Extended duration of injection interval

2 Lucas et al. Efficacy of lanreotide Autogel ® administered every 4–8 weeks in patients with acromegaly previously responsive to lanreotide microparticles, 30 mg: a Phase III trial 1 Lucas T, 2 Astorga R and the Spanish–Portuguese Multicentre Autogel Study Group on Acromegaly 1 Service of Endocrinology, Clínica Puerta de Hierro, Madrid, Spain; 2 Service of Endocrinology, Hospital ‘Virgen del Rocío’, Sevilla, Spain Manuscript accepted for publication in Clin Endocrinol Study number: A Poster presented at ECE 2005

3 Lucas et al. – Objectives Confirm equivalent efficacy of lanreotide Autogel, 120 mg, administered at intervals of 4, 6 or 8 weeks, and lanreotide microparticles, 30 mg, administered every 7–14 days to patients with acromegaly Compare the safety of the two formulations

4 Lucas et al. – Design and Methods Phase III, open, multicentre, crossover study 97 patients with active acromegaly  Receiving lanreotide microparticles, 30 mg, fixed injection intervals for at least 2 months  Switched to lanreotide Autogel, 120 mg  Lanreotide microparticles every 14 days  lanreotide Autogel, every 8 weeks  Lanreotide microparticles every 10 days  lanreotide Autogel, every 6 weeks  Lanreotide microparticles every 7 days  lanreotide Autogel, every 4 weeks Blood samples taken before final injection of lanreotide microparticles and Autogel, and in final dosing period for lanreotide Autogel Symptoms of acromegaly assessed at the beginning and end of study Systemic and local tolerability recorded after each injection

5 Lucas et al. – Results (1) Both formulations showed similar efficacy in reducing serum GH; similar efficacy for each of the injection frequencies of lanreotide Autogel Mean GH ratio Lanreotide Autogel/microparticles Lanreotide Autogel 120 mg days42 days56 days Day Week Day Week Day Week

6 Lucas et al. – Results (2) Biological markers Plasma concentrations of IGF-1 did not change significantly over the course of the study

7 Lucas et al. – Results (3) Symptoms of acromegaly Symptoms of acromegaly generally mild or moderate in intensity Greater symptom control achieved at the end of treatment with lanreotide Autogel compared with lanreotide microparticles Tolerability As expected, most common adverse events were gastrointestinal Local tolerability comparable for the two formulations Other endpoints Lanreotide Autogel well accepted by patients: mean acceptance score 8.3/10 Acceptance similar between dosing groups

8 Lucas et al. – Conclusions Lanreotide Autogel, 120 mg every 4–8 weeks, at least as effective and well tolerated as lanreotide microparticles, 30 mg, every 7–14 days Lanreotide Autogel well accepted by patients Longer dosing interval of lanreotide Autogel, 120 mg, maintains the same overall monthly dose as lanreotide microparticles, 30 mg, but has benefits in cost and patient compliance

9 Lucas et al. – Key Messages Lanreotide Autogel, 120 mg, every 4–8 weeks as effective as lanreotide microparticles, 30 mg every 7–14 days Lanreotide Autogel, presented in a pre-filled syringe is convenient for patients and clinicians Lanreotide Autogel is the only somatostatin analogue approved for use with this extended dosing interval The longer dosing period provides:  Greater ease of use and convenience  A reduced number of clinic visits  Cost savings  Improved patient compliance