Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that new data
from clinical studies on investigational uses of cancer medicines
cabozantinib (Cabometyx®), liposomal irinotecan (Onivyde®), and
lanreotide autogel (Somatuline®, marketed as Somatuline Depot® in
the United States) will be presented at the 2019 American Society
of Clinical Oncology (ASCO) Annual Meeting. The meeting takes place
in Chicago, Illinois, U.S., 31 May–4 June 2019; data featuring
Ipsen medicines includes:
- New data from the Phase 3
CELESTIAL trial on the association of adverse events with efficacy
outcomes for cabozantinib in patients with advanced hepatocellular
carcinoma
- Overview of the Phase 3
COSMIC-312 trial of cabozantinib in combination with atezolizumab
vs sorafenib in patients with advanced hepatocellular carcinoma who
have not received previous systemic anticancer therapy
- First Phase 2 data from the
CaboGIST study (trial 1317) from the European Organization for
Research and Treatment of Cancer on the activity and safety of
cabozantinib in patients with metastatic gastrointestinal stromal
tumor after failure of imatinib and sunitinib
- Preliminary results from the
RESILIENT study of liposomal irinotecan injection in patients with
small cell lung cancer
- Results from a Phase 2 multicenter
study of lanreotide autogel in the treatment of clinical
symptoms associated with inoperable malignant intestinal
obstruction
“At Ipsen, patients inspire and drive us to tackle some of the
most difficult-to-treat cancers, particularly where few effective
options exist. ASCO gives us the opportunity to share the progress
we have made in our mission of developing and delivering
therapeutic solutions that meet the real needs of patients and may
help improve their lives,” said Dr. Alexandre Lebeaut, Ipsen’s
Executive Vice President, R&D, and Chief Scientific Officer.
“With our continued clinical programs and collaborations, we are
making strides in renal, liver and small cell lung cancers and
other cancers with high unmet need, and we look forward to
continuing to advance these programs.”
Follow Ipsen on Twitter via @IpsenGroup and @IpsenUS and keep up
to date with ASCO 2019 congress news and updates by using the
hashtag #ASCO19.
Overview of key Ipsen presentations at ASCO 2019:
Medicine Abstract title
Abstract number/timing(CDT)
Cabometyx®
(cabozantinib)
Phase 3 (COSMIC-311) randomized,
double-blind, placebo- controlled study of cabozantinib in patients
with radioiodine (RAI)- refractory differentiated thyroid cancer
(DTC) who have progressed after prior VEGFR-targeted therapy
Abstract TPS6097 Poster 82a – Category:
Head and Neck Cancer; Saturday, 1 June, 1:15 PM - 4:15 PM; Hall A
TIP
Association of adverse events (AEs) with
efficacy outcomes for cabozantinib (C) in patients (pts) with
advanced hepatocellular carcinoma (aHCC) in the Phase 3 CELESTIAL
trial
Abstract 4088 Poster 193 – Category:
Gastrointestinal (Noncolorectal) Cancer; Monday, 3 June, 8:00 AM -
11:00 AM; Hall A
Phase 3 (COSMIC-312) study of cabozantinib
(C) in combination with atezolizumab (A) vs sorafenib (S) in
patients (pts) with advanced hepatocellular carcinoma (aHCC) who
have not received previous systemic anticancer therapy
Abstract TPS4157 Poster 254a – Category:
Gastrointestinal (Noncolorectal) Cancer; Monday, 3 June, 8:00 AM -
11:00 AM; Hall A TIP
Onivyde® (nal-IRI/liposomalirinotecan)
RESILIENT: Study of Irinotecan Liposome
Injection (nal-IRI) in Patients with Small Cell Lung Cancer:
Preliminary Findings from Part 1 Dose-defining Phase
Abstract 8562 Poster 318 – Category: Lung
Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic
Cancers; Poster - Sunday, 2 June, 8:00 AM - 11:00 AM; Hall A
Somatuline®
Autogel®(lanreotideautogel/depot)
Efficacy and Safety of Lanreotide Autogel
(LAN) 120 mg in theTreatment of Clinical Symptoms Associated With
Inoperable Malignant Intestinal Obstruction (IMIO): Results From A
Phase II Multicenter Study
Abstract 4118 Poster 223 – Category:
Gastrointestinal (Noncolorectal) Cancer; Poster - Monday, 3 June,
8:00 AM - 11:00 AM; Hall A
Overview of key investigator sponsored study presentations
featuring Ipsen medicines at ASCO 2019:
Medicine Abstract title
Abstract number/timing(CDT)
Cabometyx®
(cabozantinib)
Activity and safety of cabozantinib in
patients with metastatic gastrointestinal stromal tumor after
