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`DUSA Pharmaceuticals, Inc.
`For Immediate Release December 6, 1999
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`DUSA RECEIVES FDA APPROVAL
`OF LEVULAN® PDT FOR ACTINIC KERATOSES
`
`Wilmington, Massachusetts, December 6, 1999 - DUSA Pharmaceuticals, Inc.
`(NASDAQ NMS: DUSA) announced today that its first products, the Levulan® Kerastick™
`and the BLU-U™ brand light source, have been approved for use in the treatment of Actinic
`Keratoses (AKs) of the face and scalp.
`
`AKs are common, precancerous skin lesions caused by chronic sun exposure. If left
`untreated, AKs may develop into squamous cell cancers of the skin.
`
`Dr. Geoffrey Shulman, DUSA's President and CEO, stated "DUSA is delighted to have
`received FDA approval only 17 months after submitting its first NDA and PMA, confirming
`that DUSA's Levulan® Photodynamic Therapy is a safe and effective treatment for Actinic
`Keratoses of the face and scalp."
`
`Dr. Shulman continued "DUSA's next steps include completion and filing of a PMA
`amendment for the commercial version of its BLU-U™, completion of manufacturing scale-
`up and inventory build-up to prepare for product launch. DUSA recently announced a
`marketing and development agreement with its new worldwide dermatology partner,
`Schering AG, and Schering's wholly-owned U.S. affiliate, Berlex Laboratories, Inc. Berlex is
`gearing up for the planned commercial launch in the United States during the second
`quarter of 2000. Both DUSA and Schering are excited about introducing the Levulan®
`Kerastick™ as an innovative new product for the treatment of this common, pre-cancerous
`condition. DUSA believes that Levulan® PDT, as a standardized, physician-administered
`therapy with selective healing and excellent cosmetic results, can become an important
`part of the AK therapeutic armamentarium."
`
`Levulan® PDT is a two step treatment. First, the Levulan® solution is applied to the
`individual AKs using the Kerastick™ (aminolevulinic acid HCl). Patients are then advised to
`protect themselves from sun exposure until the next day, when the AKs are exposed to
`blue light using DUSA's BLU-U™ brand Blue Light Photodynamic Therapy Illuminator.
`
`During treatment with the BLU-U™, patients experience a stinging or burning reaction in
`the treated areas. In general, this reaction improves immediately after treatment and ends
`within 24 hours. Reddening and swelling of the AK and surrounding skin may also occur.
`This effect is temporary, generally improves markedly by the end of the first week, and
`should completely resolve by 4 weeks after treatment. Other side effects of the treatment
`may include scaling, itching and skin color changes.
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