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FOR RELEASE AT 8:30 AM
CONTACT:
PATRICIA GABRIEL RICHARD SALEM GEOFFREY SHULMAN/SHARI LOVELL
RUDER FINN BERLEX LABORATORIES DUSA PHARMACEUTICALS, INC.
(212) 593-6369 (973) 276-2371 (416) 363-5059
NOVEL THERAPY RECEIVES FDA APPROVAL FOR TREATMENT OF COMMON SKIN LESIONS
FIRST TOPICAL PHOTODYNAMIC THERAPY TO REMOVE ACTINIC KERATOSES
MONTVILLE, NJ AND WILMINGTON, MA (SEPTEMBER 27, 2000) -- Berlex Laboratories,
Inc. and DUSA Pharmaceuticals, Inc. (NASDAQ NMS:DUSA) announced today that the
U.S. Food and Drug Administration (FDA) has granted approval of the commercial
BLU-U(TM) Blue Light Photodynamic Therapy Illuminator, used exclusively in the
LEVULAN(R) Photodynamic Therapy (PDT) System for treatment of
non-hyperkeratotic actinic keratoses (AKs) of the face or scalp. The LEVULAN
PDT System is the first to utilize light activated drugs to treat these common
skin lesions. Distribution of the LEVULAN PDT System will begin immediately.
The active ingredient in the LEVULAN PDT System is aminolevulinic acid (ALA).
This new photodynamic therapy system for treating AKs is the first to deliver
ALA topically; the solution is applied directly to the lesion, followed by
exposure to the BLU-U.
Approximately 40 percent of squamous cell carcinomas, the second leading cause
of skin cancer deaths in the United States, begin as actinic keratoses. Actinic
keratoses are the third most frequent reason for visiting a dermatologist. AKs
appear on the skin as rough, scaly, discolored patches and are most often seen
on the face and scalp.
"Actinic keratoses can develop into skin cancer and should be treated," says Dr.
J. Richard Taylor, Chief of Dermatology at Miami VA Medical Center.
"Photodynamic therapy combining visible blue light with a topical solution is a
major innovation in treating this potentially serious condition."
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Three major medical groups -- the American Cancer Society, the Skin Cancer
Foundation, and the American Academy of Dermatology -- recommend that people
with AKs seek treatment for them immediately.
The LEVULAN PDT System combines the application of a topical solution
(aminolevulinic acid HCl) with the BLU-U(TM) Photodynamic Therapy Illuminator to
target and destroy AKs while leaving healthy skin unharmed. A typical candidate
for this type of photodynamic therapy is a patient at least 40 years old, fair
skinned, with more than seven lesions.
A physician applies the topical solution to the affected area using the LEVULAN
KERASTICK (aminolevulinic acid HCl) for Topical Solution, 20%. The special
applicator tip on the KERASTICK ensures that the proper dosage is precisely
applied to each AK. The patient returns to the physician's office 14 to 18 hours
later and, while wearing special protective goggles, exposes the affected area
to the BLU-U Photodynamic Therapy Illuminator, a non-laser fluorescent light
source. When the solution reacts to this visible blue light, the lesion is
destroyed.
In clinical trials, the LEVULAN PDT System achieved complete clearing of all AK
lesions with one treatment in more than 70 percent of patients at 12 weeks. A
second treatment, if necessary, was done at 8 weeks. With one or two treatments,
88 percent of patients had 75 percent or more of their AK lesions cleared.
Following completion of therapy, 84 percent of patients said that they would use
LEVULAN KERASTICK again if they had more AKs in the future. Ninety-four percent
of patients rated the way their appearance responded to treatment as excellent
or good.
"One of the greatest benefits to using the LEVULAN PDT System is that it causes
few side effects and minimizes disruption of daily activities," says
Dr. Taylor. "This is particularly important to patients, many of whom have
experienced painful redness and scarring from other topical or surgical
treatments."
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Transient local symptoms of stinging and/or burning, itching, erythema, and
edema may occur during treatment with the LEVULAN PDT System. However, during
clinical trials, fewer than 3 percent of patients discontinued light treatment
due to stinging and/or burning.
Committed to developing novel therapeutics that address unmet medical needs,
Berlex Laboratories, Inc. researches, develops, manufactures, and markets
ethical pharmaceuticals in four strategic areas: Dermatology, Female Healthcare,
Diagnostic Imaging, and Therapeutics for life-threatening and disabling
diseases. The company has entered into collaborative R&D and marketing
agreements in all of its strategic business areas and will continue to pursue
additional cooperative ventures. Berlex Laboratories obtained exclusive
worldwide marketing and distribution rights (excluding Canada) for the LEVULAN
PDT System for dermatology indications from DUSA Pharmaceuticals, Inc. Berlex
Laboratories, Inc. has business divisions in Montville and Wayne, NJ and in
Richmond, CA. For more information about Berlex and its products, you may visit
our website at www.berlex.com.
DUSA Pharmaceuticals, Inc. is a biopharmaceutical company engaged primarily in
the development of LEVULAN Photodynamic Therapy (PDT) and Photodetection (PD)
for multiple medical indications. PDT and PD utilize light-activated compounds
such as LEVULAN to induce a therapeutic or detection effect. DUSA is a world
leader in topically or locally applied PDT and PD. LEVULAN and KERASTICK are
registered trademarks of DUSA Pharmaceuticals, Inc. 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
DISTRIBUTION AND THE AVAILABILITY OF THE PRODUCTS, THE BELIEF THAT ACTINIC
KERATOSES SHOULD BE TREATED, THE BELIEF THAT THE LEVULAN PDT SYSTEM IS A MAJOR
INNOVATION, AND EXPECTATIONS RELATING TO SIDE EFFECTS DURING AND FOLLOWING
TREATMENT. SUCH RISKS AND UNCERTAINTIES INCLUDE, BUT ARE NOT LIMITED TO, THE
DEGREE OF MARKET PENETRATION, RELIANCE ON THIRD PARTIES TO MANUFACTURE THE
LEVULAN KERASTICK AND BLU-U AND OTHER RISKS IDENTIFIED IN DUSA'S SEC FILINGS
FROM TIME TO TIME.
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