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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): August 5, 2010
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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001-31533
(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
(Registrant’s 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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DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA), a dermatology company developing and
marketing Levulan® Photodynamic Therapy (PDT), today announced that on the afternoon of
August 5, 2010, the U.S. Food and Drug Administration (FDA) notified DUSA that it has not granted
DUSA’s request for Orphan Drug Designation for the use of
Levulan PDT for the prevention of
cutaneous squamous cell carcinomas (SCCs) in patients who have a proven history of multiple
localized cutaneous SCCs over a 12 month period. The FDA acknowledged that
cutaneous SCC is a serious problem in
patients at high risk for developing SCCs, such as solid organ transplant recipients (SOTRs), and
that aminolevulinic acid would be a potential preventative therapy in these patients. However, the
FDA also stated that they believe there are other factors which place patients at high risk of
developing SCCs that should be included in determining the target population. As a result, DUSA
plans to close out its SOTR pilot clinical trial program for this indication.
Except for historical information, this report contains certain forward-looking statements that
represent our current expectations and beliefs concerning future events, and involve certain known
and unknown risk and uncertainties. These forward-looking statements relate to DUSA’s plan to
close out its SOTR pilot clinical trial program. These forward-looking
statements are further qualified by important factors that could cause actual results to differ
materially from future results, performance or achievements expressed or implied by those in the
forward-looking statements made in this release. These factors include, without limitation,
actions by regulatory authorities, the status of our patent portfolio, action of third parties, the
impact of competitive products, and other risks and uncertainties identified in DUSA’s Form 10-K
for the year ended December 31, 2009 and other 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 August 6, 2010 |
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: August 6, 2010 |
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 August 6, 2010 |