Item 8.01 Other Events.
On October 3, 2007, DUSA issued a press release, attached to and made part of
this report, announcing that the Korea Food and Drug Administration (KFDA) has
approved Levulan® Kerastick® for Photodynamic Therapy (PDT) for the treatment of
actinic keratoses (AKs) through its marketing partner Daewoong Pharmaceutical
Co., Ltd and its affiliate DNC Daewoong Derma & Plastic Surgery Network Company
(DNCompany). Having received approval, subsequent market launch is expected in
the first quarter of 2008.
Except for historical information, this report 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 expectations for
launch in the first quarter of 2008, manufacture and supply by DUSA, marketing
and distribution by Daewoong, perceptions of success in the market, expectations
for commercialization in 11 Asian countries. 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.
Item 9.01 - Financial Statement and Exhibits.
Item No. Description
99.1 Press Release, dated October 3, 2007
