Type of information: Termination of an agreement
Company: Servier (France) GeNeuro (Switzerland)
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Type agreement: development - commercialisation
- monoclonal antibody. The monoclonal antibody GNbAC1 targets the envelope protein of an endogenous retrovirus which could play a critical role in the pathogenesis of multiple sclerosis. Discovered in the early 90’s, the Human endogenous retrovirus of type W is closely associated with multiple sclerosis and, due to its neurotoxic properties, could be a causal factor of the disease. This retrovirus is normally latent in the genome of individuals, but it can be re-activated by certain co-factors to expresses a pathogenic protein, MSRV-Env. Recent evidence has demonstrated that this ENV-protein is expressed in multiple sclerosis lesions from an early stage, is pro-inflammatory and inhibits remyelination.
Disease: multiple sclerosis
- • On December 2, 2014, GeNeuro announced that it has entered into a strategic partnership with Servier, to develop and market GNbAC1 in Multiple Sclerosis (MS). As the first drug addressing a causal factor of the disease, GNbAC1 has the potential to radically change the way MS patients are treated. Under the terms of the agreement, GeNeuro will be responsible for the development of GNbAC1 until completion of Phase IIb, after which Servier can exercise the option to license the product for all markets excluding the USA and Japan.
- Financial considerations include the payment by Servier to GeNeuro of US$47 million to finance the completion of Phase IIb. Subsequent to exercising the option agreement, Servier will cover the costs of the Phase III global development program and pay GeNeuro up to $408 million in future development and sales milestones, as well as royalties on future sales. Servier will also have the option to take an equity stake in GeNeuro as a minority shareholder in the next 12 months.
- • On September 18, 2018, Servier and GeNeuro announced that GeNeuro has regained worldwide rights ex US and Japan to its lead compound GNbAC1 in multiple sclerosis (MS) from Servier. In 2014, Servier acquired an option to license the development and commercialization of GNbAC1 for MS in all territories ex-US and Japan for €37.5 million. Servier made the decision to decline this option based on R&D strategic reasons and international development priorities. Servier will continue supporting GeNeuro as a shareholder. In March 2018, GeNeuro and Servier released successful data from the CHANGE-MS Phase IIb clinical trial at 12 months, demonstrating a consistent positive impact on key neuroprotection markers associated with disease progression in MS. These positive results in relapsing remitting patients enable the development of GNbAC1 for all forms of MS, potentially as a monotherapy for patients with progressive
forms of the disease, as well as in combination with existing drugs for relapsing forms.
- GeNeuro, which held US rights, is currently engaged in partnering discussions regarding the development in the US, and having regained global rights, will expand those discussions to new geographic territories and treatment
- The extension ANGEL-MS study, funded by Servier, will be shortened. Its termination will have no financial impact for GeNeuro. GeNeuro is also continuing its Phase IIa clinical trial with GNbAC1 in 60 recently diagnosed adults with
type I diabetes. The top-line results at 6 months of this 12 month study are expected by the end of September 2018.
- • On December 18, 2015, GeNeuro announced that simultaneous with the start of GNbAC1's Phase IIb, development partner Servier has exercised its equity investment option, as part of an agreement signed in November 2014, to become a minority shareholder in GeNeuro by purchasing shares from existing shareholder Eclosion2. The terms of the partnership agreement provide for GeNeuro to receive US$40 (€37.5) million from Servier for the completion of the Phase IIb study. Subject to exercising its option for a licensing agreement, Servier has agreed to finance the global Phase III development program and pay GeNeuro up to an additional US$355 (€325) million in future development and sales related milestones, as well as royalties on future sales.