Ipsen has been active in oncology since 1986, branching out from a solid base in prostate, neuroendocrine tumors (NETs), bladder, kidney, pancreatic and breast cancers.
A focused strategy
Focusing on these selected oncology diseases, Ipsen aims to provide fully integrated patient care, contribute to improved diagnosis and provide treatment options tailored to patient needs along with targeted support services. Our goal is to develop high-quality, innovative treatments that address unmet medical needs.
An increased focus to Oncology
Ipsen has been active in oncology since 1986 and, over the years, has grown its reputation and portfolio, branching out from a solid base in prostate, neuroendocrine tumors (NETs), bladder, kidney, pancreatic and breast cancers.
Somatuline® is key to Ipsen’s leadership in the treatment of NETs. New indications were launched in 2015 in the United States and in 2016 in Europe, as Somatuline® was shown by the CLARINET® study to reduce the risk of disease progression or death by 53% in gastroenteropancreatic NETs patients whose disease is unresectable or metastasized.
In addition, the efficacy of Somatuline® in patients with lung NETs is being assessed in the multinational SPINET® study. Ipsen is the first and only company assessing the efficacy and safety of a somatostatin analog (SSA) in a prospective phase 3 trial in these patients.
Somatuline® is marketed in over 55 countries, 27 of them in Europe.
Effective treatments to improve the health and lives of patients, whose carcinoid syndrome is not adequately controlled with SSA therapy, are needed. In October 2014, Ipsen and Lexicon Pharmaceuticals entered into an exclusive licensing agreement for Ipsen to commercialize telotristat outside of the United States and Japan
In February 2017, Lexicon received FDA approval for Xermelo® in the USA. Outside of the USA, telotristat is subject to evaluation, by the relevant regulatory authorities, of the benefits and risks before being made available to patients.
Ipsen’s leadership in NETs was further supported by the 2015 acquisition of OctreoPharm Sciences, and is expected to be enhanced by the potential approval of telotristat in carcinoid syndrome in the EU.
A reinforced oncology pipeline
Ipsen’s oncology pipeline was reinforced in March 2016 with the in-licensing of cabozantinib from Exelixis. In September 2016, the European Medicines Agency approved Cabometyx® (cabozantinib tablets) for the treatment of second-line advanced renal cell cancer based on the results of the METEOR phase 3 trial.
Also, in March 2018, Ipsen announced that Cabometyx® (cabozantinib) received positive CHMP (Committee for Medicinal Products for Human Use) opinion for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma. The CHMP positive opinion was based on the CABOSUN trial, which demonstrated that cabozantinib prolongs progression-free survival (PFS) in treatment-naive aRCC patients with intermediate- or poor-risk. This treatment offers an opportunity to extend survival for patients suffering from RCC, which is responsible for nine out of ten cases of kidney cancers.
A major strategic step forward in bolstering Ipsen’s growing oncology presence and leveraging its oncology infrastructure in the United States was taken in early 2017 with the acquisition of oncology assets of Merrimack Pharmaceuticals. The highlight of the transaction was the acquisition of commercialization rights for Onivyde® (irinotecan liposome injection), a landmark, FDA-approved treatment for metastatic pancreatic cancer. Decapeptyl® (triptorelin) is a synthetic hormone therapy primarily indicated for the hormonal treatment of locally advanced metastatic prostate cancer, that can be now injected subcutaneously too. In March 2017, the MHRA in the UK, in coordination with 14 other European regulatory agencies, approved a new indication for Decapeptyl® as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, for women at high-risk of breast cancer recurrence. Hexvix® (hexaminolevulinate), is a photosensitizing agent that improves detection and resection of non-invasive bladder cancer and is a significant improvement for urologists and their patients
Partnerships with patients and healthcare providers
To ensure that NET patients are fully informed, Ipsen launched the website www.livingwithnets.com at the end of 2016. Designed by and with patients for the use of patients, the site provides the full picture of the condition and offers information and support for patients to help them on their journey. In the United States, Ipsen supports IPSEN CARES™ (Coverage, Access, Reimbursement and Education Support), a programme that assists patients in overcoming obstacles to start or continue treatment with Somatuline® for gastroenteropancreatic NET and acromegaly, as well as Increlex® and Dysport®, including coverage access, distribution and financial concerns. Furthermore, Ipsen is committed to promoting transparent and evidence-based discussions between stakeholders on policies concerning the management of conditions on which it focuses – including NETs, rare diseases and urological cancers.
Sales in oncology in 2017
(62.1% of sales in 2017)