– Review of NAPOLI-1 Data Evaluated Impact of
Protocol-defined Dose Modifications Used to Manage Adverse Events
on Overall Survival in Patients Treated with ONIVYDE® –
Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen,
(Euronext: IPN; ADR: IPSEY), today announced that five new
sub-analyses of the pivotal Phase 3 NAPOLI-1 trial will be
presented at this year’s American Society of Clinical Oncology’s
Gastrointestinal Cancer Symposium (ASCO GI) taking place in San
Francisco, California, from January 18-20. The results of these
post-hoc analyses may offer physicians insight into treatment
strategies for metastatic pancreatic cancer patients who have
progressed following gemcitabine-based therapy and are being
treated with ONIVYDE® (irinotecan liposome injection) in
combination with fluorouracil (5-FU) and leucovorin (LV). There
will be seven ONIVYDE® poster presentations at this year's
conference. Three additional posters will be presented focused on
neuroendocrine tumors (NETs) or Somatuline® Depot (lanreotide)
Injection 120mg.
Wang-Gillam A, Hubner R, Mirakhur B, et al. Dose
modifications of liposomal irinotecan (nal-IRI) +
5-fluorouracil/leucovorin (5-FU/LV) in NAPOLI-1: impact on
efficacy. ASCO GI 2018 Abstract # 388; Friday, January 19, from
11:30AM PST – 1:00PM PST
In NAPOLI-1 (NCT01494506), a randomized phase 3 study in
patients with metastatic pancreatic cancer previously treated with
gemcitabine-based therapy, ONIVYDE®+5-FU/LV improved overall
survival (OS; primary endpoint) vs 5-FU/LV (6.1 mos vs 4.2 mos; HR
= 0.67, 95% CI 0.49–0.92; P = 0.012). In a post-hoc analysis
examining the impact of protocol-defined dose reductions or delays
used to manage adverse events (AEs) on overall survival (OS) in
ONIVYDE®-treated patients, there was a numerical but not
statistically significant difference in OS between patients who did
have a dose reduction (patients = 34, OS = 9.3 mos) or dose delay
(patients = 49, OS = 8.4 mos) vs. patients who did not require dose
reductions (patients = 83, OS = 5.4 mos; HR = 0.66 [95% CI 0.43,
1.01]) or dose delays (patients = 68, OS = 5.6 mos; HR = 0.82 [95%
CI 0.56, 1.23]). Adverse events (AE) seen in this post-hoc analysis
was consistent with AEs reported in the NAPOLI-1 clinical
trial.
In this post-hoc analysis, all patients who required a dose
modification during the first 6 weeks of the trial were included.
Dose reductions were defined as any reduction in dose from initial
administered dose, and delays were defined as any delay in dosing
greater than three days from the target dosing date. The study
protocol allowed ≤2 dose reductions for ONIVYDE® and 5-FU/LV and
for delays up to 3 weeks.
“Delays and dose reductions during the course of treatment
frequently occurred in patients with metastatic pancreatic cancer
who are generally fragile and weak from their illness,” said
lead investigator Andrea Wang-Gillam, MD, PhD, Associate Professor,
Divisions of Hematology and Oncology at Washington University
School of Medicine. “These analyses provide physicians with
additional insights on possible treatment strategies for this
patient population.”
Wang-Gillam A, Hubner R, Mirakhur B, et al. Nomogram for
predicting overall survival (OS) in patients (pts) treated with
liposomal irinotecan (nal-IRI) ± 5-fluorouracil/leucovorin
(5-FU/LV) in metastatic pancreatic ductal adenocarcinoma (mPDAC)
previously treated with gemcitabine-based therapy in NAPOLI-1. ASCO
GI 2018 Abstract # 459; Friday, January 19, from 11:30AM PST –
1:00PM PST
In a second post-hoc analysis of the NAPOLI-1 trial, researchers
developed a diagram, or nomogram, representing the relationship
between multiple variables to help predict OS in patients with
metastatic adenocarcinoma of the pancreas after disease progression
following gemcitabine‐based therapy. Following both a univariate
and multivariate analysis, eight predictive factors of OS were
identified including ONIVYDE® + 5-FU/LV treatment, Karnofsky
Performance Status (KPS), neutrophil-to-lymphocyte ratio (NLR),
albumin level, baseline CA19-9, stage 4 at diagnosis, BMI, and
presence of liver metastasis. The nomogram, which distinguishes
between risk groups, and may aid in clinical decision-making, will
be presented during poster session B (Board M6 – Abstract 459) on
Friday, January 19 from 11:30AM-1:00PM PST.
“Ipsen is committed to continuing to understand the patients we
serve, and it’s critical that we invest in ongoing research and
additional studies that will better inform the treatment paradigm –
this is particularly needed in pancreatic cancer where there are
limited treatment options,” said David Cox, Vice President,
Global Medical Affairs – North America.
