TxCell SA (FR0010127662 – TXCL), a biotechnology company developing innovative, cost-effective, personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces today a further enhancement to the development of its lead product Ovasave(R) for the treatment of Inflammatory Bowel Diseases (IBD), including Crohn’s disease and ulcerative colitis. The collaboration, option, development and license agreement between TxCell and Ferring International Center SA (Ferring) has been assigned to Trizell Holding SA (Trizell), an affiliate member of the Dr Frederik Paulsen Foundation.
Trizell was established by the Dr Frederik Paulsen Foundation (the Foundation) to provide specialist management and scientific and development expertise that is dedicated to advanced therapies, i.e. cellular and gene therapies. This new class of highly promising biological therapies includes TxCell’s Ovasave(R).
Ferring, an affiliate company of the Foundation, executed an exclusive worldwide agreement in December 2013 with TxCell, securing the option to be the commercializing entity for Ovasave(R) for the treatment of IBD, including Crohn’s disease and ulcerative colitis. Ferring and its affiliates have an operating presence in more than 55 countries and have an established global franchise in IBD. The deal is estimated as being potentially worth up to EUR 76 million in upfront and milestone payments plus royalties subject to the achievement of sales milestones and is unchanged by the Trizell assignment.
“Products at the forefront of innovation, such as TxCell’s personalized medicine, require expert and dedicated development teams. As such, TxCell’s lead product Ovasave(R) for severe refractory Crohn’s disease will benefit enormously from the additional focus and expertise that Trizell will supply,” said Damian Marron, CEO TxCell. “This is a clear example of the dedication and support TxCell was seeking when we entered into our earlier agreement with Ferring for Ovasave(R). There are currently over 100,000 refractory Crohn’s patients per year in Europe and the US alone for whom there is no therapeutic treatment today. These patients could benefit enormously from availability of Ovasave(R).”
“This assignment to the Foundation’s specialist company reinforces our increasing commitment to new products like Ovasave(R) which offer potential breakthroughs in the treatment for diseases with high unmet medical needs. Accordingly, we will be following its continued progress through development very closely as it is intended that Ferring will be the final commercializing party,” said Mr Michel Pettigrew, Chief Operating Officer and President of the Executive Board of Ferring.
TxCell develops innovative, cost-effective, personalized T cell immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need. TxCell has created ASTrIA, a unique and proprietary technology platform based on the properties of autologous antigen-specific regulatory T lymphocytes (Ag-Tregs). The company has initiated a phase IIb study of its lead product candidate, Ovasave(R) in refractory Crohn’s disease patients. This follows a phase I/IIa study in the same patient population reporting positive clinical efficacy and good tolerability. TxCell signed a strategic partnership for Ovasave(R) with the Swiss company Ferring International Center SA, an affiliate company of the Dr Frederik Paulsen Foundation, in December 2013 that has been assigned to an affiliate member of the Foundation, Trizell SA, for further development. TxCell’s second product candidate, Col-Treg is for the treatment of autoimmune uveitis, a rare disease of the eye. A placebo-controlled, dose-ranging proof of principle clinical study is planned to start in the first half of 2015. Listed on Euronext-Paris, TxCell, a spin-off of Inserm (France’s National Institute for Health and Medical Research) is located in the Sophia Antipolis technology park, Nice, France. The company has 55 employees based at its headquarters and at its manufacturing site in Besançon.
For more information, please visit www.txcell.com
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