Below you will find all Ipsen documentation related to regulated information.
- For patients living with neuroendocrine tumors, insufficiently controlled carcinoid syndrome can be a major burden that severely impacts quality of life
- Xermelo® (telotristat ethyl) 250mg demonstrates sustained improvement of carcinoid syndrome diarrhea when associated with somatostatin analogues (SSA)
- Xermelo® is a first-in-class tryptophan hydroxylase inhibitor in convenient oral form with a favorable safety profile
- Independent Radiology Review Committee confirms primary endpoint analysis per investigator: cabozantinib provided statistically significant improvement of progression-free survival, with a 52 percent reduction in the rate of progression or death compared to sunitinib
- Ipsen and Exelixis will host an investor and media webcast from Madrid to discuss the data on Sunday, September 10 starting at 18h45 CEST
- Cabometyx® is an innovative molecule already approved by EMA for the treatment of advanced renal cell carcinoma (aRCC) in adults following prior VEGF-targeted therapy.
- The filing in first line aRCC is based on the CABOSUN results, a phase II trial demonstrating that Cabometyx® prolongs progression-free survival (PFS) in treatment-naive patients with intermediate- or poor-risk advanced RCC compared to sunitinib.[i]
- Positive opinion based on the results of two randomized Phase 3 trials, TELESTAR and TELECAST
Half-year IPSEN liquidity contract statement entered into with NATIXISDownload ( pdf - 141 kB)
– First phase 3 trial in a global clinical development program to explore the combination of these agents –
– Exelixis, Bristol-Myers Squibb and Ipsen to co-fund this trial –Download ( pdf - 188 kB)
IRC confirms cabozantinib significantly improved progression-free survival compared to sunitinib
E.U. regulatory submission remains on track for Q3 2017Download ( pdf - 338 kB)
- Significantly expands Ipsen’s growing oncology portfolio
- Immediate U.S. commercialization rights for ONIVYDE® for metastatic pancreatic cancer in adult patients
Strong operating performance exceeds guidance with Group sales up 11.8% driven by Specialty Care and Core Operating Margin improvement despite Cabometyx launch investments
Acquisition of Onivyde and new Primary Care products expected to close during the first half of 2017Download press release ( pdf - 758 kB)
Download presentation ( pdf - 762 kB)
Download transcript ( pdf - 205 kB)
Ipsen today announced the appointment of Harout Semerjian as President, Head of Specialty Care International Region & Global Franchises, effective February 2, 2017. He will report to David Meek, CEO of Ipsen, and will be a member of the Executive Leadership Team.Download ( pdf - 219 kB)
Half-year IPSEN liquidity contract statement entered into with NATIXISDownload ( pdf - 136 kB)
Under the terms of the agreement, Ipsen will gain exclusive commercialization rights for the current and potential future ONIVYDE indications in the U.S., as well as the current licensing agreements with Shire for commercialization rights ex-U.S. and PharmaEngine for Taiwan. The transaction also includes Merrimack’s commercial and manufacturing infrastructure, and generic doxorubicin HCl liposome injection.Download the press release ( pdf - 82 kB)
Download the presentation ( pdf - 897 kB)
- Amendment enhances productive year with CABOMETYXTM regulatory approvals and commercial launches in the United States and European Union
- Exelixis to receive $10 million upfront payment, with subsequent regulatory and commercial milestones
- Acceleration of Group sales growth at 12.2%1 in the third quarter resulting in 10.5%1 sales growth for the first 9 months driven by Specialty Care
- Guidance 2016 raised
The 2016 Georges Mathé Prize was presented on October 10, 2016 during the ESMO (European Society of Medical Oncology) meeting in Copenhagen. The Prize, supporting translational research of excellence, was established in memory of the pioneer of cancer research in France, Georges Mathé, deceased in 2010. The Prize was awarded to a young Greek researcher, Doctor Alexios Matikas, a clinical oncologist from the University Hospital Heraklion, for his research project on immunological determinants of response to treatment in breast cancer. The Fellowship will support his research in Karolinska Institutet (Stockholm, Sweden), into the immunological determinants of response to treatment in breast cancer.Download ( pdf - 403 kB)
Georges Mathe 2016 ( jpg - 602 kB)
- Cabozantinib met the primary endpoint of improving progression-free survival as compared to sunitinib, decreasing the rate of disease progression or death by 31 percent
- Objective response rate significantly improved: 46 percent for cabozantinib versus 18 percent for sunitinib
- Ipsen to host investor and media webcast from Copenhagen to discuss the data on Monday, October 10
Download the presentation ( pdf - 1 MB)
Ipsen, a global specialty-driven pharmaceutical group, today announced that Cabometyx™ (cabozantinib), Somatuline® Autogel® (lanreotide) and telotristat ethyl (*previously known as telotristat etiprate) will be the subject of 16 presentations at the European Society for Medical Oncology (ESMO) 2016 congress.Download ( pdf - 76 kB)
- Cabometyx™ (cabozantinib) is the first and only targeted therapy to improve Overall Survival (OS), Objective Response Rate (ORR), and Progression Free Survival (PFS) in RCC in METEOR randomized Phase 3 trial.
