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Ipsen to present new data from its oncology portfolio at the 2018 European Society for Medical Oncology (ESMO) congress

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Regulatory News:

Ipsen ((Euronext: IPN, OTC:IPSEY) today announced that cabozantinib
(Cabometyx®), irinotecan liposome injection (Onivyde®),
lanreotide (Somatuline®) and the combination of lanreotide
and telotristat (Xermelo®) are the subject of 12
presentations at the 2018 European Society for Medical Oncology (ESMO)
annual congress. The meeting takes place in Munich, Germany, October
19-23, 2018.

"Ipsen has had a momentous 12 months since ESMO 2017, particularly
with the positive regulatory milestones achieved for Cabometyx
®
in renal cell and hepatocellular carcinoma, and for Xermelo
® in
neuroendocrine tumours. Our story continues with a strong presence at
ESMO 2018 with 12 posters presenting meaningful data for patients with
hepatocellular carcinoma, renal cell carcinoma, medullary thyroid
cancer, pancreatic cancer and neuroendocrine tumours
," said Alexandre
Lebeaut M.D., Executive Vice President, Research & Development and Chief
Scientific Officer, Ipsen.

"Our oncology products, notably Cabometyx®,
Onivyde
®, Somatuline® and
Xermelo
® have been evaluated by scientific
teams around the world; either directly by investigators, by our
partners, or by Ipsen, and results from some of these investigations
will be shared at ESMO 2018. We are committed in our efforts against
cancer, and through our interactions at ESMO will continue to advance
innovation for patient care in oncology,"
added Dr Lebeaut.

Cabozantinib (Cabometyx®)
will be featured in 5 posters:

Poster session, Sunday October 21st,
13:15 ‐ 14:15, Hall A3

CELESTIAL study

  • [Poster 702P] Outcomes by baseline alpha-fetoprotein (AFP) levels in
    the phase 3 CELESTIAL trial of cabozantinib (C) versus placebo (P) in
    previously treated advanced hepatocellular carcinoma (HCC) (Kelley et
    al.)

Presenting author: R.K. Kelley [Sponsor: Exelixis]

  • [Poster 703P] Assessment of disease burden in the phase 3 CELESTIAL
    trial of cabozantinib (C) versus placebo (P) in advanced
    hepatocellular carcinoma (HCC) (Blanc et al.)

Presenting author: JF Blanc [Sponsor: Exelixis]

  • [Poster 704P] Outcomes by prior transarterial chemoembolization (TACE)
    in the phase 3 CELESTIAL trial of cabozantinib (C) versus placebo (P)
    in patients (pts) with advanced hepatocellular carcinoma (HCC) (Yau et
    al.)

Presenting author: T Yau [Sponsor: Exelixis]

Poster session, Monday October 22nd,
13:15 ‐ 14:15, Hall A3

COSMIC-021 study (Cabozantinib + atezolizumab)

  • [Poster 872P] Phase 1b study (COSMIC-021) of cabozantinib in
    combination with atezolizumab in solid tumors: Results of the dose
    escalation stage in patients with treatment-naïve advanced RCC
    (Agarwal et al.)

Presenting author: N Agarwal [Sponsor: Exelixis]

Poster session, Sunday October 21st,
13:15 ‐ 14:15, Hall A3

EXAMINER study

  • [Poster 129TiP] A noninferiority trial of cabozantinib (C) comparing
    140 mg vs 60 mg orally per day to evaluate the efficacy and safety in
    patients (pts) with progressive, metastatic medullary thyroid cancer
    (MTC) (Krajewska et al.)

Presenting author: J Krajewska [Sponsor: Exelixis]

Poster session, Sunday October 21st,
13:15 ‐ 14:15, Hall A3

Irinotecan liposome injection (Onivyde®)
will be featured in 4 presentations:

  • [Poster 749P] The prognostic value of the Modified Glasgow Prognostic
    Score (mGPS) in predicting overall survival (OS) in patients with
    metastatic pancreatic ductal adenocarcinoma (mPDAC) receiving
    liposomal irinotecan (nal-IRI)+5-fluorouracil and leucovorin
    (5-FU/LV). (Chen, et al.)

