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.
A LEADER IN NEUROENDOCRINE TUMORS
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. Ipsen and Lexicon Pharmaceuticals entered into an exclusive licensing agreement for Ipsen to commercialize telotristat outside of the United States and Japan in October 2014. Lexicon received FDA approval for Xermelo® in the USA at the end of February 2017 and outside the USA telotristat is still subject to the evaluation of the benefits and risks by regulatory authorities before being made available.
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 EU.
A STRONG PIPELINE
Ipsen’s oncology pipeline was reinforced in March 2016 with the in-licensing of cabozantinib from Exelixis. In Septem ber 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. In September 2016 also, Ipsen and Exelixis announced positive results from the phase 2 CABOSUN trial of cabozantinib versus sunitinib in previously untreated advanced RCC. This treatment offers an opportunity to extend survival for patients suffering from RCC, 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 is 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 early March 2017, the MHRA in the UK, in coordination with 14 other European regulatory agencies, has 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), a significant improvement for urologists and their patients, is a photosensitizing agent that improves detection and resection of non-invasive bladder cancer.
PARTNERSHIPS WITH PATIENTS AND HEALTHCARE PROVIDERS
To ensure that NETs 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 all the information and support patients need to help them on their journey.
In the United States, Ipsen supports IPSEN CARES™ (Coverage, Access, Reimbursement and Education Support), a program that assists patients in overcoming obstacles to start or continue treatment with Somatuline® for gastroenteropancreat ic NETs and acromegaly, as well as Increlex® and Dysport®, including coverage access, distribution and financial concerns.
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)