The Role of Peplin Operations Pty Ltd

When LEO Pharma A/S acquired Peplin Operations Pty Ltd in 2009 it was a development stage Australian biotech company, focused on advancing and commercialising innovative medical dermatology products. Peplin was founded in Brisbane in 1998 as a means to advance promising research undertaken by its founder Dr James Aylward.

Dr Aylward, utilising facilities at the Queensland Institute of Medical Research (QIMR), was interested in evaluating the anti-cancer properties of natural products sourced from non-indigenous plants of the genus Euphorbiaceae.

In particular, Dr Aylward was focused on the science behind an observation that the sap of Euphorbia peplus (active compound ingenol mebutate) had a history of community use as a “folklore” treatment for skin lesions, in particular skin cancer.

Peplin secured a Queensland State Government grant as well as private funding to pursue the early development of this science. The promising early study observations supported an initial public share offering for Peplin in September 2000.

In June 2004, two INDs were filed with US Food and Drug Administration (FDA) for the clinical development of ingenol mebutate for solar keratoses and basal cell carcinoma. The research program then entered clinical development in the US, in August 2004 with Phase I solar keratoses results being reported in January 2005.

Peplin initiated a comprehensive Phase II clinical program for ingenol mebutate gel for solar keratoses and basal cell carcinoma in Australia in March 2005.

Peplin initiated its first Phase III trial for solar keratoses in September 2008 and completed it in May 2009. Additional Phase III trials were completed in late 2009.

In November 2009, LEO Pharma A/S, a foundation based, privately owned global pharmaceutical company based in Denmark acquired Peplin.