Presentations demonstrate promising advances
for the treatment of advanced hepatocellular carcinoma, metastatic
pancreatic cancer and neuroendocrine tumors
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that clinical
trials with cabozantinib (Cabometyx®) in a variety of tumor types
will be the subject of four presentations at the European Society
for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain, from
27 September – 1 October 2019.
“At Ipsen, our mission is to accelerate the discovery,
development and commercialization of new medicines. So, we’re
delighted to be sharing new studies at ESMO that demonstrate
potential advances in treatment for select cancers where few
effective therapeutic options exist, so no patient is left behind,”
said Dr. Alexandre Lebeaut, Ipsen’s Executive Vice President,
R&D and Chief Scientific Officer.
Key studies including Ipsen medicines to be presented at ESMO
2019 Congress:
- An overview of the trial design of the pivotal Phase III
(COSMIC-312) study of cabozantinib (C) in combination with
atezolizumab vs sorafenib in patients with advanced hepatocellular
carcinoma (aHCC) who have not received prior systemic anticancer
therapy
- A new QTWiST analysis of the Phase III CELESTIAL study
looking at the effect of second-line cabozantinib on health states
for patients with aHCC after sorafenib
“While we’re making strides in our own research programs for
other hard-to-treat-cancers, like small cell lung cancer and
pancreatic adenocarcinoma, our complementary work with partners is
catalyzing and broadening our efforts to fast-track new approaches
for patients with significant unmet needs,” said Bartek Bednarz,
Ipsen, Senior Vice-President, Oncology Franchise. “ESMO 2019 marks
an important milestone for our partnership with Exelixis to further
develop cabozantinib (Cabometyx®), as we have exceeded 100 joint
cabozantinib-related abstracts accepted to medical congresses in
our shared vision to progress the treatment for difficult-to-treat
cancers.”
Follow Ipsen on Twitter via @IpsenGroup and keep up to date with
ESMO 2019 Congress news and updates by using the hashtag
#ESMO19.
Overview of key presentations featuring Ipsen medicines in
development at the ESMO 2019 Congress:
Medicine
Abstract title
Abstract number/timing (CEST)
Cabometyx®
(cabozantinib)
Effect of second-line cabozantinib on
health states for patients with advanced hepatocellular carcinoma
(aHCC) after sorafenib: QTWiST analysis from the CELESTIAL
study
Abstract 754P – Poster Display – Sunday,
29 September, 12:00 PM; Hall 4
Outcomes based on plasma biomarkers for
the phase III CELESTIAL trial of cabozantinib (C) versus placebo
(P) in advanced hepatocellular carcinoma (aHCC)
Abstract 678PD – Poster Discussion –
Category: Gastrointestinal tumours, non-colorectal – Saturday, 28
September, 5:10 PM; Hall 7
Prognostic and predictive factors from the
phase III CELESTIAL trial of cabozantinib (C) versus placebo (P) in
previously treated advanced hepatocellular carcinoma (aHCC)
Abstract 749P – Poster Display – Sunday,
29 September, 12:00 PM; Hall 4
Phase III (COSMIC-312) study of
cabozantinib (C) in combination with atezolizumab vs sorafenib in
patients (pts) with advanced hepatocellular carcinoma (aHCC) who
have not received prior systemic anticancer therapy
Abstract 833TiP – Poster Display – Sunday,
29 September, 12:00 PM; Hall 4
Onivyde® (irinotecan liposome injection)
(nal-IRI/liposomal irinotecan)
Integrated population pharmacokinetic
modelling of liposomal irinotecan in patients with various tumour
types, including untreated metastatic pancreatic cancer (mPC)
Abstract 691P – Poster Display – Sunday,
29 September, 12:00 PM; Hall 4
Somatuline® Autogel® (lanreotide
autogel/depot)
Baseline characteristics from CLARINET
FORTE: Evaluating lanreotide autogel (LAN) 120 mg every 14 days in
patients with progressive pancreatic or midgut neuroendocrine
tumours during a standard first-line LAN regimen
Abstract 1388P – Poster Display – Sunday,
29 September, 12:00 PM; Hall 4
Key investigator sponsored study presentation featuring Ipsen
medicine in development at the ESMO 2019 Congress:
Medicine
Abstract title
Abstract number/timing (CEST)
Onivyde® (irinotecan liposome injection)
(nal-IRI/liposomal irinotecan)
Multicenter randomized phase II trial of
5-Fluorouracil/leucovorin (5-FU/LV) with or without liposomal
irinotecan (nal-IRI) in metastatic biliary tract cancer (BTC) as
second-line therapy after progression on gemcitabine plus cisplatin
(GemCis): NIFTY trial
Abstract 829TiP – Poster Display – Sunday,
29 September, 12:00 PM; Hall 4
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 ONIVYDE® (irinotecan liposome injection)
ONIVYDE® is an encapsulated formulation of irinotecan available
as a 43 mg/10 mL single dose vial. This liposomal form is designed
to increase length of tumor exposure to both irinotecan and its
active metabolite, SN- 38.
