{"id":31856,"date":"2020-03-11T17:43:19","date_gmt":"2020-03-11T15:43:19","guid":{"rendered":"https:\/\/www.ipsen.com\/qa-us\/?post_type=press_release&#038;p=31856"},"modified":"2025-01-27T19:08:17","modified_gmt":"2025-01-27T17:08:17","slug":"multi-national-presto-study-presented-by-enets-withsimultaneous-publication-in-advances-in-therapy","status":"publish","type":"press_release","link":"https:\/\/www.ipsen.com\/us\/press-releases\/multi-national-presto-study-presented-by-enets-withsimultaneous-publication-in-advances-in-therapy\/","title":{"rendered":"Multi-National PRESTO Study Presented by ENETS with Simultaneous Publication in Advances in Therapy"},"content":{"rendered":"\n<p>\u2013 In PRESTO, almost all nurse participants (97.8%) reported a preference* for the Somatuline\u00ae Depot<br>(lanreotide) redesigned pre-filled syringe compared with the syringe for long-acting release octreotide<br>\u2013<br>CAMBRIDGE, Mass. March 11, 2020 \u2014 Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext:<br>IPN; ADR: IPSEY) today announced the presentation of the PRESTO study by ENETS, and its<br>simultaneous publication in the peer-reviewed journal, Advances in Therapy.<br>1<br>PRESTO was a multi-national, multi-center, prospective, non-interventional, simulated-use study that<br>enrolled 90 nurses with \u2265 2 years\u2019 experience injecting with the lanreotide (Somatuline\u00ae Depot)<br>syringe and\/or the syringe for long-acting release octreotide. The primary objective of the PRESTO<br>study was to assess nurse preference between the redesigned Somatuline\u00ae Depot syringe and the<br>syringe for long-acting release octreotide after performing injections into injection pads.<br>The PRESTO study incorporated an anonymous, web-based questionnaire, where nurses reported<br>their overall preference. Virtually all participants (97.8%) expressed a preference (85.6% \u201cstrong\u201d,<br>12.2% \u201cslight\u201d) for the redesigned Somatuline\u00ae Depot syringe versus the octreotide syringe.<br>Comparative safety and efficacy between Somatuline\u00ae Depot and octreotide were not evaluated in<br>this study.<br>&#8220;The experiences, attitudes and knowledge of both patients and healthcare practitioners, including<br>nurses, was essential in the redesign of the syringe,&#8221; said Daphne T. Adelman, Clinical Nurse<br>Specialist from Northwestern University in Chicago, and a lead author on the PRESTO study. &#8220;In the<br>absence of head-to-head trials, these data give healthcare professionals important insights. The<br>ENETS poster presentation and the Advances in Therapy publication of the PRESTO study provide<br>further details on the benefits of the redesigned syringe.&#8221;<br>Indications for Somatuline\u00ae Depot include the treatment of adult patients with unresectable, well- or<br>moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine<br>tumors (GEP-NETs) to improve progression-free survival; treatment of adults with carcinoid<br>syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy;<br>and the long-term treatment of patients with acromegaly who have had an inadequate response to<br>surgery and\/or radiotherapy, or for whom surgery and\/or radiotherapy is not an option. Please see<br>Important Safety Information below and accompanying full Prescribing Information.<br>\u201cThe redesigned Somatuline\u00ae Depot syringe was developed based on feedback from physicians,<br>nurses and patients;<br>2 and the PRESTO study, for the first time, demonstrates the nurses\u2019 preference<br>for it versus the octreotide syringe,\u201d said Tamer Garawin, M.D., Vice President, Medical Affairs<br>Oncology at Ipsen Biopharmaceuticals. \u201cPRESTO is an example of how Ipsen continues our<br>commitment to partnering with patients and healthcare providers, especially nurses, who play a key<br>role in the management of GEP-NETs and acromegaly.\u201d<br>In addition to the PRESTO study, Ipsen had a record 12 abstracts accepted by ENETS.<br>PRESS RELEASE<br>*ABOUT PRESTO<br>PRESTO was a randomized, multinational, multicenter, noninterventional, simulated-use study<br>involving nurses (n=90) with experience injecting with the Somatuline\u00ae Depot syringe and\/or the<br>syringe for long-acting release octreotide. The primary objective of this study was to assess<br>preferences of nurses between injecting with the Somatuline\u00ae Depot syringe and the syringe for longacting release octreotide. Nurses attended a single testing session, during which they injected<br>injection pads with each type of syringe twice before reporting their preferences. Data were collected<br>using an anonymous, self-administered, web-based questionnaire. Limitations of this study included<br>the need for a change in injection pad after 10 injection sessions due to clogging issues which<br>resulted in two separate cohorts, and that the injections performed were simulated. There were<br>imbalances noted in sociodemographics and clinical setting of nurses which potentially introduces<br>biased reporting of preferences. Another limitation was that some nurses were recruited from the<br>CRO (Contract Research Organization) network organizing the study. This study was not designed to<br>evaluate the efficacy or safety of Somatuline\u00ae Depot or long-acting release octreotide and no<br>assessment of efficacy or safety should be interpreted based on this study.