Presentations showcase insights in advanced
renal cell carcinoma, gastroenteropancreatic neuroendocrine tumors
and acromegaly
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that results
from a network meta-analysis (NMA) in advanced renal cell carcinoma
(aRCC), and a UK-focused budget impact study assessing long-acting
somatostatin analogues (LA-SSAs) for the treatment of acromegaly
and gastroenteropancreatic neuroendocrine tumors (GEP NET) will be
presented at the International Society of Pharmacoeconomics and
Outcomes Research (ISPOR) Europe 2019 Annual Conference. ISPOR
takes place in Copenhagen, Denmark, from 2 – 6 November 2019.
Key studies to be presented at ISPOR Europe 2019:
- An assessment of the budget impact of LA-SSAs in the
treatment of acromegaly and GEP NET, considering attributes related
to the drug delivery of LA-SSAs in the UK.
- An NMA analyzing cabozantinib versus standard-of-care
comparators in progression free survival (PFS) and overall survival
(OS) in the first-line treatment of advanced renal cell
carcinoma.
“We’re excited to be sharing two interesting sets of results –
namely a comparison of first-line therapies and budget impact of a
treatment approach for acromegaly and gastroenteropancreatic
neuroendocrine tumors,” said Ulf Staginnus, Senior Vice President,
Head Global Market Access and Pricing, Ipsen. “With more than 5,000
global healthcare leaders, seeking robust health solutions and new
insights, ISPOR Europe 2019 is the perfect stage to share these
results.”
The delivery attributes of both LA-SSAs were considered in the
UK-focused study assessing the budget impact of the LA-SSAs,
lanreotide versus octreotide in the treatment of acromegaly and
GEP-NET. Model inputs (including drug acquisition and
administration costs) were based on publicly available sources. The
analysis compared the current and hypothetical market share
scenarios from three perspectives in the UK: the National Health
Service (NHS), a regional clinical commissioning group (CCG), and a
local institution (hospital). Results suggested that increasing the
use of lanreotide to a hypothetical 80% market share for lanreotide
in the UK would reduce overall LA-SSAs patient treatment expenses
by £2.9 million annually in the UK (a reduction of 3.6% from the
current budget estimate of £80.6 million).
In the area of treatment provision in aRCC, Ipsen used an NMA to
respond to the challenge presented to healthcare professionals by
the introduction of targeted therapies in the last year with no way
to objectively compare them. While randomized trials are the gold
standard for comparative effectiveness research, they are not
always available for clinically and economically important
treatment comparisons. In this case, the NMA may offer some helpful
insights as it suggests that cabozantinib significantly increases
progression free survival (PFS) in intermediate and poor-risk
patients when compared with standards-of-care and concludes that
cabozantinib may be considered as an efficient treatment option in
first-line aRCC.
“Modern quantitative data reviews of available agents offer
additional insights into existing healthcare,” said Bartek Bednarz,
Senior Vice-President, Global Product and Portfolio Strategy,
Ipsen. “The network meta-analysis (NMA) for cabozantinib and budget
impact model for somatostatin analogues shared at ISPOR Europe 2019
are just part of Ipsen’s ongoing commitment to demonstrating
benefit for payers and improving options for patients with high
unmet needs.”
Follow Ipsen on Twitter via @IpsenGroup and keep up to date with
ISPOR Europe 2019 Conference news and updates by using the hashtag
#ISPOREurope.
