prior to FDA
approval. The approvable letter confirms this. We can now look forward to
receiving the final approval, and commercial availability, of the LEVULAN(R)
Photodynamic Therapy System for non-hyperkeratotic actinic keratoses (AKs) of
the face or scalp, at any time."
DUSA Pharmaceuticals, Inc. is a biopharmaceutical company engaged primarily in
the development of LEVULAN(R) Photodynamic Therapy (PDT) and Photodetection (PD)
for multiple medical indications. PDT and PD utilize light-activated compounds
such as LEVULAN(R) to induce a therapeutic or detection effect. DUSA is a world
leader in topically or locally applied PDT and PD. The Company is incorporated
in New Jersey, with offices in Wilmington, MA, Valhalla, NY, and Toronto,
Ontario.
Except for historical information, this news release contains certain
forward-looking statements that involve known and unknown risk and
uncertainties, which may cause actual results to differ materially from any
future results, performance or achievements expressed or implied by the
statements made. These forward-looking statements relate to the timing of the
approval by the FDA of the PMA Supplement, timing of the introduction of the
LEVULAN(R) PDT System and commencement of sales. Such risks and uncertainties
include, but are not limited to, final regulatory approval of the commercial
version of the BLU-U(TM), dependence upon third-party manufacturers of the
KERASTICK(R) and the BLU-U(TM), the timing of the launch of the LEVULAN(R) PDT
System and ability to develop a market for the products, and other risks
identified in DUSA's SEC filings from time to time.
For further information contact: D. GEOFFREY SHULMAN, MD, President & CEO or
SHARI LOVELL, Director, Shareholder Services Tel: 416.363.5059 Fax 416.363.6602
or visit www.dusapharma.com
