Business Wire

European Commission approves Ipsen’s Cabometyx® (cabozantinib) for the first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinoma

Del

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the European Commission (EC) has approved Cabometyx® (cabozantinib) 20, 40, 60 mg for the first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinoma (aRCC). This approval allows for the marketing of Cabometyx® (cabozantinib) in this indication in all 28 member states of the European Union, Norway and Iceland.

“Today’s EC approval is a step forward for advanced kidney cancer patients in Europe who will be able to access a new oral first-line treatment option that offers significant improvement over the standard of care,” said Harout Semerjian, Executive Vice President, Chief Commercial Officer, Ipsen. “Ipsen remains committed to improving patients’ lives by continuing to develop new therapies and expanding the potential of Cabometyx ® across different indications.”

Giuseppe Procopio, M.D., Head of the Genitourinary Unit at Fondazione Istituto Nazionale Tumori Milan, stated: “The value of treatment with Cabometyx ® has been corroborated by the data generated in clinical trials, and since 2016 physicians have also witnessed the potential of it when treating patients following VEGF-targeted therapy. For both of these reasons, physicians will be pleased to soon have access to this new first-line treatment option for intermediate- or poor-risk advanced RCC patients.”

Today’s decision is based on the CABOSUN trial, which demonstrated that cabozantinib significantly prolongs progression-free survival (PFS) compared to sunitinib in treatment-naive aRCC patients with intermediate- or poor-risk. Cabozantinib is the first and only monotherapy to demonstrate superior clinical efficacy over sunitinib in treatment-naïve aRCC patients with intermediate- or poor-risk.

The detailed recommendations for the use of this product are described in the Summary of Product Characteristics (SmPC), available here (https://cabometyx.eu/).

About the CABOSUN study

On May 23, 2016, Exelixis announced that CABOSUN met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS compared with sunitinib in patients with intermediate- or poor-risk aRCC per IMDC (International Metastatic RCC Carcinoma Database Consortium) criteria as determined by investigator assessment. CABOSUN was conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the NCI-CTEP. These results were first presented by Dr. Toni Choueiri at the meeting of the European Society for Medical Oncology (ESMO) 2016, and published in the Journal of Clinical Oncology (Choueiri, JCO, 2018).1

On June 19 2017 Exelixis announced that the analysis of the review by a blinded independent radiology review committee (IRC) has confirmed the primary efficacy endpoint results of investigator-assessed progression-free survival (PFS) from the CABOSUN randomized phase 2 trial of cabozantinib as compared with sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria. Per the IRC analysis, cabozantinib demonstrated a clinically meaningful and statistically significant reduction in the rate of disease progression or death as measured by PFS. The incidence of adverse events (any grade) and the incidence of grade 3 or 4 adverse events between cabozantinib and sunitinib were comparable.

CABOSUN is a randomized, open-label, active-controlled phase II trial that enrolled 157 patients with aRCC determined to be intermediate- or poor-risk per IMDC criteria. Patients were randomized 1:1 to receive cabozantinib (60 mg once daily) or sunitinib (50 mg once daily, four weeks on followed by two weeks off). The primary endpoint was PFS. Secondary endpoints included overall survival and objective response rate. Eligible patients were required to have locally advanced or metastatic clear-cell RCC, ECOG performance status 0-2, and had to be intermediate- or poor-risk per IMDC criteria (Heng, JCO, 2009).2 Prior systemic treatment for RCC was not permitted.

About advanced Renal Cell Carcinoma

With the incidence predicted to rise 22% by 2020, renal cell carcinoma (RCC) threatens to become one of the fastest growing cancers in the world.3 Targeted therapies including tyrosine kinase inhibitors (TKIs) of the VEGF receptor (VEGFR) introduced a decade ago, significantly transformed the treatment landscape of aRCC.4

The American Cancer Society’s 2017 statistics cite kidney cancer as one of the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.5 Clear cell RCC is the most common type of kidney cancer in adults.6 If detected in its early stages, the five-year survival rate for RCC is high. For patients with advanced- or late-stage metastatic RCC, however, the five-year survival rate is only 12% with no identified cure for the disease.7 Approximately 30,000 patients in the U.S. and 68,000 globally require treatment.8

The majority of clear cell RCC tumors have lower than normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL, and VEGF.9-10 These proteins promote tumor angiogenesis (blood vessel growth), growth, invasiveness, and metastasis.11, 12, 13, 14 MET and AXL may provide escape pathways that drive resistance to VEGFR inhibitors. 12 - 14

About CABOMETYX ® (cabozantinib)

Cabometyx® is an oral small molecule inhibitor of receptors, including VEGFR, MET, AXL and RET. In preclinical models, cabozantinib has been shown to inhibit the activity of these receptors, which are involved in normal cellular function and pathologic processes such as tumor angiogenesis, invasiveness, metastasis and drug resistance.

