Sanofi has informed Hanmi Pharmaceutical of its intention to return all rights on Efpeglenatide, a diabetes drug candidate, to the Korean pharmaceutical company.
Sanofi has been conducting phase 3 clinical trials for the new drug, which it licensed from Hanmi Pharmaceutical in 2015.
Sanofi previously said it would complete the Phase III trial, but the multinational company reversed its position and one-sidedly declared it would return its rights to commercialize and distribute Efpeglenatide to Hanmi.
Hanmi Pharmaceutical said it would discuss the matter with Sanofi for 120 days before reaching a final decision, as stated in the initial contract. It said it is not obliged to return the 200 million euros (about 264.3 billion won) upfront payment it had already received, even when the contract is scrapped.
Developed by Hanmi, Efpeglenatide is a therapy for treating type 2 diabetes. It employs Hanmi's lapscovery delivery technology, which extends the life of a peptide or protein in the body while enhancing its efficacy and potency.
Hanmi said it would discuss ways to complete the phase 3 clinical trial of Efpeglenatide, which is in its final stage. In addition, it will look for a new global partner to commercialize the drug.
Sanofi’s decision to return its rights on Efpeglenatide to Hanmi Pharmaceutical came following its announcement in December 2019 that it would look for the best partner for global sales of Efpeglenatide. Sanofi’s plan was to complete the phase 3 clinical trial even if it entrusts the commercialization of the drug to another company.
As such, Sanofi’s abrupt decision to scrap the license deal has perplexed Hamni. "Sanofi's decision has nothing to do with the effectiveness or safety of Efpeglenatide,” said a Hanmi official. “We will consider taking legal actions against Sanofi, if necessary."