Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY) today announced the presentation of the PRESTO study by ENETS, and its simultaneous publication in the peer-reviewed journal, Advances in Therapy.1
PRESTO was a multi-national, multi-center, prospective, non-interventional, simulated-use study that enrolled 90 nurses with ‰¥ 2 years experience injecting with the lanreotide (Somatuline Depot) syringe and/or the syringe for long-acting release octreotide. The primary objective of the PRESTO study was to assess nurse preference between the redesigned Somatuline Depot syringe and the syringe for long-acting release octreotide after performing injections into injection pads.
The PRESTO study incorporated an anonymous, web-based questionnaire, where nurses reported their overall preference. Virtually all participants (97.8%) expressed a preference (85.6% strong, 12.2% slight) for the redesigned Somatuline Depot syringe versus the octreotide syringe. Comparative safety and efficacy between Somatuline Depot and octreotide were not evaluated in this study.
“The experiences, attitudes and knowledge of both patients and healthcare practitioners, including nurses, was essential in the redesign of the syringe,” said Daphne T. Adelman, Clinical Nurse Specialist from Northwestern University in Chicago, and a lead author on the PRESTO study. “In the absence of head-to-head trials, these data give healthcare professionals important insights. The ENETS poster presentation and the Advances in Therapy publication of the PRESTO study provide further details on the benefits of the redesigned syringe.”
Indications for Somatuline Depot 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. Please see Important Safety Information below and accompanying full Prescribing Information.
The redesigned Somatuline Depot syringe was developed based on feedback from physicians, nurses and patients;2 and the PRESTO study, for the first time, demonstrates the nurses preference for it versus the octreotide syringe, said Tamer Garawin, M.D., Vice President, Medical Affairs Oncology at Ipsen Biopharmaceuticals. PRESTO is an example of how Ipsen continues our commitment to partnering with patients and healthcare providers, especially nurses, who play a key role in the management of GEP-NETs and acromegaly.
In addition to the PRESTO study, Ipsen had a record 12 abstracts accepted by ENETS.
PRESTO was a randomized, multinational, multicenter, noninterventional, simulated-use study involving nurses (n=90) with experience injecting with the Somatuline Depot syringe and/or the syringe for long-acting release octreotide. The primary objective of this study was to assess preferences of nurses between injecting with the Somatuline Depot syringe and the syringe for long-acting release octreotide. Nurses attended a single testing session, during which they injected injection pads with each type of syringe twice before reporting their preferences. Data were collected using an anonymous, self-administered, web-based questionnaire. Limitations of this study included the need for a change in injection pad after 10 injection sessions due to clogging issues which resulted in two separate cohorts, and that the injections performed were simulated. There were imbalances noted in sociodemographics and clinical setting of nurses which potentially introduces biased reporting of preferences. Another limitation was that some nurses were recruited from the CRO (Contract Research Organization) network organizing the study. This study was not designed to evaluate the efficacy or safety of Somatuline Depot or long-acting release octreotide and no assessment of efficacy or safety should be interpreted based on this study.
A neuroendocrine tumor (NET) begins in the hormone-producing cells of the bodys neuroendocrine system, which is made of cells that are a combination of hormone-producing endocrine cells and nerve cells.3 NETs are a group of uncommon tumors occurring in both men and women aged 50 to 60 years oldalthough they can affect anyone of any age.3
The three main areas where NETs are found in the body are the gastrointestinal tract, the pancreas and the lungs.3
- Gastrointestinal NETs (GEP-NETs) are found in the gastrointestinal tract or digestive system and are the most common type of NETs.3
- Pancreatic NETs (pNETs) are formed in the islet cells of the pancreas and include several uncommon types of NETs.3
- Lung NETs are less common than other types, accounting for about one quarter of NETs.3
The symptoms of NETs are often not distinct and difficult to identify, and average time from initial onset of symptoms to proper diagnosis can take more than 5 years.4 Although NETs affect only a small percentage of the general population at any one time, the number of people being newly diagnosed with NETs overall is believed to be rising.3 This is mainly due to increased awareness of the condition and diagnostic testing.3 NETs are now the fastest growing class of cancers worldwide, accounting for around 2% of all cancers at any time.3
Acromegaly is an uncommon hormonal or endocrine disorder with slowly developing, but eventually distinct clinical symptoms.5 In the U.S., approximately 3,500 new cases of acromegaly are diagnosed each year.6
It is usually caused by having too much growth hormone in the body which, over time, results in some characteristic symptoms and signs, such as heavy or prominent facial features with a prominent jaw line and enlarged hands and feet.5
What is SOMATULINE DEPOT (lanreotide) Injection?
SOMATULINE DEPOT is a prescription medicine used in adults for:
- the long-term treatment of people with acromegaly when surgery or radiotherapy have not worked well enough or a patient is unable to have surgery or radiotherapy;
- the treatment of a type of cancer known as neuroendocrine tumors, from the gastrointestinal tract or the pancreas (GEP-NETs) that has spread or cannot be removed by surgery; and
- the treatment of carcinoid syndrome to reduce the need for the use of short-acting somatostatin medicine.
It is not known if SOMATULINE DEPOT is safe and effective in children.
IMPORTANT SAFETY INFORMATION
- Do not take SOMATULINE DEPOT if you are allergic to lanreotide.
- SOMATULINE DEPOT may cause serious side effects, including:
- Changes to your blood sugar (high or low blood sugar),
- Slow heart rate,
- High blood pressure, and
- Changes in thyroid function in acromegaly patients.