Somatuline® Depot and NETs
Three additional Ipsen-sponsored studies have been accepted and
will be presented as posters at this year’s ASCO GI conference,
including a prospective analysis of the ELECT trial, which
evaluates Somatuline® Depot’s impact on carcinoid syndrome in NET
patients. The remaining two accepted abstracts were survey analyses
focused on understanding the challenges and emotional burden NETs
have on patients, with results revealing the need for additional
informational resources for patients.
David Cox also said, “Identifying pain points in a
patient’s treatment journey so that we can appropriately support
them is a promise we deliver across Ipsen to provide high quality
treatment options.”
*These post-hoc analyses of the NAPOLI-1 pivotal trial are not
included in the U.S. prescribing information. See full ONIVYDE®
prescribing information below.
**The prospective analysis of the ELECT trial is not included in
the U.S. prescribing information. See full Somatuline® Depot
prescribing information below.
About Pancreatic Cancer
Pancreatic cancer is a rare and deadly disease with about 55,440
people (29,200 men and 26,240 women) being diagnosed with
pancreatic cancer in the United States alone.1 More than half are
diagnosed with metastatic disease, which has an overall 5-year
survival rate of less than three percent1, and often rapidly
progresses during or shortly after receiving chemotherapy.2
Pancreatic cancer accounts for about 3% of all cancers, and is the
3rd leading cause of cancer-related death in the United States,
surpassing breast cancer.1 It is expected to become the 2nd leading
cause of cancer related death in the U.S. by the year 2030,
surpassing colorectal cancer.1,3
About Gastrointestinal and Pancreatic Neuroendocrine
Tumors
Gastrointestinal and pancreatic neuroendocrine tumors, also
known as gastroenteropancreatic neuroendocrine tumors (GEP-NETs),
are a rare type of cancer. They are diagnosed in approximately 5
out of every 100,000 people in the U.S. There are an estimated
112,000 individuals currently living with neuroendocrine tumors in
the U.S., and the incidence and prevalence of this type of cancer
have risen 4-to-6 fold in the last 30 years. The average time until
a patient with GEP-NETs is accurately diagnosed is at least 5
years; with more than 80% of patients seeing at least three doctors
during their diagnosis. Because of this, most patients are
diagnosed while in the advanced stages of the disease, which often
leads to a poor prognosis. Additionally, many of the symptoms of
GEP-NETs are gastrointestinal in nature, thus they can be easily
misdiagnosed as Crohn’s disease or Irritable Bowel Syndrome
(IBS).
About ONIVYDE®
ONIVYDE® is an encapsulated formulation of irinotecan. This
long-circulating liposomal form is designed to increase length of
tumor exposure to both irinotecan and its active metabolite, SN38.
ONIVYDE® was approved by the U.S. FDA in combination with
fluorouracil and leucovorin for the treatment of patients with
metastatic adenocarcinoma of the pancreas after disease progression
following gemcitabine-based therapy. ONIVYDE is not indicated as a
single agent for the treatment of patients with metastatic
adenocarcinoma of the pancreas.
On April 3, 2017, Ipsen completed the acquisition from Merrimack
Pharmaceuticals of ONIVYDE® (irinotecan liposome injection) for the
treatment of patients with metastatic adenocarcinoma of the
pancreas after disease progression following gemcitabine-based
therapy, in combination with fluorouracil and leucovorin. Ipsen
gained exclusive commercialization rights for the current and
potential future indications for ONIVYDE® in the U.S., as well as
the current licensing agreements with Shire for commercialization
rights ex-U.S. and PharmaEngine for Taiwan.
IMPORTANT SAFETY INFORMATION: ONIVYDE®
INDICATION
ONIVYDE® (irinotecan liposome injection) is indicated, 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.
