DIABETIC FOOT ULCER - FACT SHEET

Indicative timetable of clinical phase III trials

Grey area represents period of patient inclusion, black area represents study completion and reporting.

The figure above indicates the timetable for the clinical trials with SBG for treatment of diabetic foot ulcer. Biotec Pharmacon has set up two double blinded studies, where SBG is studied with a non-active comparator (placebo) as control agent. The primary study endpoint is defined as the proportion of patients with target ulcers that heal within 8 weeks, with secondary endpoints being (i) proportion of patients with target ulcers heal within 12 weeks, (ii) time to healing of target ulcers, (iii) percent change in target ulcer area, and (iv) recurrence of healed target ulcers within 12 weeks post healing.

The first phase III study involves 120 patients at Nottingham University Hospitals NHS Trust and 10 other centers in UK. The second phase III study involves 130 patients at 17 centers in Spain, Poland, and Russia. All patients have now been included in the studies.

An independent statistician in November 2008 performed a blinded interim analysis to reassess the patient population in the first study, based on the first 80 first evaluable patients. The recommendation was not to adjust the patient population, meaning that the planned population was either sufficiently large to provide a significant differences between SBG and the non-active comparator (in either direction), or that the difference between the two groups is too small to demonstrate a difference even with a substantial increase in sample size. Pre-clinical data and phase I/II data indicate that SBG offers advantages compared to placebo, and the company decided to make no adjustments to the study program.

In March 2009, an independent statistician was commissioned to perform a blinded interim analysis to reassess the sample size also in the second study, with a recommendation expected by mid-May.

Provided that no changes are being made to the patient population in the second study, Biotec Pharmacon expects final results to be ready by year-end 2009 for both phase III studies. Under these assumptions, the company is well on track to file for marketing authorisation with SBG for treatment of diabetic foot ulcer in Europe in mid-2010.