Somatuline®: one solution for two rare conditions
Somatuline® (lanreotide) is an injectable somatostatin analogue that inhibits the secretion of several endocrine, exocrine and paracrine functions. It is particularly effective in inhibiting the secretion of growth hormones and certain hormones secreted by the digestive system. The indications for Somatuline® are as follows:
Acromegaly, which is often mistaken for gigantism, is a hormonal disorder, marked by a thickening and widening of the hands and feet as well as an alteration of facial features, which set in slowly over time. These symptoms are related to a pituitary tumor which produces excess growth hormone (GH). Acromegaly is rare: 40-70 cases per million).
Neuroendocrine tumors are rare diseases (±1% of digestive tumors). These tumors, most commonly found in the gastrointestinal tract, secrete abnormally high quantities of hormones which can cause diarrhea and flushing. As a result of the absence of specific symptoms, the disease is often diagnosed at a late stage.
Somatuline® and Somatuline® Autogel®, a sustained-release semi-liquid formulation, are available globally. Ipsen is always thinking ahead when it comes to new treatments, and is initiating studies aimed at combining Somatuline® with other innovative compounds for targeted therapies.
Nutropin Aq®, a treatment for growth hormone deficiency
NutropinAq® is a liquid formulation of recombinant human growth hormone administered using the NutropinAq® Pen. Growth hormone is involved in physiological processes such as growth in stature and bone development in children.
NutropinAq® is indicated for the following:
- long-term treatment of growth failure in children due to inadequate endogenous growth hormone secretion;
- long-term treatment of growth failure associated with Turner syndrome;
- treatment of growth failure in prepubescent children associated with chronic renal failure prior to kidney transplantation;
- treatment of adults with either childhood or adult onset growth hormone deficiency.
Increlex®, an orphan drug
The active substance in Increlex® is a recombinant insulin-like growth factor of human origin (IGF-1). IGF-1 is the direct hormonal mediator of growth, and must be present for normal growth of bones and cartilage in children. In severe primary IGF-1 deficiency, serum IGF-1 levels are low in spite of normal or high growth hormone levels. If IGF-1 is not present in sufficient quantities, the child will not reach normal stature. These low IGF-1 levels are usually due to growth hormone resistance associated with mutations affecting the GH receptors and the post-GH receptor signaling pathways, or defects in IGF-1 gene expression. This explains why these children cannot respond adequately to exogenous growth hormone treatment. As this is a rare condition, Increlex® was granted the status of orphan drug.
A leader in many territories
In a highly competitive market, this somatostatin analog quickly gained 21% of the global market (in volume), rising to a 53% market share in certain territories. Already available in more than 55 countries, it is still growing internationally (US, Brazil, China, Japan, Russia etc.). In Brazil, Somatuline® was added to the list of essential medicines for the treatment of acromegaly in 2012, and therefore eligible for reimbursement. In 2012, Somatuline® was also registered in Japan in collaboration with Ipsen’s local partner Teijin, and launched in 2013.
Connecting patients, learned societies and practitioners
- Placing the patient at the heart of its strategy, Ipsen is a partner of the World Neuroendocrine Tumour Cancer Awareness Day in partnership with the International NET Community Association. Ipsen also supports the APTED patient association (French association of patients with various endocrine tumours).
- Ipsen also sponsors scientific events and conferences of learned societies in endocrinology, such as the International Society of Endocrinology (ISE), the European Society of Endocrinology (ESE) or the European Neuroendocrine Tumour Society (ENETs).
- Finally, Ipsen supports practitioners by creating networks of experts to improve the diagnosis and management of pituitary conditions and to encourage exchanges between international specialists. An endocrinologist network, the Latin America Knowledge Network (LAKN), was formed in Latin America in 2010, with the support of Ipsen.
Endocrinology at Ipsen
& KEY FIGURES
Detailed results of the phase III CLARINET study at the European Cancer Congress 2013 on September 28, 2013
The product’s specific features include injectable administration and an innovative sustainedrelease formula to maximize its benefits. The self-injectable device with a retractable needle is designed for safe administration of the full dose of Somulatine® Autogel®, thus contributing to improving ease of use for patients. It is the only sustained-release, quick-acting and ready-to-use somatostatin analog on the market for once-a-month, or every 6 to 8 weeks, injection.