WARNING: 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 fluorouracil (5-FU) and leucovorin
(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
ONIVYDE® can cause severe or life-threatening neutropenia and
fatal neutropenic sepsis. In a clinical study, the incidence of
fatal neutropenic sepsis was 0.8% among patients receiving
ONIVYDE®, occurring in 1/117 patients in the ONIVYDE®/5-FU/LV arm
and 1/147 patients receiving ONIVYDE® as a single agent. Severe or
life-threatening neutropenia occurred in 20% of patients receiving
ONIVYDE®/5-FU/LV vs 2% of patients receiving 5-FU/LV. Grade 3/4
neutropenic fever/neutropenic sepsis occurred in 3% of patients
receiving ONIVYDE®/5-FU/LV, and did not occur in patients receiving
5-FU/LV. 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
ONIVYDE® can cause severe and life-threatening diarrhea. Do not
administer ONIVYDE® to patients with bowel obstruction. Severe and
life-threatening late-onset (onset > 24 hours after
chemotherapy) and early-onset diarrhea (onset ≤24 hours after
chemotherapy, sometimes with other symptoms of cholinergic
reaction) were observed. An individual patient may experience both
early- and late-onset diarrhea. In a clinical study, Grade 3/4
diarrhea occurred in 13% of patients receiving ONIVYDE®/5-FU/LV vs
4% receiving 5-FU/LV. Grade 3/4 late-onset diarrhea occurred in 9%
of patients receiving ONIVYDE®/5-FU/LV vs 4% in patients receiving
5-FU/LV; the incidences of early-onset diarrhea were 3% and no
Grade 3/4 incidences, respectively. Of patients receiving
ONIVYDE®/5-FU/LV, 34% received loperamide for late-onset diarrhea
and 26% received atropine for early-onset diarrhea.
Interstitial Lung Disease (ILD)
Irinotecan HCl can cause severe and fatal ILD. Withhold ONIVYDE®
in 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
Based on animal data with irinotecan HCl and the mechanism of
action of ONIVYDE®, ONIVYDE® can cause fetal harm when administered
to a pregnant woman. Advise pregnant women of the potential risk to
a fetus. Advise females of reproductive potential to use effective
contraception during and for 1 month after ONIVYDE® treatment.
ADVERSE REACTIONS
- The most common (≥20%) adverse
reactions in which patients receiving ONIVYDE® /5- FU/LV
experienced a ≥5% higher incidence of any Grade vs the 5-FU/LV arm,
were diarrhea (any 59%, 26%; severe 13%, 4%) (early diarrhea [any
30%, 15%; severe 3%, 0%], late diarrhea [any 43%, 17%; severe 9%,
4%]), fatigue/asthenia (any 56%, 43%; severe 21%, 10%), vomiting
(any 52%, 26%; severe 11%, 3%), nausea (any 51%, 34%; severe 8%,
4%), decreased appetite (any 44%, 32%; severe 4%, 2%), stomatitis
(any 32%, 12%; severe 4%, 1%), pyrexia (any 23%, 11%; severe 2%,
1%).
- Of less common (< 20%) adverse
reactions, patients receiving ONIVYDE® /5-FU/LV who experienced
Grade 3/4 adverse reactions at a ≥2% higher incidence of Grade 3/4
toxicity vs the 5-FU/LV arm, respectively, were sepsis (3%, 1%),
neutropenic fever/neutropenic sepsis (3%, 0%), gastroenteritis (3%,
0%), intravenous catheter-related infection (3%, 0%), weight loss
(2%, 0%), and dehydration (4%, 2%).
- The laboratory abnormalities in which
patients receiving ONIVYDE® /5-FU/LV experienced a ≥5% higher
incidence vs the 5-FU/LV arm, were anemia (any 97%, 86%; severe 6%,
5%), lymphopenia (any 81%, 75%; severe 27%, 17%), neutropenia (any
52%, 6%; severe 20%, 2%), thrombocytopenia (any 41%, 33%; severe
2%, 0%), increased alanine aminotransferase (any 51%, 37%; severe
6%, 1%), hypoalbuminemia (any 43%, 30%; severe 2%, 0%),
hypomagnesemia (any 35%, 21%; severe 0%, 0%), hypokalemia (any 32%,
19%; severe 2%, 2%), hypocalcemia (any 32%, 20%; severe 1%, 0%),
hypophosphatemia (any 29%, 18%; severe 4%, 1%), hyponatremia (any
27%, 12%; severe 5%, 3%), increased creatinine (any 18%, 13%;
severe 0%, 0%).
- ONIVYDE® can cause cholinergic
reactions manifesting as rhinitis, increased salivation, flushing,
bradycardia, miosis, lacrimation, diaphoresis, and intestinal
hyperperistalsis with abdominal cramping and early-onset diarrhea.
Grade 1/2 cholinergic symptoms other than early diarrhea occurred
in 12 (4.5%) ONIVYDE® -treated patients.
- Infusion reactions, consisting of rash,
urticaria, periorbital edema, or pruritus, occurring on the day of
ONIVYDE® administration were reported in 3% of patients receiving
ONIVYDE® or ONIVYDE® /5-FU/LV.
- The most common serious adverse
reactions (≥2%) of ONIVYDE® were diarrhea, vomiting, neutropenic
fever or neutropenic sepsis, nausea, pyrexia, sepsis, dehydration,
septic shock, pneumonia, acute renal failure, and
thrombocytopenia.
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.
USE IN SPECIFIC POPULATIONS
Pregnancy and Reproductive Potential
Advise pregnant women of the potential risk to a fetus. Advise
males with female partners of reproductive potential to use
effective contraception during and for 4 months after ONIVYDE®
treatment.
