PARIS--(BUSINESS WIRE)--
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven pharmaceutical group, today announced that Somatuline® Autogel® (lanreotide), telotristat ethyl and the investigational compound 177Lu-OPS201 are the subject of 23 presentations at the European Neuroendocrine Tumor Society (ENETS) 2017 conference.
“We are very excited to participate in this meeting and to share data regarding lanreotide, telotristat ethyl and 177Lu-OPS201,” said Dr. Sotirios Stergiopoulos, SVP Head of Global Medical Affairs, Ipsen. “In addition, Ipsen supported several projects to understand the biology, epidemiology, treatment patterns and unmet needs of patients living with Neuroendocrine Tumors (NETs). All of this demonstrates IPSEN’s commitment to improving the life of patients living with NETs.”
Lanreotide (Somatuline® Autogel®) is featured in 17 presentations:
ABSTRACTS SELECTED FOR ORAL PRESENTATIONS
[A10] Krug S et al. Interactions between SSTR Modulation via Lanreotide and Molecular Targeted Therapies in Sequential and Combination Approaches in Vitro. Session: ENETS/NANETS Young Investigator Symposium
[K12] Martínez-López A et al. Efficacy of Lanreotide (LAN), both Alone and in Combination with Targeted Therapies in a Preclinical Model of Pancreatic Neuroendocrine Tumors (pNETs). Session: 4A - Basic Science Abstracts
ABSTRACTS SELECTED FOR POSTER SESSION
[K17] Phan AT et al. Safety and Tolerability of Lanreotide Autogel/Depot (LAN) in Patients (pts) with Neuroendocrine Tumours (NETs): Pooled Analysis of Clinical Studies
[K18] Phan AT et al. Long-Term Efficacy and Safety with Lanreotide Autogel/Depot (LAN) from CLARINET and Open-Label Extension (OLE) Studies
[K5] Duchateau L et al. An Exploratory Patient Centric Analysis of the ELECT Trial: A Phase 3 Study of Efficacy and Safety of Lanreotide Autogel/Depot (LAN) Treatment for Patients (pts) with Carcinoid Syndrome (CS)
[C5] Meyer T et al. CALM-NET, A Multicentre, Exploratory Study to Assess the Clinical Value of Circulating Tumour Cells (CTCs) Enumeration in Patients (Pts) with Functioning Midgut NETs Receiving Lanreotide Autogel (LAN)
[K1] Albertelli M et al. Safety and Efficacy of High Doses Lanreotide Treatment in Patients with Progressive Neuroendocrine Tumors: Results from a Prospective Phase II Trial. Note: This is an investigator-sponsored trial.
[K15] Pavel M et al. Safety and Efficacy of 14-Day Dosing Interval of Lanreotide Autogel/Depot (LAN) for Patients with Pancreatic or Midgut Neuroendocrine Tumours (NETs) Progressing on LAN Every 28 Days: The Prospective, Open-label, International, Phase 2 CLARINET FORTE Study
[J8] Lepage C et al. REMINET: A European, Multicenter, Phase II/III Randomized Double-Blind, Placebo-Controlled Study Evaluating Lanreotide As Maintenance Therapy after First-Line Treatment in Patients with Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors. Note: This is an investigator-sponsored trial.
[K2] Almquist M et al. STREET - Somatostatin Treatment Experience Trial
[A12] Lelek S et al. Antiproliferative Effects of Lanreotide in Neuroendocrine Tumors. Note: This is an investigator-sponsored trial.
[K20] Reidy-Lagunes D et al. Lanreotide Autogel/Depot (LAN) in Lung Neuroendocrine Tumours (NETs): The Randomized, Double-Blind, Placebo (PBO)-Controlled, International Phase 3 SPINET Study
[K7] Ferolla P et al. Open-Label Multicentre Single-Arm Phase 2 Trial of Lanreotide Autogel (LAN) in Combination with Temozolomide (TMZ) in Patients with Advanced Well/Moderately Differentiated Neuroendocrine Tumours (NETs) of Lung and Thymus: ATLANT
[K9] Geilvoet W et al. Patient Satisfaction Regarding Home Injection Service for Somatostatin Analogues: A Survey among Patients with a Neuroendocrine Tumour. Note: This is an investigator-sponsored trial.
[N15] Prasad V et al. Lanreotide Autogel/Depot (LAN) in Combination with Peptide Receptor Radionuclide Therapy (PRRT) in Progressive Digestive and Lung Neuroendocrine Tumours (NETs): Design of the PRELUDE Study
[Q36] van Fraeyenhove F et al. Tumor Growth Rate to Assess Tumor Activity in Patients with Lung Neuroendocrine Tumors on Lanreotide Autogel: A Case-Series Analysis. Note: This is an investigator-sponsored trial.
[K19] Prinzi N et al. Safety of Lanreotide 120 mg ATG (LAN) in Combination with Metformin (MET) in Patients (pts) with Progressive Advanced Well-Differentiated (WD) Gastro-Intestinal (GI) or Lung Carcinoids. A Pilot, One-Arm, Open-Label, Prospective Study: The MetNET-2 Trial. Note: This is an investigator-sponsored trial.
Telotristat ethyl is featured in 5 presentations:
ABSTRACTS SELECTED FOR POSTER SESSION
[K16] Pavel M et al. Telotristat Ethyl in Carcinoid Syndrome: Safety and Efficacy Results of an Open-Label Extension of the TELECAST Phase 3 Clinical Trial
[L2] Anthony L et al. Impact of Concomitant Medication on Efficacy of Telotristat Ethyl – A Post Hoc Subgroup Analysis of the Phase 3 TELESTAR Study in Carcinoid Syndrome
[L7] Lapuerta P et al. Integrated Safety Analysis of Telotristat Ethyl in Patients with Carcinoid Heart Disease
[M3] Cella D et al. Relationship Between Symptoms and HRQoL Benefits in Patients (pts) with Carcinoid Syndrome (CS): A Post-Hoc Analysis of Telotristat Ethyl (TE) TELESTAR Trial
[M8] Pavel M et al. Correlation of Plasma (p) and Urine (u) 5-HIAA Levels in Patients (pts) with Carcinoid Syndrome (CS) – Post-Hoc Analyses from the TELESTAR Study
177Lu-OPS201 is featured in one presentation:
ABSTRACT SELECTED FOR POSTER SESSION
[N12] Nicolas G et al. Peptide Receptor Radionuclide Therapy (PRRT) with a Somatostatin Receptor (SSTR) Antagonist in Patients with SSTR-Positive, Progressive Neuroendocrine Tumours (NETs): A Phase I/II Open-Label Trial to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201
About Ipsen
Ipsen is a global specialty-driven pharmaceutical group with total sales close to €1.6 billion in 2016. 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, neuro-endocrine tumors, renal cell carcinoma and pancreatic cancer. 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 2016, R&D expenditures exceeded €200 million. The Group has more than 4,900 employees worldwide. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and are 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 trades on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
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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 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.
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