NeuroVive Pharmaceutical AB, a leader in mitochondrial medicine, and Yungjin Pharm Corporation Ltd have jointly announced that they have entered into a global licensing agreement on Yungjin Pharm’s compound KL1333 for genetic mitochondrial disorders. The in-licensed project is about to enter phase I clinical development.

KL1333 is a drug intended for treatment of orphan genetic mitochondrial disorders. KL1333 acts through modulating the levels of NAD+ and thereby rectifying mitochondrial defects. Yungjin Pharm has received an IND and a clinical study approval in Korea, and the clinical study is scheduled to start within a couple of months.

Yungjin Pharm has granted NeuroVive exclusive global rights to develop and commercialize KL1333 worldwide, except for Korea and Japan, where Yungjin Pharm retains all commercial and marketing rights. Under the terms of the agreement, NeuroVive will pay Yungjin Pharm upfront payments of 1 million USD at signing,1 million USD one year after the signing and an additional 1 million USD after the completion of a successful phase I clinical trial. Further payments will be paid upon successful achievement of clinical development (in total 12 MUSD) market and reimbursement approval (in total 42 MUSD) milestones. In addition, Yungjin Pharm will also be eligible to receive approval and sales milestone payments and tiered single to low double-digit royalties on future net sales. Both companies will develop KL1333 in their respective territories, primarily for the treatment of genetic mitochondrial disease.

“The NeuroVive team is extremely pleased to acquire the rights to the clinical stage candidate drug KL1333 for genetic mitochondrial disorders, an area of high unmet medical need. The project is a perfect fit with our existing project portfolio in mitochondrial disorders”, said Erik Kinnman, chief executive officer at NeuroVive.

“The addition of KL1333 is perfectly in line with our business model focusing on the development of orphan indication project all the way to the market. We look forward to working with Yungjin Pharm on this opportunity, with the aim to bring relief to patients suffering from genetic mitochondrial diseases”, he continued.

NeuroVive will now initiate activities in preparation for the next clinical study in Europe and/or in the US.

“With NeuroVive’s specialist expertise in mitochondrial medicine and clinical development experience, we consider them an ideal partner for Yungjin Pharm, and with this agreement global development of KL1333 has been secured. It has been a pleasure working with NeuroVive in this process and we look forward to a fruitful collaboration”, said Sujun Park, chief executive officer & president at Yungjin Pharm.