<br>ABOUT NETs<br>A neuroendocrine tumor (NET) begins in the hormone-producing cells of the body\u2019s neuroendocrine<br>system, which is made of cells that are a combination of hormone-producing endocrine cells and nerve<br>cells.3 NETs are a group of uncommon tumors occurring in both men and women aged 50 to 60 years<br>old although they can affect anyone of any age.3<br>The three main areas where NETs are found in the body are the gastrointestinal tract, the pancreas<br>and the lungs.3<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Gastrointestinal NETs (GEP-NETs) are found in the gastrointestinal tract or digestive system<br>and are the most common type of NETs.3<\/li>\n\n\n\n<li>Pancreatic NETs (pNETs) are formed in the islet cells of the pancreas and include several<br>uncommon types of NETs.3<\/li>\n\n\n\n<li>Lung NETs are less common than other types, accounting for about one quarter of NETs.3<br>The symptoms of NETs are often not distinct and difficult to identify, and average time from initial onset<br>of symptoms to proper diagnosis can take more than 5 years.4 Although NETs affect only a small<br>percentage of the general population at any one time, the number of people being newly diagnosed<br>with NETs overall is believed to be rising.3 This is mainly due to increased awareness of the condition<br>and diagnostic testing.3 NETs are now the fastest growing class of cancers worldwide, accounting for<br>around 2% of all cancers at any time.3<br>ABOUT ACROMEGALY<br>Acromegaly is an uncommon hormonal or endocrine disorder with slowly developing, but eventually<br>distinct clinical symptoms.5 In the U.S., approximately 3,500 new cases of acromegaly are diagnosed<br>each year.6<br>It is usually caused by having too much growth hormone in the body which, over time, results in some<br>characteristic symptoms and signs, such as heavy or prominent facial features with a prominent jaw<br>line and enlarged hands and feet.5<br>What is SOMATULINE\u00ae DEPOT (lanreotide) Injection?<br>SOMATULINE DEPOT is a prescription medicine used in adults for:<\/li>\n\n\n\n<li>the long-term treatment of people with acromegaly when surgery or radiotherapy have not<br>worked well enough or a patient is unable to have surgery or radiotherapy;<\/li>\n\n\n\n<li>the treatment of a type of cancer known as neuroendocrine tumors, from the gastrointestinal<br>tract or the pancreas (GEP-NETs) that has spread or cannot be removed by surgery; and<\/li>\n\n\n\n<li>the treatment of carcinoid syndrome to reduce the need for the use of short-acting somatostatin<br>medicine.<br>It is not known if SOMATULINE DEPOT is safe and effective in children.<br>IMPORTANT SAFETY INFORMATION<\/li>\n\n\n\n<li>Do not take SOMATULINE DEPOT if you are allergic to lanreotide.<\/li>\n\n\n\n<li>SOMATULINE DEPOT may cause serious side effects, including:<br>o Gallstones<br>o Changes to your blood sugar (high or low blood sugar),<br>o Slow heart rate,<br>o High blood pressure, and<br>o Changes in thyroid function in acromegaly patients.<\/li>\n\n\n\n<li>Tell your healthcare provider (HCP) if you have any of the following symptoms:<br>o Symptoms of gallstones may include sudden pain in your upper right stomach area<br>(abdomen), sudden pain in your right shoulder or between your shoulder blades,<br>yellowing of your skin and whites of your eyes, fever with chills, and nausea.<br>o Symptoms of high blood sugar may include increased thirst, increased appetite,<br>nausea, weakness or tiredness, urinating more than normal, and fruity smelling<br>breath.<br>o Symptoms of low blood sugar may include dizziness or lightheadedness, sweating,<br>confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat,<br>irritability or mood changes, and hunger.<br>o Symptoms of slow heart rate may include dizziness or lightheadedness, fainting or<br>near-fainting, chest pain, shortness of breath, confusion or memory problems, and<br>weakness or extreme tiredness.<br>o SOMATULINE DEPOT can cause the thyroid gland to not make enough thyroid<br>hormone in people with acromegaly. Symptoms of low thyroid levels may include<br>fatigue, weight gain, puffy face, being cold all the time, constipation, dry skin, thinning<br>or dry hair, decreased sweating, and depression.<\/li>\n\n\n\n<li>The most common side effects of SOMATULINE DEPOT in people with:<br>o Acromegaly: diarrhea; stomach (abdominal) pain; nausea; and pain, itching, or a<br>lump at the injection site<br>o GEP-NETs: stomach area (abdominal) pain; muscle and joint aches; vomiting;<br>headache; pain, itching or a lump at the injection site<br>o Carcinoid syndrome: headache, dizziness, muscle spasm; side effects were<br>generally similar to those commonly seen with GEP-NETs<\/li>\n\n\n\n<li>SOMATULINE DEPOT may cause dizziness. If this happens, do not drive a car or operate<br>machinery.