Healthcare Industry News: 5-FU
News Release - January 23, 2007
DUSA Pharmaceuticals, Inc.: International Guidelines Recommend Photodynamic Therapy as First-Line Treatment for Actinic KeratosesUnique System Treats Condition That May Lead to Squamous Cell Carcinoma
WILMINGTON, MASSACHUSETTS--(Healthcare Sales & Marketing Network)--Jan 23, 2007 -- According to international guidelines published in the January, 2007 issue of the Journal of the American Academy of Dermatology, Photodynamic Therapy (PDT) has been recommended by a consensus group of physicians as a highly effective first-line treatment for actinic keratoses (AKs). PDT, a combination of light therapy and photosensitive topical solution, is often used to treat AKs, a common skin condition that, if left untreated, can lead to squamous cell carcinoma (skin cancer). According to the recommendations, PDT should be considered as a first-line therapy for treating the pre-cancerous lesions. The Levulan PDT system (Levulan® Kerastick® together with the BLU-U® light source) marketed by DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA) is the only currently available PDT treatment approved by the U.S. Food and Drug Administration (FDA) for AKs. It is also available in Canada. In addition, exclusive marketing rights for Levulan PDT have been granted to Stiefel Laboratories, Inc. for Latin America and to Daewoong Pharmaceuticals Co., LTD for certain Asian countries.
The recommendations were developed during a meeting of the International Society for Photodynamic Therapy in Dermatology in January 2005. A systematic literature review was conducted (using MEDLINE), and recommendations were made based on the quality of evidence for efficacy, safety/tolerability, cosmetic outcome, and patient satisfaction/preference.(1)
"This recommendation provides physicians with a large body of evidence to treat their patients with PDT for the management of AKs. This safe and effective treatment offers significant clinical outcomes and patient satisfaction," said Robert Doman, President and COO of DUSA Pharmaceuticals. "We applaud the efforts of the International Society for Photodynamic Therapy in Dermatology for advancing international acceptance of PDT as an option for first-line treatment of a skin condition that can lead to cancer."
According to the new guidelines, PDT is better tolerated, offers superior cosmetic outcomes and is more popular with patients than other therapies, including cryosurgery and topical 5-fluorouracil (5-FU).
"These guidelines represent a step in the right direction to provide patients with highly effective, well tolerated and cosmetically beneficial treatments for actinic keratoses - helping to prevent the development of more serious pre-cancerous skin conditions," said Barbara A. Gilchrest, M.D., Boston University, School of Medicine. "The European experience summarized in this article suggests that broad area topical PDT may also reduce future skin cancers in high risk patients and that PDT may provide the first non-surgical non-scarring alternative for certain common superficial skin cancers, a major advance. Such use for PDT is already approved by European regulatory agencies as safe and effective."
The American Academy of Dermatology (AAD), states that AKs affect more than ten million Americans. The Academy also estimates that 40% of squamous cell carcinomas (SCC), the second leading cause of skin cancer deaths in the United States, begin as AKs. In light of topical PDT's high AK cure rates and the advantage of excellent cosmetic outcomes, the international panel recommended the treatment as a first-line therapy for AKs, stating, "PDT is particularly well suited for the treatment of AKs."
About Levulan PDT
The Levulan PDT system is FDA-approved for the treatment of minimally to moderately thick actinic keratoses (AKs) of the face or scalp. This unique system uses a combination of light and a photosensitizer to target AKs.
The BLU-U® Blue Light Photodynamic Therapy Illuminator is also FDA cleared for light alone treatment of moderate inflammatory acne. Levulan + BLU-U PDT is in the midst of the commercial clinical development process with the goal to obtain FDA approval for the treatment of moderate to severe inflammatory acne.
About DUSA Pharmaceuticals, Inc.
DUSA Pharmaceuticals, Inc. is an integrated dermatology specialty pharmaceutical company focused primarily on the development and marketing of its Levulan Photodynamic Therapy (PDT) technology platform, and complementary dermatology products. Levulan PDT is currently approved for the treatment of pre-cancerous actinic keratoses, and is being developed for the treatment of acne and photodamage. DUSA's other dermatology products include Nicomide®, and the AVAR® line, resulting from its early 2006 merger with Sirius Laboratories, Inc. These products target patients with acne and rosacea. DUSA is also developing certain internal indications of Levulan PDT. DUSA is based in Wilmington, Mass. Please visit our Web site at www.dusapharma.com.
Forward Looking Statements
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 obtaining FDA approval for the treatment of acne. Furthermore, the factors that may cause differing results include the regulatory process, sufficient funding, maintenance of DUSA's patent portfolio, reliance on third parties, and other risks identified in DUSA's SEC filings from time to time.
(1) Braathen L, Szeimies RM, Basset-Seguin N, et al. Guidelines on the use of photodynamic therapy for nonmelanoma skin cancer: An international consensus. J AM Acad Dermatol 2007; 125-143
Source: DUSA Pharmaceuticals
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