On April 3, 2017, Ipsen completed the acquisition from Merrimack
Pharmaceuticals of ONIVYDE® and gained exclusive commercialization
rights for the current and potential future indications for
ONIVYDE® in the U.S. Servier1 is responsible for the development
and commercialization of ONIVYDE® outside of the U.S. and Taiwan
under an exclusive licensing agreement with Ipsen Biopharm Ltd.
ONIVYDE® is approved by the U.S. FDA in combination with
fluorouracil (5-FU) and leucovorin (LV) for the treatment of
patients with metastatic adenocarcinoma of the pancreas after
disease progression following gemcitabine-based therapy. Limitation
of Use: ONIVYDE is not indicated as a single agent for the
treatment of patients with metastatic adenocarcinoma of the
pancreas.
[1]Servier is an independent international pharmaceutical
company, governed by a non-profit foundation, with headquarters in
the Paris metropolitan area. For more information:
www.servier.com
IMPORTANT SAFETY INFORMATION - UNITED STATES BOXED WARNINGS:
SEVERE NEUTROPENIA and SEVERE DIARRHEA Fatal neutropenic sepsis
occurred in 0.8% of patients receiving ONIVYDE. Severe or
life-threatening neutropenic fever or sepsis occurred in 3% and
severe or life-threatening neutropenia occurred in 20% of patients
receiving ONIVYDE in combination with 5-FU and LV. Withhold ONIVYDE
for absolute neutrophil count below 1500/mm3 or neutropenic fever.
Monitor blood cell counts periodically during treatment Severe
diarrhea occurred in 13% of patients receiving ONIVYDE in
combination with 5-FU/LV. Do not administer ONIVYDE to patients
with bowel obstruction. Withhold ONIVYDE for diarrhea of Grade 2–4
severity. Administer loperamide for late diarrhea of any severity.
Administer atropine, if not contraindicated, for early diarrhea of
any severity
CONTRAINDICATION ONIVYDE® is contraindicated in patients
who have experienced a severe hypersensitivity reaction to ONIVYDE®
or irinotecan HCl
Warnings and precautions Severe neutropenia: See Boxed
WARNING. In patients receiving ONIVYDE/5-FU/LV, the incidence of
Grade 3/4 neutropenia was higher among Asian (18/33 [55%]) vs White
patients (13/73 [18%]) Neutropenic fever/neutropenic sepsis was
reported in 6% of Asian vs 1% of White patients
Severe diarrhea: See Boxed WARNING. Severe and
life-threatening late-onset (onset >24 hours after chemotherapy
[9%]) and early-onset diarrhea (onset ≤24 hours after chemotherapy
[3%], sometimes with other symptoms of cholinergic reaction) were
observed
Interstitial lung disease (ILD): Irinotecan HCl can cause
severe and fatal ILD. Withhold ONIVYDE® I patients with new or
progressive dyspnea, cough, and fever, pending diagnostic
evaluation. Discontinue ONIVYDE® in patients with a confirmed
diagnosis of ILD
Severe hypersensitivity reactions: Irinotecan HCl can
cause severe hypersensitivity reactions, including anaphylactic
reactions. Permanently discontinue ONIVYDE® in patients who
experience a severe hypersensitivity reaction
Embryo-fetal toxicity: ONIVYDE® can cause fetal harm when
administered to a pregnant woman. Advise females of reproductive
potential to use effective contraception during and for 1 month
after ONIVYDE® treatment
Adverse reactions
- The most common adverse reactions (≥20%) were diarrhea (59%),
fatigue/asthenia (56%), vomiting (52%), nausea (51%), decreased
appetite (44%), stomatitis (32%), and pyrexia (23%)
- The most common Grade 3/4 adverse reactions (≥10%) were
diarrhea (13%), fatigue/asthenia (21%), and vomiting (11%)
- Adverse reactions led to permanent discontinuation of ONIVYDE®
in 11% of patients receiving ONIVYDE/5- FU/LV; The most frequent
adverse reactions resulting in discontinuation of ONIVYDE® were
diarrhea, vomiting, and sepsis
- Dose reductions of ONIVYDE® for adverse reactions occurred in
33% of patients receiving ONIVYDE/5 FU/LV; the most frequent
adverse reactions requiring dose reductions were neutropenia,
diarrhea, nausea, and anemia
- ONIVYDE® was withheld or delayed for adverse reactions in 62%
of patients receiving ONIVYDE/5-FU/LV; the most frequent adverse
reactions requiring interruption or delays were neutropenia,
diarrhea, fatigue, vomiting, and thrombocytopenia
- The most common laboratory abnormalities (≥20%) were anemia