Overview of key Ipsen presentations at ISPOR Europe
2019:
Medicine
Abstract title
Abstract number/timing (CEST)
Cabometyx®
(cabozantinib)
Cabozantinib versus standard-of-care
comparators: a network meta-analysis of progression free survival
and overall survival in the first-line treatment of advanced renal
cell carcinoma
PCN42; Board D5
RESEARCH POSTER SESSION 2
CANCER
Monday, November 4, 2019
Display Hours: 15:30 - 19:00
Somatuline® Autogel® (lanreotide
autogel/depot)
Budget impact analysis of somatostatin
analogues in the treatment of GEP-NET and acromegaly in the UK
PDG23; Board J3
RESEARCH POSTER SESSION 4
DRUGS & GENERICS
Tuesday, November 5, 2019
Display Hours: 15:45 - 19:00
N/A
Retrospective Gesetzliche
Krankenversicherung (statutory health insurance) (GKV) research
study on the initial treatment of bladder carcinoma (BCA) by
transurethral bladder resection (TURB) - a comparative analysis of
costs and urological follow-up therapies using standard white
light- (WL-) vs. Blue light- (WL-)TURB
PCN502; Board W12
RESEARCH POSTER SESSION 2
CANCER
Monday, November 4, 2019
Display Hours: 15:30 - 19:00
N/A
Assessing the human and economic burden of
short stature: a systematic literature review
PMU142; Board V19
RESEARCH POSTER SESSION 4
MULTIPLE DISEASES
Tuesday, November 5, 2019
Display Hours: 15:45 - 19:00
ABOUT IPSEN PRODUCTS
This press release mentions investigational uses of Ipsen
products. Product indications and approvals for use vary by
jurisdiction; please see SmPC/PI for full indications and safety
information, including Boxed Warnings.
ABOUT CABOMETYX® (cabozantinib)
CABOMETYX® 20mg, 40mg and 60mg film-coated unscored tablets
Active ingredient: Cabozantinib (S)-malate 20mg, 40mg and
60mg
Other components: Lactose
Indications: Treatment of advanced renal cell carcinoma
(RCC) in treatment-naïve adults with intermediate or poor risk or
adults following prior vascular endothelial growth factor
(VEGF)-targeted therapy and in adults as monotherapy for the
treatment of hepatocellular carcinoma (HCC) who have previously
been treated with sorafenib.
In the U.S., CABOMETYX® tablets are approved for the treatment
of patients with advanced RCC and for the treatment of patients
with hepatocellular carcinoma (HCC) who have been previously
treated with sorafenib.
CABOMETYX® tablets are also approved in: the European Union,
Norway, Iceland, Australia, Switzerland, South Korea, Canada,
Brazil, Taiwan, Chile, Russia, Ukraine, Serbia, Turkey, Israel,
Lebanon, Jordan , UAE, Saudia Arabia, Hong Kong, Singapore and
Macau for the treatment of advanced RCC in adults who have received
prior VEGF-targeted therapy; in the European Union, Norway,
Iceland, Australia, Canada, Brazil, Taiwan, Chile, Russia, Serbia,
Turkey, Israel, Jordan , UAE, Saudia Arabia, Hong Kong and
Singapore for previously untreated intermediate- or poor-risk
advanced RCC; and in the European Union, Norway, Iceland
,Australia, Jordan, UAE, Saudia Arabia, Hong Kong and Singapore for
HCC in adults who have previously been treated with sorafenib.
Dosage and administration: The recommended dose of
CABOMETYX® is 60 mg once daily. Treatment should continue until the
patient is no longer clinically benefiting from therapy or until
unacceptable toxicity occurs. Management of suspected adverse drug
reactions may require temporary interruption and/or dose reduction
of CABOMETYX therapy. For dose modification, please refer to full
SmPC. CABOMETYX® is for oral use. The tablets should be swallowed
whole and not crushed. Patients should be instructed to not eat
anything for at least 2 hours before through 1 hour after taking
CABOMETYX®.
Contraindications: Hypersensitivity to the active
substance or to any of the excipients listed in the SmPC.
Special warnings and precautions for use:
Monitor closely for toxicity during first 8 weeks of therapy.
Events that generally have early onset include hypocalcemia,
hypokalemia, thrombocytopenia, hypertension, palmar-plantar
erythrodysesthesia syndrome (PPES), proteinuria, and
gastrointestinal (GI) events.
Perforations and fistulas: serious gastrointestinal
perforations and fistulas, sometimes fatal, have been observed with
cabozantinib. Patients with inflammatory bowel disease, GI tumor
infiltration or complications from prior GI surgery should be
evaluated prior to therapy and monitored; persistent or recurring
diarrhea while on treatment may be a risk factor for the
development of anal fistula, if perforation and unmanageable
fistula occur, discontinue cabozantinib.
