By applying dozens of analytical methodologies, we have been able to demonstrate its analytical comparability to the reference product. An efficient manufacturing process for our biosimilar candidate has been developed and is now in place. We are currently in a phase I clinical trial, comparing the pharmacokinetics, safety, and tolerability of FYB202 and the reference product Stelara®. Bioeq GmbH is the sponsor of the clinical study and responsible for the design and operative execution. We have, in addition, filed our own patent applications, such as in the area of drug formulation.
At the end of 2017, we transferred the FYB202 project to a joint venture entity called “FYB 202 GmbH & Co. KG”, in which Formycon holds a 24.9 percent interest. The remaining 75.1 percent is owned by Berlin-based Aristo Pharma GmbH, which is part of Strüngmann Group. Under the terms of the deal, all development costs incurred subsequent to the pilot phase, as well as all prior project investments, will be allocated in proportion to the respective ownership shares. Likewise, both of the joint venture partners will share any future income from out-licensing or product sales in proportion to their ownership shares