<\/li>\n\n\n\n<li>Tell your HCP right away if you have signs of an allergic reaction after receiving<br>SOMATULINE DEPOT, including swelling of your face, lips or tongue; breathing problems;<br>fainting, dizziness or feeling lightheaded (low blood pressure); itching; skin flushing or<br>redness; rash; or hives.<\/li>\n\n\n\n<li>Before taking SOMATULINE DEPOT, tell your HCP about all your medical conditions<br>including if you: have diabetes; have gallbladder, heart, thyroid, kidney or liver problems;<br>are pregnant or plan to become pregnant; or are breastfeeding or plan to breastfeed. It is not<br>known if SOMATULINE DEPOT will harm your unborn baby or pass into breast milk. You<br>should not breastfeed if you receive SOMATULINE DEPOT and for 6 months after your last<br>dose. SOMATULINE DEPOT may affect your ability to become pregnant.<\/li>\n\n\n\n<li>Tell your HCP about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements. SOMATULINE DEPOT and other<br>medicines may affect each other, causing side effects. SOMATULINE DEPOT may affect the<br>way other medicines work, and other medicines may affect how SOMATULINE DEPOT<br>works. Your dose of SOMATULINE DEPOT or your other medications may need to be<br>changed. If you have diabetes, your HCP may change your dose of diabetes medication<br>when you first start receiving SOMATULINE DEPOT or if your dose of SOMATULINE DEPOT<br>is changed.<\/li>\n\n\n\n<li>Especially tell your HCP if you take:<br>o Insulin or other diabetes medicines,<br>o A cyclosporine (Gengraf, Neoral, or Sandimmune), or<br>o Medicines that lower your heart rate, such as beta blockers.<br>Know the medicines you take. Keep a list of them to show your HCP when you get a new<br>medicine.<br>Tell your HCP if you have any side effect that bothers you or that does not go away. These are not all<br>the possible side effects of SOMATULINE DEPOT. For more information, ask your HCP.<br>To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-<br>463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov\/medwatch.<br>It is not known if SOMATULINE DEPOT is safe and effective in children.<br>Please see full Prescribing Information, including Patient Information<br>About Ipsen in North America<br>Ipsen (Euronext: IPN; ADR: IPSEY) is a global biopharmaceutical company focused on innovation<br>and specialty care. The company develops and commercializes innovative medicines in three key<br>therapeutic areas \u2013 Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources,<br>investments and energy on discovering, developing and commercializing new therapeutic options to<br>provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsen\u2019s North<br>American operations are located in Cambridge, Massachusetts, one of the company\u2019s three global<br>hubs. Based in the heart of Kendall Square, our fully integrated biopharmaceutical business includes<br>Commercial, Research &amp; Development, Manufacturing, and Global External Innovation and<br>Partnering. Combined with our Canadian headquarters in Mississauga, Ontario, and other locations,<br>Ipsen employs approximately 600 people in North America. For more information please visit<br>www.ipsenus.com or www.ipsen.ca Connect with us on Twitter and LinkedIn.<br>Forward Looking Statement<br>The forward-looking statements, objectives and targets contained herein are based on the Group\u2019s<br>management strategy, current views and assumptions. The statements here reflect the outcome of a<br>small simulated study and it is uncertain whether the outcome can be extrapolated to the general<br>nurse or healthcare population. Such statements involve known and unknown risks and uncertainties<br>that may cause actual results, performance or events to differ materially from those anticipated<br>herein. All of the above risks could affect the Group\u2019s future ability to achieve its financial targets,<br>which were set assuming reasonable macroeconomic conditions based on the information available<br>today. Use of the words &#8220;believes&#8221;, &#8220;anticipates&#8221; and &#8220;expects&#8221; and similar expressions are intended<br>to identify forward-looking statements, including the Group\u2019s expectations regarding future events,<br>including regulatory filings and determinations. Moreover, the targets described in this document were<br>prepared without taking into account external growth assumptions and potential future acquisitions,<br>which may alter these parameters. These objectives are based on data and assumptions regarded as<br>reasonable by the Group. These targets depend on conditions or facts likely to happen in the future,<br>and not exclusively on historical data. Actual results may depart significantly from these