{"id":36096,"date":"2021-12-17T13:37:28","date_gmt":"2021-12-17T11:37:28","guid":{"rendered":"https:\/\/www.ipsen.com\/press-releases\/ipsen-and-genfit-enter-into-exclusive-licensing-agreement-for-elafibranor-a-phase-iii-asset-evaluated-in-primary-biliary-cholangitis-as-part-of-a-long-term-global-partnership\/"},"modified":"2024-08-09T07:20:27","modified_gmt":"2024-08-09T05:20:27","slug":"ipsen-and-genfit-enter-into-exclusive-licensing-agreement-for-elafibranor-a-phase-iii-asset-evaluated-in-primary-biliary-cholangitis-as-part-of-a-long-term-global-partnership","status":"publish","type":"press_release","link":"https:\/\/www.ipsen.com\/press-releases\/ipsen-and-genfit-enter-into-exclusive-licensing-agreement-for-elafibranor-a-phase-iii-asset-evaluated-in-primary-biliary-cholangitis-as-part-of-a-long-term-global-partnership\/","title":{"rendered":"Ipsen and GENFIT enter into exclusive licensing agreement for elafibranor, a Phase III asset evaluated in Primary Biliary Cholangitis, as part of a long-term global partnership"},"content":{"rendered":"<ul>\n<li style=\"margin-bottom:3px\">Agreement gives Ipsen global1\u00a0rights to develop and commercialize GENFIT\u2019s late-stage, first-in-class PPAR alpha and delta agonist elafibranor in Primary Biliary Cholangitis (PBC)<\/li>\n<li style=\"margin-bottom:3px\">Investigational treatment elafibranor being evaluated in the global Phase III trial, ELATIVETM, with topline data expected early 2023<\/li>\n<li style=\"margin-bottom:3px\">GENFIT receives \u20ac120m upfront and is eligible to receive up to \u20ac360m in milestone payments as well as tiered double-digit royalties of up to 20%<\/li>\n<li style=\"margin-bottom:3px\">Ipsen becomes 8% shareholder of GENFIT via an equity investment of \u20ac28m<\/li>\n<\/ul>\n<p><b>Paris (France), 17 December 2021 \u2013\u00a0<\/b>Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) have entered into a long-term strategic partnership for global collaboration between the two companies. The agreement gives Ipsen exclusive worldwide* license to develop, manufacture and commercialize GENFIT\u2019s investigational treatment elafibranor, for people living with Primary Biliary Cholangitis (PBC). The partnership also gives Ipsen access to future clinical programs led by GENFIT and combines GENFIT\u2019s scientific expertise and proprietary technologies in liver disease with Ipsen\u2019s development and commercialization capabilities. To underscore the long-term commitment represented by this partnership, Ipsen will also purchase newly issued GENFIT equity representing 8% post-issuance through a \u20ac28m investment in GENFIT, becoming one of the largest shareholders.<br \/>\nThe ongoing, pivotal Phase III global trial, ELATIVETM,\u00a01\u00a0is evaluating the safety and efficacy of elafibranor in 150 people living with PBC who have an inadequate response or intolerance to ursodeoxycholic acid (UDCA). Global recruitment is well underway. There is significant unmet medical need for people with PBC and, following positive Phase II data,\u00a02\u00a0elafibranor was granted Breakthrough Therapy Designation by the U.S Food and Drug Administration (FDA) and Orphan Drug Designation by the U.S. FDA and European Medicines Agency (EMA).\u00a03,4\u00a0Results from the Phase II randomized double-blind, placebo controlled trial found that after 12 weeks of dosing with elafibranor, patients with PBC unresponsive to UDCA experienced significantly reduced levels of disease-activity markers including alkaline phosphatase (ALP) and composite endpoints with bilirubin as well as other markers of disease activity when compared to placebo.2<br \/>\n<b>David Loew, Chief Executive Officer, Ipsen<\/b>, said \u201cToday\u2019s announcement marks an exciting new stage in Ipsen\u2019s ambitions to expand our portfolio to support more people living with rare diseases around the world. We are excited by elafibranor\u2019s data package, demonstrating the potential benefit of this first-in-class, innovative treatment option to help the PBC community. We look forward to the results of the ongoing Phase III program and regulatory submissions around the world to bring this potential new treatment option to patients. Ipsen is pleased to partner with GENFIT, a company that shares our common values and goals of bringing to market first-in-class treatments to improve the lives of people living with rare conditions like PBC.