BASKING RIDGE, N.J., January 18, 2017 – Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen
(Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that four abstracts were selected for
poster presentation during the annual ASCO Gastrointestinal Cancers Symposium being held in
San Francisco, California, on January 19 – 21, 2017.
“These studies collectively demonstrate Ipsen’s steadfast focus on enhancing our understanding
of overall treatment approaches for patients living with gastrointestinal and pancreatic
neuroendocrine tumors,” said David Cox, Vice President, Medical Affairs and Regulatory Affairs,
Ipsen Biopharmaceuticals, Inc. “Through these and other research, Ipsen’s ultimate goal is to
develop therapeutic options for patients living with rare and debilitating diseases.”
Posters on the following topics will be presented on Friday, January 20, 2017
between 12:30 PM2:00 PM PT and 5:30 PM-6:30 PM PT at the Moscone West Building:
- Board H4; Abstract 378: Study of lanreotide depot (LAN) for symptomatic control of
carcinoid syndrome (CS) in patients with neuroendocrine tumor (NET) previously
responsive to octreotide (OCT): Subanalysis of patient-reported symptoms from the
phase III ELECT study. Lead Author: Rodney Pommier
- Board J3; Abstract 397: Treatment patterns among patients with metastatic GEP-NET treated at a tertiary referral center. Lead Author: Jessica Jalbert
- Board J4; Abstract 398: Safety and tolerability of lanreotide autogel/depot (LAN) in
patients (pts) with neuroendocrine tumors (NETs): Pooled analysis of clinical
studies. Lead Author: Alexandria Phan
- Board M11; Abstract 471: An open-label, single-group, multicenter phase II study of
lanreotide autogel (LAN) in Japanese patients with neuroendocrine tumors (NETs).
Lead Author: Tetsuhide Ito
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.
Important Safety Information
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.
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 Ipsen in North America
Ipsen Biopharmaceuticals, Inc. is the US affiliate of Ipsen, a global specialty-driven pharmaceutical
group. The US head office is located in Basking Ridge, New Jersey. Ipsen Biopharmaceuticals
Canada, Inc. is an integrated business unit within North America and has its head office located in
Mississauga, Ontario. Ipsen Bioscience, Inc., the Ipsen US research and development center
focused on peptide research in oncology and endocrinology, is located in Cambridge,
Massachusetts. At Ipsen Bioscience, we focus on creating a highly cooperative and passionate
R&D organization through partnerships, innovation, and continuous learning to effectively deliver
new treatments for patients. At Ipsen, we focus our resources, investments, and energy on
discovering, developing, and commercializing new therapeutic options for oncologic, neurologic,
and endocrine diseases. For more information on Ipsen in North America, please visit
www.ipsenus.com or www.ipsen.ca.
Ipsen is a global specialty-driven pharmaceutical group with total sales exceeding €1.4 billion in
2015. Ipsen sells more than 20 drugs in more than 115 countries, with a direct commercial
presence in more than 30 countries. Ipsen’s ambition is to become a leader in specialty healthcare
solutions for targeted debilitating diseases. Its fields of expertise cover oncology, neurosciences
and endocrinology (adult & pediatric). Ipsen’s commitment to oncology is exemplified through its
growing portfolio of key therapies improving the care of patients suffering from prostate cancer,
bladder cancer and neuroendocrine tumors. Ipsen also has a significant presence in primary care.
Moreover, the Group has an active policy of partnerships. Ipsen’s R&D is focused on its innovative
and differentiated technological platforms, peptides and toxins, located in the heart of the leading
biotechnological and life sciences hubs (Les Ulis/Paris-Saclay, France; Slough/Oxford, UK;
Cambridge, US). In 2015, R&D expenditure totaled close to €193 million. The Group has more
than 4,600 employees worldwide. Ipsen’s shares are traded on segment A of Euronext Paris (stock
code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”).
The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American
Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United
States under the symbol 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.
Somatuline DEPOT is a registered trademark of IPSEN PHARMA S.A.S
# # #
January 2017 SMD-US-001112