Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a
peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal
and portal blood flow, and inhibit gastric acid secretion. Teduglutide binds to the
glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine
cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric
plexus. Activation of these receptors results in the local release of multiple mediators
including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor
(KGF).

This multicenter, double-blind, international, Phase III trial will have a treatment period
of 28 weeks. Subjects in this study are those who received teduglutide or placebo in protocol
CL0600-004 (NCT00081458). These subjects will receive daily subcutaneous injections of 0.05
milligrams or 0.10 milligrams of teduglutide per kilogram of body weight. Subjects will have
visits every 4 to 6 weeks and will be assessed for parenteral nutrition (PN) reduction with a
follow-up period of 4 weeks duration for those subjects who do not complete this protocol, or
do not enter into the long-term safety extension protocol CL0600-010.

Inclusion Criteria:

At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their
participation in this study.

Subjects who meet all of the following criteria can be enrolled in this study:

- Signed and dated informed consent form (ICF) to participate before any study-related
procedures are performed

- Completion of protocol CL0600-004 (NCT00081458)

Exclusion Criteria:

- History of cancer or clinically significant lymphoproliferative disease with fewer
than 5 years documented disease-free state

- History of alcohol or drug abuse (within previous year)

- Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit

- Pregnant or lactating women

- Any condition or circumstance, which in the investigator's opinion would put the
subject at any undue risk, prevent completion of the study, or interfere with analysis
of the study results