DUSA Announces Stiefel's Receipt of Pricing Approval of Levulan PDT in Brazil
Thursday March 6, 6:30 am ET
Commercial Launch to Follow
WILMINGTON, MASSACHUSETTS--(MARKET WIRE)--Mar 6, 2008 -- DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA), received notice on March 5, 2008 that Stiefel Laboratories, Inc., DUSA's marketing partner for Latin America, has now received final pricing approval for Levulan® (aminolevulinic acid HCl) Kerastick® for Photodynamic Therapy (PDT) for the treatment of actinic keratoses (AKs) in Brazil by the Regulatory Chamber of Medicines (Camara de Regulacao do Mercado de Medicamentos) (CMED). The market launch of Levulan PDT in Brazil is expected to follow shortly. Stiefel previously received regulatory approval for Levulan Kerastick from ANVISA (Agencia Nacional de Vigilancia Sanitaria) in 2006.
"The pricing approval and upcoming market launch of Levulan PDT in Brazil marks an important step toward bringing this unique treatment option to the dermatology community in Brazil," said Robert Doman, President and CEO of DUSA. "We are very optimistic about the potential for Levulan PDT in the Brazilian marketplace and we will continue to work closely with Stiefel to bring Levulan PDT to additional Latin American countries in the coming year."
In Latin America, Stiefel has also received regulatory approval for Levulan in Argentina, Mexico, Chile and Colombia with approvals and subsequent product launches in additional markets scheduled to follow within the next several months.
"We are very excited to bring Levulan Kerastick PDT to the Brazilian market," said Charles W. Stiefel, CEO and Chairman of the Board, Stiefel Laboratories. "We believe that our close relationships with healthcare providers in Brazil, coupled with our leading marketing and sales teams, will optimize Levulan Kerastick PDT sales and profits for both companies."
About Actinic Keratoses
Actinic keratoses (AKs) are rough-textured, dry, scaly patches on the skin, caused by excessive exposure to ultraviolet (UV) light, such as sunlight. They are often referred to as "sun spots" and they occur most frequently on sun exposed areas such as the face, scalp, ears, neck, hands and arms, and are generally viewed as precancerous lesions.
About Levulan Photodynamic Therapy (PDT)
Levulan PDT is a unique 2-step treatment for Grade 1 or 2 actinic keratoses (AKs that have not yet become enlarged and thick) of the face or scalp. In the U.S., the therapy consists of treatment with Levulan® Kerastick® Topical Solution, 20% followed by illumination with DUSA's BLU-U® brand light source.
surf's up......crikey
