Completion of the first-stage condition of SAL200 Evaluation License and Option Agreement
▶ Completion of the first-stage condition of the Agreement with Swiss partner
▶ The supply comparator dug, the smooth progress of the Agreement
▶ Dose adjustment for the Phase 2 study will be reviewed following the internal evaluation
We would like to announce that we have completed the supply of investigational products, including SAL200 and a comparator drug, as part of the ‘Evaluation License and Option Agreement’ signed with a Swiss pharmaceutical company for the treatment of MRSA infections, SAL200.
For the internal evaluation studies of SAL200 by the Swiss partner, we have supplied the SAL200 investigational product along with the comparator drug. Despite the considerable time spent on the setup, including in-house production and QC of the comparator drug, we have successfully completed production and it gives us a meaning fact that we have established the production system for another recombinant drug as well. Consequently, we have fulfilled the first-stage conditions of providing SAL200 and the comparator drug, indicating a planned progress in the Option Agreement.
The Option Agreement with our Swiss partner for SAL200 was signed at the end of October last year. During the Option Agreement period, it is planned to conduct internal evaluation studies, including the review of dose adjustments for SAL200 in the US Phase 2 clinical trial to determine the optimal clinical development program.
In the subsequent stages, we anticipate that our Swiss partner with ample FDA clinical and approval experiences in the infectious disease drug development will proceed with actual development. Drawing on their experiences in sales of antibiotics and antifungals in the US and Europe, we expect that SAL200 will successfully go through clinical and commercialization phases.
We consider the supply of investigational products as a crucial step, indicating the smooth progress of SAL200 out-licensing. We strongly believe that the internal evaluation studies by our Swiss partner will lead to a decision on the dose adjustment for SAL200 in the Phase 2 study and ultimately contribute to the successful progression of clinical and commercialization, and we will contribute our best effort for it.
Thank you.
it is iNtRON.