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ipsen (IPN) Details

Ipsen S.A. operates as a pharmaceutical company worldwide. It offers drugs in the areas of uro-oncology, endocrinology, neurology, gastroenterology, cardiovascular, and cognitive disorders. The company’s products include Decapeptyl, a peptide formulation for injection in the treatment of advanced prostate cancer; Hexvix that is used to enhance detection of bladder cancer; and Somatuline and Somatuline Autogel, which are used in the treatment of acromegaly and neuroendocrine tumours. Ipsen S.A. also offers NutropinAq, a liquid formulation used in the treatment of growth failure in children and growth hormone deficiency in adults; Increlex, a formulation used for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor 1 deficiency; and Dysport, a botulinum neurotoxin type A complex used to treat spasticity of upper limbs following a stroke, as well as the spasticity of other muscles. In addition, it provides Smecta, a natural clay-based drug used in the treatment of chronic and acute diarrhea; Forlax, a drug based on a linear polyethylene glycol polymer used in the treatment of constipation; and Tanakan that is used in the treatment of age-related cognitive disorders. Further, the company offers Nisis and Nisisco oral formulations containing valsartan used in the treatment of hypertension; and Adenuric for the treatment of gout. Additionally, it is developing products in the areas of neurology, endocrinology, and uro-oncology, including BN82451, Tasquinimod, Somatuline Autogel, Dysport, Dysport Next Generation, and Decapeptyl. The company was founded in 1929 and is headquartered in Boulogne-Billancourt, France. Ipsen S.A. is a subsidiary of Mayroy S.A.

4,602 Employees
Last Reported Date: 03/26/14
Founded in 1929

ipsen (IPN) Top Compensated Officers

Chairman, Chief Executive Officer and Member ...
Total Annual Compensation: €1.4M
Deputy Chief Executive Officer and Interim Ex...
Total Annual Compensation: €1.1M
Compensation as of Fiscal Year 2013.

ipsen (IPN) Key Developments

New England Journal of Medicine Publishes Ipsen's Somatuline(R) Clarinet(R) Phase III Results in Patients with Metastatic Gastroenteropancreatic neuroendocrine tumors

Ipsen announced that the New England Journal of Medicine has published clinical trial results showing that Somatuline Autogel/Somatuline Depot (lanreotide) Injection 120 mg (referred to as Somatuline) achieved statistically significant prolongation of progression free survival over placebo in patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). CLARINET, an investigational phase III randomized, double-blind, placebo-controlled study of the antiproliferative effects of Somatuline was conducted in 48 centers across 14 countries. The data gathered from 204 GEP-NET patients over the 96-week study showed that placebo-treated patients had a median PFS of 18.0 months and 33.0% had not progressed or died at 96 weeks, whereas the median PFS for Somatuline treated patients was not reached and 65.1% had not progressed or died at 96 weeks (stratified logrank test, p<0.001). This represented a 53% reduction in risk of disease progression or death based on a hazard ratio of 0.47 (95% CI: 0.30--0.73). These statistically and clinically significant antiproliferative effects of Somatuline were observed in a large population of patients with grade G1 or G2 (World Health Organization classification) GEP-NETs, and independent of hepatic tumor volume (<=25% or >25%). Quality of life measures were not different between the Somatuline and placebo groups. Safety data generated from the study are consistent with the known safety profile of Somatuline. The data from CLARINET is considered investigational, as Somatuline is not indicated for anti-proliferative treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in any market. Somatuline is approved for treatment of symptoms associated with neuroendocrine tumors, which can include the treatment of GEP-NET patients experiencing symptoms from carcinoid syndrome, in many markets where it is marketed as Somatuline Autogel. Somatuline is not approved in the US to treat GEP-NETs or the symptoms thereof, where it is marketed as Somatuline Depot for acromegaly. CLARINET is a randomized, double-blind, placebo-Controlled study of Lanreotide Antiproliferative Response in patients with enteropancreatic Neuroendocrine Tumors ( NCT00353496). This 96-week multinational study was conducted in collaboration with UK & Ireland Neuroendocrine Tumour Society (UKI NETS) and the European Neuroendocrine Tumour Society (ENETS). A total of 204 patients from 48 centers across 14 countries with well or moderately differentiated non-functioning enteropancreatic neuroendocrine tumors and a proliferation index (Ki67) of <10%, were randomized to treatment with Somatuline Autogel 120 mg (n=101) or placebo (n=103). At enrollment, primary tumor locations were pancreas (44%), midgut (36%), hindgut (7%) and unknown (13%). Most patients had stable disease (96%) and were treatment-naïve (84%). 30% of patients had a Ki67 of 3%--<=10% (WHO grade 2) and 33% had an hepatic tumor load >25%. The primary efficacy endpoint was time to either disease progression (centrally assessed using Response Evaluation Criteria In Solid Tumors, RECIST 1.0) or death. Two baseline computed tomography or magnetic resonance imaging scans were performed (the second one done 12 to 24 weeks after the first imaging test), followed by additional scans at 12- week intervals during the first year and 24-week intervals during the second year up to 96 weeks.