Presenting author: L-T Chen [Sponsor: Ipsen]

  • [Poster 734P] Impact of dose reduction or dose delay on the efficacy
    of liposomal irinotecan (nal-IRI)+5-fluorouracil/leucovorin (5-FU/LV):
    Survival analysis from NAPOLI-1. (Chen, et al.)

Presenting author: L-T Chen [Sponsor: Ipsen]

  • [Poster 735P] Real-world dosing patterns of patients (pts) with
    metastatic pancreatic cancer (mPC) treated with liposomal irinotecan
    (nal-IRI) in US oncology clinics. (Ahn, et al.)

Presenting author: D Ahn [Sponsor: Ipsen]

  • [Poster 733P] NAPOLI-1 Phase 3 trial outcomes by prior surgery, and
    disease stage, in patients with metastatic pancreatic ductal
    adenocarcinoma (mPDAC). (Macarulla, et al.)

Presenting author: T Macarulla [Sponsor: Shire]

Poster session, Sunday October 21st,
13:15 ‐ 14:15, Hall A3

Lanreotide (Somatuline®)
will be featured in 2 presentations:

PRELUDE (TGR)

  • [Poster 1331P] Tumour growth rate (TGR) when using lanreotide Autogel®
    (LAN) before, during and after peptide receptor radionuclide therapy
    (PRRT) in advanced neuroendocrine tumours (NETs). (Prasad, et al.)

Presenting author: V Prasad [Sponsor: Ipsen]

Poster session, Sunday October 21st,
13:15 ‐ 14:15, Hall A3

CLARINET (diabetes)

  • [Poster 1319P] Post-hoc analysis of CLARINET phase III study to
    investigate the influence of diabetic status on progression-free
    survival (PFS) of patients with neuroendocrine tumours (NETs) treated
    with lanreotide (LAN) or placebo (PBO). (Pusceddu, et al.)

Presenting author: V Pusceddu [Sponsor: Ipsen]

Poster session, Sunday October 21st,
13:15 ‐ 14:15, Hall A3

Lanreotide (Somatuline®)
& telotristat (Xermelo
®)
will be featured in 1
presentation:

TELESTAR & TELECAST (LAN patients)

  • [Poster 4378P] Efficacy and safety of telotristat ethyl (TE) in
    combination with lanreotide (LAN) in patients with a neuroendocrine
    tumour and carcinoid syndrome (CS) diarrhoea (CSD): Meta-analysis of
    phase 3 double-blind placebo (PBO)-controlled TELESTAR and TELECAST
    studies. (Hörsch, et al.)

Presenting author: D Hörsch [Sponsor: Ipsen]

ABOUT CABOMETYX®
(cabozantinib)

Cabometyx® is an oral small molecule inhibitor of receptors,
including VEGFR, MET, AXL and RET. In preclinical models, cabozantinib
has been shown to inhibit the activity of these receptors, which are
involved in normal cellular function and pathologic processes such as
tumor angiogenesis, invasiveness, metastasis and drug resistance.

In February of 2016, Exelixis and Ipsen jointly announced an exclusive
licensing agreement for the commercialization and further development of
cabozantinib indications outside of the United States, Canada and Japan.
This agreement was amended in December of 2016 to include
commercialization rights for Ipsen in Canada.

On April 25, 2016, the FDA approved Cabometyx® tablets for
the treatment of patients with advanced RCC who have received prior
anti-angiogenic therapy and on September 9, 2016, the European
Commission approved Cabometyx® tablets for the treatment of
advanced RCC in adults who have received prior vascular endothelial
growth factor (VEGF)-targeted therapy in the European Union, Norway and
Iceland. Cabometyx® is also approved in Australia, Canada,
South Korea and Switzerland. Cabometyx® is available in 20
mg, 40 mg or 60 mg doses. The recommended dose is 60 mg orally, once
daily.

