Ipsen announced that the US Food and Drug Administration (FDA) has approved for marketing Somatuline Depot (lanreotide) Injection 60, 90 and 120 mg in the United States.
Somatuline Depot is indicated for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. Somatuline Depot will be available in a pre-filled syringe eliminating any need for reconstitution and thus enabling freedom of easy administration to patients.
In October 2006, Ipsen granted to Tercica the development and commercialization rights for Somatuline Depot in the US and Canada. At the same time, Ipsen acquired a 25% stake in Tercica on a non-diluted basis. According to the terms of the agreement, the FDA approval of Somatuline Depot triggers a €30 million milestone payment that Tercica will pay to Ipsen by issuing a convertible bond (converted into Tercica common stock at a conversion price of €5.92). Tercica will simultaneously issue an additional $15 million convertible bond to Ipsen (converted into Tercica common stock at a conversion price of $7.41) which will be paid in cash to Tercica.
Tercica now expects to launch Somatuline Depot in the United States in the fourth quarter 2007.
Jean-Luc Bélingard, chairman and CEO of Ipsen said "We are very proud to be able to announce today that a product originated from Ipsen's R&D will be available globally. This is Ipsen's first ever FDA approval, a major achievement made possible thanks to the outstanding dedication and commitment of our teams. We feel confident that our partner Tercica will market Somatuline Depot very successfully by offering to patients suffering from acromegaly a new treatment option that has been proven to be effective, and very convenient to use. With Somatuline, Increlex, NutropinAq and its very rich pipeline of research products, Ipsen confirms its strong commitment to the progress of endocrinology worldwide."
Acromegaly is a disorder caused by the over-production of growth hormone usually by a benign tumour of the anterior pituitary gland. Acromegaly occurs in approximately 60 people per million of population. In acromegaly patients, the pituitary gland releases too much growth hormone (GH) into the bloodstream, the GH then triggers the liver to produce IGF-1, which in turn directly stimulates bone and tissue growth. The most common signs and symptoms of this serious condition include: enlarged hands, feet, and head, facial changes such as bulging forehead, enlarged lower jaw, tongue and lips, wider spacing between teeth, enlarged heart, liver, kidneys, spleen and other organs, joint pain and fatigue, reduced sex drive and loss of concentration.
Somatuline Depot (also marketed as Somatuline Autogel outside the USA) is a sustainedrelease formulation for injection containing lanreotide, a somatostatin analogue (a hormone that inhibits the release of growth hormone). Somatuline was initially developed and continues to be used mainly in the treatment of acromegaly, a disorder caused by the overproduction of growth hormone or prolactin due to a benign tumour of the anterior pituitary gland. This product subsequently underwent further development in Europe in the treatment of symptoms associated with neuroendocrine tumours (particularly of a carcinoid type). Ipsen believes that the Somatuline Autogel formulation, to which it holds the patent, represents a major technological advance. As far as the Group is aware, this represents the first semisolid formulation for injection without any excipient, since the active substance itself controls the sustained release. Somatuline Autogel releases the active substance with no excipient other than water over a period of at least 28 days, thus requiring just one injection per month compared with the two or three injections previously necessary. This product is presented in a pre-filled syringe for easy administration.
The active substance in Somatuline and Somatuline Autogel is lanreotide, which inhibits the growth and secretion of several endocrine, exocrine and paracrine functions. It is particularly effective in inhibiting the secretion of growth hormone.
Somatuline Autogel is marketed in almost 60 countries (including 26 in Europe) by Ipsen for the treatment of acromegaly and neuroendocrine tumours or acromegaly alone. Somatuline had sales of €92 million in 2006, out of which 68% were generated in the Major Western European Countries (France, Germany, Italy, Spain, United Kingdom). Somatuline Autogel accounted for 86% of total sales of this product. Somatuline and Somatuline Autogel are prescribed mainly by endocrinologists, gastroenterologists, oncologists, surgeons and intensive care specialists.
Ipsen is an innovation driven international specialty pharmaceutical group with over 20 products on the market and a total worldwide staff of nearly 4,000. The company's development strategy is based on a combination of products in targeted therapeutic areas (oncology, endocrinology and neuromuscular disorders) which are growth drivers, and primary care products which contribute significantly to its research financing.