Norgine signs exclusive licensing agreement with Innovacell for ICEF15

Norgine B.V. ("Norgine") and Innovacell today announced they have entered into an exclusive licensing agreement for Europe, SADAC and MENA for ICEF15. Innovacell and Norgine will co-develop ICEF15 and Norgine will commercialise the product. The start of the ICEF15 phase IIb clinical trial is imminent and it is anticipated that the first patient will be dosed in Q1 2014.

ICEF15 is developed for both men and women suffering from faecal incontinence with sphincter weakness or damage. ICEF15 is a personalised cell-based product concept based upon proliferating autologous myoblasts from a biopsy taken from the patients' own muscle. The patient's proliferated muscle cells are re-injected into the patient's external anal sphincter muscle, using Innovacell's proprietary injection device, thereby regenerating the muscle´s full functionality.

Phase I/II clinical trial data have shown a rapid reduction in the symptoms of faecal incontinence as well as an improvement in the quality of life. In addition, data from a retrospective study (5 years - post treatment) show that ICEF15 has a lasting effect.

It is estimated that in major European countries, around 5 per cent of all adult men and women will suffer from faecal incontinence.

Ekkehart Steinhuber, CEO at Innovacell, said, "By partnering with Norgine, Innovacell is accessing demonstrated gastroenterology and commercial expertise and capabilities that will accelerate development and market entry of ICEF15 in Europe, SADAC and MENA. ICEF15 could help many patients to overcome faecal incontinence, a very debilitating condition, and regain their quality of life."

Peter Stein, CEO at Norgine, said, "Our collaboration with Innovacell is a major step forward in developing a truly innovative therapy in a disease area in which we have strong expertise.  Faecal incontinence is a common and distressing condition that may severely restrict patients' activities and through the development and marketing of ICEF15, we hope to offer a novel and long life lasting treatment option."

He added: "ICEF15 is a strong addition to our portfolio. Our approach to partnering is flexible and our efforts are always focused to find and work with partners who have complementary skills and a shared vision for improving healthcare. Partnering is a key priority for our long-term growth and success as an independent and leading pan-European specialty pharmaceutical company."