DGAP-News

WILEX AG: Phase III ARISER data for the adjuvant treatment of clear cell renal cancer with RENCAREX(R) including retrospective subgroup analysis presented at ASCO - Seite 2

defined as the per protocol population. In these patients with a CAIX score
>= 2.6 both the hazard ratio and the significance level (N=139; HR=0.51;
p=0.007) improved even further.

In patients under the age of 65 years RENCAREX(R) showed a clinically and
statistically significant DFS with a CAIX score >= 2.0 (N=286; HR=0.60;
p=0.01).

Treatment with RENCAREX(R) has an excellent safety profile and is well
tolerated. The retrospective subgroup analysis indicates that RENCAREX(R)
significantly improves DFS in patients with a high CAIX score i.e. a high
antigen density. The treatment effect could be detected within 24 months of
the start of treatment. Thus the CAIX score may be helpful in identifying
and stratifying patients who may benefit from RENCAREX(R) adjuvant therapy.
RENCAREX(R) could deliver an effective therapy for patients with ccRCC and
a high CAIX score.

Professor Arie Belldegrun commented: 'The ARISER trial, which is one of the
most important prospective trials in kidney cancer in the past decade, has
demonstrated a surprisingly long Disease Free Survival. This might pose a
challenge for adjuvant ccRCC drug development without appropriate patient
stratification. The finding that a subgroup of patients had a 40% lower
risk of recurrence if treated with RENCAREX(R) is important and should be
confirmed in a future prospective trial now that we know that CAIX density
can serve as a predictive companion diagnostic for RENCAREX(R).'

WILEX plans to start discussions with regulatory authorities (FDA and
European Authorities) in the second half of 2013 on a confirmatory
prospective Phase III trial with RENCAREX(R) in the adjuvant therapy of
ccRCC in the defined subgroup using the biomarker CAIX for stratification.

The definition of the subgroup might lead to a revised peak sales potential
of RENCAREX(R) in the adjuvant setting of ccRCC of over 300 million USD.
The stratification by the biomarker CAIX may also be applicable to other
indications with CAIX expression such as colon, non-small cell lung, head
and neck and oesophageal cancer.

Following the recommendation of the IDMC to terminate the ARISER study,
WILEX and its partner Prometheus are currently in discussion on the
formalities and timing regarding the termination of the existing licensing
agreement for the US marketing rights of RENCAREX(R). Once completed, WILEX
will be able to offer a new partner world-wide rights (excluding southern
Europe).

Invitation to the conference call to present the ARISER subgroup data
WILEX will hold a public conference call for media, analysts and investors