Ipsen’s commitment to oncology is demonstrated by its growing portfolio of therapies aimed at improving the lives of patients with neuroendocrine tumors, prostate, bladder and kidney cancer.
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. In particular, Ipsen aims to become a leader in the treatment of neuroendocrine tumors and to improve patient outcomes at each stage of the disease. A major step toward this goal was the launch of Somatuline® in 2015 as a treatment for gastroenteropancreatic tumors in the United States and in 2016 in Europe. These approvals were based on the landmark CLARINET® study demonstrating the antitumor effect of Somatuline® to reduce the risk of disease progression or death by 53% in patients with gastroenteropancreatic neuroendocrine tumors.
A leader in neuroendocrine tumors
In addition to Somatuline®, Ipsen’s leadership in NETs will be further reinforced with the anticipated launches of telotristat etiprate (ex. US) in the next years as a treatment for symptom control in combination with somatostatin analog for patients with carcinoid syndrome, in partnership with Lexicon Pharmaceuticals.
Moreover, in October 2015, Ipsen acquired OctreoPharm Sciences to gain access to new resources to advance diagnosis and treatment of neuroendocrine tumors using radiopharmaceuticals. This new therapeutic expertise has been further reinforced by the licensing agreement from 3B Pharmaceuticals in early 2016 to develop novel radiopharmaceuticals in oncology. This product portfolio will allow the coverage of the full spectrum of neuroendocrine tumor management while providing theranostic solutions to patients.
A strong pipeline
In early 2016, Ipsen bolstered its oncology pipeline with a very important oncology deal with the US company Exelixis. Ipsen acquired (ex-North America and Japan) a potential best in class oral drug with solid scientific data. Cabozantinib has the potential to become a key drug in various oncology indications. Its commercial launch is expected in 2017 in Europe for the second line treatment of kidney cancer as the drug is the first therapy to demonstrate in the METEOR® phase III trial, robust and meaningful improvements in all three key efficacy parameters: overall survival, progression-free survival and objective response rate.
Long lasting partnerships
Ipsen has built its strength in oncology through strong, long-lasting partnerships with research hubs, such as Harvard University or Curie Institute. This long-standing approach resulted in several new key partnerships, such as with Telesta, 3B Pharmaceuticals, Exelixis or Peptimimesis between May 2015 and March 2016.
Ipsen is a key partner of the most important medical societies, in Europe and the United States in urology (EAU, ESOU), in endocrinology (ENETS, ENDO) and in oncology (ESMO, ASCO).
In many countries, the Group cooperates closely with patient groups to raise awareness of its targeted disabling conditions and make progress towards earlier diagnosis. Ipsen also supports initiatives (e.g. Acromegaly Day, World NET Cancer Day) or programs (e.g. IPSEN CARES™ in the United States) to support access of patient to treatment and raise awareness on these diseases. In addition, Ipsen is actively involved in creating networks of experts to promote international dialog between specialists with world experts in the field. Ipsen supports a personalized approach to patient management and launched the 3i Pathways program (identify, individualize, improve) to facilitate decision-making by healthcare professionals and to improve communication among specialized physicians and with patients. It aims at increasing patients’ involvement in the management of their disease.
Somatuline® is an injectable treatment that is particularly effective in inhibiting the secretion of growth hormone as well as certain hormones secreted in the digestive system, which are respectively involved in two rare conditions: acromegaly and neuroendocrine tumors. Somatuline® is the only somatostatin analogue indicated in EU and US for the treatment of pancreatic and gastrointestinal neuroendocrine tumors. The approval in this indication represents a significant step forward in the treatment of this type of tumors, which are rare and difficult to diagnose.
Decapeptyl® is a synthetic hormone made of triptorelin, decapeptide analog of GnRH (gonadotrophin releasing hormone), an hormone secreted by the hypothalamus. Decapeptyl® is primarily indicated for the hormonal treatment of locally advanced metastatic prostate cancer and is also approved for the treatment of endometriosis, uterine fibroma, precocious puberty and female infertility. In prostate cancer indication, Decapeptyl® LP 11.25mg offers now a subcutaneous route of injection, allowing men to benefit from subcutaneous and intramuscular options (subcutaneous route of injection has not been studied for women and children and is not recommended).
March 1st, 2017, the Medicines and Healthcare products Regulatory Agency (MHRA) in UK, in association with 14 others European regulatory agencies, approved a new indication for Decapeptyl® as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in women at high risk of recurrence who are confirmed as pre-menopausal after completion of chemotherapy.
The authorization is based on international randomized clinical trials conducted by the International Breast Cancer Study Group (IBCSG) including a total of 5,700 patients in 27 countries. Two randomized Phase 3 trials were conducted, SOFT (Suppression of Ovarian Function Trial) and TEXT (Tamoxifen and Exemestane Trial), which evaluated pre-menopausal women with early-stage hormone-receptor-positive breast cancer. Results were published in the New England Journal of Medicine (NEJM).
The International Recommendations St. Gallen, the European Society for Medical Oncology (ESMO), the National Comprehensive Cancer Network (NCCN), and ASCO have been updated to include ovarian function suppression in combination with either tamoxifen or an aromatase inhibitor, as a new therapeutic option in women with a high risk of recurrence.
Hexvix® is a photosensitizing agent used in the detection and treatment of bladder cancer. It produces specific fluorescence in the tumor cells in the bladder during a procedure called “cystoscopy”, which involves the examination of the bladder via the urethra. As a result, it improves detection and resection of non-invasive bladder cancer and considerably reduces the risks of incomplete resection of missing a tumor that may not be seen through examination under white light. This technology represents a significant improvement for urologists and their patients.
Cabometyx™ is the tablet formulation of cabozantinib. Its targets include MET, AXL and VEGFR-1, -2 and – 3. In preclinical models, cabozantinib has been shown to inhibit the activity of these receptors, which are involved in normal cellular function and pathologic processes such as tumor angiogenesis, invasiveness, metastasis and drug resistance. Cabometyx™ is available in 20 mg, 40 mg or 60 mg doses. The recommended dose is 60 mg orally, once daily. On April 25, 2016, the FDA approved Cabometyx™ tablets for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. On September 9, 2016, the European Commission approved Cabometyx™ tablets for the treatment of advanced renal cell carcinoma in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway and Iceland.
Sales in oncology in 2016
(57.1% of sales in 2016)