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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): March 27, 2000
DUSA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
NEW JERSEY 0-19777 22-3103129
(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"), has reported that
it has filed with the U.S. Food and Drug Administration a PMA Supplement
relating to the commercial version of the BLU-U(TM) brand light device. This
supplement follows FDA approval of DUSA's Levulan(R) Kerastick(TM) 20% topical
solution with Photodynamic Therapy (PDT) for Actinic Keratoses (AKs) of the
face and scalp and the clinical trial version of the BLU-U(TM) in December,
1999. While DUSA believes that the modifications made to the device do not
affect its performance and FDA review should take approximately two to three
months, FDA regulations give the agency up to six months to review a supplement.
The agency also will inspect DUSA's Wilmington, Massachusetts facility before
giving its approval. The FDA also may choose to reinspect DUSA's third-party
manufacturer.
DUSA also announced the participation by Berlex Laboratories, the U.S.
affiliate of Schering AG, DUSA's dermatology marketing partner, at the American
Academy of Dermatology annual meeting on March 9-15, 2000.
Except for historical information, this report, including the exhibit
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 FDA's approval of
the commercial BLU-U(TM) system; expectations regarding the launch of the
products by Berlex and expectations regarding the use of the products by
dermatologists. Such risks and uncertainties include, but are not limited to the
regulatory approval process, dependence upon third-party manufacturers of the
Kerastick(TM), the timing of the launch by Berlex of Levulan(R) PDT, ability to
develop a market for the products, and other risks identified in DUSA's SEC
filings from time to time, including its recently filed Form S-3 registration
statement.
ITEM 7. FINANCIAL STATEMENTS AND OTHER EXHIBITS.
(c) Exhibits.
[99] Press Release dated March 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 thereunto duly authorized.
DUSA PHARMACEUTICALS, INC.
Dated: March 27, 2000 By: /s/ D. Geoffrey Shulman
--------------- ----------------------------------------
D. Geoffrey Shulman, MD, FRCPC
President, Chief Executive Officer,
and Chief Financial Officer
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[DUSA GRAPHIC]
INNOVATION IN PHOTODYNAMIC THERAPY
DUSA PHARMACEUTICALS, INC.
FOR IMMEDIATE RELEASE
DUSA REPORTS FILING OF
BLU-U(TM) PMA SUPPLEMENT
Wilmington, MA. March 27, 2000 - DUSA PHARMACEUTICALS, INC. (NASDAQ NMS: DUSA)
reports that on March 20 it filed a PMA Supplement with the FDA for the
commercial version of its BLU-U(TM) brand light source. This supplement follows
FDA approval of the Company's Levulan(R) Kerastick(TM) 20% topical solution
with Photodynamic Therapy (PDT) for Actinic Keratoses (AKs) of the face and
scalp and the clinical trial version of the BLU-U(TM) in December, 1999. While
we believe the modifications we are making to our device do not affect its
performance and FDA review should take approximately two to three months, FDA
regulations give the agency up to six months to review a supplement. The agency
also will inspect our Wilmington, Massachusetts facility before giving its
approval. The FDA also may choose to reinspect our third-party manufacturer.
DUSA's dermatology marketing partner, Schering AG, and its wholly-owned US
affiliate, Berlex Laboratories, will launch the Levulan(R) Kerastick and the
BLU-U(TM) in the US shortly after FDA approval of the PMA supplement. Launch is
currently planned for the second quarter of this year.
Berlex displayed the Levulan(R) Kerastick(TM) and its representatives were
present to describe Levulan(R) PDT at the recent American Academy of Dermatology
(AAD) annual meeting March 9-15 in San Francisco. The Berlex Dermatology
exhibitor's booth received very strong interest from dermatologists. Dr.Mark
Ling, one of DUSA's Phase lll investigators, also reviewed the therapy at an AAD
forum dedicated to PDT in dermatology, stating that, in his opinion, Levulan(R)
PDT could become an important part of the management of AKs by dermatologists.
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 FDA's approval of the commercial BLU-U(TM)
system; expectations regarding the launch of the products by Berlex and
expectations
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regarding the use of the products by dermatologists Such risks and uncertainties
include, but are not limited to the regulatory approval process, dependence upon
third-party manufacturers of the Kerastick(TM), the timing of the launch by
Berlex of Levulan(R) PDT, ability to develop a market for the products, and
other risks identified in DUSA's SEC filings from time to time, including its
recently filed Form S-3 registration statement.
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
