WILMINGTON, MASSACHUSETTS--(CCNMatthews - May 17, 2007) - DUSA Pharmaceuticals, Inc. (NASDAQ GM:DUSA) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for Levulan(R) (aminolevulinic acid HCl) Photodynamic Therapy (PDT) for the treatment of esophageal dysplasia. This disease occurs in some patients with Barrett's esophagus, a leading cause of esophageal cancer. The incidence of esophageal cancer is one of the most rapidly growing in the U.S., with more than 11,000 new diagnoses each year. Patients diagnosed with high grade dysplasia are at high risk for developing esophageal cancer and currently have limited treatment options.
"We are pleased to receive orphan drug designation for Levulan" said Robert Doman, DUSA's President and Chief Operating Officer. "We believe that Levulan, in combination with our proprietary endoscopic light delivery system, is ideal for this significant unmet medical need and we are excited that it may someday provide patients at high risk of developing esophageal cancer with an effective and well tolerated therapeutic alternative."
Independent investigator clinical studies have reported that treatment of dysplasia with ALA PDT may help avoid the need for the removal of the esophagus and its associated morbidity. Findings from the study, "Low Incidence of Esophageal Adenocarcinoma Following Optimal Regimen of ALA PDT for High Grade Dysplasia in Barrett's Esophagus," will be presented at the Digestive Disease Week (DDW) meeting in Washington, D.C. on Sunday, May 20, 2007.
"This is a potential breakthrough for Barrett's patients and we've demonstrated this treatment can work effectively," says Laurance Lovat, M.D., senior lecturer and consultant gastroenterologist, University College Hospital in Lo ndon, and lead investigator for the independent research being presented at DDW. "This non-surgical treatment would allow us to eradicate precancerous cells without having the patient suffer the unpleasant side effects of current treatments including severe scarring or the radical invasive removal of the esophagus. This option appears much safer and requires less recovery time." DUSA provided the Levulan(R) to support this study.
Barrett's esophagus is a precancerous condition in which the lining of the esophagus is replaced with abnormal cells that could lead to dysplasia, and ultimately, esophageal cancer. Barrett's esophagus affects an estimated 700,000 adults in the United States and is often associated with gastroesophageal reflux disease or GERD. Treatments currently available for severe precancerous tissue changes or high grade dysplasia, include highly invasive esphagectomy (surgical removal of the esophagus) and endoscopic therapies, which carry the risk of severe scarring of the esophagus. Although the exact cause of Barrett's esophagus is unknown, people with chronic GERD (gastroesophageal reflux disease), obese people, men, and Caucasians are at increased risk of developing the disease.
About Levulan PDT
Photodynamic therapy is a photochemical process that involves the interaction of a photosensitizer, light, and oxygen to selectively destroy malignant or certain benign, but rapidly growing cells. The procedure involves administration of a drug and subsequent illumination of the target cells with an appropriate light to activate the PDT process. Levulan(R) is DUSA's proprietary formulation of aminolevulinic acid (ALA), a compound that is found naturally in the human body. When taken systemically, Levulan(R) is converted into a photosensitizer by rapidly growing cells, such as those found in esophageal dysplasia, where it can then be activated by light. This light is delivered to the target tissue using DUSA 's proprietary light delivery system which allows the endoscopic light treatment to be performed more rapidly, under direct visualization and with greater precision.
About the Orphan Drug Act
The Orphan Drug Act (ODA) encourages drug companies to seek regulatory approval for products that treat a rare disease or condition that affects a relatively small number of people. Once the company receives approval from the Food and Drug Administration to market its orphan-designated product, the company is entitled to seven (7) years of marketing exclusivity for the orphan indication. Orphan Drug Designation also makes it possible to apply for various government funding grants and tax incentives to support the development program for that indication.
About DUSA Pharmaceuticals, Inc.
DUSA Pharmaceuticals, Inc. is an integrated dermatology pharmaceutical company focused primarily on the development and marketing of its Levulan(R) Photodynamic Therapy (PDT) technology platform, and complementary dermatology products. Levulan PDT is currently indicated for the treatment of minimally to moderately thick actinic keratoses (Grade 1 or 2) of the face or scalp, and is being studied for the treatment of acne. DUSA's other dermatology products include ClindaReach(TM), Nicomide(R) and the AVAR(R) line. DUSA is also sponsoring research for additional indications for internal uses of Levulan PDT. DUSA is based in Wilmington, MA. Please visit the company's website at www.dusapharma.com for more information.
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 belief that Levulan PDT is ideal for this disease and may provide future therapy, and possible effect of the treatment and its benefits. Furthermore, the factors that may cause differing results include the ability to penetrate the market, 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, including its annual report on Form 10-K for the year ended December 31, 2006.
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INDUSTRY: Pharmaceuticals and Biotech - Biotech, Pharmaceuticals and Biotech - Drugs, Pharmaceuticals and Biotech - Equipment and Supplies, Pharmaceuticals and Biotech - Trials SUBJECT: HLT - HEALTH