Norgine and Innovacell Dose First Patient in Phase IIb Clinical Trial of ICEF15, a Personalised Cell Therapy to Treat Faecal Incontinence

Norgine B.V. (“Norgine”) and Innovacell today announced that the first patient has been dosed in the Phase IIb STEFFI study, which has been designed to evaluate the clinical efficacy and safety of ICEF15 (autologous skeletal muscle derived cells), versus placebo in patients suffering from faecal incontinence. The STEFFI study will also help to identify the optimal dose for the functional regeneration of the external anal sphincter.

The STEFFI Phase IIb study is a European multicenter, randomised, double-blind, placebo-controlled, parallel-group, dose-finding clinical trial expecting to enrol approximately 250 patients.

ICEF15 is a personalised therapy based upon proliferating autologous skeletal muscle derived cells from a biopsy taken from the patients’ own muscle for the treatment of both men and women suffering from faecal incontinence with sphincter weakness or damage. 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 muscle functionality.

There is a significant unmet medical need for treating faecal incontinence. It is estimated that in major European countries, around 5 per cent[i] of all adult men and women will suffer from faecal incontinence. There is a strong association between increasing age and faecal incontinence, but it is also suggested that women are at greater risk of faecal incontinence and that the cause of this is primarily related to childbirth.[ii]

Ekkehart Steinhuber, CEO at Innovacell said, “As the first centre has now enrolled a patient in this Phase IIb study, we look forward to evaluating the potential of this treatment in a larger cohort of patients. ICEF15 has the potential to become the first-choice treatment over current therapies and could also offer a once in a lifetime treatment option.”

 Peter Stein, CEO at Norgine said, “We are excited about the progress we are making with ICEF15. This milestone further demonstrates Norgine’s commitment to partner with Innovacell in developing an innovative treatment with a particular focus on high unmet need. ICEF15 has the potential to improve patient’s quality of life in a disease area where there are currently limited treatment options.”

*ICEF15 is also known as NPJ5007.

Notes to editors

About the STEFFI study

The STEFFI study is a Phase IIb European multicenter, randomised, double-blind, placebo-controlled, parallel-group, dose-finding clinical trial which is expected to enrol approximately 250 patients. The study population is female and male patients with faecal incontinence resulting from external anal sphincter weakness or sphincter damage. The key aims of the study are to show the clinical efficacy and safety of Skeletal Muscle Derived Cells in patients suffering from FI, and to find the optimal cell count for the functional regeneration of the external anal sphincter. The primary endpoint of the study is the change in the frequency of faecal incontinence episodes compared to baseline.

About Norgine

Norgine is a leading independent European specialty pharmaceutical company that has been established for over 100 years and has a presence in all major European markets. In 2013, Norgine’s total revenue was €274 million and the company employs over 1,000 people.

Norgine’s focus is the development and marketing of pharmaceutical products that address significant unmet clinical needs in therapeutic areas such as gastroenterology, hepatology, critical and supportive care. Norgine owns a manufacturing and development site in Hengoed, UK and a manufacturing site in Dreux, France.

In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US.

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

About Innovacell

Innovacell Biotechnologie AG is a privately-held Phase III biotechnology company based in Innsbruck, Austria. The company is engaged in the clinical development of autologous (i.e. patient’s own cells), minimally invasive cell therapies. Innovacell’s personalized products are potentially curative one-off treatments, which re-establish functionality of sphincter muscles in patients, i.e. with stress urinary incontinence (SUI) or fecal incontinence (FI).

Innovacell’s products are highly innovative in terms of com composition and methodology.

Innovacell owns and operates one of the biggest manufacturing facilities for the expansion of autologous cells in Europe. For more information: http://www.innovacell.com.

Innovacell’s supervisory board is chaired by the experienced financial expert, Dr. Harald Pöttinger, CEO of Alpine Equity Management AG, based in Bregenz, Austria.