– New Syringe Designed to Help Enhance
Injection Experience –
Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN;
ADR: IPSEY), announced today that the United States Food and
Drug Administration (FDA) has approved a new pre-filled syringe for
Somatuline® Depot (lanreotide).1 The syringe includes updated
features, such as larger flanges, designed to help make it easier
for healthcare providers to administer the injection.1 The
indications remain the same as those for the previous pre-filled
syringe and 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 conditions of GEP-NETs and acromegaly can be associated
with a number of uncomfortable and unpleasant symptoms, and
innovation aimed at improving the injection process is a step
forward,” said Daphne Adelman, Clinical Nurse Specialist,
Northwestern University, Chicago, and one of the authors of the
study.
Ipsen conducted five separate but complementary studies in
partnership with patients, their caregivers, nurses and other
healthcare professionals to better understand the current use of
the existing Somatuline® Depot pre-filled syringe and to evaluate
ways to improve the features of the device.1 The result of this
collaboration is a redesigned delivery system intended to make it
easy to grip the syringe and administer the injection. The new
syringe features a needle shield removal system, more stable
plunger and thermoform tray that has recessed areas designed to
help prevent accidental plunger depression.1 The built-in safety
system, which may help to prevent needle stick injury by locking in
place following the administration, has not been changed.1
“We consistently look for opportunities to respond to the needs
of the communities we serve, and this approval would not have been
possible without the direct involvement of nurses and the patients
with GEP-NETs and acromegaly whom they treat,” said Bradley
Bailey, SVP, and Franchise Head Oncology/Endocrinology Business
Unit at Ipsen. “We listened and collaborated to enhance the
existing pre-filled syringe, making it sturdier for healthcare
providers when administering treatment, with the intention of
improving the injection process. We look forward to bringing this
innovation to healthcare providers for their patients soon.”
The new pre-filled syringe is for deep subcutaneous injection
and is intended for administration by a healthcare professional.
Healthcare providers can expect to receive the new syringe during
Q3 2019. The device is approved for use in the U.S., EU and
additional ex-U.S. markets.
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.2 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.2
The three main areas where NETs are found in the body are the
gastrointestinal tract, the pancreas and the lungs.2
- Gastrointestinal NETs (GEP-NETs) are
found in the gastrointestinal tract or digestive system and are the
most common type of NETs.2
- Pancreatic NETs (pNETs) are formed in
the islet cells of the pancreas and include several uncommon types
of NETs.2
- Lung NETs are less common than other
types, accounting for about one quarter of NETs.2
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.3 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.2 This is mainly due to increased awareness
of the condition and diagnostic testing.2 NETs are now the fastest
growing class of cancers worldwide, accounting for around 2% of all
cancers at any time.2
ABOUT ACROMEGALY
Acromegaly is an uncommon hormonal or endocrine disorder with
slowly developing, but eventually distinct clinical symptoms.4 In
the U.S., approximately 3,500 new cases of acromegaly are diagnosed
each year.5
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.4
ABOUT SOMATULINE® DEPOT
SOMATULINE® DEPOT (lanreotide) is a somatostatin analog
indicated for:
- 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; the goal of treatment in acromegaly is to reduce growth
hormone (GH) and insulin growth factor-1 (IGF-1) levels to
normal;
- 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; and
- the treatment of adults with carcinoid
syndrome; when used, it reduces the frequency of short-acting
somatostatin analog rescue therapy.
IMPORTANT SAFETY INFORMATION
Contraindications
- SOMATULINE DEPOT is contraindicated in
patients with hypersensitivity to lanreotide. Allergic reactions
(including angioedema and anaphylaxis) have been reported following
administration of lanreotide.
Warnings and Precautions
- Cholelithiasis and Gallbladder
Sludge
- SOMATULINE DEPOT may reduce gallbladder
motility and lead to gallstone formation.
- Periodic monitoring may be needed.
- If complications of cholelithiasis are
suspected, discontinue SOMATULINE DEPOT and treat
appropriately
- Hypoglycemia or Hyperglycemia
- Patients treated with SOMATULINE DEPOT
may experience hypoglycemia or hyperglycemia.
