Ipsen Data Presented during ENETS Annual Conference 2020 Capture New Patient and Healthcare Professional Insights in the Treatment of NETs and Acromegaly

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) today announced the presentation of 13 new abstracts ¹ during the 17 th European Neuroendocrine Tumor Society (ENETS) Annual Conference, taking place virtually worldwide, (March 11-13, 2020) and the simultaneous publication of the PRESTO study in the medical journal, Advances in Therapy. ² These data reinforce Ipsen’s personal approach to working with patients living with neuroendocrine tumors (NETs) and acromegaly, and healthcare professionals treating these conditions.

NETs are rare tumors, but incidences are increasing,³ partly due to improvements in diagnosis and increased awareness⁴. NETs and the symptoms associated with them have a substantial negative impact on patients’ overall health, quality of life and work life.

Acromegaly is a rare, chronic pituitary hormonal disorder with physical, neuropsychiatric and neurocognitive symptoms. Due to the insidious onset, slow progression and lack of awareness of the disease, acromegaly often takes 5–10 years to diagnose. Diagnostic delays can lead to an increased number and more severe symptoms and comorbidities that can become difficult to manage, reduce the quality of life and increase the risk of mortality.⁵

Among the results to be showcased by Ipsen during ENETS 2020, several studies featured the Somatuline^® Autogel^® (lanreotide autogel) new syringe. Alongside PRESTO, these included a patient and nurse satisfaction appraisal of use related to the Somatuline^® Autogel^® new syringe compared with the previous syringe (SONATE), an evaluation of patient satisfaction with the new syringe when self-injecting (AUTOSOMA) and more broadly, novel perspectives on healthcare professional preferences for different somatostatin analogs in the management of NETs and acromegaly.

Amauri Soares, Vice-President, Medical Affairs Oncology at Ipsen commented: “Transforming the lives of patients living with debilitating conditions such as NETs and acromegaly requires a joined-up, co-creating approach and the Somatuline ^® Autogel ^® new syringe was developed based on feedback from physicians, nurses, caregivers and patients who use these delivery systems every day. So, we are proud to be sharing new data during ENETS that demonstrates our commitment beyond clinical studies to uncover patient and nurse preferences, and to better understand patient treatment administration needs whether in hospital or at home. Ultimately, we are committed to ensuring these insights will continue to help us address the high unmet needs of these patients living with rare diseases.”

Among the Ipsen data to be showcased during ENETS 2020, key presentations include:

• PRESTO: Evaluation of Nurse Preferences Between the Lanreotide Autogel (LAN) New Syringe and Octreotide Long-Acting Release (LAR) Current Syringe: An International Simulated Use Study
• Patient and Healthcare Practitioner Perspectives of Somatostatin Analogs in the Management of Neuroendocrine Tumors and Acromegaly: A Systematic Literature Review (SLR)
• SONATE: Patient and nurse satisfaction with the new Lanreotide Autogelpre-filled syringe in neuroendocrine tumors: a prospective study (France)
• AUTOSOMA: Development and initial validation of a brief questionnaire to assess patient satisfaction with self-injection of Lanreotide Autogel: Results during a home training programme (Spain)
• EXPLAIN: Evaluating the use of Plasma Proteins to Predict Progressive Disease in Patients with Small Intestinal Neuroendocrine Tumours

Ipsen also announced the parallel publication of the multinational, simulated-use PRESTO study in the peer-reviewed medical journal, Advances in Therapy.² The PRESTO study design included the international recruitment of nurses experienced in performing injections in patients with NETs and/or acromegaly, which limited a center or country effect.

The study questionnaire was carefully designed through a systematic literature search and developed with input from end users (nurses/patients) and an expert in patient-reported outcomes to ensure consistency with real-life decision-making. Nurses participating in the PRESTO study rated and ranked the importance of nine attributes for the Somatuline ^® Autogel ^® new syringe and the Octreotide LAR current syringe.

“The experiences, attitudes and knowledge of both patients and healthcare practitioners such as nurses are essential for meaningful progress in complex disease management,” said Daphne T Adelman, Clinical Nurse Specialist from Northwestern University in Chicago, U.S. and a lead author on the PRESTO study. “In the absence of head-to-head clinical trials, these data give healthcare professionals important and meaningful insights for the optimal management of patients. The ENETS poster presentation and the Advances in Therapy publication for the PRESTO study further validate the new syringe design enhancements and have broader implications for optimizing patients’ treatment experience.”

Overview of Ipsen presentations featuring Somatuline^® Autogel^® (lanreotide autogel) during the ENETS 2020 Annual Conference:¹

Abstract title	Poster number
Evaluation of Nurse Preferences Between the Lanreotide Autogel New Syringe and Octreotide Long-Acting Release Syringe: An International Simulated Use Study (PRESTO)	H29
Quality of Life, Tumour Heterogeneity and Biomarker Levels in Patients with Progressive Pancreatic or Midgut Neuroendocrine Tumours: Baseline Data from CLARINET FORTE	H25
Patient and Healthcare Practitioner Perspectives of Somatostatin Analogs in the Management of Neuroendocrine Tumors and Acromegaly: A Systematic Literature Review	H13
OPERA: Observational study of Perception of information and quality of life in patients with gastroEnteropancreatic neuRoendocrine tumors starting lAnreotide autogel – Baseline characteristics	D23
Patient and nurse satisfaction with the new lanreotide autogel pre-filled syringe in neuroendocrine tumors (NET): a prospective study (SONATE)	H30
Effectiveness of Lanreotide 120 mg (LAN) in Patients with Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours (panNET) in Routine Clinical Practice	P09
Development and initial validation of a brief questionnaire to assess patient satisfaction with self-injection of lanreotide autogel: Results during a home training programme (AUTOSOMA)	H16
Somatostatin analogs: the economic value of lanreotide autogel delivery attributes in the treatment of GEP-NET versus octreotide LAR – a UK budget impact analysis	H14
Lanreotide autogel and octreotide LAR treatment patterns: results from a nationwide French retrospective study	H12
Longitudinal Changes in Plasma 5-hydroxyindoleacetic Acid (5-HIAA) and Other Biomarkers during Treatment of Functional Midgut Neuroendocrine Tumours (NETs) with Lanreotide Autogel: CALM NET Study Results	F22
Use of Plasma Proteins to Predict Progressive Disease in Patients with Small Intestinal Neuroendocrine Tumours - The Nordic NET Biomarker Group (EXPLAIN)	F12 Oral presentation
Resource use in patients with carcinoid syndrome: a retrospective analysis using the French health insurance national (SNDS) database	P11
Progression-Free Survival and Clinical Outcomes with Long-Term Use of Telotristat Ethyl in US Clinical Practice	H21

Follow Ipsen on Twitter via @IpsenGroup and keep up to date with ENETS 2020 Conference news and updates by using the hashtag #ENETS20.

About Ipsen

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 also has a well-established Consumer Healthcare business. With total sales over €2.5 billion in 2019, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. 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 5,800 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.

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References

1. Data on File. ENETS 2020
2. Adelman D et al. Adv Ther 2020 Mar 11. doi:10.1007/s12325-020-01255-8 [Epub ahead of print]
3. Dasari AC et al. JAMA Oncol 2017;3:1335–422.
4. Hallet JC et al. Cancer 2015;121:589–97
5. Brue F et al. OrphanetJ Rare Dis 2016;11:135–52

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