- Tell your healthcare provider (HCP) if you have any of the following symptoms:
- Symptoms of gallstones may include sudden pain in your upper right stomach area (abdomen), sudden pain in your right shoulder or between your shoulder blades, yellowing of your skin and whites of your eyes, fever with chills, and nausea.
- Symptoms of high blood sugar may include increased thirst, increased appetite, nausea, weakness or tiredness, urinating more than normal, and fruity smelling breath.
- Symptoms of low blood sugar may include dizziness or lightheadedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, irritability or mood changes, and hunger.
- Symptoms of slow heart rate may include dizziness or lightheadedness, fainting or near-fainting, chest pain, shortness of breath, confusion or memory problems, and weakness or extreme tiredness.
- SOMATULINE DEPOT can cause the thyroid gland to not make enough thyroid hormone in people with acromegaly. Symptoms of low thyroid levels may include fatigue, weight gain, puffy face, being cold all the time, constipation, dry skin, thinning or dry hair, decreased sweating, and depression.
- The most common side effects of SOMATULINE DEPOT in people with:
- Acromegaly: diarrhea; stomach (abdominal) pain; nausea; and pain, itching, or a lump at the injection site
- GEP-NETs: stomach area (abdominal) pain; muscle and joint aches; vomiting; headache; pain, itching or a lump at the injection site
- Carcinoid syndrome: headache, dizziness, muscle spasm; side effects were generally similar to those commonly seen with GEP-NETs
- SOMATULINE DEPOT may cause dizziness. If this happens, do not drive a car or operate machinery.
- Tell your HCP right away if you have signs of an allergic reaction after receiving SOMATULINE DEPOT, including swelling of your face, lips or tongue; breathing problems; fainting, dizziness or feeling lightheaded (low blood pressure); itching; skin flushing or redness; rash; or hives.
- Before taking SOMATULINE DEPOT, tell your HCP about all your medical conditions including if you: have diabetes; have gallbladder, heart, thyroid, kidney or liver problems; are pregnant or plan to become pregnant; or are breastfeeding or plan to breastfeed. It is not known if SOMATULINE DEPOT will harm your unborn baby or pass into breast milk. You should not breastfeed if you receive SOMATULINE DEPOT and for 6 months after your last dose. SOMATULINE DEPOT may affect your ability to become pregnant.
- Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOMATULINE DEPOT and other medicines may affect each other, causing side effects. SOMATULINE DEPOT may affect the way other medicines work, and other medicines may affect how SOMATULINE DEPOT works. Your dose of SOMATULINE DEPOT or your other medications may need to be changed. If you have diabetes, your HCP may change your dose of diabetes medication when you first start receiving SOMATULINE DEPOT or if your dose of SOMATULINE DEPOT is changed.
- Especially tell your HCP if you take:
- Insulin or other diabetes medicines,
- A cyclosporine (Gengraf, Neoral, or Sandimmune), or
- Medicines that lower your heart rate, such as beta blockers.
Know the medicines you take. Keep a list of them to show your HCP when you get a new medicine.
Tell your HCP if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of SOMATULINE DEPOT. For more information, ask your HCP.
To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
It is not known if SOMATULINE DEPOT is safe and effective in children.
About Ipsen in North America
Ipsen (Euronext: IPN; ADR: IPSEY) is a global biopharmaceutical company focused on innovation and specialty care. The company develops and commercializes innovative medicines in three key therapeutic areas “ Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing new therapeutic options to provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsens North American operations are located in Cambridge, Massachusetts, one of the companys three global hubs. Based in the heart of Kendall Square, our fully integrated biopharmaceutical business includes Commercial, Research & Development, Manufacturing, and Global External Innovation and Partnering. Combined with our Canadian headquarters in Mississauga, Ontario, and other locations, Ipsen employs approximately 600 people in North America. For more information please visit www.ipsenus.com or www.ipsen.ca Connect with us on Twitter and LinkedIn.
Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are based on the Groups management strategy, current views and assumptions. The statements here reflect the outcome of a small simulated study and it is uncertain whether the outcome can be extrapolated to the general nurse or healthcare population. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Groups future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words “believes”, “anticipates” and “expects” and similar expressions are intended to identify forward-looking statements, including the Groups expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from generic products that might translate into a loss of market share. Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Groups patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Groups activities and financial results. The Group cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Groups partners could generate lower revenues than expected. Such situations could have a negative impact on the Groups business, financial position or performance. The Group expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Groups business is subject to the risk factors outlined in its registration documents filed with the French Autorit des Marchs Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to the Groups 2018 Registration Document available on its website (www.ipsen.com).
- Adelman D et al. Adv Ther 2020 Mar 11. doi:10.1007/s12325-020-01255-8
- Data on File
- Oronsky, B, Ma, PC, Morgensztern, D & Carter, CA et al (2017). Nothing But NET: A Review of Neuroendocrine Tumors and Carcinomas. Neoplasia. 19(12):991-1002.
- Modlin, IM, Moss, SF, Chung, DC, Jensen, RT, & Snyderwine E (2008). Priorities for Improving the Management of Gastroenteropancreatic Neuroendocrine Tumors. Journal of the National Cancer Institute, 100, 1282-1289.
- Acromunity: Acromegaly information and support. Available at: https://www.acromunity.com [Accessed March 2019].
- Burton et al (2016). Incidence and prevalence of acromegaly in a large US health plan. Database. Pituitary.19:262“267.
SOMATULINE DEPOT is a registered trademark of IPSEN PHARMA S.A.S.
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2020 Ipsen Biopharmaceuticals, Inc.
March 2020 SMD-US-003889
Director, Product Communications