LEO Pharma announces positive results for two Phase III AK clinical trials

LEO Pharma today announced positive results for the company’s two Phase III actinic (solar) keratosis (AK) clinical trials using PEP005 (ingenol mebutate) Gel for the treatment of lesions on head treatment areas, which include the face and scalp. AK is a common pre-cancerous skin condition caused by sun exposure, which can develop into skin cancers if left untreated.

“The Peplin team has done an excellent job of executing the development program and completing the Phase III trials within the expected timeframe. We are happy to have confirmed the basis for a novel, competitive product, even if we still have some way to go”

“The strong results from the trials are an important step towards a unique and novel treatment model for AK. The results are also an important step in LEO Pharma’s growth strategy. The trials confirm the results of prior trials and we are closer to being able to provide the patients a 3-day course of therapy than ever,” said Lars Olsen, LEO Pharma’s Executive Vice President for Research & Development.

The trials were initiated and run by US and Australia-based Peplin, Inc., acquired by LEO Pharma in the fall of 2009. Two Phase III trials each achieved their primary and secondary efficacy endpoints with statistically significant clearance of AK lesions vs. vehicle.

The two completed Phase III clinical trials, known as REGION-IIa and REGION-IIb, enrolled approximately 250 patients each and evaluated the use of a 0.015% concentration of PEP005 Gel applied daily for three consecutive days to AK lesions on the face and scalp.

“The Peplin team has done an excellent job of executing the development program and completing the Phase III trials within the expected timeframe. We are happy to have confirmed the basis for a novel, competitive product, even if we still have some way to go,” Olsen said.

LEO Pharma has one additional Phase III clinical trial currently ongoing with PEP005 Gel for AK lesions. This Phase III trial, known as REGION-Ib, is for lesions on non-head locations, which includes the trunk and extremities, and was designed to replicate the previously completed, successful REGION-I trial and confirm its results. REGION-Ib has completed enrollment of approximately 250 patients earlier this year and data is expected towards the end of Q1 2010.

LEO Pharma expects to market the new treatment for AK in 2012.