failure of imatinib and sunitinib. European Organization for
Research and Treatment of Cancer (EORTC) Phase 2 trial 1317
“CaboGIST” EORTC Sponsored Study
Abstract 11006 Oral: Category: Sarcoma;
Monday, 3 June, 10:00 AM - 10:12 AM; E450
PDIGREE: An adaptive Phase 3 trial of
PD-inhibitor nivolumab and Ipilimumab (IPI-NIVO) with VEGF TKI
cabozantinib (CABO) in metastatic untreated Renal Cell Cancer
(Alliance A031704) NCI Sponsored Study
Abstract TPS4596 Poster 417a – Category:
Genitourinary (Nonprostate) Cancer; Poster - Monday, 3 June, 1:15
PM - 4:15 PM; Hall A
Prognostic value of sequential 18F- FDG +
Na18F PET/CT (NaF+FDG PET) in metastatic genitourinary (GU) cancer
patients (pts) treated with Cabozantinib/ Nivolumab +/- Ipilimumab
(CaboNivoIpi) NCI Sponsored Study
Abstract 4544 Poster 370 – Category:
Genitourinary (Nonprostate) Cancer; Poster - Monday, 3 June, 1:15
PM - 4:15 PM; Hall A
Circulating tumor cell (CTC) enumeration
in patients (pts) with metastatic genitourinary (mGU) tumors
treated in a phase I study of cabozantinib and nivolumab (CaboNivo)
+/- ipilimumab (CaboNivoIpi)
Abstract 4555 Poster 381 – Category:
Genitourinary (Nonprostate) Cancer; Poster - Monday, 3 June, 1:15
PM - 4:15 PM; Hall A
Correlates of overall survival (OS) in
metastatic vs. primary uveal melanoma (UM) and results of a
randomized trial of cabozantinib (cabo) vs. chemotherapy (chemo)
Alliance A091201 NCI Sponsored Study
Abstract 9506 – Oral: Category:
Melanoma/Skin Cancers; Poster - Tuesday, 4 June, 11:45 AM - 11:57
AM; S406
Onivyde® (nal-IRI/liposomalirinotecan)
A multicenter phase Ib/II study of
nalirinotecan, 5fluouracil and leucovorin in combination with
nivolumab as second-line therapy for patients with advanced
unresectable biliary tract cancer
Abstract TPS4154 Poster 252b – Category:
Gastrointestinal (Noncolorectal) Cancer; Poster - Monday, 3 June,
8:00 AM - 11:00 AM; Hall A
ABOUT IPSEN PRODUCTSThis 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.
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 US. 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 international pharmaceutical company, governed
by a non-profit foundation, with headquarters in the Paris
metropolitan area.
IMPORTANT SAFETY INFORMATION - UNITED STATESBOXED
WARNINGS: SEVERE NEUTROPENIA and SEVERE DIARRHEAFatal
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 treatmentSevere 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
CONTRAINDICATIONONIVYDE is contraindicated in patients
who have experienced a severe hypersensitivity reaction to ONIVYDE
or irinotecan HCl
Warnings and PrecautionsSevere 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 for ONIVYDE®.
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
ONIVYDE is a registered trademark of Ipsen Biopharm Limited.
XERMELO® is not marketed by Ipsen in the United States. The
approved indications may vary by country. CABOMETYX® is marketed by
Exelixis, Inc. in the United States. Ipsen has exclusive rights for
the commercialization and further clinical development of
CABOMETYX® outside of the United States and Japan.
ABOUT SOMATULINE®
(lanreotide)IndicationsSOMATULINE® DEPOT (lanreotide)
is a somatostatin analog indicated for:
- 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 INFORMATIONContraindications
- 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 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.
Most Common Adverse Reactions
- GEP-NETs: Adverse reactions in
>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 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.
- 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 IpsenIpsen 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 StatementThe 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).
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version on businesswire.com: https://www.businesswire.com/news/home/20190523005596/en/
Christian MarcouxCorporate Communications+33 (0) 1 58 33 67
94christian.marcoux@ipsen.com
Kelly BlaneyCorporate Communications+44 (0) 7903
402275kelly.blaney@ipsen.com
Financial CommunityEugenia LitzVice President, Investor
Relations+44 (0) 1753 627721eugenia.litz@ipsen.com
Myriam KoutchinskyInvestor Relations Manager+33 (0)1 58 33 51
04myriam.koutchinsky@ipsen.com
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