Ladies and Gentlemen,
In connection with the information provided yesterday by Selvita S.A. on withholding the clinical programme for SEL24, the Management Board of Celon Pharma S.A. informs that such situations occur naturally in the process of creating innovative medicinal products, as demonstrated by numerous examples of clinical projects carried out in American or European markets.
At the same time the Management Board of Celon Pharma S.A. emphasises that one of the key aspects of our strategy for the development of innovative medicinal products is the constant effort to reduce the risk of project implementation by giving proper importance to the safety of characterisation of clinical candidates, proceeding in accordance with regulatory guidelines, as well as quantitative and therapeutic diversity of projects.
The competences of our team made up of dozens of people specialising in the field of preclinical and clinical development of medicines, many years of experience in the development of medicinal products, as well as constant monitoring of the safety of their use gives us solid grounds to assume that our strategy, although spread over time, will be implemented not only consistently, but also effectively. In accordance with the previously adopted assumptions, we maintain our readiness to introduce 6 projects into clinical development over the next 9 months, thus significantly eliminating the overall risk to our programme.
At the same time Celon Pharma S.A. expresses hope that Selvita’s cooperation with the American regulator will not only make it possible to resume the SEL24 clinical programme, but also to successfully complete it to the benefit of patients with acute myeloid leukemia.
The Management Board of the Company and the Investor Relations Division remain at your disposal in case of any questions.
Maciej Wieczorek, PhD
President of the Board of Celon Pharma S.A.: