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FORM 8-K
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 27, 2000
DUSA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
NEW JERSEY 0-19777 22-3103129
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(State or other (IRS Employer
jurisdiction of (Commission Identification
incorporation) File Number) Number)
25 UPTON DRIVE
WILMINGTON, MASSACHUSETTS 01887
(Address of principal executive offices, including ZIP code)
(978) 657-7500
(Registrant's telephone number, including area code)
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ITEM 5. OTHER EVENTS.
The Registrant, DUSA Pharmaceuticals, Inc., ("DUSA") reports that the U.S.
Food and Drug Administration ("FDA") has granted approval of the commercial
version of DUSA's light device, the BLU-U(TM) brand Blue Light Photodynamic
Therapy Illuminator. The BLU-U(TM) is used exclusively in the LEVULAN(R)
photodynamic therapy ("PDT") system for the treatment of non-hyperkeratotic
actinic keratoses ("AKs") of the face or scalp. The LEVULAN(R) PDT System
includes the BLU-U(TM) and the KERASTICK(R), the drug delivery component of the
system. The active ingredient in the LEVULAN(R) PDT System is aminolevulinic
acid ("ALA"). The KERASTICK(R) utilizes a special applicator tip to ensure a
proper dosage of ALA to each skin lesion. Following the application of ALA by
LEVULAN(R) KERASTICK(R), the area is exposed to the BLU-U(TM) Illuminator.
Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, wiLL distribute
the LEVULAN(R)PDT System.
Except for historical information, this report and the exhibit contain
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(R) 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(R) KERASTICK(R) and BLU-U(TM) and other risks identified in DUSA's SEC
filings from time to time.
ITEM 7. FINANCIAL STATEMENTS AND OTHER EXHIBITS.
(c) Exhibits.
[99] Press Release dated September 27, 2000.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
DUSA PHARMACEUTICALS, INC.
Dated: September 27, 2000 By: /s/ D. Geoffrey Shulman
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D. Geoffrey Shulman, MD, FRCPC
President, Chief Executive
Officer, and Chief Financial
Officer
