-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, F0bJMBctn9swREyhq4A0db+CVGD3AXZ5bYQdY/uIj262JLdWa2Zyu/bm2P9ZMgO3 8/4jZ6r2OTLvoYnYF1X+0Q== 0000950123-04-012360.txt : 20041022 0000950123-04-012360.hdr.sgml : 20041022 20041022142847 ACCESSION NUMBER: 0000950123-04-012360 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20041022 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041022 DATE AS OF CHANGE: 20041022 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DUSA PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000879993 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 223103129 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-31533 FILM NUMBER: 041091557 BUSINESS ADDRESS: STREET 1: 25 UPTON DRIVE CITY: WILMINGTON STATE: MA ZIP: 01887 BUSINESS PHONE: 9786577500 MAIL ADDRESS: STREET 1: 25 UPTON DRIVE CITY: WILMINGTON STATE: MA ZIP: 01887 FORMER COMPANY: FORMER CONFORMED NAME: DEPRENYL USA INC / NJ DATE OF NAME CHANGE: 19930328 8-K 1 y67847e8vk.txt FORM 8-K FORM 8-K UNITED STATES 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): October 22, 2004 DUSA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) NEW JERSEY 0-19777 22-3103129 (State or other (Commission (IRS Employer jurisdiction of File Number) Identification incorporation) 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): [ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [ ] Soliciting material pursuant to Rule 14a-12 under the Securities Act (17 CFR 240.14a-12) [ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14a-12(b)) [ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) ITEM 8.01. OTHER EVENTS. DUSA Pharmaceuticals, Inc. ("DUSA") issued a press release on October 22, 2004 attached to and made part of this report, reporting the initiation of a new multicenter Phase II clinical study using the Company's Levulan(R) Kerastick(R) and BLU-U(R) photodynamic therapy (PDT) for the treatment of moderate to severe acne vulgaris of the face. Except for historical information, this report 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 number of clinical trial sites, the protocol parameters including incubation times, number and time intervals of treatments, efficacy endpoints, and safety and tolerability assessments, the opportunity for a treatment alternative and other risks identified in DUSA's SEC filings from time to time. ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS. (c) Exhibits [99] Press Release dated October 22, 2004. 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. Dated: October 22, 2004 By: /s/ D. Geoffrey Shulman ------------------------------------- D. Geoffrey Shulman, MD, FRCPC President and Chief Executive Officer EXHIBIT INDEX
NO. DESCRIPTION - -------- ------------------------------------ 99 Press Release dated October 22, 2004
EX-99 2 y67847exv99.txt PRESS RELEASE EXHIBIT 99 (DUSA LOGO) INNOVATION IN PHOTODYNAMIC THERAPY DUSA PHARMACEUTICALS, INC.(R) FOR RELEASE AT 8:00 A.M. DUSA PHARMACEUTICALS INITIATES PHASE II LEVULAN(R) PDT CLINICAL TRIAL FOR ACNE WILMINGTON, MASSACHUSETTS OCTOBER 22, 2004. DUSA Pharmaceuticals, Inc. NASDAQ NMS: DUSA), reported today the initiation of a new multicenter Phase II clinical study using the Company's Levulan(R) Kerastick(R) (aminolevulinic acid HCL, ALA) and BLU-U(R) photodynamic therapy (PDT) for the treatment of moderate to severe acne vulgaris of the face. Independent investigator studies have reported that a single topical ALA PDT treatment can help to improve moderate and refractory acne vulgaris, and that several treatments resulted in significant improvement, by both reducing the bacteria at the site of lesions and by acting to reduce activity of sebaceous glands. However, some of the early studies used ALA applied under occlusion for several hours, which was associated with significant side effects such as pain during treatment, a strong inflammatory reaction, and hyperpigmentation. More recently, an independent investigator study used the Levulan(R) Kerastick(R) applied for 15 minutes over the face without occlusion, followed by light treatment with DUSA's BLU-U(R) for 6 minutes. Using this short drug incubation time, the investigator reported improvement in acne, but without pain, inflammation, or hyperpigmentation. (a) Based on information from these anecdotal and independent investigator studies, DUSA has decided to initiate a study examining the safety and efficacy of short contact Levulan(R) Kerastick(R) combined with the BLU-U(R) for the treatment of patients with moderate to severe facial acne vulgaris. The new study, with up to 80 patients, including a control group, will be carried out at 3 clinical trial sites in the United States. It will examine the effect of varying drug incubation times, followed by a standardized light dose using the BLU-U(R). There will be up to four Levulan(R) PDT treatments given at 2-week intervals. The primary efficacy parameters will be acne lesion count and acne severity score, assessed 8 weeks following the final Levulan(R) PDT treatment. Safety and tolerability will also be assessed throughout the study. Dr. Diane Berson, a renowned dermatologist at New York-Presbyterian-Weill Cornell Medical Center in New York, states "It has been a long time since we have seen a novel therapy for the treatment of acne vulgaris. A new and effective treatment would be welcomed by the medical community. I am excited to be a part of the clinical trials that will evaluate the potential of Levulan(R) PDT for the treatment of acne." Approximately 8 of every 10 persons worldwide have acne at some point during their lives, and acne is the most common reason patients visit dermatologists in the United States. Acne is also known to have a potentially profound impact on a patient's outlook on life. Current standard-of-care for moderate inflammatory acne includes topical or systemic antibiotics, retinoids, cleansers, and blue light such as that provided by DUSA's BLU-U(R) therapy. However, oral antibiotics for acne have been associated with increased bacterial drug resistance, and a recent article in the Journal of the American Medical Association showed an increased risk of breast cancer. Severe recalcitrant cystic acne is generally treated by orally administered isotretinoin (Accutane(R), Isotrex(R)). Although highly effective, isotretinoin continues to become more and more regulated by the federal government because of its potentially serious side effects, including a high risk of birth defects in the fetus if taken during pregnancy, and, in a small percentage of patients, depression. While taking isotretinoin, patients must undergo regular blood testing. (a) Original Investigator Reports: 1. Goldman M, Boyce S. A single-center study of aminolevulinic acid and 417 nm photodynamic therapy in the treatment of moderate to severe acne vulgaris. J Drugs Dermatol 2003; 2: 393-6. 2. Itoh Y, Ninomiya Y, Tajima S et al. Photodynamic therapy of acne vulgaris with topical [symbol]-aminolevulinic acid and incoherent light in Japanese patients. Brit J Dermatology 2001; 144: 575-9. 3. Hongcharu W, Taylor C, Chang Y et al. Topical ALA-photodynamic therapy for the treatment of acne vulgaris. J Investigative Dermatology 2000; 115: 183-92. 4. Itoh Y, Ninomiya Y, Tajima S et al. Photodynamic therapy for acne vulgaris with topical aminolevulinic acid. Arch Dermatol 2000; 136: 1093-5. DUSA Pharmaceuticals, Inc. is a biopharmaceutical company engaged primarily in the development and marketing of Levulan Photodynamic Therapy (PDT) and Photodetection (PD) for multiple medical conditions, with a primary focus on dermatology. PDT and PD utilize light-activated compounds to induce a therapeutic or detection effect. DUSA is a world leader in topically or locally applied PDT and PD. DUSA maintains 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 the number of clinical trial sites, the protocol parameters including incubation times, number and time intervals of treatments, efficacy endpoints, and safety and tolerability assessments, the opportunity for a treatment alternative and other risks identified in DUSA's SEC filings from time to time. 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
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