FORM 8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
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 6, 2008
DUSA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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New Jersey
(State or other
jurisdiction of
incorporation)
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0-19777
(Commission File
Number)
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22-3103129
(IRS Employer
Identification
Number) |
25 Upton Drive
Wilmington, Massachusetts 01887
(Address of principal executive offices, including ZIP code)
(978) 657-7500
(Registrants telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Securities Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
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On March 6, 2008, DUSA Pharmaceuticals, Inc. (DUSA) issued a press release, attached to and
made part of this report, announcing that it received notice on March 5, 2008 that Stiefel
Laboratories, Inc. (Stiefel), DUSAs marketing partner for Latin America, has now received final
pricing approval for Levulan® (aminolevulinic acid HCl) Kerastick® for
Photodynamic Therapy (PDT) for the treatment of actinic keratoses (AKs) in Brazil by the Regulatory
Chamber of Medicines (Câmara de Regulação do Mercado de Medicamentos) (CMED). The market launch of
Levulan PDT in Brazil is expected to follow shortly. Stiefel previously received regulatory
approval for Levulan Kerastick from ANVISA (Agencia Nacional de Vigilancia Sanitaria) in 2006.
Except for historical information, this report, including the 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 the
launch of the product, working with Stiefel to open new Latin American markets, and beliefs
regarding sales and profits. Furthermore, the factors that may cause differing results include
reliance on third parties, the uncertainties of the regulatory approval process, market acceptance
of our product, reliance on third party manufacturers, and other risks identified in DUSAs SEC
filings from time to time.
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Item 9.01 |
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Financial Statement and Exhibits. |
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Item No. |
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Description |
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99.1
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Press Release, dated March 6, 2008 |
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.
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DUSA PHARMACEUTICALS, INC.
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Dated: March 6, 2008 |
By: |
/s/Robert F. Doman
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Robert F. Doman, President and |
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Chief Executive Officer |
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EXHIBIT INDEX
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Item No. |
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Description |
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99.1
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Press Release, dated March 6, 2008 |