TxCell and Ferring International Center sign collaboration, option, development and license agreement for TxCell’s lead product Ovasave(R) for the treatment of IBD

VALBONNE, France, and SAINT-PREX, Switzerland I March 14, 2014 I TxCell SA, a biotech developing innovative, personalized cell-based immunotherapies using antigen-specific regulatory T-cells (Ag-Tregs) for chronic inflammatory and autoimmune diseases, and Ferring International Center SA, a private biopharmaceutical with a global franchise in inflammatory bowel disease (IBD), affiliates in more than 55 countries, product availability in over 100 countries, and 4,500 employees, today announces the signing of a collaboration, option, development and license agreement potentially worth up to EUR 76 million plus royalties subject to the achievement of milestones.

In the agreement, TxCell has granted Ferring an option to acquire an exclusive worldwide license for the development, manufacture and marketing of TxCell’s lead candidate Ovasave for the treatment of IBD, including Crohn's disease and ulcerative colitis. TxCell will undertake a forthcoming phase IIb study with Ovasave in refractory Crohn’s disease. Ferring will then be responsible for the conduct and funding of further development and commercialisation after the exercise of the option. There are currently around 100,000 refractory Crohn’s patients per year in Europe and in the US alone for whom there is no therapeutic treatment today(1).

Initially, TxCell will receive EUR 3 million for the acquisition of the option by Ferring, of which EUR 1 million was paid upon signature of the agreement and the remainder will be paid depending on the progress of the Ovasave phase IIb trial planned to start in the second half of 2014. TxCell will also be eligible in the future in the event of the exercise of the option to development, commercial and manufacturing milestones and payments up to a total of EUR 73 million. TxCell will also receive tiered royalties up to double digits on future sales of Ovasave.

“This agreement between TxCell and Ferring is a key milestone for TxCell,” said Damian Marron, CEO, TxCell. “The alliance of TxCell’s unique personalized cellular immunotherapy technology with Ferring’s renowned expertise in IBD will ensure that TxCell’s lead product, Ovasave, can be developed effectively and marketed globally to the sufferers of refractory Crohn’s disease. The agreement underlines the value of TxCell’s ASTrIA platform and the quality of the work of TxCell’s research, development and manufacturing teams”.

“This agreement reinforces Ferring’s continued commitment to bringing innovative therapies to patients suffering from gastrointestinal diseases. Ovasave represents an exciting potential addition to our current gastroenterology product portfolio,” said Pascal Danglas, Executive Vice President, Clinical and Product Development and member of the Executive Board of Ferring International Center SA.

(1)According to PharMetrics Analysis, September 2008

About TxCell

TxCell is developing innovative personalized cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need using its unique and proprietary ASTrIA technology platform based on the properties of autologous antigen-specific regulatory T lymphocytes (Ag-Tregs). The company has completed a phase I/IIa study of its lead product candidate, Ovasave(R) in refractory Crohn’s disease patients and has reported good tolerability and positive signals of efficacy. The company plans to initiate a phase IIb study in the same patient population. 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 39 employees based at its headquarters and at its manufacturing site in Besançon.

For more information, please visit www.txcell.com.

About Ferring International Center

Headquartered in Switzerland, Ferring International Center is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology and endocrinology. Ferring has its own operating subsidiaries in 55 countries and markets its products in more than 100 countries. To learn more about Ferring or its products please visit www.ferring.com.

SOURCE: TxCell

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