Thromboembolic events: Events of venous thromboembolism
sometimes fatal, have been observed, use with caution in patients
with a history of or risk factors for thromboembolism; discontinue
if acute myocardial infarction or other significant arterial
thromboembolic complication occurs.
Hemorrhage: severe hemorrhages, sometimes fatal, have
been observed, not recommended for patients that have or are at
risk of severe hemorrhage.
Wound complications: treatment should be stopped at least
28 days prior to scheduled surgery (including dental).
Hypertension: monitor blood pressure (BP); reduce with
persistent hypertension and discontinue should uncontrolled
hypertension or hypertensive crisis occur.
Palmar-plantar erythrodysesthesia (PPES): interrupt
treatment if severe PPES occurs.
Proteinuria: monitor urine protein, discontinue in
patients with nephrotic syndrome.
Reversible posterior leukoencephalopathy syndrome (RPLS):
discontinue in patients with RPLS.
QT interval prolongation: use with caution in patients
with a history of QT prolongation, those on antiarrhythmics or with
pre-existing cardiac disease.
Hepatic effects: abnormal liver function tests have
frequently been observed, monitor during treatment for symptoms of
hepatic encephalopathy, not recommended in severe hepatic
impairment.
Laboratory tests: electrolyte abnormalities have been
observed, monitor during treatment.
Excipients: do not use in patients with hereditary
problems of galactose intolerance, Lapp lactase deficiency or
glucose-galactose malabsorption.
Drug interactions: Cabozantinib is a CYP3A4 substrate.
Potent CYP3A4 inhibitors may result in an increase in cabozantinib
plasma exposure (e.g. ketoconazole, ritonavir, itraconazole,
erythromycin, clarithromycin, grapefruit juice). Coadministration
with CYP3A4 inducers may result in decreased cabozantinib plasma
exposure (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital,
St John's Wort). Cabozantinib may increase the plasma concentration
of P-glycoprotein substrates (e.g. fexofenadine, aliskiren,
ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc,
posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol,
tolvaptan). MRP2 inhibitors may increase cabozantinib plasma
concentrations (e.g. cyclosporine, efavirenz, emtricitabine). Bile
salt sequestering agents may impact absorption or reabsorption
resulting in potentially decreased cabozantinib exposure. No dose
adjustment when co-administered with gastric pH modifying agents. A
plasma protein displacement interaction may be possible with
warfarin. INR values should be monitored in such a combination.
Women of childbearing potential/contraception in males and
females: Ensure effective measures of contraception (oral
contraceptive plus a barrier method) in male and female patients
and their partners during therapy and for at least 4 months after
treatment.
Pregnancy and lactation: CABOMETYX® should not be used during
pregnancy unless the clinical condition of the woman requires
treatment. Lactation – discontinue breast-feeding during and for at
least 4 months after completing treatment.
Adverse reactions:
The most common serious adverse reactions are diarrhea,
hypertension, dehydration, hyponatraemia, nausea, decreased
appetite, embolism, fatigue, hypomagnesaemia, PPES, hepatic
encephalopathy and asthenia. Very common (>1/10): anemia,
hypothyroidism, decreased appetite, hypomagnesemia, hypokalaemia,
dysgeusia, headache, dizziness, hypertension, hemorrhage,
dysphonia, dyspnoea, cough, diarrhea, nausea, vomiting, stomatitis,
constipation, abdominal pain, dyspepsia, PPES, rash, pain in
extremity, fatigue, mucosal inflammation, asthenia, peripheral
oedema, weight decreased, serum ALT increased, AST increased.