- Blood glucose levels should be
monitored when SOMATULINE DEPOT treatment is initiated, or when the
dose is altered, and antidiabetic treatment should be adjusted
accordingly.
- Cardiovascular Abnormalities
- SOMATULINE DEPOT may decrease heart
rate.
- In cardiac studies with acromegalic
patients, the most common cardiac adverse reactions were sinus
bradycardia, bradycardia, and hypertension.
- In patients without underlying cardiac
disease, SOMATULINE DEPOT may lead to a decrease in heart rate
without necessarily reaching the threshold of bradycardia.
- In patients suffering from cardiac
disorders prior to treatment, sinus bradycardia may occur. Care
should be taken when initiating treatment in patients with
bradycardia.
- Thyroid Function Abnormalities
- Slight decreases in thyroid function
have been seen during treatment with lanreotide in acromegalic
patients.
- Thyroid function tests are recommended
where clinically appropriate.
- Monitoring/Laboratory Tests: In
acromegaly, serum GH and IGF-1 levels are useful markers of the
disease and effectiveness of treatment.
Adverse Reactions
- Acromegaly: Adverse reactions in
>5% of patients who received SOMATULINE DEPOT were diarrhea
(37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%),
injection-site reactions (9%), constipation (8%), flatulence (7%),
vomiting (7%), arthralgia (7%), headache (7%), and loose stools
(6%).
- GEP-NETs: Adverse reactions
>10% of patients who received SOMATULINE DEPOT were abdominal
pain (34%), musculoskeletal pain (19%), vomiting (19%), headache
(16%), injection site reaction (15%), hyperglycemia (14%),
hypertension (14%), and cholelithiasis (14%).
- Carcinoid Syndrome: Adverse
reactions occurring in the carcinoid syndrome trial were generally
similar to those in the GEP-NET trial. Adverse reactions occurring
in ≥5% of patients who received SOMATULINE DEPOT and at least 5%
greater than placebo were headache (12%), dizziness (7%), and
muscle spasm (5%).
Drug Interactions: SOMATULINE DEPOT may decrease the
absorption of cyclosporine (dosage adjustment may be needed);
increase the absorption of bromocriptine; and require dosage
adjustment for bradycardia-inducing drugs (e.g.,
beta-blockers).
Special Populations
- Lactation: Advise women not to
breastfeed during treatment and for 6 months after the last
dose.
- Moderate to Severe Renal and Hepatic
Impairment: See full prescribing information for dosage
adjustment in patients with acromegaly.
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.
Please click here for the full Prescribing
Information and 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
This press release contains forward-looking information within
the meaning of the Private Securities Litigation Reform Act of 1995
and other federal securities laws. Any statements contained herein
which do not describe historical facts, including, among others,
statements regarding the newly designed pre-filled syringe now
approved in the U.S., and the prevalence and burden of GEP-NETs,
Carcinoid Syndrome, and Acromegaly are forward-looking statements
which involve risks and uncertainties that could cause actual
results to differ materially from those discussed in such
forward-looking statements.
The forward-looking statements, objectives and targets contained
herein are based on the Group's management strategy, current views
and assumptions. 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 healthcare 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 fulfill 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.
1. Data on file.2. Oronsky, B, Ma, PC, Morgensztern, D &
Carter, CA et al (2017). Nothing But NET: A Review of
Neuroendocrine Tumors and Carcinomas. Neoplasia. 19(12):991-1002.3.
Modlin, IM, Moss, SF, Chung, DC, Jensen, RT, & Snyderwine E
(2008). Priorities for Improving the Management of
Gastroenteropancreatice Neuroendocrine Tumors. Journal of the
National Cancer Institute, 100, 1282-1289.4. Acromunity: Acromegaly
information and support. Available at: https://www.acromunity.com
[Accessed March 2019].5. 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.© 2019 Ipsen
Biopharmaceuticals, Inc.
June 2019SMD-US-003055
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190624005654/en/
Maryann QuinnDirector, Product
Communications+1-857-529-1151maryann.quinn@ipsen.com
Elliot Fox+1-212-257-6724efox@w2ogroup.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