Ipsen and Galderma Announces Expansion of Partnership Focusing on Neurotoxins

Ipsen and Galderma announced the expansion of their partnership focusing on neurotoxins. Under the terms of the agreement, distribution rights to Ipsen's Dysport (botulinum toxin Type A) in its aesthetic medicine and dermatological indications in the United States and Canada have been included in the collaboration deal. Furthermore, Galderma will pay EUR 25 million (USD 34 million) to Ipsen and benefit from improved margins in these territories. Meanwhile, Ipsen will be responsible for the production and supply of the product and will be entitled to receive royalties from Galderma. The two companies have also agreed to extend their R&D partnership. According to the extended deal, Ipsen acquires control of the intellectual property of the liquid toxin Galderma in the United States, Canada, Brazil, and Europe further to the payment of EUR 10 million, and Galderma keeps commercialisation rights. The partnership that concerns commercialisation rights in the US, Canada, Brazil, and Europe is extended until 2036. In particular, acquisition of distribution rights for Dysport in North America for its aesthetic medicine and dermatological indications follows Valeant (Canada)'s decision to sell to Nestle rights to a number of dermatological treatments, namely, Restylane (hyaluronic acid), Perlane (hyaluronic acid), Emervel (hyaluronic acid), and Sculptra (poly-L-lactic acid), as well as aesthetic toxin Dysport. The partners have decided to invest in a long-term collaboration in pharmaceutical markets that make up the major share of the global pharmaceutical markets. Dysport is a growing product in Ipsen's portfolio; in the first quarter the drug enjoyed a sales increase of 6.3% year on year to attain EUR 60.8 million.

Ipsen S.A. Announces Supplemental New Drug Application Submitted to the U.S. Food and Drug Administration

Ipsen S.A. announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for Somatuline(R) Depot 120mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors. In the European Union, Ipsen has submitted national marketing authorization variations for Somatuline(R) Autogel(R) 120mg injection to the drug regulatory authorities in 25 countries of the European Union. Regulatory submission is supported by the results of the CLARINET(R) Phase III study, which demonstrated the antiproliferative effect of Somatuline(R) in the treatment of patients with GEP-NETs. The data from CLARINET(R) showed that investigational treatment with Somatuline(R) substantially prolonged time to disease progression or death versus placebo (hazard ratio 0.47, p=0.0002). Safety data generated from the CLARINET(R) study were consistent with the known safety profile of Somatuline. The data from CLARINET(R) is purely investigational, as Somatuline(R) is not authorized for the indication of antiproliferative treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in any market. In many countries where it is marketed as Somatuline(R) Autogel(R), Somatuline(R) is approved for treatment of acromegaly and for the symptoms associated with neuroendocrine tumors, which can include the treatment of GEP-NET patients experiencing symptoms from carcinoid syndrome, and Somatuline(R) is approved in many countries for the treatment of acromegaly. Somatuline(R) Depot is approved in the US for the treatment of acromegaly but not for the treatment of GEP-NETs or the symptoms thereof.


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