Ipsen Receives Positive CHMP Opinion for Approval of Xermelo® (Telotristat Ethyl), for the Treatment of Carcinoid Syndrome Diarrhea in Patients Inadequately Controlled by Somatostatin Analogue Therapy
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending the approval of Xermelo® (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy. The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 28 countries of the European Union, as well as Norway, Liechtenstein and Iceland.
David Meek, Chief Executive Officer of Ipsen, said: “The positive CHMP opinion for Xermelo ® is an important milestone towards providing innovative solutions along every step of the treatment pathway for neuroendocrine tumors. Xermelo ® is a novel treatment option and is the first oral tryptophan hydroxylase inhibitor, studied in combination with a somatostatin analog to demonstrate significant relief to patients and can contribute to an improved quality of life. We are very pleased to move closer to providing a new treatment option for European patients suffering from this debilitating condition.”
“The medical community is very pleased to have Xermelo ® as a new therapeutic option for patients with carcinoid syndrome”, said Professor Juan Valle, University of Manchester and The Christie in Manchester, UK. He added “The positive safety and efficacy data of telotristat ethyl has meant that it has already been integrated in the majority of international guidelines including ENETS 1 guidelines reflecting the high level of unmet need in this condition”.
The detailed recommendations for the use of this product will be described in the Summary of Product Characteristics (SmPC), to be made available once the medication receives marketing authorization from the European Commission.
About the TELESTAR Phase 3 Pivotal Trial
The efficacy and safety of telotristat ethyl 250 mg taken tid were established in a 12-week double-blind, placebo-controlled, randomised, multicentre phase 3 trial. The study included a 36-week open-label extension period during which all patients were treated with a higher dose of telotristat ethyl. A total of 135 patients were recruited in 12 countries (AU, BE, CA, FR, DE, IL, IT, NL, ES, SE, UK, USA). The mean age was 64 years (range 37 to 88 years) and 52% were male. All patients had a well-differentiated metastatic neuroendocrine tumours with documented history of carcinoid syndrome, and were treated with stable-dose SSAs for ≥ 3 months before enrolment. Patients had an average of four or more bowel movements (BM) per day: at baseline, mean daily BM frequency averaged over the baseline period were 5.2 and 6.1 counts/day in the placebo and telotristat ethyl 250 mg groups, respectively. The study included a 12-week double-blind treatment (DBT) period, in which patients initially received placebo (n=45) or telotristat ethyl 250 mg (n=45) or a higher dose (telotristat ethyl 500 mg; n=45) three times daily. During the study, patients were allowed to use rescue medication (short-acting SSA therapy) and anti-diarrheals for symptomatic relief but were required to be on stable-dose of long-acting SSA therapy for the duration of the DBT period.
The primary endpoint was the mean change from baseline in daily BM frequency averaged over the 12-week double blind period. Estimated difference in BM frequency per day versus placebo averaged over 12 weeks was -0.81 for telotristat ethyl 250mg (p<0.001).
A substantially greater proportion of patients on telotristat ethyl 250 mg tid achieved a durable response, defined as at least a 30 percent reduction in daily bowel movements over at least half the days of the 12-week DBT period: 44 percent on telotristat ethyl, as compared to 20 percent on placebo (p<0.040). When the full effect of telotristat ethyl is observed (during the last 6 weeks of the DBT period) the proportion of responders with at least 30% BM reduction was 51% (23/45) in the 250 mg group versus 22% (10/45) in the placebo group (post-hoc analysis).
Telotristat ethyl significantly reduced the percent change from baseline in urinary 5-hydroxyindole acetic acid (u-5HIAA) versus placebo at week 12 (p< 0.001).
About the TELECAST Phase 3 Trial
The Phase 3 TELECAST study was designed similarly to TELESTAR study as a companion to this pivotal Phase 3 study to provide additional efficacy and safety information in patients with carcinoid syndrome.
A total of 76 patients were evaluated for efficacy. The mean age was 63 years (range 35 to 84 years) and 55% were male. All patients had well-differentiated metastatic neuroendocrine tumour with carcinoid syndrome. Most patients (92.1%) had fewer than 4 BM per day and all except 9 were treated by SSA therapy.