In February of 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada and Japan. This agreement was amended in December of 2016 to include commercialization rights for Ipsen in Canada. On April 25, 2016, the FDA approved Cabometyx® tablets for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy and on September 9, 2016, the European Commission approved Cabometyx® tablets for the treatment of advanced RCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway and Iceland. Cabometyx® is available in 20 mg, 40 mg or 60 mg doses. The recommended dose is 60 mg orally, once daily.

On December 19, 2017, Exelixis received approval from the FDA for Cabometyx® for the expanded indication of treatment of advanced RCC.

On May 17, 2018, Ipsen announced that the European Commission approved Cabometyx® for the first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinomain the European Union, Norway and Iceland.

About Ipsen

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, Neuroscience 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 over €1.9 billion in 2017, 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 5,400 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.

Ipsen 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 2017 Registration Document available on its website (www.ipsen.com).

1 “Choueiri TK, Hessel C, Halabi S, et al. Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update. Eur J Cancer. 2018;94:115-25.

2 Heng D.Y., Xie W., Regan M.M., et al. Prognostic factors for overall survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor-targeted agents: Results from a large, multicenter study. Journal of Clinical Oncology. 2009; 27:5794-5799.

3 Ferlay J, Soerjomataram I, Dikshit R, et al: Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 136:E359-86, 2015

4 Jacobsen J, Grankvist K, Rasmuson T, et al. Expression of vascular endothelial growth factor protein in human renal cell carcinoma. BJU Int. 2004;93:297–302.

5 American Cancer Society. Cancer Facts & Figures 2017. Atlanta: American Cancer Society; 2017.

6 Jonasch E., Gao J., Rathmell W.K., Renal cell carcinoma. BMJ. 2014; 349:g4797.

7 Ko, J. J., Choueiri, T.K., et al. First-, second- third-line therapy for mRCC: benchmarks for trial design from the IMDC. British Journal of Cancer. 2014; 110: 1917-1922.

8 Decision Resources Report: Renal Cell Carcinoma. October 2014 (internal data on file).

9 Harshman, L.C. and Choueiri, T.K., Targeting the hepatocyte growth factor/c-Met signaling pathway in renal cell carcinoma. Cancer J. 2013; 19(4):316-23.

10 Rankin et al., Direct regulation of GAS6/AXL signaling by HIF promotes renal metastasis through SRC and MET. Proc Natl Acad Sci U S A. 2014; 111(37):13373-8.

11 Zhou L, Liu X-D, Sun M, et al. Targeting MET and AXL overcomes resistance to sunitinib therapy in renal cell carcinoma. Oncogene. 2016;35(21):2687–2697.

12 Koochekpour et al.,The von Hippel-Lindau tumor suppressor gene inhibits hepatocyte growth factor/scatter factor-induced invasion and branching morphogenesis in renal carcinoma cells. Mol Cell Biol. 1999; 19(9):5902–5912.

13 Takahashi A, Sasaki H, Kim SJ, et al. Markedly increased amounts of messenger RNAs for vascular endothelial growth factor and placenta growth factor in renal cell carcinoma associated with angiogenesis. Cancer Res.1994;54:4233-4237.

14 Nakagawa M, Emoto A, Hanada T, Nasu N, Nomura Y. Tubulogenesis by microvascular endothelial cells is mediated by vascular endothelial growth factor (VEGF) in renal cell carcinoma. Br J Urol. 1997;79:681-687

Contact information

For further information :
Ipsen
Media
Ian Weatherhead, +44 (0) 1753 627733
Vice President, Corporate External Communications
ian.weatherhead@ipsen.com
or
Brigitte Le Guennec, +33 (0)1 58 33 51 17
Senior Manager, Global External Communications
brigitte.le.guennec@ipsen.com
or
Financial Community
Eugenia Litz, +44 (0) 1753 627721
Vice President, Investor Relations
eugenia.litz@ipsen.com
or
Myriam Koutchinsky, +33 (0)1 58 33 51 04
Investor Relations Manager
myriam.koutchinsky@ipsen.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(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

Bella Hadid Headlines True Religion’s Latest Campaign20.8.2018 12:32Pressemelding

True Religion has tapped Bella Hadid to be the face of the brand. The supermodel embodies all things True Religion, past, present and future; iconic, edgy and everlasting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180820005283/en/ Bella Hadid Headlines True Religion’s Latest Campaign (Photo: Business Wire) An inherit fan of the brand, Bella was the natural choice to meld the iconic essence of the brand with the modern view of its future. An all-star team was assembled including photographer Boo George, stylist Mimi Cuttrell, and hair and makeup duo Jen Atkin and Mary Phillips to create imagery and complementary looks that usher True Religion into a new era that honors the heritage of the brand. A quintessential, confident LA girl with roots at home and abroad, Bella’s voice was not only an inspiration, but an integral part in imagining this campaign, envisioning the brand through her eyes for the next generation of True

