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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): June 29, 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)
181 University Avenue, Suite 1208
Toronto, Ontario M5H 3M7 CANADA
(Address of principal executive offices, including ZIP code)
(416) 363-5059
(Registrant's telephone number, including area code)
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Item 5. Other Events.
The Registrant reports that it has received notice from the United States
Food and Drug Administration (the "FDA") that the FDA has completed the review
of the Registrant's new drug application for the use of Levulan(R) photodynamic
therapy in the treatment of multiple actinic keratoses ("AK") of the face and
scalp. The notice states that the application is approvable. However, before the
FDA approves the Registrant's therapy for marketing, Registrant must submit and
receive approval of its labeling. In addition, and as previously reported by the
Registrant, the third-party manufacturer's facilities of the bulk supply of
5-aminolevulinic acid hydrochloride, the main ingredient in Levulan(R), must be
reinspected by the FDA (after the manufacturer completes required modifications)
and must be compliant with FDA's current Good Manufacturing Practices
regulations. The Registrant believes that the manufacturer is actively working
to resolve the deficiencies, however, the Registrant cannot determine precisely
when the modifications will be completed, when the FDA will schedule a
reinspection, or whether the FDA will be satisfied with the modifications.
Except for historical information, this report, including the exhibit,
contains certain forward-looking statements that involve known and unknown risks
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 Registrant's
beliefs concerning the status of the third-party manufacturer's activities to
bring its facilities into compliance with FDA's Good Manufacturing Practices
regulations and the timing of approval of such facilities which will effect the
timing of FDA's approval of the Registrant's product, its belief that its
product is safe and effective, and the importance of its product as an AK
therapy. These risks and uncertainties include, but are not limited to the
regulatory approval process, reliance on third-party manufacturers, competitive
products, and other risks and uncertainties stated in the Registrant's SEC
filings, from time to time, including its Form S-3 Registration Statement which
was declared effective on June 18, 1999 which incorporates this report by
reference.
ITEM 7. FINANCIAL STATEMENTS AND OTHER EXHIBITS.
(c) Exhibits
[99] Press Release dated June 29, 1999.
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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
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D. Geoffrey Shulman, MD, FRCPC
President and Chief Executive Officer
Dated: June 29, 1999
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DUSA Pharmaceuticals, Inc.
For Release at 8:00 a.m. June 29, 1999
DUSA PHARMACEUTICALS RECEIVES
FDA APPROVABLE LETTER
Toronto, Ontario June 29, 1999 - DUSA Pharmaceuticals, Inc. (NASDAQ NMS: DUSA)
reported today that it has received notice from the US Food and Drug
Administration (FDA) that FDA has completed the review of DUSA's New Drug
Application (NDA) for Levulan(R) Photodynamic Therapy in the treatment of
Multiple Actinic Keratoses of the face and scalp. The letter states that after a
complete review of DUSA's NDA, the NDA is approvable.
As DUSA expected, certain items must still be completed before final FDA
marketing approval can be granted, including agreement on wording of the
labeling and re-inspection by FDA of DUSA's drug manufacturer's facilities after
it completes modifications required to become GMP compliant. Those modifications
are in progress, and the manufacturer is actively working to resolve the
deficiencies.
Dr. Geoffrey Shulman, DUSA's President and CEO, stated "DUSA is delighted to
have received FDA "approvability" only 12 months after submitting its first NDA,
reinforcing DUSA's belief that Levulan(R) Photodynamic Therapy is a safe and
effective treatment for Multiple Actinic Keratoses. DUSA believes that as the
first standardized therapy for this common pre-cancerous skin condition, it can
become an important part of the AK therapeutic armamentarium, especially because
of its selective healing and excellent cosmetic results. I would also like to
acknowledge the tremendous effort by the DUSA team that led to this milestone
achievement for the Company."
DUSA Pharmaceuticals, Inc. is a development stage pharmaceutical 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 executive offices in
Toronto, Ontario, R&D administration in Valhalla, New York and manufacturing,
technology and operations offices in Wilmington, MA.
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 DUSA's belief that
its product is safe and effective, and the importance of its use as an AK
therapy. These risks and uncertainties include but are not limited to the
regulatory approval process, reliance on third-party manufacturers, competitive
products, and other risks and uncertainties stated in the Company's SEC filings,
from time to time.
For further information contact:
DUSA Pharmaceuticals, Inc. - Shari Lovell, Director, Shareholder Services
Tel: 416.363.5059 Fax 416.363.6602 or visit our web site at www.dusapharma.com
