Peplin Completes Enrolment in its Phase 3 Clinical Trials for PEP005 Gel in AK on the Face and Scalp

EMERYVILLE, Calif. & BRISBANE, Australia--(Business Wire)--
Peplin, Inc. (ASX:PLI) today announced the completion of enrolment of its two
Phase 3 clinical trials for the use of PEP005 (ingenol mebutate) Gel to treat
actinic (solar) keratoses (AK), a common pre-cancerous skin lesion, on head
treatment areas, which include the face and scalp.

These Phase 3 clinical trials are referred to as REGION-IIa and REGION-IIb and
enrolled approximately 250 patients each. They are designed to replicate the
positive results demonstrated in earlier trials, specifically the results of the
Phase 2b trial (PEP005-015) announced earlier this year. Peplin plans to
announce the REGION-II trial results in the fourth quarter of this year.

Peplin`s Chief Executive Officer, Tom Wiggans said: "The continued enthusiasm
for our trials, as demonstrated by the remarkable speed of enrolment, highlights
the unsatisfied medical need which PEP005 Gel addresses. The REGION-II trials
are especially important as they are treating AKs on the face and scalp, which
comprise an estimated 70% of the AK market and have the potential to provide the
most patient benefit."

"Based on the data we have generated up to this point, we believe PEP005 Gel and
its short course of therapy represent an advance in the treatment of a common
skin condition, which, if left untreated, can progress to squamous cell
carcinoma."

The REGION-II trials are both randomised, double-blind, vehicle-controlled
studies that are being conducted at multiple sites in the US and Australia.
Patients self apply the study medication (0.015%) or vehicle gel for three
consecutive days to a 25-cm2 treatment area containing four to eight AK lesions
on the face or scalp. The primary efficacy endpoint for the REGION-II trials is
the complete clearance rate of AK lesions and the secondary efficacy endpoint is
the partial clearance rate of AK lesions within the treatment area. Peplin is
also measuring the overall mean and median reduction in AK lesion count.

In addition to the REGION-II trials on head locations, Peplin recently completed
its REGION-Ia trial for non-head locations, which included the trunk and
extremities, and plans to initiate the REGION-Ib trial during the third quarter
of 2009 to corroborate the results of the previously completed trial. Peplin
plans to file a New Drug Application in mid-2010.

ABOUT PEPLIN

Peplin is a development stage specialty pharmaceutical company focused on
advancing and commercialising innovative medical dermatology products. Peplin is
currently developing ingenol mebutate, or PEP005, which 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. Peplin`s lead product candidate is a
patient-applied topical gel containing ingenol mebutate, a compound the use of
which Peplin has patented for the treatment of actinic (solar) keratosis, or AK.
This product candidate referred to as PEP005 (ingenol mebutate) Gel is currently
in Phase 3 clinical trials, having just completed their first Phase 3, known as
REGION-Ia.

ABOUT AK

Actinic keratoses (AK), also known as solar keratosis or sun spots, is generally
considered the most common pre-cancerous skin condition. AK usually appears as
small, rough, scaly areas on the face, lips, ears, back of hands, forearms,
scalp or neck. If left untreated, AK lesions may progress to a form of skin
cancer called squamous cell carcinoma, or SCC. The Lewin Group, Inc., estimates
that the total direct costs for AK in the United States was $1.2 billion in
2004, and in 2002 there were approximately 8.2 million office visits for the
treatment of AK. The Lewin Group also estimated that there were 58 million
people in the United States living with AK in 2004. According to a May 2006
issue of The Journal of Family Practice, in northern hemisphere populations, 11%
to 25% of adults have at least one AK lesion, compared with 40% to 60% of adults
in Australia, which has the highest prevalence of AK worldwide.

FORWARD LOOKING STATEMENTS

This press release contains "forward-looking statements" as defined under U.S.
federal securities laws, including, but not limited to, Peplin`s clinical
development plan and timing of clinical trials referred to herein. These
forward-looking statements can be identified through the use of words such as
"anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates,"
"may," "will," and variations of these words or similar expressions. Forward
looking statements are based on management's current, preliminary expectations
and actual results could differ materially as a result of various risks and
uncertainties, including, but not limited to, delays in clinical trials
resulting from, among other things, ambiguous or negative interim results,
unforeseen safety issues, failure to conduct the clinical trials in accordance
with regulatory requirements or clinical protocols, suspension or termination of
a clinical trial by the FDA or other regulatory authorities, lack of adequate
funding to continue a clinical trial and other important factors disclosed from
time to time in Peplin`s disclosures to the ASX and in its Form 10 Registration
Statement and most recent quarterly report on Form 10-Q filed with the US
Securities and Exchange Commission. Forward-looking statements speak only as of
the date they were made. No undue reliance should be placed on any
forward-looking statements. Such information is subject to change, and we
undertake no obligation to update such statements.

Further Information:
Peplin, Inc.
Tom Wiggans, +1-510-653 9700
Chief Executive Officer
tom.wiggans@peplin.com
or
Media:
Hill & Knowlton
Camilla Myers, 02-9286 1248
cmyers@hillandknowlton.com.au

Copyright Business Wire 2009