– In PRESTO, almost all nurse participants
(97.8%) reported a preference* for the Somatuline® Depot
(lanreotide) redesigned pre-filled syringe compared with the
syringe for long-acting release octreotide –
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.
*ABOUT PRESTO
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.
ABOUT NETs
A neuroendocrine tumor (NET) begins in the hormone-producing
cells of the body’s 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 old although 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
ABOUT ACROMEGALY
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:
- Gallstones
- 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.
Please see full Prescribing Information, including Patient
Information
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. Ipsen’s North American operations are
located in Cambridge, Massachusetts, one of the company’s 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 Group’s 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 Group’s 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 Group’s 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 Group’s 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 Group’s 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 Group’s partners could generate
lower revenues than expected. Such situations could have a negative
impact on the Group’s 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
Group’s business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des Marchés
Financiers. The risks and uncertainties set out are not exhaustive
and the reader is advised to refer to the Group’s 2018 Registration
Document available on its website (www.ipsen.com).
References
- 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.
All other trademarks and registered trademarks
are property of their respective owners.
© 2020 Ipsen Biopharmaceuticals, Inc.
March 2020 SMD-US-003889
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200311005429/en/
Maryann Quinn Director, Product Communications 857-529-1151
Maryann.quinn@ipsen.com
Ipsen (EU:IPN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Ipsen (EU:IPN)
Historical Stock Chart
From Sep 2023 to Sep 2024