Ipsen Announces the Availability of the Newly Designed Delivery System for Somatuline® Autogel® (lanreotide injection)

Mississauga, ON – January 7, 2020 – Ipsen Biopharmaceuticals Canada Inc. today announced the availability of a new delivery system for Somatuline^® Autogel^® (lanreotide injection) 60, 90, and 120 mg.  The new pre-filled syringe is now available for Canadian patients and includes updated features designed to help make it easier for healthcare providers and patients to administer the injection. Somatuline^® Autogel^® (lanreotide injection) is approved for the treatment of enteropancreatic neuroendocrine tumours (NETs) in adult patients with Grade 1 or a subset of Grade 2 (equivalent to Ki67<10%) unresectable, locally advanced or metastatic disease, to delay progression;^[i] treatment of adult patients with carcinoid syndrome; long-term treatment of patients with acromegaly due to pituitary tumours who have had an inadequate response to or cannot be treated with surgery or radiotherapy.^[ii]

“We’re constantly looking for opportunities to serve our patients better, and the development of the new delivery system was made possible thanks to the collaboration of the nurses we work with everyday, and their patients,” says Ed Dybka, General Manager, Ipsen Canada. “We listened carefully because we wanted to develop a sturdy, easy-to-use pre-filled syringe with the intention of improving the injection process, and we are pleased that our innovation can potentially make treatment easier for Canadian patients.”

The new pre-filled syringe features a needle shield removal system, a reinforced plunger, thermoform tray, and wide, curved, grooved finger flanges designed to accommodate a variety of hand sizes. The pre-filled syringe still contains a built-in safety system, which may help to prevent needle stick injury by locking in place following administration.

“We work hands-on with patients every day, and we see what works and what doesn’t, so including our perspective in the redesign was an important part of improving the overall experience for patients,” says Jennifer Petronis, R.N., Certified Oncology Nurse CON(C), Ambulatory Care. “NETs and Acromegaly both result in significant disease burden, so anything that can improve a patient’s treatment experience, and make it more seamless to deliver, is welcomed.”

“We applaud the engagement Ipsen has undertaken with nurses and patients in the development of this innovation. This commitment is a testament to the company’s focus on making patient needs and comfort a priority,” says Jackie Herman, NET patient and President of the Carcinoid-Neuroendocrine Tumour Society of Canada (CNETS Canada) and Peggy MacDonald, President of the Atlantic Acromegaly Support Society.

About Enteropancreatic Neuroendocrine Tumours (NETs) and Carcinoid Syndrome

Enteropancreatic neuroendocrine tumours are growths that have developed from neuroendocrine cells in the gastrointestinal tract (intestines and appendix) or the pancreas. Symptoms come about because some neuroendocrine tumours produce and secrete certain hormones in excess – overloading the system.^[iii] Of the approximately 12,000 – 15,000 Canadians with NETs, only 10% have a complete and accurate diagnosis.^[iv]

Carcinoid syndrome occurs when rare cancerous neuroendocrine tumours called carcinoid tumours release proteins into the bloodstream, causing signs and symptoms, including diarrhea and flushing.^[v] Carcinoid tumours generally occur in the esophagus, stomach, intestines, appendix, and lungs.^[vi]

About Acromegaly

Acromegaly is a rare and debilitating disease. It happens when the pituitary gland (a pea-sized gland in the brain) produces too much growth hormone. This can cause changes in the bones of the face and in the levels of other specific hormones. If left untreated, acromegaly can lead to other medical problems.^[vii] Approximately 3 to 4 persons in one million are newly diagnosed with acromegaly each year. This means that approximately 60 people in each one million have acromegaly. In total, there are at least 2,000 Canadians affected by acromegaly with still more waiting to be diagnosed.^[viii]

About Somatuline^® Autogel^® (lanreotide injection)

Somatuline^® Autogel^® is indicated for:

• The treatment of enteropancreatic neuroendocrine tumours in adult patients with Grade 1 or a subset of Grade 2 (equivalent to Ki67<10%) unresectable, locally advanced or metastatic disease, to delay progression.
• The treatment of adult patients with carcinoid syndrome; when used, Somatuline^® Autogel^® reduces the administration frequency of short-acting somatostatin analog rescue therapy.^[ix]
• The long-term treatment of patients with acromegaly due to pituitary tumours who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.
• The relief of symptoms associated with acromegaly.

About Ipsen

Ipsen Biopharmaceuticals Canada Inc., the Canadian affiliate of Ipsen, is headquartered in Mississauga, Ontario with established operations since October 2015.  For more information on Ipsen Biopharmaceuticals Canada Inc. visit www.ipsen.ca.  Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas – Oncology, Neuroscience and Rare Diseases. Its commitment to Oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen’s R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,700 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.

For further information:

[i] Somatuline Autogel (lanreotide) Product Monograph Canada. Version number: 225592; Date of Revision: May 3, 2019.

[ii] Somatuline Autogel (lanreotide) Product Monograph Canada. Version number: 225592; Date of Revision: May 3, 2019.

[iii] Somatuline Autogel (lanreotide) Product Monograph Canada. Version number: 225592; Date of Revision: May 3, 2019.

[iv] CNETs Canada, https://cnetscanada.org/wp-content/uploads/2016/03/2014-NETS-One-Pager_Final.pdf, Last accessed September 4, 2019

[v] Somatuline Autogel (lanreotide) Product Monograph Canada. Version number: 225592; Date of Revision: May 3, 2019.

[vi] Somatuline Autogel (lanreotide) Product Monograph Canada. Version number: 225292; Date of Revision: May 3, 2019.

[vii] Somatuline Autogel (lanreotide) Product Monograph Canada. Version number: 225592; Date of Revision: May 3, 2019.

[viii] Canadian Pituitary Patient Network, https://canadianpituitary.org/acromegaly-awareness-day, Last accessed September 4, 2019

[ix] Somatuline Autogel (lanreotide) Product Monograph Canada. Version number: 225592; Date of Revision: May 3, 2019.