targets given<br>the occurrence of certain risks and uncertainties, notably the fact that a promising product in early<br>development phase or clinical trial may end up never being launched on the market or reaching its<br>commercial targets, notably for regulatory or competition reasons. The Group must face or might face<br>competition from generic products that might translate into a loss of market share. Furthermore, the<br>Research and Development process involves several stages each of which involves the substantial<br>risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards<br>to a product in which it has invested significant sums. Therefore, the Group cannot be certain that<br>favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials,<br>or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the<br>product concerned. There can be no guarantees a product will receive the necessary regulatory<br>approvals or that the product will prove to be commercially successful. If underlying assumptions<br>prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those<br>set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to,<br>general industry conditions and competition; general economic factors, including interest rate and<br>currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care<br>legislation; global trends toward health care cost containment; technological advances, new products<br>and patents attained by competitors; challenges inherent in new product development, including<br>obtaining regulatory approval; the Group&#8217;s ability to accurately predict future market conditions;<br>manufacturing difficulties or delays; financial instability of international economies and sovereign risk;<br>dependence on the effectiveness of the Group\u2019s patents and other protections for innovative products;<br>and the exposure to litigation, including patent litigation, and\/or regulatory actions. The Group also<br>depends on third parties to develop and market some of its products which could potentially generate<br>substantial royalties; these partners could behave in such ways which could cause damage to the<br>Group\u2019s activities and financial results. The Group cannot be certain that its partners will fulfil their<br>obligations. It might be unable to obtain any benefit from those agreements. A default by any of the<br>Group\u2019s partners could generate lower revenues than expected. Such situations could have a<br>negative impact on the Group\u2019s business, financial position or performance. The Group expressly<br>disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or<br>estimates contained in this press release to reflect any change in events, conditions, assumptions or<br>circumstances on which any such statements are based, unless so required by applicable law. The<br>Group\u2019s business is subject to the risk factors outlined in its registration documents filed with the<br>French Autorit\u00e9 des March\u00e9s Financiers. The risks and uncertainties set out are not exhaustive and<br>the reader is advised to refer to the Group\u2019s 2018 Registration Document available on its website<br>(www.ipsen.com).<br>For further information:<br>Maryann Quinn<br>Director, Product Communications<br>857-529-1151<br>Maryann.quinn@ipsen.com<br>References<\/li>\n<\/ul>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Adelman D et al. Adv Ther 2020 Mar 11. doi:10.1007\/s12325-020-01255-8<\/li>\n\n\n\n<li>Data on File<\/li>\n\n\n\n<li>Oronsky, B, Ma, PC, Morgensztern, D &amp; Carter, CA et al (2017). Nothing But NET: A Review of<br>Neuroendocrine Tumors and Carcinomas. Neoplasia. 19(12):991-1002.<\/li>\n\n\n\n<li>Modlin, IM, Moss, SF, Chung, DC, Jensen, RT, &amp; Snyderwine E (2008). Priorities for Improving<br>the Management of Gastroenteropancreatice Neuroendocrine Tumors. Journal of the National<br>Cancer Institute, 100, 1282-1289.<\/li>\n\n\n\n<li>Acromunity: Acromegaly information and support. Available at: https:\/\/www.acromunity.com<br>[Accessed March 2019].<\/li>\n\n\n\n<li>Burton et al (2016). Incidence and prevalence of acromegaly in a large US health plan. Database.<br>Pituitary.19:262\u2013267.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\">#<\/h2>\n\n\n\n<p>SOMATULINE DEPOT is a registered trademark of IPSEN PHARMA S.A.S.<br>All other trademarks and registered trademarks are property of their respective owners.<br>\u00a9 2020 Ipsen Biopharmaceuticals, Inc.<br>March 2020<br>SMD-US-003889<\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":7,"template":"","categories":[568],"tags":[],"class_list":["post-31856","press_release","type-press_release","status-publish","has-post-thumbnail","hentry","category-oncology-pressrelease","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Multi-National PRESTO Study Presented by ENETS with Simultaneous Publication in Advances in Therapy - United States<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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