The primary endpoints were the percent change from Baseline in u5-HIAA at Week 12 and incidence of treatment emergent adverse events (TEAEs). The mean u5-HIAA excretion at baseline was 69.1 mg/24hours in the telotristat ethyl 250 mg tid group (n=17) and 84.8 mg/24hours in the placebo group (n=22). The percent change from baseline in u5-HIAA excretion at week 12 was +97.7% in the placebo group versus -33.2% in the telotristat ethyl 250 mg tid group.
Notably, 40% of patients in the telotristat ethyl 250 mg tid treatment arm achieved a ≥30% reduction in BM frequency for at least 50% of the days in the double-blind treatment period, while there were no responders in the placebo arm (p=0.001).
General safety information about Xermelo
In clinical trials, over 230 patients with carcinoid syndrome were treated with Xermelo®. The placebo-controlled safety analyses were focused on the integrated data from the 12-week placebo-controlled double-blind periods from the two phase 3 randomized clinical trials. For this safety analysis, 71 patients received placebo and 70 patients received Xermelo® 250 mg three times daily. The most commonly reported adverse reactions in patients treated with telotristat ethyl were abdominal pain (26%), gamma-glutamyl transferase increased (11%) and fatigue (10%). They were generally of mild or moderate intensity. The most frequently reported adverse reaction leading to discontinuation of telotristat ethyl was abdominal pain in 7.1% of patients (5/70).
About carcinoid syndrome (CS)
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.
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.
Xermelo® 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, Xermelo® was designed to reduce the production of serotonin within neuroendocrine tumors.
On 22 October 2014, Ipsen and Lexicon announced that they had entered into an exclusive licensing agreement for Ipsen to commercialize Xermelo® (telotristat ethyl) in all territories excluding the United States and Japan, where Lexicon retains the rights. On 28 February 2017, Lexicon received U.S. Food and Drug Administration (FDA) approval for Xermelo® as a first and only orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.
Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neurosciences and Rare Diseases. Its commitment to oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales close to €1.6 billion in 2016, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen's R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,100 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.
Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words "believes," "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements, including the Group’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from generic products that might translate into a loss of market share. Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Group’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance. The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.
The risks and uncertainties set out are not exhaustive and the reader is advised to refer to the Group’s 2016 Registration Document available on its website (www.ipsen.com).
Didier Véron, Tel.: +33 (0)1 58 33 51 16
Senior Vice-President, Public Affairs and Communication
Brigitte Le Guennec, Tel.: +33 (0)1 58 33 51 17
Corporate External Communication Manager
E-mail : email@example.com
Eugenia Litz, Tel.: +44 (0) 1753 627721
Vice-President Investor Relations
Côme de La Tour du Pin, Tel.: +33 (0)1 58 33 53 31
Investor Relations Manager
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Ant Financial to Share Full Suite of AI Capabilities with Asset Management Companies20.6.2018 01:10 | Pressemelding
Ant Financial Services Group (“Ant Financial” or “the Company”) today announced that the Company will share a full suite of AI capabilities with asset management companies in China to support their digital transformation. Following its successful launch last year, Caifuhao, an AI-powered corporate account on the Ant Fortune platform, has brought tangible benefits to 27 fund management companies. “By combining Ant Financial’s AI technologies with the capabilities of asset management companies in investor education and fund management, together we are making customized wealth management services more accessible for ordinary users,” said Eric Jing, Executive Chairman and CEO of Ant Financial. With the support of AI-powered services offered by their Caifuhao account, including operational optimization, content generation, compliance and risk management, 27 fund management companies have been able to increase their operational efficiency by 70% while reducing their overall costs by 50%. Add
Avalara Announces Closing of Initial Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares19.6.2018 21:20 | Pressemelding