Veristat Congratulates Alnylam on the FDA Approval of ONPATTRO™ (patisiran)20.8.2018 11:30Pressemelding

Veristat, a full service Clinical Research Organization (CRO), congratulates Alnylam on the recent FDA approval of ONPATTRO™ (patisiran), a lipid complex injection for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. “On behalf of the entire Veristat team that has supported Alnylam in the development of this therapy, we are humbled to have contributed towards this first-in-class drug approval for Alnylam, for the patients with hATTR amyloidosis and their families,” said John P. Balser, Ph.D., President and Co-Founder of Veristat. “We are continuing to support Alnylam as they look to expand regulatory approval of this treatment to other regions of the world.” Veristat began working with Alnylam over 11 years ago and helped design the studies and prepare the Investigational New Drug (IND) submission for patisiran. Our collaboration continued throughout the entire patisiran program inclusive of a phase 2 study, a phase 3 pivotal study

FRISS Brings Claim Fraud Analysis to a Next Level With Web-IQ´s Innovative Online Network Solution20.8.2018 11:30Pressemelding

Asking your neighbor or friend to sign as a witness to a claim for car damages at your insurance company will work no more, with the new Claim Fraud Analysis feature of FRISS. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180820005039/en/ Eldert van Wijngaarden (Web-IQ) and Philip van Waning (FRISS) shaking hands. (Photo: Business Wire) FRISS, the worldwide provider of AI powered fraud and risk solutions for the P&C insurance industry, recently added a new and innovative feature in their fraud analytics solution: Online Network Analysis from Web-IQ. This feature automatically identifies if the claimants and the insured or other involved persons are related to each other in an on-line environment. This is a proven and strong indicator for fraudulent claims. Especially with car accidents and other types of claims where multiple persons are involved, it adds a whole new approach to the traditional claim analyses. “Research sho

Global IBC Future Zone and IABM Future Trends Theatre to Explore the Latest Tech Shaping the Industry20.8.2018 11:18Pressemelding

IBC2018, the world’s most influential media, entertainment and technology show, today announces the line-up for the IBC Future Zone and IABM Future Trends Theatre. Well established as part of the IBC Exhibition, from 14-18 September, the Future Zone brings together the very latest ideas, innovations and concept technologies from international industry and academia and showcases them in a single specially-curated area sitting alongside exhibition Hall 8. This year, the focus is on showing how new technologies grow from their first inception and progress through to research, development, and validation projects; right through to maturing into the ground-breaking applications and future product standards. Major industry trail-blazers presenting their visions of the future, include Japan’s NHK and BBC R&D from the UK. Both companies will demonstrate a number of technology advances, including: Web-VR applications; object-based media scenarios; pathways to 8K resolution for UHD; and Artifici

Ocean Ambassador of the Netherlands Joins Endowment for Clean Ocean’s Entrepreneur Judges Committee20.8.2018 11:07Pressemelding

The Endowment for Clean Oceans (ECO) announced Willemijn Peeters, Ocean Ambassador of the Netherlands and the Founding Director of Searious Business has joined ECO’s Entrepreneur Committee that will vet contestants’ plans to remove macro and micro plastics from the world’s oceans. “I am working to solve the problem of what to do with the plastic once it is removed from the ocean, by helping to create a market for plastic recovered from the ocean,” said Peeters. “Just like we need to end the use of single use plastic, we need to replace the manufacture of virgin plastic and replace it with recycled plastics, and as much as possible needs to be plastic recovered from the ocean.” View source version on businesswire.com: https://www.businesswire.com/news/home/20180820005004/en/ Contact information The Endowment for Clean Oceans Daniel Perrin Daniel.Perrin@endowmentforcleanoceans.org or connect@seariousbusiness.com

HeartSciences Showcases MyoVista® Wavelet ECG at 2018 European Society of Cardiology Congress (ESC)20.8.2018 11:00Pressemelding

HeartSciences, a medical device company developing next generation ECG devices using continuous wavelet transform (CWT) signal processing and artificial intelligence, is proud to announce its participation as an exhibitor at the upcoming 2018 European Society of Cardiology Congress (ESC). The Congress will take place at Messe Munich International in Munich, Germany and will run from August 25 to August 29, 2018. HeartSciences will highlight its MyoVista® Wavelet ECG (wavECG™) Cardiac Testing Device as well as recent clinical study results published in the Journal of the American College of Cardiology (JACC) This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180820005047/en/ MyoVista Wavelet ECG 12-Lead Cardiac Testing Device (Photo: Business Wire) The JACC article titled “Prediction of Abnormal Myocardial Relaxation from Signal Processed Surface ECG” presented the results from the investigator-initiated clinical study that focus