GeNeuro and Servier sign partnership to develop first medicine addressing a causal factor of Multiple Sclerosis
GeNeuro responsible for development of GNbAC1 till completion of Phase IIb in Multiple Sclerosis, receiving $47M from Servier, after which Servier can exercise licensing option in all markets excluding the USA and Japan.
GeNeuro retains independence & full control of the U.S. & Japan and for applications of its technology in other diseases.
After exercising option, Servier will cover Phase III global development costs and pay GeNeuro up to US$408M 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 2015.
December 2, 2014, Geneva, Switzerland, and Suresnes, France - GeNeuro SA, a pioneer of new therapies for neurology and autoimmune disorders, announced today that it has entered into a strategic partnership with Servier, the leading independent French pharmaceutical company, 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.
GNbAC1, a humanized monoclonal antibody, targets MSRV-Env, the envelope protein of MS associated retrovirus, a member of the HERV-W family, the expression of which is usually silent but reactivated and expressed in MS lesions from an early stage in the disease. This protein has been shown to be both pro-inflammatory and an inhibitor of remyelination, the two major drivers of MS pathophysiology.
By targeting MSRV-Env, GeNeuro expects to bring to patients a safe, effective treatment that can halt progression of both relapsing-remitting and progressive forms of the disease without hampering the patient’s immune system. GNbAC1 has successfully completed Phase IIa, demonstrating an optimal safety profile and encouraging signs of efficacy on a first small cohort of patients. “GNbAC1’s original mode of action proposes a true innovation in the field of MS” says Prof Hans-Peter Hartung, chairman of the Department of Neurology of the University Hospital Düsseldorf and chairman of GeNeuro’s Advisory Board.
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 US$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.
For François Curtin, CEO of GeNeuro stated: “This strategic agreement with Servier is a recognition of the innovative nature and huge potential of GeNeuro’s technology. Combining GeNeuro’s technical expertise with Servier’s scientific, medical and financial resources will create an exciting new alliance to fuel the development of our unique approach, ultimately benefitting MS patients around the world.”
Jesús Martin-Garcia, Chairman of GeNeuro declared: “This agreement is an ideal way to develop GeNeuro’s technology and deliver its full value for patients and stakeholders. With all further development costs in MS funded by our partner, GeNeuro has a clear path forward with a manageable geographic focus on two of the world’s major markets.”
Emmanuel Canet, VP Research & Development at Servier underlined that: “The importance of this agreement demonstrates Servier’s willingness to dedicate its research to serious diseases with major unmet medical needs. This new partnership should allow Servier to provide patients with a new treatment against a particularly disabling disease”.
Christian de Bodinat, Director of the Neuro-psychiatry Therapeutic Innovation Centre mentioned: “MS – and especially its progressive forms – is still today a major source of handicap in the world with no satisfactory therapeutic options. We are also confident that the strong expertise of GeNeuro in MS combined with Servier’s clinical experience in neurology will result in a perfect match for driving GNbAC1 to success.”
Olivier Laureau, President of Servier added: “Not only will this new strategic alliance allow Servier to enrich its portfolio in a disease with a huge unmet medical need, but we are especially proud to count as partner a company that was spun-off from Institut Mérieux, a French institution internationally recognized for its excellence in research.”
About Multiple Sclerosis
Multiple Sclerosis is an autoimmune disease affecting the brain and spinal cord, driven by inflammatory and neuro-degenerative processes. It damages the myelin sheath, the material that surrounds and protects nerve cells, resulting in axonal damage. This slows down or blocks nervous conduction between the brain and the body, which leads to the symptoms of MS. The causes of MS are still unclear.
This disease takes three main forms:
Primary Progressive Multiple Sclerosis (PPMS, about 10% of patients at onset), where symptoms continually worsen from the time of diagnosis.
Relapsing-Remitting Multiple Sclerosis (RRMS, about 90% of patients at onset), characterized by unpredictable attacks of neurological symptoms followed by partial or complete recovery.
Secondary Progressive MS (SPMS), developed after several years of relapsing-remitting MS, in which symptoms worsen without relapses.
Present MS treatments address RRMS forms, targeting the patient’s immune system to lower the frequency of relapses, with not always a clear impact on overall disease progression, and at the cost of an increased risk of opportunistic infections and cancers. The situation is even less satisfactory in progressive forms of the disease (about 40% of patients), with a high medical need and no approved treatment for PPMS forms.
Servier is an independent French pharmaceutical research company. Its development is based on the continuous pursuit of innovation in the therapeutic areas of cardiovascular-, metabolic-neurologic-, psychiatric-, bone- and joint diseases as well as cancer.
In 2013, the company recorded a turnover of 4.2 billion euros.
91 percent of Servier drugs are consumed outside France.
27 percent of turnover from Servier drugs were reinvested in Research and Development in 2013.
With a strong international presence in 140 countries, Servier employs more than 21,000 people worldwide.
More information: www.servier.com
About GeNeuro and its technology
GeNeuro was created in 2006 at Eclosion, the Geneva life sciences accelerator, as a spin-off of Institut Mérieux where the technology was originally discovered. It develops first-in-class therapies against diseases associated with the expression of pathogenic proteins of human endogenous retroviral origin (HERV). Its lead product GNbAC1 targets MSRV-Env, a protein expressed in MS lesions from an early stage, which has been shown to be both pro-inflammatory and an inhibitor of remyelination, the two major drivers of MS progression.
The Multiple Sclerosis associated retrovirus (MSRV) is a member of the HERV-W family and was initially isolated in cell cultures from patients affected with Multiple Sclerosis. MSRV is normally latent in the genome of individuals, but it can be re-activated by viral infections and other co-factors to express a pathogenic protein, MSRV-Env. MSRV-Env provides the missing link between the observation that viral infections are associated with the onset of the disease and expression of the pathogenic factor (the MSRV-Env protein), which can then explain the inflammatory and demyelinating characteristics of MS.
By targeting MSRV-Env, GeNeuro expects to bring to patients a safe, long-term treatment that can halt progression of the disease, addressing both the inflammatory and demyelinating mechanisms relevant for all forms of MS. As the first drug addressing a causal factor of the disease, it will radically change the way MS patients are treated.
Further information can be found at: www.geneuro.com