Avalara, Inc. (NYSE: AVLR) today announced the closing of its initial public offering of 8,625,000 shares of common stock, including the full exercise by the underwriters of their option to purchase 1,125,000 additional shares of common stock, at a price to the public of $24.00 per share. The shares began trading on the New York Stock Exchange on June 15, 2018 under the symbol “AVLR.” Goldman Sachs & Co. LLC, J.P. Morgan, and BofA Merrill Lynch acted as book-running managers for the offering. JMP Securities, KeyBanc Capital Markets, and Stifel acted as co-managers. The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at 866-471-2526, or by email at firstname.lastname@example.org, or from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at
Unilever Calls on Content Creators and Distributors to Eradicate Stereotypes19.6.2018 17:42 | Pressemelding
Unilever is calling on content creators and distributors to act now to eliminate outdated stereotypes. The move marks the latest step in the company’s industry-leading Unstereotype initiative, which launched two years ago with the aim of eliminating harmful and diminishing portrayals of people across advertising. As part of its Unstereotype commitment Unilever is expanding that initiative across all forms of content and branded entertainment, and today announces a three-year multi-million-dollar deal with Rexona, the world’s biggest deodorant brand, and Simon Fuller’s XIX Entertainment. Rexona (also known as Sure, Degree and Shield depending on the country) will partner with NOW UNITED, the first ever global pop group comprised of 14 artists from 14 countries including Brazil, China, Germany, India, Philippines, Senegal, US and UK. Together, will co-create content across multiple channels that unites different cultures through the joy of dance, celebrating movement and inspiring people
Universal Laser Systems Expands Its Materials Database with Henkel, Hexcel and Saint-Gobain Materials19.6.2018 12:05 | Pressemelding
Universal Laser Systems (ULS) announces the addition of Henkel, Hexcel® and Saint-Gobain materials to its materials database, the most extensive repository of laser material processing parameters for materials in the range of 10 watts to 500 watts. The Henkel, Hexcel and Saint-Gobain materials new to the ULS materials database were specifically added for laser processing with the ULTRA and XLS platforms, suited for high accuracy and precision laser cutting, laser ablation and laser surface modification. The materials include: Henkel Bergquist™ Gap Pad® VO Thermal Material Henkel Bergquist™ Hi-Flow® 105 Thermal Material Henkel LOCTITE® EA 7000 AERO Film Henkel Hysol® EA 9696 AERO Film Henkel Bergquist™ Sil-Pad A2000 Thermal Material Hexcel® HexForce® 353 Aramid Fabric Hexcel® HexForce® 282 Carbon Fabric Saint-Gobain CHEMFILM® DF100 Cast PTFE Film Saint-Gobain CHEMFILM® ETFE-E2 Extruded Fluoropolymer Film Laser processing notes, describing the results of the laser-material interaction fo
Valence Advises Itaúsa on Sale of Brazilian Chemical Co Elekeiroz to H.I.G. Capital19.6.2018 11:57 | Pressemelding
The Valence Group acted as advisor to Itaúsa on its sale of Brazilian chemical company Elekeiroz for R$160 million (EV), reduced by the net debt and proportionate to its shareholding (96.5% of total capital stock). The Company is a leading local producer of oxo-alcohols, plasticizers and anhydrides. About Itaúsa Itaúsa is a Brazilian holding company which controls several companies active in areas such as the financial sector; industries include wood panels, bathroom fittings and fixtures; infra-structure; and retail. It is one of the largest private conglomerates in Brazil and one of the largest in the world. About Elekeiroz Founded in 1894 and headquartered in Várzea Paulista – São Paulo, Elekeiroz operates in the chemicals manufacturing market. Through two production sites in Várzea Paulista and Camaçari – Bahia, the Company’s portfolio includes Oxo-Alcohols, Plasticizers, Phthalic & Maleic Anhydrides, Sulfuric Acid and other by-products. Elekeiroz has a diversified client base, com
Dole Adds Industry Veteran Michael Solomon as President of Dole Fresh Vegetables19.6.2018 10:00 | Pressemelding
Dole Food Company, Inc. announced the appointment of Michael H. Solomon as the new President of Dole Fresh Vegetables effective June 18, 2018. As Dole Fresh Vegetables President, Solomon will have responsibility for all of the division's operations across North America. He will report directly to Dole Food Company President and Chief Executive Officer Johan Linden. With 30 years experience, including within the food and beverage industry, Solomon has a proven success record of taking high-performance brands to the next level, increasing performance and margins in sales, plant operations, and profit growth. Among other positions, Solomon has held roles of President of POM Wonderful and President and CEO of Ready Pac Foods, Inc., prior to joining Dole. “Michael has built an impressive track record of strategic, operational and commercial accomplishments,” said Johan Linden, President and Chief Executive Officer of Dole Food Company. “He has considerable experience and knowledge of the fr