- Cabometyx™ (cabozantinib) improves OS across all evaluated patient subgroups.
- Cabometyx™ (cabozantinib) has a unique mechanism of action with the potential to overcome resistance to VEGFR tyrosine kinase inhibitors.
First and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity.Download ( pdf - 168 kB)
- Group sales up 9.7%1 driven by Specialty Care growth of 14.3%1 , notably due to strong performance of Somatuline®
- Core Operating Income up 12.6% fueled by strong top-line growth
- Core diluted EPS of €1.74, up 16.0%
Download the presentation ( pdf - 423 kB)
Download the transcript ( pdf - 112 kB)
Ipsen and Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, today announced that Teijin Pharma has filed a supplemental application with Pharmaceuticals and Medical Devices Agency to use Ipsen’s subcutaneous drug Somatuline® (lanreotide) for the treatment of neuroendocrine tumors (NETs). The drug is currently available in Japan as a treatment for acromegaly and pituitary gigantism.Download ( pdf - 109 kB)
- CHMP recommends approval of Cabometyx™ (cabozantinib) for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy based on the results of a large, randomized Phase 3 trial, METEOR.
- Cabometyx™ (cabozantinib) is the first and only multi-kinase inhibitor with established clinical benefits demonstrated for all three key efficacy endpoints: overall survival (OS), progression-free survival (PFS) and objective response rate (ORR).
- Cabometyx™ (cabozantinib) significantly improved overall survival across all evaluated patient subgroups.
Ipsen today announced that the European Medicines Agency (EMA), the European regulatory authority, has accepted the submission of filing for telotristat etiprate as an adjunct to somatostatin analogue therapy for the long-term treatment of carcinoid syndrome to improve symptom control in adult patients with metastatic neuroendocrine tumors.Download ( pdf - 225 kB)
The Board of Directors of Ipsen, met on 8 July 2016, and has appointed David Meek as Chief Executive Officer, effective July 18, 2016. On this date, Marc de Garidel will assume the role of non-executive chairman and will continue to serve the Board of Directors through his deep industry expertise. In addition, Marc de Garidel will advise Mayroy, the Ipsen controlling holding company.Download ( pdf - 46 kB)
Ipsen (Euronext: IPN; ADR: IPSEY) today announced it has appointed Natixis to purchase on its behalf from July 4, 2016, a target number of 400,000 Ipsen SA shares, or about 0.48% of the share capital at the date of this press release, for a period of at least 2 months and until December 30, 2016, at the maximum. The shares purchased under this agreement will be mainly allocated to cover its free performance share allocation plan.PR Rachat d'actions 2016 ( pdf - 166 kB)
Ipsen, a global specialty-driven pharmaceutical group, announced today the successful issue of its inaugural unsecured 7-year Notes for a total of €300 million.
These Notes mature on June 16, 2023 and pay interest at an annual rate of 1.875%. Application has been made for the Notes to be admitted to trading on the regulated market of Euronext Paris.
Additional data from pivotal METEOR trial underscore clinically meaningful benefit of CABOMETYX™ across subgroups of patientsDownload ( pdf - 115 kB)
- Details of clinically meaningful increase in overall survival from METEOR trial to be presented in an oral abstract session and published simultaneously in The Lancet Oncology
- Overall survival and progression-free survival benefits consistent across all subgroups evaluated
Ipsen today announced the appointment of Eugenia Litz as Vice President Investor Relations for the Ipsen Group, effective today. She will report to Aymeric Le Chatelier, Executive Vice President, Chief Financial Officer.