On December 19, 2017, Exelixis received approval from the FDA for
Cabometyx® for the expanded indication of treatment of
first-line advanced RCC.

On May 17, 2018, Ipsen announced that the European Commission approved
Cabometyx® for the first-line treatment of adults with
intermediate- or poor- risk advanced renal cell carcinoma in the
European Union, Norway and Iceland.

Cabozantinib is not yet approved for the treatment of hepatocellular
carcinoma.

Indications: CABOMETYX® is indicated for the treatment
of advanced renal cell carcinoma (RCC) in treatment-naïve adults with
intermediate or poor risk or in adults following prior vascular
endothelial growth factor (VEGF)-targeted therapy

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 hypocalcaemia, hypokalaemia,
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 tumour 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.

Haemorrhage: not recommended for patients that have or are at risk of
severe haemorrhage. 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 erythrodysaesthesia (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 antiarrythmics 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.

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, diarrhoea, PPES, pulmonary embolism, fatigue and
hypomagnesaemia. Very common (>1/10): anaemia, lymphopenia, neutropenia,
thrombocytopenia, hypothyroidism, dehydration, decreased appetite,
hyperglycaemia, hypoglycaemia, hypophosphataemia, hypoalbuminaemia,
hypomagnesaemia, hyponatraemia, hypokalaemia, hyperkalaemia,
hypocalcaemia, hyperbilirubinaemia, peripheral sensory neuropathy,
dysgeusia, headache, 6 / 8 dizziness, hypertension, dysphonia, dyspnoea,
cough, diarrhoea, nausea, vomiting, stomatitis, constipation, abdominal
pain, dyspepsia, oral pain, dry mouth, PPES, dermatitis acneiform, rash,
rash maculopapular, dry skin, alopecia, hair colour 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 oesophageal reflux disease, haemorrhoids,
pruritus, peripheral oedema, wound complications. Uncommon (>1/1000 to
<1/100): convulsion, anal fistula, hepatitis cholestatic, osteonecrosis
of the jaw. Selected adverse events: GI perforation, fistulas,
haemorrhage, 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

ABOUT ONIVYDE ® (US: irinotecan liposome
injection ; ex-US : liposomal irinotecan)

ONIVYDE is an encapsulated formulation of irinotecan available as a 43
mg/10 mL single dose vial. This long-circulating liposomal form is
designed to increase length of tumor exposure to both irinotecan and its
active metabolite, SN- 38.

Ipsen has 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 Servier for commercialization rights
ex-U.S. and PharmaEngine for Taiwan.

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.

Important Safety Warnings – 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 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: 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

Use in Specific 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 SOMATULINE®

Somatuline® Autogel® / Depot®
is made of the active substance lanreotide, which is a somatostatin
analoguethat inhibits the secretion of growth hormone and certain
hormones secreted by the digestive system.

The main indications of Somatuline® and Somatuline®
Autogel® are the following:

  • Treatment of acromegaly when circulating levels of growth hormone
    and/or Insulin-like Growth Factor- 1 remain abnormal after surgery
    and/or radiotherapy, or in patients who otherwise require medical
    treatment.
  • Treatment of symptoms associated with carcinoid syndrome related to
    neuroendocrine tumors (exUS).
  • Anti-proliferative treatment of gastroenteropancreatic neuroendocrine
    tumors.

