A recognized partner in acromegaly
Our ambition is to become a recognized and unique partner in patient program management and provide innovative resources. Acromegaly is a rare disease caused by excess growth hormone production as a result of a tumor in the pituitary gland. Acromegaly can cause a wide range of symptoms that tend to develop slowly over time, but common signs include a thickening and widening of the hands and feet as well as an alteration of facial features. Patients with acromegaly often experience a long journey of multiple doctors’ visits and debilitating symptoms that can last for years before the correct diagnosis is made. Many patients experience substantial pain and discomfort, which affects sleep, family life, and their ability to work, causing depression and anxiety. Early diagnosis, effective treatment and frequent monitoring are critical for improving clinical symptoms and outcomes of the disease. Ipsen continues to work on solutions that will improve the quality of life of patients living with acromegaly.
The Group is currently developing extended-release formulations of Somatuline® that would enable patients to have fewer injections.
A long-term commitment
Ipsen’s long-term commitment to treat adult and pediatric endocrine disorders is supported by its portfolio of growth disorder products. Our therapies for short stature, NutropinAq® and Increlex®, have the potential to treat the continuum of this disabling condition from growth-hormone deficiency to growth-hormone resistance.
As part of its mission to be a global advocate for patients affected by rare endocrine disorders, Ipsen is engaged with patient groups, key scientific leaders, medical societies and institutions to develop educational projects and initiatives that help physicians manage the treatment of these conditions worldwide.
The Group is also involved in supporting the development of networks of experts to promote international dialog between specialists, including several initiatives with the European Society of Endocrinology.
Ipsen actively supports the development of SAGIT (Signs and symptoms, Associated comorbidities; Growth hormone levels; Insulin-like growth factor-1 levels and Tumor Size), a tool that has been designed to assist endocrinologists in managing acromegaly in everyday practice. Although still in development, SAGIT is a promising instrument offering the potential to assess the status and evolution of disease in patients with acromegaly and to guide physicians in decision making.
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 gastroenteropancreatic neuroendocrine tumors and acromegaly, Increlex® and Dysport®, including coverage access, distribution and financial concerns.
In Europe, the Group has set up INKEP (Ipsen Network of Knowledge Exchange Program), an exchange program for small groups of physicians focusing on pediatric endocrinology which combines scientific presentations, case discussions and interactive sit-in clinic visits. Other initiatives in pediatric endocrinology include APPRI in France, a personalized training program for patients that helps increase their autonomy at home during treatment with the recombinant growth hormone NutropinAq® and the NutropinAq® injection pen, improving compliance with the treatment. Two years after its launch, more than 100 prescribers are using this service in France.
Somatuline® injection is used for the long-term treatment of acromegaly in patients who cannot be treated with surgery or radiation. Somatuline® works by reducing the amount of growth hormone that the body produces. Somatuline® is also used to treat neuroendocrine tumors from the gastrointestinal tract or the pancreas (GEP-NET) that has spread or cannot be removed by surgery. Somatuline® has been proven to deliver sustained control of acromegaly, with more than 80% of patients experiencing more than 50% decline in growth hormone levels from baseline and nearly 60% of patients demonstrating normalized insulin-like growth factor (IGF-1) levels. Somatuline® is a semi-solid formulation for injection with the active substance controlling the sustained release of the treatment. The new device with a retractable needle enables the full dose of the medicine to be safely administered. The device allows self-injection for certain indications in many countries. Somatuline® is marketed in over 55 countries, including 27 in Europe, for the treatment of acromegaly and neuroendocrine tumors.
Increlex® is a recombinant insulin-like growth factor (IGF-1) of human origin that treats growth delay in children who lack it in their bodies. If IGF-1 is not present in sufficient quantities, the patient will not reach normal stature, despite having normal or high growth-hormone levels. As a result, these children do not respond adequately to growth hormone treatment. Increlex® has obtained orphan drug status based on the low incidence of the disease, which affects fewer than 5 people per 10,000.
NutropinAq® is a liquid formulation of recombinant human growth hormone administered using the Nutropin Aq® Pen. Nutropin Aq® was available in more than 20 countries at the end of 2015, notably in Europe and Australia. It is indicated for the treatment of growth failure from various origins.
Decapeptyl® is an injectable hormone therapy drug with several indications. Because it stimulates the release of hormones produced by the pituitary gland, which in turn controls hormonal secretions by the testicules and ovaries, it is marketed in many countries as a treatment for precocious puberty in boys and girls. Additional gynecological indications have also been approved, including uterine fibroids, endometriosis and in vitro fertilization.
Endocrinology at Ipsen
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.
Ipsen at a glance
The group in 2015