Lactation
Advise nursing women not to breastfeed during and for 1 month
after ONIVYDE® treatment.
Pediatric
Safety and effectiveness of ONIVYDE® have not been established
in pediatric patients.
DOSAGE AND ADMINISTRATION
The recommended dose of ONIVYDE® is 70 mg/m2 intravenous (IV)
infusion over 90 minutes every 2 weeks, administered prior to LV
and 5-FU. The recommended starting dose of ONIVYDE® in patients
known to be homozygous for the UGT1A1*28 allele is 50 mg/m2
administered by IV infusion over 90 minutes. There is no
recommended dose of ONIVYDE® for patients with serum bilirubin
above the upper limit of normal. Premedicate with a corticosteroid
and an anti-emetic 30 minutes prior to ONIVYDE®. Withhold ONIVYDE®
for Grade 3/4 adverse reactions. Resume ONIVYDE® with reduced dose
once adverse reaction recovered to ≤Grade 1. Discontinue ONIVYDE®
in patients who experience a severe hypersensitivity reaction and
in patients with a confirmed diagnosis of ILD.
Do not substitute ONIVYDE® for other drugs containing irinotecan
HCl.
Please see full U.S. Prescribing Information including Boxed
WARNING for ONIVYDE®.
About SOMATULINE® DEPOT
Somatuline® Depot (lanreotide) Injection 120 mg is 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. Somatuline® Depot is also indicated for
the treatment of carcinoid syndrome; when used, it reduces the
frequency of short-acting somatostatin analog rescue therapy.
IMPORTANT SAFETY INFORMATION: SOMATULINE® DEPOT
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.
- Hypoglycemia or Hyperglycemia
- Pharmacological studies show that
Somatuline® Depot, like somatostatin and other somatostatin
analogs, inhibits the secretion of insulin and glucagon. 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 in the GEP-NET pivotal
trial, 23% of Somatuline®Depot-treated patients had a heart rate of
less than 60 bpm compared to 16% of placebo-treated patients. The
incidence of bradycardia was similar in the treatment groups.
Initiate appropriate medical management in patients with
symptomatic bradycardia.
- 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
occurring in greater than 10% of patients who received
Somatuline® Depot in the GEP-NET trial 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 greater than 5% of patients who received Somatuline® Depot
in the carcinoid syndrome trial and occurring 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 Somatuline®
Depot Prescribing Information
including Patient Information.
About Ipsen in North America
Ipsen Biopharmaceuticals, Inc. is a U.S. affiliate of Ipsen
(Euronext: IPN; ADR: IPSEY), a global specialty-driven
biopharmaceutical group focused on innovation and specialty care.
The U.S. head office is located in Basking Ridge, New Jersey, and
its Canadian office, Ipsen Biopharmaceuticals Canada, Inc., an
integrated business unit within North America, is located in
Mississauga, Ontario. Additional research and development and
manufacturing sites are located in Cambridge, Massachusetts, as
part of Ipsen Bioscience, Inc., the Ipsen U.S. research and
development center, which is focused on the discovery of
potentially highly differentiated and competitive products in
Oncology, Neurosciences and Rare Diseases. Ipsen North America
employs more than 400 people and is dedicated to providing hope for
the patients whose lives are challenged by difficult-to-treat
diseases. At Ipsen, we focus our resources, investments and energy
on discovering, developing and commercializing new therapeutic
options for oncologic, neurologic and rare diseases. For more
information on Ipsen in North America, please visit www.ipsenus.com
or www.ipsen.ca.
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, Neurosciences 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 close to €1.6
billion in 2016, 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 5,100
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 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 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 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.
ONIVYDE® is a registered trademark of Ipsen
Biopharm LimitedSomatuline® DEPOT is a registered trademark of
Ipsen Pharma S.A.S.All other trademarks are the property of their
respective owners.
MP-US-000237January 2018
1
American Cancer Society. Cancer Facts and
Figures 2017. Atlanta: American Cancer Society; 2018.
https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html
2 Ammermann et al. Decision Resources. Disease Landscape and &
Forecast: Pancreatic Cancer. June 2016. 3 Rahib L, Smith BD,
Aizenberg, et al. Projecting cancer incidence and deaths to 2030:
the unexpected burden of thyroid, liver, and pancreas cancers in
the United States. Cancer Res. 2014 Jun 1;74(11):2913-21. doi:
10.1158/0008-5472.CAN-14-0155.
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NA MediaIpsen Biopharmaceuticals, Inc.Marisol
Peron, 908-275-6330Vice President, North American
Communicationsmarisol.peron@ipsen.comorW2O GroupSothea
Shreck, 646-795-6059sschreck@w2ogroup.com
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