Letter to the shareholders
The news from our RENCAREX trial unfortunately marked a severe setback in one of our key product programmes. The results of the ARISER trial were surprising and unexpected for both the Executive Management Board and our staff.
We are currently making every effort to identify the reasons for the poor performance of our drug and will thoroughly investigate the trial data. We will of course inform the market as soon as we have any significant findings. We owe this not only to the patients who participated in the trial, but also to you, our shareholders. At the same time, we will talk to our licensing partners, Prometheus and Esteve. Please understand that in the meantime we would prefer not to provide premature or speculative answers to the questions understandably directed to us on the ARISER trial or RENCAREX.
However, we would also like to use this opportunity to direct the attention of our shareholders and market partners to our attractive product portfolio and our broad business model.
WILEX is about much more than just RENCAREX. In our Therapeutics segment, we have successfully conducted two phase IIa trials with our uPA inhibitor MESUPRON in the indications of pancreatic and breast cancer and are currently searching for a partner for further development. We have achieved significant progress over the past few months in the development of the projects acquired from UCB, even if the attention of our shareholders may have been focused more on our other product candidates. The MEK inhibitor WX-554 is currently undergoing a phase Ib/II programme in cancer patients suffering from various tumours, and the PI3K inhibitor WX-037 has completed comprehensive preclinical trials. Clinical development is currently in preparation. We attribute great medical significance to these two candidates, especially when used in combination.
To put our company on a broader base, we established two new business segments over the past few years. REDECTANE, our radiolabelled antibody for diagnosing clear cell renal cell carcinoma, has already shown good data in a phase III trial. We are currently preparing a second phase III trial to collect additional data on performance and safety. It is our clear objective to launch this product as soon as possible. In addition, the diagnostics segment has a portfolio of biomarker tests that are already being marketed via WILEX Inc., and our subsidiary Heidelberg Pharma GmbH offers preclinical services for various indications. Furthermore, research work for various pharmaceutical and biotechnology companies is being conducted with our proprietary ADC technology platform with the goal of entering into licensing agreements. We are making good progress in this field too.
This severe setback in our previously successful corporate development is an opportunity to re-evaluate our strategy and all options with the Supervisory Board. We plan on providing you with an outlook on our development activities as soon as possible.
Munich, 26 October 2012
The Executive Management Board