iNtRON Biotechnology said it has signed a conditional license agreement with Basilea Pharmaceutical, a Switzerland-based multinational pharmaceutical company, prior to the main technology transfer agreement for SAL200, iNtRON's antibacterial bio-drug candidate.
iNtRON had signed a technology transfer agreement with Roivant Sciences in 2018, worth up to $667.5 million, for SAL200. Immediately after the contract, the Korean company received a non-refundable upfront fee of $10 million and received approval for the phase 2 clinical trial plan (IND) from the U.S. FDA.
However, development was halted when iNtRON received a contract termination request from Roivant 's subsidiary, Lysovant, in June 2022.
At that time, the company stated that the reason for the contract termination was not due to drug efficacy or safety issues.
Instead, the company stressed that Roivant made such a decision based on the time and cost incurred for development being much higher than initially expected.
As it is challenging to conduct a costly global phase 2 clinical trial independently, iNtRON expressed its intention to continue the development by finding a new partner.
Basilea specializes in new drug development for infectious diseases. Its two major drugs, which have obtained FDA approval, include Cresemba (antifungal treatment) and Zevtera (bacterial infection treatment).
Basilea has been reviewing iNtRON's data and records accumulated during the latter's FDA phase 2 clinical trial approval process for SAL200 and decided to push for an internal evaluation test to consider adjusting the clinical dose in the upcoming phase 2 trial.
As a result, Basilea entered into this option agreement to secure the rights to use SAL200 during the internal evaluation period.
Upon signing this agreement, iNtRON will receive an upfront fee, followed by an additional contract fee after the completion of the evaluation study, which will last up to one year.
However, the company did not unveil the exact contract amount, citing contractual reasons.
Although the decision to enter into the main technology transfer agreement will be made based on the results of this evaluation test, the main terms for the technology transfer agreement have already been agreed upon with this conditional license agreement.
"Basilea is a company that not only has tangible and specialized capabilities in developing new infectious disease drugs but also guarantees stability, especially with their experience in FDA clinical trials and approvals," iNtRON CEO Yoon Kyung-won said. "They are the right partner to ensure the success of SAL200."