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Agreements

Date: 2013-12-17

Type of information: Licensing agreement

Compound: ICEF15

Company: Norgine (The Netherlands) Innovacell (Austria)

Therapeutic area:

Type agreement:

licensing
commercialisation

Action mechanism:

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.

Disease: faecal incontinence with sphincter weakness or damage

Details:

* On December 17, 2013, Norgine and Innovacell have announced they have entered into a collaboration and exclusive licensing agreement for Europe, SADAC and MENA regions for ICEF15. Through this collaboration Innovacell will co-develop ICEF15 with Norgine, and Norgine will commercialise the product through its sales and marketing operations. ICEF15 is developed for both men and women suffering from faecal incontinence with sphincter weakness or damage. 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. Data from a phase I/II clinical trial 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.

Financial terms:

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Is general: Yes