Important Safety Information – United States

Contraindications:

Somatuline 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 may reduce
    gallbladder motility and lead to gallstone formation. Periodic
    monitoring may be needed.
  • Hypoglycemia or Hyperglycemia: Pharmacological studies show that
    Somatuline, like somatostatin and other somatostatin analogs, inhibits
    the secretion of insulin and glucagon. Blood glucose levels should be
    monitored when Somatuline treatment is initiated, or when the dose is
    altered, and antidiabetic treatment should be adjusted accordingly.
  • Cardiac Abnormalities: Somatuline may decrease heart rate. In 81
    patients with baseline heart rates of ≥ 60 beats per minute (bpm)
    treated with Somatuline DEPOT in the GEPNETs clinical trial, the
    incidence of heart rate < 60 bpm was 23% (19/81) with Somatuline vs
    16% (15/94) with placebo; 10 patients (12%) had documented heart rates
    < 60 bpm on more than one visit. The incidence of documented episodes
    of heart rate < 50 bpm or bradycardia reported as an adverse event was
    1% in each treatment group. Initiate appropriate medical management in
    patients who develop symptomatic bradycardia.

    In patients
    without underlying cardiac disease, Somatuline 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.
  • Drug Interactions: The pharmacological gastrointestinal effects of
    Somatuline may reduce the intestinal absorption of concomitant drugs.
    Concomitant administration of Somatuline Depot may decrease the
    relative bioavailability of cyclosporine and may necessitate the
    adjustment of cyclosporine dose to maintain therapeutic levels.

Adverse Reactions:

In the GEP-NET pivotal trial, the most common adverse reactions
(incidence >10% and more common than placebo) in patients treated with
Somatuline DEPOT vs placebo were abdominal pain (34% vs
24%),musculoskeletal pain (19% vs 13%), vomiting (19% vs 9%), headache
(16% vs 11%), injection site reaction(15% vs 7%), hyperglycemia (14% vs
5%), hypertension (14% vs 5%), and cholelithiasis (14% vs 7%).

You may report suspected adverse reactions to FDA at 1-800-FDA-1088 or
to Ipsen Biopharmaceuticals, Inc. at 1-888-980-2889.

Please see the full Prescribing Information for Somatuline® Depot by
accessing the following link

ABOUT XERMELO®
(TELOTRISTAT ETHYL)

Xermelo® is a novel, orally administered, inhibitor of
the enzyme tryptophan hydroxylase (TPH). Through inhibition of TPH, the
rate-limiting step in the synthesis of serotonin, Xermelo®
was designed to reduce the production of serotonin within neuroendocrine
tumors.

On 22 October 2014, Ipsen and Lexicon announced that they had entered
into an exclusive licensing agreement for Ipsen to commercialize Xermelo®
(telotristat ethyl) in all territories excluding the United States and
Japan, where Lexicon retains the rights. On 28 February 2017, Lexicon
received U.S. Food and Drug Administration (FDA) approval for Xermelo®
as a first and only orally administered therapy for the treatment of
carcinoid syndrome diarrhea in combination with somatostatin analog
(SSA) therapy in adults inadequately controlled by SSA therapy.

General safety information about Xermelo®

In clinical trials, over 230 patients with carcinoid syndrome were
treated with Xermelo®. The placebo-controlled safety
analyses were focused on the integrated data from the 12-week
placebo-controlled double-blind periods from the two phase 3 randomized
clinical trials. For this safety analysis, 71 patients received placebo
and 70 patients received Xermelo® 250 mg three times daily.
The most commonly reported adverse reactions in patients treated with
telotristat ethyl were abdominal pain (26%), gamma-glutamyl transferase
increased (11%) and fatigue (10%). They were generally of mild or
moderate intensity. The most frequently reported adverse reaction
leading to discontinuation of telotristat ethyl was abdominal pain in
7.1% of patients (5/70).

Trademarks:

ONIVYDE is a registered trademark of Ipsen Biopharm Limited.

CABOMETYX® (cabozantinib) and XERMELO®
(telotristat ethyl) are 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 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 €1.9 billion in 2017, 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 5,400 employees
worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United
States through a Sponsored Level I American Depositary Receipt program
(OTC: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 2017 Registration Document available on its website
(www.ipsen.com).

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