Eugenia Litz takes over Stéphane Durant des Aulnois nominated Finance Director Iberia.
Eugenia will manage the Ipsen Group financial communication and build strong relations with investors and the financial community.
In accordance with the provisions of Article 241-2 of the General Regulations of the Autorité des Marchés Financiers (AMF) and the European Regulation n° 2273/2003 dated 22 December 2003, the present document describes the objectives and characteristics of the share repurchase program proposed to the approval of the Combined Shareholders’ Meeting to be held on 31 May 2016. The preliminary notice of meeting has been published in the Bulletin des Annonces Légales Obligatoires (BALO) dated 13 April 2016.IPSEN - Descriptif programme de rachat d'actions EN ( pdf - 217 kB)
Ipsen in collaboration with Exelixis will share these results with European regulatory authorities and evaluate potential next steps in development and submission strategy for cabozantinib as a treatment of first-line advanced renal cell carcinomaDownload ( pdf - 72 kB)
- Oncodesign is becoming a strategic partner for Ipsen in preclinical pharmacology for its oncology research programs
- Oncodesign teams are moving to Ipsen’s private open innovation campus in Paris-Saclay
- Group sales up 4.7%1
- Specialty care sales up 9.7%1, driven by the accelerated growth of Somatuline® in neuroendocrine tumors
- Primary care sales down 11.0%1 , impacted by the slowdown in international markets
- 2016 financial objectives confirmed
Ipsen and Probi today jointly announced the signature of a license and supply agreement for the commercialization of Probi’s probiotic strain Lactobacillus plantarum 299v (LP299V® ). The agreement covers 18 countries, primarily within EU and emerging markets. This clinicallydocumented probiotic with patents in the gastro-intestinal field is expected to complement Ipsen’s strong medical portfolio in gastroenterology. From Probi’s perspective it could become one of the largest distribution agreements so far, and is of high strategic importance for both companies.Download ( pdf - 230 kB)
CABOMETYX™ (cabozantinib) is the first therapy to demonstrate improved overall survival, progression-free survival and objective response rate in a large, randomized phase 3 trial of patients with advanced kidney cancer.
In February 2016, Exelixis and Ipsen entered into an exclusive licensing agreement to develop and commercialize cabozantinib in regions outside the United States, Canada and Japan.Download ( pdf - 49 kB)
Leveraging its instrumental contribution to the BioIntelligence consortium, Ipsen has decided to deploy the 3DEXPERIENCE platform.Download ( pdf - 57 kB)
Ipsen announced today that its 2015 Registration Document has been filed with the French “Autorité des Marchés Financiers” (AMF) on 29 March 2016 and registered under the number D.16-0216.Download the press release ( pdf - 111 kB)
2015 Registration document ( pdf - 5 MB)
- Research partnership for novel therapeutic peptides targeting a transmembrane receptor overexpressed in a large number of cancers and implicated in their development.
- Option for Ipsen to acquire the exclusive rights to develop and market the new drug candidates.
- Operating performance in line with guidance, with Group sales up 10.4%1 and Core Operating Income up 23.8%
- Core diluted EPS of €2.78, up 25.3%, and sound cash flow generation with closing cash of €214.0 million
- Proposal of a dividend of €0.85 per share
Download the presentation ( pdf - 261 kB)
- Cabozantinib commercialized for medullary thyroid cancer (MTC) and filed for advanced renal cell carcinoma (RCC)
- $200 million upfront payment and subsequent regulatory and commercial milestones
- Separation of functions between Chairman and Chief Executive Officer (CEO)
- Search under way for a new CEO
- Marc de Garidel, Chairman & CEO of Ipsen, to become nonexecutive Chairman upon arrival of new CEO
- Departure of Deputy CEO Christel Bories
Single injections of both Dysport® (abobotulinumtoxinA) doses (10U/kg/leg and 15U/kg/leg) significantly reduce muscle hypertonia and spasticity translating into clinical and functional benefits.Download ( pdf - 78 kB)
Ipsen acquires the intellectual property for Galderma’s liquid toxin in some key Asia-Pacific territories (APAC1 ).Download ( pdf - 74 kB)