Ipsen nets FDA approval for new pre-filled syringe for Somatuline Depot

– New Syringe Designed to Help Enhance Injection Experience –

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN; ADR:
IPSEY), announced today that the United States Food and Drug
Administration (FDA) has approved a new pre-filled syringe for Somatuline^®
Depot (lanreotide). The syringe includes updated
features, such as larger flanges, designed to help make it easier for
healthcare providers to administer the injection. The
indications remain the same as those for the previous pre-filled syringe
and include the treatment of adult patients with unresectable, well- or
moderately-differentiated, locally advanced or metastatic
gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve
progression-free survival; treatment of adults with carcinoid syndrome;
when used, it reduces the frequency of short-acting somatostatin analog
rescue therapy; and the long-term treatment of patients with acromegaly
who have had an inadequate response to surgery and/or radiotherapy, or
for whom surgery and/or radiotherapy is not an option.

“The conditions of GEP-NETs and acromegaly can be associated with a
number of uncomfortable and unpleasant symptoms, and innovation aimed at
improving the injection process is a step forward,” said Daphne
Adelman, Clinical Nurse Specialist, Northwestern University, Chicago,
and one of the authors of the study.

Ipsen conducted five separate but complementary studies in partnership
with patients, their caregivers, nurses and other healthcare
professionals to better understand the current use of the existing
Somatuline^® Depot pre-filled syringe and to evaluate ways to
improve the features of the device.¹ The result of this
collaboration is a redesigned delivery system intended to make it easy
to grip the syringe and administer the injection. The new syringe
features a needle shield removal system, more stable plunger and
thermoform tray that has recessed areas designed to help prevent
accidental plunger depression.¹ The built-in safety system,
which may help to prevent needle stick injury by locking in place
following the administration, has not been changed.¹

“We consistently look for opportunities to respond to the needs of the
communities we serve, and this approval would not have been possible
without the direct involvement of nurses and the patients with GEP-NETs
and acromegaly whom they treat,” said Bradley Bailey, SVP, and
Franchise Head Oncology/Endocrinology Business Unit at Ipsen. “We
listened and collaborated to enhance the existing pre-filled syringe,
making it sturdier for healthcare providers when administering
treatment, with the intention of improving the injection process. We
look forward to bringing this innovation to healthcare providers for
their patients soon.”

The new pre-filled syringe is for deep subcutaneous injection and is
intended for administration by a healthcare professional. Healthcare
providers can expect to receive the new syringe during Q3 2019. The
device is approved for use in the U.S., EU and additional ex-U.S.
markets.