-----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, O9/QAxTbtKgPEbIXABpW/wHJwJluwuqTqRXLjneBaGRbQWBOIwcimcJFMHAATsiJ UsHdGmdfAR8qnAZa5k59IA== 0000950123-05-013944.txt : 20051121 0000950123-05-013944.hdr.sgml : 20051121 20051121152352 ACCESSION NUMBER: 0000950123-05-013944 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20051121 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051121 DATE AS OF CHANGE: 20051121 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: 051217853 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 y15045e8vk.txt 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): November 21, 2005 DUSA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) New Jersey 0-19777 22-3103129 (State or other jurisdiction (Commission File (IRS Employer of incorporation) Number) 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): [ ] 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 240.14d-2(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 the morning of November 21, 2005, attached to and made a part of this report as Exhibit 99, announcing that it has filed lawsuits against physicians in California, Florida, and Tennessee to prevent their continued use of versions of its Levulan(R) brand of aminolevulinic acid HCl (ALA) produced by compounding pharmacies, for use in DUSA's patented photodynamic therapy (PDT) treatment for actinic keratosis, basal cell carcinoma, acne and other dermatological conditions. Additionally, some doctors are also being sued for misuse of DUSA's trademarks and for violations of the Latham Act for using the Levulan(R) brand name on their web sites and promotional materials, but performing patient treatments with ALA obtained from other sources. Except for historical information, this report, including the attached exhibit, 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 company's expectations regarding its relationships. Furthermore, the factors that may cause differing results include the uncertainties of litigation, sufficient funding, maintenance of our patent portfolio and other risks identified in DUSA's SEC filings from time to time. Item 9.01 - Financial Statement and Exhibits. Item No. Description - -------- ----------- 99 Press Release, dated November 21, 2005 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: November 21, 2005 By: /s/ D. Geoffrey Shulman ------------------------------ D. Geoffrey Shulman, MD, FRCPC Chairman of the Board and Chief Executive Officer Exhibit Index Item No. Description - -------- ----------- 99 Press Release, dated November 21, 2005 EX-99 2 y15045exv99.txt PRESS RELEASE EXHIBIT 99 [LOGO OF DUSA] INNOVATION IN PHOTODYNAMIC THERAPY DUSA Pharmaceuticals, Inc.(R) For Release at 8:00 a.m. DUSA PHARMACEUTICALS SUES PHYSICIANS FOR INFRINGEMENT OF ITS LEVULAN(R) PHOTODYNAMIC THERAPY PATENTS Suits Charge Use of Compounded ALA for PDT Infringes DUSA's Patent Rights WILMINGTON, MA (November 21, 2005) - DUSA Pharmaceuticals, Inc. (R) (NASDAQ NMS: DUSA) announced today it has filed lawsuits against physicians in California, Florida, and Tennessee to prevent their continued use of versions of its Levulan(R) brand of aminolevulinic acid HCl (ALA) produced by compounding pharmacies, for use in the company's patented photodynamic therapy (PDT) treatment for actinic keratosis, basal cell carcinoma, acne and other dermatological conditions. The suits allege that ALA obtained from sources other that DUSA Pharmaceuticals is being used by physicians for patient treatments that are covered under patents exclusively licensed by DUSA, resulting in direct infringement of these patent(s). Additionally, some doctors are also being sued for misuse of DUSA's trademarks and for violations of the Latham Act for using the Levulan(R) brand name on their web sites and promotional materials, but performing patient treatments with ALA obtained from other sources. "DUSA has worked diligently to develop and obtain U.S. Food and Drug Administration (FDA) marketing approval for Levulan(R)," said Robert Doman, DUSA's President and Chief Operating Officer. "As an FDA approved manufacturer of drugs and medical devices, DUSA must meet the FDA's high standards for safety, efficacy, potency, stability, and purity for our products. Unlike compounded ALA, which has not been approved for marketing by the FDA, our products have undergone years of extensive and expensive clinical testing and evaluation to reach the dermatology marketplace. Our state-of-the-art manufacturing facility has also been built and maintained to FDA standards." In 2004 and in early 2005, DUSA sued two compounding pharmacies, The Cosmetic Pharmacy of Tucson, AZ, and the New England Compounding Center in Framingham, MA, for violations of U.S. patent law. The Cosmetic Pharmacy presented no defense against the suit so a default judgment was entered by the court in DUSA's favor. The court also took the unusual step of awarding attorney fees to DUSA. The suit against the New England Compounding Center is still pending. The lawsuits allege that these compounding pharmacies were promoting their compounded ALA for use in DUSA's patented therapies and were therefore inducing physicians to infringe DUSA's patents. Doman continued, "Use of compounded ALA for our patented therapies is a violation of DUSA's intellectual property rights. Because DUSA's patents cover uses of ALA, compounding pharmacies are putting physicians at legal risk by offering it for sale and encouraging its use. While we will continue to value and protect the longstanding relationships that we have made with the dermatology community and with our loyal doctors who use DUSA's proprietary Levulan(R), as a business, DUSA must protect its investment in its products and enforce its intellectual property rights against those physicians who use compounded ALA." About DUSA Pharmaceuticals 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, with its primary focus in dermatology. PDT and PD utilize light-activated compounds such as Levulan(R) to induce a therapeutic or detection effect. The Company 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 company's expectations regarding its relationships. Furthermore, the factors that may cause differing results include the uncertainties of litigation, sufficient funding, maintenance of our patent portfolio and other risks identified in DUSA's SEC filings from time to time. For further information contact: Bob Doman, President & COO Scott Lundahl, Vice President, Intellectual Property & Regulatory Affairs Tel: 978.657.7500 or Shari Lovell, Director, Shareholder Services Tel: 416.363.5059 Fax 416.363.6602 or visit www.dusapharma.com -----END PRIVACY-ENHANCED MESSAGE-----