In March 17, 2008, QLT announced that the US Food and Drug Administration (FDA) removed the label restrictions for its acne product, Aczone(TM) (see also News section). Following this announcement, QLT's stock surged by 55%.

Aczone(TM) was approved by the FDA in July 2005 with a label restriction. This decision forced the company to put Aczone(TM) commercialization on hold and to conduct a post-approval study in order to remove the restriction. QLT then performed a phase 4 clinical trial in 56 glucose-6-phosphate dehydrogenase (G6PD)-deficient patients. In November 2006, the company communicated the positive outcome of this study, and in May 2007, it submitted a supplemental New Drug Application (sNDA) to the FDA. Only two days ago, QLT announced that the FDA completed its review of the company's sNDA and removed the glucose-6-phosphate dehydrogenase G6PD screening and blood monitoring previous requirements on the Aczone(TM) label.

Although the situation for QLT in 2008 is financially complicated (see also Spotlight on February 22, 2008), the company believes that Visudyne(R), a commercialized treatment for age-related macular degeneration, and Aczone(TM) are anchor products in both the ocular and dermatology fields.

The company announced in January it was selling its United States division, QLT USA, Inc., which holds the rights to Aczone(TM) as well as to QLT's drug delivery technology, Atrigel(R). According to QLT chief executive officer, commercializing Aczone(TM) will make the US asset more valuable.

If commercialized, Aczone(TM) will directly compete against prescription topical products for acne, such as benzoyl products, and it will indirectly compete with systemic antibiotic prescription products and topical over-the-counter therapies.

Aczone(TM) contains dapsone 5% (w/w) formulated in an aqueous gel for topical treatment of acne. The product utilizes QLT's patented Solvent Microparticle System(TM).

More information on QLT company is available in DelScience's report: "Company profile: QLT, Inc.".

Source: QLT, Inc.