Common (>1/100 to <1/10): abscess, thrombocytopenia,
neutropenia, dehydration, hypoalbuminemia, hypophosphatemia,
hyponatremia, hypocalcemia, hyperkalemia, hyperbilirubinemia,
hyperglycemia, hypoglycemia, peripheral sensory neuropathy,
tinnitus, venous thrombosis, arterial thrombosis, pulmonary
embolism, gastrointestinal perforation, fistula, gastroesophageal
reflux disease, hemorrhoids, oral pain, dry mouth, hepatic
encephalopathy, pruritus, alopecia, dry skin, dermatitis acneiform,
hair colour change, muscle spasms, arthralgia, proteinuria, blood
ALP increased, GGT increased, blood creatinine increased, amylase
increased, lipase increased, blood cholesterol increased, white
blood cell count decreased. Uncommon (>1/1000 to <1/100):
lymphopenia, convulsion, pancreatitis, glossodynia, hepatitis
cholestatic, osteonecrosis of the jaw, blood triglycerides
increased, wound complications. Frequency not known:
cerebrovascular accident, myocardial infarction. Selected adverse
reactions: GI perforation, hepatic encephalopathy, diarrhea,
fistulas, hemorrhage, RPLS. Prescribers should consult the SmPC in
relation to other adverse reactions. Overdose: no specific
treatment, in the event of suspected overdose, cabozantinib should
be withheld and supportive care instituted.
For more information, see the regularly updated registered
product information on the European Medicine Agency
www.ema.europa.eu
CABOMETYX® is marketed by Exelixis, Inc. in the United States.
Cabometyx (r) is a registered Trademark of Exelixis, Inc. Ipsen has
exclusive rights for the commercialization and further clinical
development of CABOMETYX® outside of the United States and
Japan.
ABOUT SOMATULINE® autogel (lanreotide)
Somatuline® Autogel® is made of the active substance lanreotide,
which is a somatostatin analogue that inhibits the secretion of
growth hormone and certain hormones secreted by the digestive
system. The main indications of Somatuline® and Somatuline®
Autogel® are:2
- The treatment of individuals with acromegaly when the
circulating levels of Growth Hormone (GH) and/or Insulin-like
Growth Factor-1 (IGF-1) remain abnormal after surgery and/or
radiotherapy, or in patients who otherwise require medical
treatment.
- The treatment of grade 1 and a subset of grade 2 (Ki-67 index
up to 10%) gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
of midgut, pancreatic or unknown origin where hindgut sites of
origin have been excluded, in adult patients with unresectable
locally advanced or metastatic disease.
- The treatment of symptoms associated with neuroendocrine
(particularly carcinoid) tumors.
IMPORTANT SAFETY INFORMATION
The detailed recommendations for the use of Somatuline® Autogel®
are described in the Summary of Product Characteristics (SmPC),
available here.
2 Somatuline® Autogel® SmPC. November 2018
Somatuline® and Autogel® are registered trademarks of Ipsen
Pharma.
In the United States, Ipsen markets lanreotide as Somatuline®
Depot.
INDICATIONS
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 shortacting 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.
Please see full U.S. Prescribing Information, including
SOMATULINE® DEPOT.
Somatuline Depot is a registered trademark of Ipsen Pharma
S.A.S.
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 €2.2 billion in
2018, 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 5,700 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.
Forward Looking Statement
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
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receive the necessary regulatory approvals or that the product will
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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
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currency exchange rate fluctuations; the impact of pharmaceutical
industry regulation and health care legislation; global trends
toward health care cost containment; technological advances, new
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The Group also depends on third parties to develop and market some
of its products which could potentially generate substantial
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Group cannot be certain that its partners will fulfil their
obligations. It might be unable to obtain any benefit from those
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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
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statements are based, unless so required by applicable law. The
Group’s business is subject to the risk factors outlined in its
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Document available on its website (www.ipsen.com).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191030005991/en/
For further information:
Christian Marcoux, M.Sc. SVP, Global Communications +33 (0) 1 58
33 67 94 christian.marcoux@ipsen.com
Kelly Blaney Vice President, Global Communications +44 (0) 7903
402275 kelly.blaney@ipsen.com
Financial Community Eugenia Litz Vice President, Investor
Relations +44 (0) 1753 627721 eugenia.litz@ipsen.com
Myriam Koutchinsky Investor Relations Manager +33 (0)1 58 33 51
04 myriam.koutchinsky@ipsen.com
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