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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): December 6, 1999
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.
On Monday, December 6, 1999, Registrant announced that it had received
approval from the United States Food and Drug Administration of the Levulan(R)
Kerastick(TM) for Topical Solution, 20% to be used in conjunction with its
BLU-U(TM) brand light device for treatment of actinic keratoses (AKs) of the
face or scalp.
The Registrant will be completing and submitting an amendment to its PMA
device approval shortly to cover the commercial version of the BLU-U(TM). During
the coming months, the Registrant will complete manufacturing scale-up of its
products and build inventory in preparation for product launch in the United
States by its dermatology strategic partner, Schering AG, and its US affiliate,
Berlex Laboratories, Inc. The Registrant has been advised that Schering is
planning a launch in the second quarter of 2000, assuming that the PMA amendment
has been approved.
Except for historical information, this report and the news release
attached as an 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 forwardlooking statements relate to the
Registrant's completion and submission of a PMA amendment, and timing of the
introduction of the Levulan(R) Kerastick(TM) and BLU-U(TM) system during the
second quarter of 2000, the belief that the system will become an important AK
therapy and the status of DUSA as a world leader in topical PDT and PD
therapies. Such risks and uncertainties include, but are not limited to final
approval of the commercial version of the BLU-U(TM) and the approval of the
Levulan(R) PDT system by other world-wide health regulatory authorities,
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.
ITEM 7. FINANCIAL STATEMENTS AND OTHER EXHIBITS.
(c) Exhibits
[99.1] Press Release dated December 6, 1999 regarding FDA Approval of
Levulan Kerastick(TM) for photodynamic treatment of actinic keratoses
of the face and scalp.
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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.
By: /s/ D. Geoffrey Shulman
------------------------------
D. Geoffrey Shulman, MD, FRCPC
President and Chief Executive Officer
Dated: December 6, 1999
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DUSA LOGO
INNOVATION IN PHOTODYNAMIC THERAPY
DUSA PHARMACEUTICALS, INC.
FOR IMMEDIATE RELEASE
DUSA RECEIVES FDA APPROVAL
OF LEVULAN(R) PDT FOR ACTINIC KERATOSES
WILMINGTON, MASSACHUSETTS, DECEMBER 6, 1999 -DUSA Pharmaceuticals, Inc. (NASDAQ
NMS: DUSA) announced today that its first products, the Levulan(R)
Kerastick(TM) and the BLU-U(TM) brand light source, have been approved for
use in the treatment of Actinic Keratoses (AKs) of the face and scalp.
AKs are common, precancerous skin lesions caused by chronic sun exposure. If
left untreated, AKs may develop into squamous cell cancers of the skin.
Dr. Geoffrey Shulman, DUSA's President and CEO, stated "DUSA is delighted to
have received FDA approval only 17 months after submitting its first NDA and
PMA, confirming that DUSA's Levulan(R) Photodynamic Therapy is a safe and
effective treatment for Actinic Keratoses of the face and scalp."
Dr. Shulman continued "DUSA's next steps include completion and filing of a PMA
amendment for the commercial version of its BLU-U(TM), completion of
manufacturing scale-up and inventory build-up to prepare for product launch.
DUSA recently announced a marketing and development agreement with its new
worldwide dermatology partner, Schering AG, and Schering's wholly-owned U.S.
affiliate, Berlex Laboratories, Inc. Berlex is gearing up for the planned
commercial launch in the United States during the second quarter of 2000. Both
DUSA and Schering are excited about introducing the Levulan(R) Kerastick(TM)
as an innovative new product for the treatment of this common, pre-cancerous
condition. DUSA believes that Levulan(R) PDT, as a standardized,
physician-administered therapy with selective healing and excellent cosmetic
results, can become an important part of the AK therapeutic armamentarium."
Levulan(R) PDT is a two step treatment. First, the Levulan(R) solution
is applied to the individual AKs using the Kerastick(TM) (aminolevulinic acid
HCl). Patients are then advised to protect themselves from sun exposure until
the next day, when the AKs are exposed to blue light using DUSA's BLU-U(TM)
brand Blue Light Photodynamic Therapy Illuminator.
During treatment with the BLU-U, patients experience a stinging or burning
reaction in the treated areas. In general, this reaction improves immediately
after treatment and ends within 24 hours. Reddening and swelling of the AK and
surrounding skin may also occur. This effect is temporary, generally improves
markedly by the end of the first week, and should completely resolve by 4 weeks
after treatment. Other side effects of the treatment may include scaling,
itching and skin color changes.
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Phase III clinical studies showed that 8 weeks after Levulan + BLU-U(TM)
treatment, approximately 80% of treated patients had 75% or more of their
treated AKs clear completely. About 65% of patients had complete clearing of
100% of their treated AK lesions. Patients who were not completely cleared at
week 8 were retreated at that time. The final assessment at week 12 showed that
90% of patients had 75% or more of their treated AKs completely cleared, and 72%
of patients had 100% of their treated AKs completely cleared.
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 lightactivated 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
forwardlooking 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 DUSA's next steps toward commercialization
and timing of the introduction of the Levulan(R) Kerastick(TM) and
BLU-U(TM) system during the second quarter of 2000, the belief that the
system will become an important AK therapy and the status of DUSA as a world
leader in topical PDT and PD therapies. Such risks and uncertainties include,
but are not limited to final approval of the commercial version of the
BLU-U(TM) and the approval of the Levulan(R) PDT system by other world-wide
health regulatory authorities, 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:
DUSA PHARMACEUTICALS, INC. -
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
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