BASKING RIDGE, N.J., September 30, 2016 – Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that nine studies have been selected for
poster presentations at the annual symposium of the North American Neuroendocrine Tumor
Society (NANETS) being held in Jackson, Wyoming, September 30 – October 1, 2016.
“The data accepted for poster presentation at this year’s NANETS annual symposium shows the
continued commitment of Ipsen to the patient community,” said Cynthia Schwalm, EVP, North
America Commercial Operations, Ipsen. “We are excited about our continuing research.”
Posters on the following topics will be presented on September 30 between 4:15 p.m.– 6:30p.m. (MDT) at the Jackson Lake Lodge, Lower Level:
- Study of lanreotide depot/autogel for symptomatic control of carcinoid syndrome (CS) in neuroendocrine tumors patients: follow-up analysis of the ELECT prospective, randomized, double-blind and open-label phases
- Long-term safety/tolerability of lanreotide autogel/depot (LAN) in neuroendocrine tumors (NETs) patients with carcinoid syndrome (CS): the ELECT long-term open label extension
- Pharmacokinetic (PK) differences between subcutaneous and intramuscular administration of lanreotide: Results from a Phase I study
- Treatment patterns, clinical outcomes, and health care resource utilization in patients with metastatic gastroenteropancreatic neuroendocrine tumors (mGEP- NETs)
- Simulated-use study of a single-use delivery device for lanreotide depot in untrained health care professionals
- Tumor growth rate in intestinal/pancreatic neuroendocrine tumors: post hoc exploratory analysis of data from the CLARINET study
- SPINET: a randomized, double-blind, placebo-controlled phase III study of lanreotide autogel/depot in patients with advanced lung neuroendocrine tumors
- What matters most? An exploration of decision criteria considered by patients with GEP-NET and physicians using holistic MCDA
- To treat or watch? Identifying drivers of decisions for patients with GEP-NET using reflective MCDA Indication
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 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 GEP- NETs 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 favourable 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 factorsoutlined in its registration documents filed with the French Autorité des Marchés Financiers.
Somatuline DEPOT is a registered trademark of IPSEN PHARMA S.A.S.
For further information:
Vice President, North America, Communications
Senior Communications Manager Tel.: 908-275-6508
September 2016 SMD-US-0000828