Having received approval, market launch is expected in the first quarter of 2008. Earlier, Dusa entered into an exclusive marketing, distribution and supply agreement with Daewoong Pharmaceutical and DNCompany. Under the terms of this collaborative agreement, Dusa will manufacture and supply Levulan, while Daewoong Pharmaceutical and DNCompany will market and distribute Levulan in 11 Asian countries, including Korea.
Actinic keratoses (AKs) are rough-textured, dry, scaly patches on the skin, caused by excessive exposure to ultraviolet (UV) light, such as sunlight. Levulan Photodynamic Therapy (PDT) is a two-step treatment for Grade 1 or Grade 2 actinic keratoses (AKs that have not yet become enlarged and thick) of the face or scalp. The treatment uses a light activated drug therapy to selectively destroy AKs. The therapy consists of treatment with Levulan Kerastick topical solution, 20% followed by illumination with a blue light source.
Bob Doman, president and CEO of Dusa, said: “The approval of Levulan in Korea is another important milestone for Dusa, which reinforces our strategy of gaining worldwide distribution of Levulan PDT in conjunction with strategic partners. We were particularly impressed with how quickly Daewoong filed and gained regulatory approval in Korea. Daewoong, with an existing customer base of over 2,500 dermatologists and plastic surgeons, is well positioned to gain rapid penetration in the Asian markets.”
Shin Soo, CEO of DNCompany, said: “We have expectations that the product will be commercially available in 11 Asian countries, including China, where we have already begun the regulatory approval process.”