(BFM Bourse) – A few months before the announcement of the results of a decisive clinical study, the American biotech company Sarepta and Lysogene have terminated a license agreement which could have brought in 125 million dollars in milestones for the French firm.
The paths of Sarepta, an American biotech still in search of profitability despite several gene therapies already on the market in Duchenne muscular dystrophy – yet expensive treatments at around 300,000 dollars per patient and per year, and the French firm separate.
Lysogene announced Thursday morning in a press release the termination of the licensing agreements entered into in October 2018 granting Sarepta the rights, outside Europe, of its experimental treatment LYS-SAF302, a gene therapy developed in response to a form of mucopolysaccharidosis (or mucopolysaccharidosis syndrome). Sanfilippo, a rare and incurable neurodegenerative disease).
This termination, which will take effect on July 11, 2022, follows unsuccessful discussions for the transfer to Lysogene of responsibility for the production of the commercial product LYS-SAF302 on a global level, explains the tricolor biotech.
The rights relating to the commercialization and development of the treatment in the United States and in other territories outside Europe will therefore revert to Lysogene, which had in addition retained the European rights, as well as the responsibility for the commercial supply. worldwide of LYS-SAF302. Lysogene will receive unspecified indemnities from Sarepta for the reimbursement of certain costs associated with the termination. The license agreement called for the company to receive up to $ 125 million in milestone payments and a high single-digit percentage on any sales. Sarepta also holds 6.7% of the capital.
President and CEO Karen Aiach thanked Sarepta “for helping us move the LYS-SAF302 program forward over the past few years.” “With data analysis expected in a few months, we are more confident than ever that LYS-SAF302 is an important treatment option for patients with MPSIIIA, and we remain fully engaged with the MPSIIIA community,” added the boss. and co-founder of the company, ensuring that Lysogene continued its efforts to become a leading gene therapy technology platform targeting diseases of the central nervous system (CNS).
The efficacy, safety and tolerance of LYS-SAF302 are currently being evaluated in an international phase 2/3 trial, the “AAVance” study, involving 20 children with type IIIA MPS.
“Our priority remains to move forward on our existing programs with the completion of the pivotal study with LYS-SAF302, the end of the recruitment of the safety cohort and the initiation of the recruitment of the efficacy cohort in the trial. clinical trial with LYS-GM101 for the treatment of GM1 gangliosidosis, and the development of our preclinical programs in Fragile X and nGaucher/Parkinson’s disease We are also constantly seeking opportunities to expand our portfolio with new new CNS gene therapy actives”.
On the stock market, the Lysogene share fell by 1.8% to 1.866 euros around 10 a.m., bringing its capitalization to 32.2 million euros (compared to around 82.1 million on its introduction in February 2017).
Guillaume Bayre – ©2022 BFM Bourse
Are you following this action?
Receive all the information about LYSOGENE in real time: