Berlex Laboratories to Enter the Dermatology Market with Levulan-R- PDT.

MONTVILLE, NJ--(BUSINESS WIRE)--Nov. 23, 1999--

Berlex Laboratories, Inc. today announced that the company has obtained exclusive U.S. distribution and marketing rights for Levulan(R) (aminolevulinic acid HCI) Photodynamic Therapy/Photodetection (PDT/PD) for dermatology indications from DUSA Pharmaceuticals. Subject to final FDA approval, Berlex plans to introduce the first product from this technology platform, the Levulan(R) Kerastick(TM) for the treatment of Actinic Keratoses (AKs), a common sun-induced, pre-cancerous skin condition. In conjunction with Berlex's marketing efforts, DUSA will supply directly to end-users its BLU-U(TM) light source, a non-laser blue light, that activates the Levulan(R) topical solution, resulting in the destruction of the abnormal cells in the AK lesion.

Actinic keratosis is a common skin condition caused by cumulative sun exposure, especially in fair-skinned individuals. Approximately 4 million people are treated for AKs in the U.S. every year. DUSA has successfully completed two Phase III studies of Levulan(R) PDT for AKs of the head and scalp at a total of 16 U.S. study sites. The combined results of these studies showed that over 90% of the AK lesions had cleared after one or two Levulan(R) PDT treatments compared to 25% clearing in the placebo control group. DUSA filed a New Drug Application (NDA) with the Food & Drug Administration (FDA) in July 1998 and received an approvable letter in June 1999. On November 5, 1999, an FDA Advisory Panel made recommendations for product labeling and Phase IV clinical studies. The market introduction will occur approximately 4 months after the FDA grants final marketing approval.

Berlex and DUSA believe that the Levulan(R) PDT system will provide the first standardized, physician-applied, easy-to-use selective approach to the treatment of AKs. Currently, the two most common treatments for AKs are cryosurgery with liquid nitrogen and topical 5-fluorouracil cream (5-FU). While these treatments can work well, liquid nitrogen, which is painful and non-selective, can cause scarring and pigmentation problems in some patients. 5-FU is particularly useful for patients with extensive lesions; however, the twice-daily treatment causes redness and irritation, making compliance very difficult for the 4-6 week treatment regimen. Alternatively, the side effects profile for Levulan(R) PDT showed a well-tolerated burning, stinging discomfort during the light treatment; there were no other significant treatment-related side effects and no systemic photosensitivity.

"This marketing and distribution agreement with DUSA is an important first step in our strategy to expand our global presence in Dermatology to the U.S.," said Elise Klein, General Manager Dermatology for Berlex Laboratories. "Launching the Levulan(R) PDT system is a great opportunity; we're confident that it will provide dermatologists and patients with a safe and effective new treatment option. Although Levulan(R) PDT will be our initial U.S. Dermatology product, our parent company has a 50-year history of innovation and leadership in this area. We look forward to applying this same expertise here. In the future, we'll file regulatory submissions in the U.S. for Dermatology products in our global portfolio. We're also interested in identifying other partnership opportunities to expand our worldwide Dermatology presence."

Committed to developing novel therapeutics that address unmet medical needs, Berlex Laboratories, Inc. researches, manufactures, and markets ethical pharmaceuticals in four strategic areas: Dermatology, Female Healthcare, Diagnostic Imaging, and Therapeutics for life-threatening and disabling diseases. The company has entered into collaborative R&D and marketing agreements in all of its strategic business areas and will continue to pursue additional cooperative ventures. The U.S. pharmaceutical subsidiary of Schering Berlin Inc, Berlex Laboratories, Inc. has business divisions in Montville and Wayne, New Jersey and in Richmond, California. For more company information, please visit www.berlex.com.

Schering Berlin Inc., is the U.S. management holding company for Schering AG, Germany. In addition to Berlex Laboratories, Schering Berlin Inc. has five U.S. research-driven subsidiaries: Medrad Inc. (magnetic resonance injection systems and vascular injection systems), Diatide Inc (diagnostic radiopharmaceuticals), AgrEvo USA Company (crop production and crop protection), Berlichem Inc. (pharmaceutical chemicals), and Schering Berlin Venture Corporation (equity investments in leading-edge technologies). Schering Berlin Inc. is located in Montville, New Jersey.