Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the European Medicines Agency (EMA), the European regulatory authority, has accepted the submission of filing for telotristat etiprate as an adjunct to somatostatin analogue therapy for the long-term treatment of carcinoid syndrome to improve symptom control in adult patients with metastatic neuroendocrine tumors.
In addition to this European submission, Ipsen will pursue a worldwide regulatory plan for marketing authorization submissions in the territories where it operates. As such the Marketing Authorization Application was submitted to SwissMedic (the Swiss Regulatory Agency) on July 5th 2016. In October 2014, Ipsen and Lexicon announced that they had entered into an exclusive licensing agreement for Ipsen to commercialize telotristat etiprate in all territories excluding the United States and Japan, where Lexicon retains the rights. Lexicon filed a New Drug Application in the United States on 30 March 2016 and was granted priority review on 31 May 2016 by the U.S. Food and Drug Administration (FDA).
Regulatory submission is supported by the results of TELESTAR, a pivotal, placebo-controlled phase 3 clinical trial and TELECAST, the phase 3 companion study to TELESTAR. Results from TELESTAR demonstrated a statistically significant (p<0.001) reduction from baseline in the average number of daily bowel movements over the first 12-week study period in both treatment arms (250 mg tid and 500 mg tid) compared with placebo, thereby meeting the study’s primary endpoint. A statistically significant (p<0.001) reduction in urinary 5-hydroxyindoleacetic acid (the main metabolite of serotonin) was also observed at week 12 compared with placebo in both treatment arms. The most common adverse reactions associated with the use of telotristat etiprate were nausea, abdominal pain, fatigue and gamma-glutamyl transferase increased in the pooled placebo-controlled data of the two phase 3 clinical trials, TELESTAR and TELECAST.
David Meek, Chief Executive Officer of Ipsen, said: “Ipsen is a global leader in neuroendocrine tumors, and is committed to improve patient outcomes from diagnosis to each stage of the disease including symptomatic treatment of carcinoid syndrome. We look forward to working with the EMA so that as many patients as possible can benefit from telotristat etiprate”.
About carcinoid syndrome
Well-differentiated neuroendocrine
tumor (NET) is a relatively rare tumor type that arises from cells of
the neuroendocrine system. Carcinoid syndrome (CS) occurs when
well-differentiated NETs secrete large amounts of serotonin and other
vasoactive products into the systemic circulation. Classically, symptoms
associated with CS include cutaneous flushing, diarrhea, wheezing,
abdominal pain, and in the long-term, valvular heart disease.
Somatostatin analogues (SSA) are the cornerstone of therapy for the relief of CS and tumor control. SSA inhibit the release of serotonin by NETs and have become first-line therapy for CS. However, SSA may not adequately control symptoms for all patients.
Due to the severe morbidity of CS and the lack of established treatment options, the population of patients with CS needing further control in addition to their SSA therapy is one with a high unmet medical need.
About telotristat etiprate
Telotristat etiprate is a novel,
orally administered, inhibitor of the enzyme tryptophan hydroxylase
(TPH). Through inhibition of TPH, the rate-limiting step in the
synthesis of serotonin, the compound was designed to reduce the
production of serotonin within neuroendocrine tumors. Carcinoid syndrome
occurs when well differentiated neuroendocrine tumors secrete large
amounts of serotonin and other vasoactive products into the systemic
circulation. Telotristat etiprate has been developed as an adjunct to
SSA therapy for the long term treatment of CS to improve symptom control
in adult patients with metastatic NETs.
Telotristat etiprate received priority review status and orphan drug designation from the FDA in the United States, and has received orphan drug designation from the EMA.
About Ipsen
Ipsen is a global specialty-driven
pharmaceutical group with total sales exceeding €1.4 billion in 2015.
Ipsen sells more than 20 drugs in more than 115 countries, with a direct
commercial presence in more than 30 countries. Ipsen’s ambition is to
become a leader in specialty healthcare solutions for targeted
debilitating diseases. Its fields of expertise cover oncology,
neurosciences and endocrinology (adult & pediatric). Ipsen’s commitment
to oncology is exemplified through its growing portfolio of key
therapies improving the care of patients suffering from prostate cancer,
bladder cancer and neuro-endocrine tumors. Ipsen also has a significant
presence in primary care. Moreover, the Group has an active policy of
partnerships. Ipsen's R&D is focused on its innovative and
differentiated technological platforms, peptides and toxins, located in
the heart of the leading biotechnological and life sciences hubs (Les
Ulis/Paris-Saclay, France; Slough/Oxford, UK; Cambridge, US). In 2015,
R&D expenditures neared €193 million. The Group has more than 4,600
employees worldwide. Ipsen’s shares are traded on segment A of Euronext
Paris (stock code: IPN, ISIN code: FR0010259150) and are eligible to the
“Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120
index. Ipsen has implemented a Sponsored Level I American Depositary
Receipt (ADR) program, which trades on the over-the-counter market in
the United States under the symbol IPSEY. For more information on Ipsen,
visit www.ipsen.com.
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