Pipeline products

PEP005 (ingenol mebutate) Gel for Actinic (solar) Keratosis (AK)

Peplin is currently pursuing the use of PEP005 Gel as a topical, field-directed therapy for AK lesions on both head (face and scalp) and non-head (trunk and extremities) locations. We recently completed our REGION-I trial, our first Phase III, in May 2009 for non-head treatment areas with a 0.05% concentration for two days, meeting both our primary and secondary endpoints.  REGION-I was conducted under a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA)

We also shared the results of our dose-ranging Phase IIb study for head treatment areas, doses ranging from 0.005%-0.015%, in the first quarter of 2009.  As a result, we have selected a 0.015% PEP005 Gel concentration applied once a day for three consecutive days to move into Phase III trials.  We started enroling patients in REGION-IIa and REGION-IIb, the two Phase III face and scalp clinical trials, in June 2009.

As compared with other treatment alternatives, we believe that PEP005 Gel for AK could offer a combination of attractive benefits to patients seeking treatment for AK, including:

• a short two-to-three day treatment regimen
• localized, transient and well-tolerated side effects
• a unique mode of action distinct from other AK
• a convenient, patient-applied, take-home prescription medication
• the ability to treat visible lesions and the surrounding sun-damaged skin where lesions may develop in the future

Key completed clinical trials include: REGION-I (Phase III, non-head), PEP005-006 (Phase II, non-head), PEP005-015 (Phase IIb, head) and PEP005-007 (Phase II, face).

PEP005 (ingenol mebutate) Gel for superficial Basal Cell Carcinoma (sBCC)

Peplin is currently pursuing the use of PEP005 Gel as a topical, tumour-directed therapy for sBCC lesions.

We believe that this product candidate, once developed and, if approved for commercialization by the appropriate regulatory authorities, could offer patients an effective and well-tolerated treatment alternative for superficial BCC with a short, one or two day application regimen.

Key completed clinical trials include: PEP005-003 (Phase IIa)

PEP005 (ingenol mebutate) for other indications

We believe that there are other potential uses for PEP005 in topical formulations for treatment of skin conditions, such as cutaneous warts and other non-melanoma skin cancers, such as SCC and nodular BCC. Of these potential indications, we have completed initial clinical trials for SCC in situ and nodular BCC. These initial clinical trials have demonstrated the potential of PEP005 to clear these skin cancers following two applications.

In addition, PEP005 has shown potential anti-cancer activity in preclinical tests against certain forms of leukaemia and bladder cancers. We plan to pursue initial clinical trials of PEP005 as an intravenous therapy for certain forms of leukaemia and as an intra-cavitary formulation for superficial forms of bladder cancer. We continue to support research in several of these areas with studies based on preclinical, clinical, regulatory and marketing criteria that we have established through our strategic planning processes. Once we demonstrate clinical proof of principle in one or more of these indications, we plan to collaborate on the further development and commercialization of these oncology products.