Today, it was announced that Peplin, Inc. and LEO Pharma A/S have completed their definitive merger agreement after obtaining the approval of the majority of stockholders as well as completing the relevant regulatory activities.

The deal was originally announced on 3 September, 2009 when LEO, a privately-held, leading global pharmaceutical company within Dermatology and Critical Care, agreed to acquire all outstanding securities of Peplin for approximately USD 287.5 million in cash.

Peplin will operate as a US-based LEO subsidiary with George Mahaffey, formerly Peplin’s Chief Commercial Officer, promoted to lead the company as Chief Executive Officer.

Dr. Eugene Bauer will continue with Peplin as the President and Chief Medical Officer and Dr. Peter Welburn will also maintain his role as General Manager, Australia and Vice President, Research and Development.

Peplin will retain other key management and employees and plans to continue operations in Emeryville, California and Brisbane, Queensland.

Peplin’s lead product candidate, PEP005 Gel is currently in Phase 3 clinical trials for actinic (solar) keratosis (AK), a common pre-cancerous skin lesion, on both head and non-head locations.

Peplin CEO George Mahaffey said “We are excited to be part of the LEO Pharma organization and look forward to combining resources to efficiently register PEP005 Gel for the benefit of AK patients worldwide.”

President and CEO of LEO Pharma, Gitte Aabo, said “We are very pleased that the merger is now completed and look forward to focusing our energy on developing PEP005 as quickly as possible for the benefit of patients. In addition, LEO Pharma would like to express its appreciation for the professionalism and dedication that the people of Peplin have shown in developing PEP005.”

Actinic keratosis is a pre-cancerous skin lesion - so-called “non-melanoma skin cancer”. The number of actinic keratosis patients is both large and rapidly growing, and AK is a serious health problem. The respected British Journal of Dermatology writes: “Non-melanoma skin cancer is the most common cancer in Caucasian populations and is considered to be of epidemic proportions worldwide.” Trakatelli et al, British Journal of Dermatology 2007 156 (Suppl. 3), 1–7

The prevalence of actinic keratosis (AK) is growing rapidly due to the sunbathing holidays which the western world began to take in the 60s and 70s. The damage occurs because of over-exposure to the sun and ensuing sunburn.

People with fair skin are more likely to develop AK and today it is estimated that 100 million people in the EU, USA, Canada and Australia have the disease. Less than 10 million patients are in treatment and it is estimated that up to 10% of the patients develop cancer in the form of spinocellular carcinoma which is a form of non-melanoma skin cancer.

Today the treatment is primarily cryotherapy (treatment by freezing) and – approximately 25% of the treatments – medication. Medication is however very long – often 1 – 2 months – and cryotherapy can only treat discrete lesions – and there is often recurrence.

PEP005 is a novel compound derived from the sap of Euphorbia peplus, or E. peplus, a rapidly growing, readily available plant commonly referred to as petty spurge or radium weed. E. peplus has a long history of traditional use for a variety of conditions, including the topical self-treatment of various skin disorders, including skin cancer and pre-cancerous skin lesions.

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