- Based on R&D strategic reasons, Servier declines option to license and to further fund the development of GNbAC1 in MS
- Servier will continue to support GeNeuro as a shareholder
- Based on positive Phase IIb 12-month results, GeNeuro will pursue further development and worldwide partnering options
- GeNeuro will hold a conference call today Tuesday, September 18th at 2:30 pm CEST / 8:30 am EDST
Paris, France and Geneva, Switzerland, September 18, 2018 – 07:30am CEST – Servier and GeNeuro (Euronext Paris: CH0308403085 – GNRO) announced today 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 combination options.
Jesús Martin-Garcia, CEO of GeNeuro, stated “We understand this is a strategic decision for Servier, which we respect. It opens new opportunities for GeNeuro at this stage of our development. Based on our successful results on key measures linked to MS progression, we will continue to work to form new partnerships to bring the benefits of GNbAC1 to patients. We are sad to lose Servier, an expert partner in clinical development, focused on science and patient needs. It has been our privilege to share the journey with their team during the last four years.”
Emmanuel Canet, Executive Vice-President of Research and Development at Servier, stated: “Based on R&D strategic reasons, Servier has made the difficult choice to decline the option to license GeNeuro’s compound in MS. We were glad to work with GeNeuro harmoniously, and are proud to have contributed to the development of a new approach to treat disease progression, the major unmet medical need in MS. We are extremely grateful to all patients who participated in this development. GeNeuro has strong leadership and development capabilities. Servier believes in the potential of this approach and will continue to support the company as a shareholder.”
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.
GeNeuro will hold a conference call on Tuesday, September 18th at 2:30 pm CEST / 8:30 am EDST, followed by a Q&A session.
The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 66980001#
– France: +33 170710159
– Switzerland: +41 445831805
– UK: +44 2071943759
– USA: +1 8442860643
Following the live call, a replay will be available on the GeNeuro website: www.geneuro.com
Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 149 countries and a turnover of 4.152 billion euros in 2017, Servier employs 21,700 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generic drugs) in research and development and uses all its profits for development. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neuropsychiatric diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development.
More information: www.servier.com
GeNeuro‘s mission is to develop safe and effective treatments against neurological disorders and autoimmune diseases, such as multiple sclerosis and Type 1 Diabetes, by neutralizing causal factors encoded by HERVs, which represent 8% of human DNA. GeNeuro is based in Geneva, Switzerland and has R&D facilities in Lyon, France. It has 28 employees and rights to 16 patent families protecting its technology. For more information, visit: www.geneuro.com
Sonia MARQUES : firstname.lastname@example.org – Tel. +33 (0)1 55 72 40 21 / + 33 (0) 7 84 28 76 13
Karine BOUSSEAU : email@example.com – Tel. +33 (0)1 55 72 60 37 / + 33 (0) 6 49 92 16 05
|GeNeuro:||NewCap (France)||Halsin Partners||LifeSci Advisors|
|Jesús Martin-Garcia||Emmanuel Huynh/
Mathilde Bohin (investors)
|Mike Sinclair (media)||Chris Maggos (investors)|
|Chairman and CEO||+33 1 44 71 98 52||+44 20 7318 2955||+1 646 597 6970|
|+41 22 552 48 00||Nicolas Merigeau (media)||firstname.lastname@example.org||+41 79 367 6254|
|email@example.com||+33 1 44 71 94 firstname.lastname@example.org|
This press release contains certain forward – looking statements and estimates concerning GeNeuro’s financial condition, operating results, strategy, projects and future performance and the markets in which it operates. Such forward-looking statements and estimates may be identified by words, such as “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions. They incorporate all topics that are not historical facts. Forward looking statements, forecasts and estimates are based on management’s current assumptions and assessment of risks, uncertainties and other factors, known and unknown, which were deemed to be reasonable at the time they were made but which may turn out to be incorrect. Events and outcomes are difficult to predict and depend on factors beyond the company’s control. Consequently, the actual results, financial condition, performances and/or achievements of GeNeuro or of the industry may turn out to differ materially from the future results, performances or achievements expressed or implied by these statements, forecasts and estimates. Owing to these uncertainties, no representation is made as to the correctness or fairness of these forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates speak only as of the date on which they are made, and GeNeuro undertakes no obligation to update or revise any of them, whether as a result of new information, future events or otherwise, except as required by law.