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[DUSA LOGO]
INNOVATION IN PHOTODYNAMIC THERAPY
DUSA PHARMACEUTICALS, INC.
FOR IMMEDIATE RELEASE
DUSA PHARMACEUTICALS REVIEWS AND UPDATES
PROGRESS AT ANNUAL MEETING
WILMINGTON, MA. JUNE 15, 2000 - DUSA Pharmaceuticals, Inc. (NASDAQ NMS: DUSA)
held its Annual Meeting today at the Company's new Wilmington, Mass.
headquarters. Dr. Geoffrey Shulman, President and CEO, and the rest of the
management team, reviewed the accomplishments of the past year, and updated
shareholders on the outlook for the remainder of this year.
Dr. Shulman stated "1999 was a year of tremendous achievement for DUSA. In
December, following a multi-year clinical trial development program, the Company
received FDA approval for the Levulan(R) (aminolevulinic acid HCl, ALA)
Kerastick(TM) 20% topical solution Photodynamic Therapy (PDT). The treatment is
indicated for non-hyperkeratotic Actinic Keratoses (AKs) of the face and scalp.
The clinical trial version of the BLU-U(TM) brand light source was also
approved."
"The other key milestone for '99 was the signing in November of a worldwide
dermatology marketing, development and supply agreement with Schering AG of
Germany, to market Levulan(R) PDT for dermatology indications, and to jointly
develop additional indications. With Schering AG's strong commitment to
dermatology, and excellent worldwide marketing capabilities, DUSA feels that
Schering AG is an ideal dermatology partner. The financial terms reflected the
late stage of Levulan(R) PDT development, with DUSA due to receive a total of
$30 million in upfront and launch-related payments, a significant share of
ongoing revenues, and ongoing support for dermatology R&D. Subsequently, in
March 2000, the Company further solidified its financial position, completing a
private placement with net proceeds of over $40 million, leaving DUSA, at the
end of Q1 2000, with cash and US government securities totaling nearly $68
million."
"Also in March, DUSA filed a PMA Supplement with the FDA for the commercial
version of the BLU-U(TM), intended to demonstrate that the light delivery
characteristics of the commercial units are equivalent to the clinical trials
units. An inspection of DUSA's Wilmington facilities, where the BLU-U(TM) was
designed, is also expected as part of the review. Although initial indications
from the FDA led DUSA to expect that an approval could happen by sometime in
June, the inspection of our Wilmington facilities has still not occurred, so a
June approval now appears unlikely. However, we have recently been informed that
the Supplement should be reviewed shortly and that an inspection is being
scheduled. Commercial production of the Kerastick(TM) and the BLU-U(TM) has
begun, in order to build inventory while the PMA Supplement is under review."
Dr. Shulman continued "The achievements of recent months position DUSA for rapid
growth in 2 main areas. Firstly, Berlex Laboratories, Inc., Schering AG's
wholly-owned US affiliate, has assembled an excellent marketing team and direct
sales force for the product launch. As an innovative new treatment for this
common pre-cancerous skin disorder, with excellent healing and cosmetic results,
it has already generated considerable interest among dermatologists, and DUSA
management believes that it will become an important part of the AK therapeutic
armamentarium. Schering AG is also
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planning to file for approval in Europe, Latin America, Australia, and other
selected territories."
"Secondly, with DUSA's increased personnel and financial resources, the Company
has been preparing for a major expansion in its Levulan(R) PDT and
Photodetection (PD) development program. DUSA and Schering AG are jointly
developing Levulan(R) PDT for additional dermatology indications, with initial
efforts focused on 3 common skin disorders: acne, warts and onychomycosis (nail
fungus). For acne, Phase II blue and red light drug dose-ranging studies are
expected to begin during Q3 '00, while Phase I/II studies on warts and nail
fungus are expected to begin during Q4 '00. For each of these disorders,
anecdotal human clinical data from independent investigator reports suggests
significant improvement after ALA PDT.
"We believe that Levulan(R) PDT/PD also has great potential for a variety of
internal indications. DUSA has completed a Phase I/II study on hospital-based
bladder cancer photodetection, and is now working on a development plan to
optimize the procedure. Investigator studies in other DUSA-supported internal
indications that are expected to begin during the second half of the year
include Levulan(R) PDT for the prevention of restenosis after angioplasty, and
the treatment of pre-cancerous Barrett's esophagus. Other indications being
considered for future studies include the detection and/or treatment of CIN
(pre-cancer of the cervix), and as a guide to resection and/or treatment for
brain cancer. For all of these indications, there is also independent human data
suggesting efficacy after ALA PDT/PD."
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 timing of the
introduction of the Levulan(R) Kerastick(TM) and BLU-U(TM) system; expectations
regarding future payments including milestones, product revenue and research
support from Schering AG, the timing of the review by the FDA of the PMA
Supplement, expectations of the importance of DUSA's AK therapy; Schering AG's
plans in territories outside the U.S., expectations for commencement of new
clinical studies, and the product's potential for additional indications. Such
risks and uncertainties include, but are not limited to, final approval of the
commercial version of the BLU-U(TM), dependence upon third-party manufacturers
of the Kerastick(TM), the timing of the launch of Levulan(R) PDT 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