(97%), lymphopenia (81%), neutropenia (52%), increased ALT (51%),
hypoalbuminemia (43%), thrombocytopenia (41%), hypomagnesemia
(35%), hypokalemia (32%), hypocalcemia (32%), hypophosphatemia
(29%), and hyponatremia (27%)
Drug interactions
- Avoid the use of strong CYP3A4 inducers, if possible, and
substitute non-enzyme inducing therapies ≥2 weeks prior to
initiation of ONIVYDE®
- Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if
possible, and discontinue strong CYP3A4 inhibitors ≥1 week prior to
starting therapy
Special populations
- Pregnancy and Reproductive Potential: See WARNINGS &
PRECAUTIONS. Advise males with female partners of reproductive
potential to use condoms during and for 4 months after ONIVYDE
treatment
- Lactation: Advise nursing women not to breastfeed during and
for 1 month after ONIVYDE treatment
Please see full U.S. Prescribing Information, including BOXED
WARNINGS, for ONIVYDE®.
ONIVYDE® is a registered trademark of Ipsen Biopharm
Limited.
ABOUT CABOMETYX® (cabozantinib)
CABOMETYX® is not marketed by Ipsen in the U.S.
CABOMETYX® 20mg, 40mg and 60mg film-coated unscored tablets
Active ingredient: Cabozantinib (S)-malate 20mg, 40mg and
60mg
Other components: Lactose
Indications: 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 and Taiwan for the treatment of advanced RCC in adults who
have received prior VEGF-targeted therapy; in the European Union
for previously untreated intermediate- or poor-risk advanced RCC;
in Canada for adult patients with advanced RCC who have received
prior VEGF targeted therapy; and in the European Union, Norway and
Iceland for HCC in adults who have previously been treated with
sorafenib.
CABOMETYX® is not indicated for previously untreated advanced
HCC.
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
erythrodysaesthesia 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; if perforation and
unmanageable fistula occur, discontinue cabozantinib.
Thromboembolic events: use with caution in patients with
a history of or risk factors for thromboembolism; discontinue if
acute myocardial infarction (MI) or other significant arterial
thromboembolic complication occurs.
Hemorrhage: 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: 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.
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. 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. Drive and use machines:
Caution is recommended
Adverse reactions:
The most common serious adverse reactions are hypertension,
diarrhea, PPES, pulmonary embolism, fatigue and hypomagnesaemia.
Very common (>1/10): anemia, lymphopenia neutropenia,
thrombocytopenia, hypothyroidism, dehydration, decreased appetite,
hyperglycemia, hypoglycemia, hypophosphatasemia, hypoalbuminemia,
hypomagnesaemia, hyponatremia, hypokalemia, hyperkalemia,
hypocalcemia, hyperbilirubinemia, peripheral sensory neuropathy,
dysgeusia, headache, dizziness, hypertension, dysphonia, dyspnea,
cough, diarrhea, nausea, vomiting, stomatitis, constipation,
abdominal pain, dyspepsia, oral pain, dry mouth, PPES, dermatitis
acneiform, rash, rash maculopapular, dry skin, alopecia, hair color
change, pain in extremity, muscle spasms, arthralgia, proteinuria,
fatigue, mucosal inflammation, asthenia, weight decreased, serum
ALT, AST, and ALP increased, blood bilirubin increased, creatinine
increased, triglycerides increased, white blood cell decreased, GGT
increased, amylase increased, blood cholesterol increased, lipase
increased. Common (>1/100 to <1/10): abscess, tinnitus,
pulmonary embolism, pancreatitis, abdominal pain upper,
gastro-esophageal reflux disease, hemorrhoids, pruritus, peripheral
edema, wound complications. Uncommon (>1/1000 to <1/100):
convulsion, anal fistula, hepatitis cholestatic, osteonecrosis of
the jaw. Selected adverse events: GI perforation, fistulas,
hemorrhage, RPLS.
Prescribers should consult the SPC in relation to other adverse
reactions.
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® (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
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).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190925005896/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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