\u201d<\/p>\n<p><b>Pascal Prigent, Chief Executive Officer of GENFIT<\/b>\u00a0added: \u201cWe are excited to partner with Ipsen and launch this long-term strategic collaboration, with the goal to accelerate our growth and generate value for our shareholders. Ipsen\u2019s world-class development capabilities, well-established global commercial footprint and excellent track record in delivering therapies to patient populations with unmet medical need makes it the ideal partner for GENFIT. Today\u2019s landmark agreement demonstrates our ability to advance highly promising assets into late-stage development in-house and derive significant value. While we hope, above all, that this partnership with Ipsen will be a significant step towards having a positive impact on the lives of millions of patients suffering from life-threatening liver diseases, we also believe our shareholders will recognize the benefit offered by this collaboration model. The transaction proceeds indeed reinforce GENFIT\u2019s long-term financial visibility, including further funding for GENFIT to expand its pipeline, and they also provide opportunities for targeted business development, as exemplified by today\u2019s other announcement regarding our in-licensing of a new molecule.\u201d<\/p>\n<p>PBC is a rare, progressive, chronic autoimmune disease of the liver.5\u00a0Bile is a liquid produced inside the liver that is used to help digest fats and remove waste products from the body.6\u00a0PBC leads to a slow, progressive destruction of the small bile ducts of the liver, causing bile and other toxins to build up in the liver (known as cholestasis).5\u00a0Further damage can lead to scarring, fibrosis and eventually cirrhosis of the liver.5\u00a0Common symptoms of PBC include fatigue and pruritus\u2019 (itching) which can be debilitating and, in more advanced cases, jaundice.5\u00a0Untreated, PBC can lead to liver failure, or in some cases death. PBC is more common in women with nine women diagnosed for every man; it is also a leading cause of liver transplantation.5<\/p>\n<p>GENFIT remains responsible for the Phase III ELATIVETM\u00a0trial until the completion of the double-blind period. Ipsen will assume responsibility for all additional clinical development, including completion of the long-term extension period of the ELATIVETM\u00a0trial, and global* commercialization. This newly established strategic partnership will also provide Ipsen with access to GENFIT\u2019s research capabilities and other clinical programs through rights to first negotiation.<br \/>\nUnder the agreement, Ipsen will pay GENFIT up to \u20ac480m, comprising upfront cash payment of \u20ac120m, as well as regulatory, commercial, and sales-based milestone payments up to \u20ac360m, plus tiered double-digit royalties of up to 20%. Ipsen also becomes a shareholder of GENFIT through the purchase of 3,985,239 newly issued shares representing 8% of GENFIT S.A after issuance, via a \u20ac28m investment. The new shares will be issued pursuant to the twentieth resolution of GENFIT\u2019s 30 June 2021 shareholders\u2019 meeting and will be subject, upon issuance, to a lock-up period ending, in the event of positive ELATIVE\u00a0TM\u00a0results, on the earlier of the date on which the EMA makes a formal recommendation to the European Commission for the marketing authorisation of elafibranor in PBC or the date on which the U.S. FDA grants approval of elafibranor in PBC. Issuance of the new shares is expected to take place on or about December 22, 2021. In addition, the Board of Directors of GENFIT will propose at the next shareholders\u2019 meeting that Ipsen becomes a board member.<br \/>\nThe transaction is expected to be dilutive to Ipsen\u2019s profitability over the near term, primarily reflecting R&amp;D and launch-preparation expenses. This is in line with Ipsen\u2019s medium-term outlook regarding its strategic focus on building a high-value and sustainable pipeline through external innovation.<\/p>\n<p><b>Conference call<\/b><br \/>\nA conference call and webcast for investors and analysts will begin at 14:30 CET today. Participants should dial in to the call early and can register\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=ZFkKd_5g8bvYudhpePc4SThROTFVntYJeMaIj2SsT5TTTVCfb4kCye8H1IjAZevxsAqIjJNo3ChjjW8DqGc2lom0mBFSE4lE5GM5UU7aazfFnIGsGu1qMhAecMGC5SYLF_jilTxJDdCofT2lSFZwRm94R__ORCBNwoZKtbX9_htw6ouEH4xIQHT7OlHd56QAPomFQM2jsySrxPLlRNA6KfDcY92Dq1P7kBBMCOZa722HCzM0L0SbX1kYoY-W9Pla3qyeHbeRha9LjB9IIXGdVbm6wtZbAReA-WeYCukZgmlWgS8I22igImAKFyEzPxEEd4xDwfwJVULvgHxR0zvDXH_Sj1aPXytg41D4-AReyZFd_Np_Qq5VUFqSnHjVgIVwKghPeEMIMRnyaaKzbFBlE9cmBOtVwQAGfD_05euzz8dM4TwCujGqLH8aBN3HLNPTmXWDkIb2tW4VO5b0aybUkcGsZa-nJ103WVu-Sv5wGn7Hfx11JBe7Mq2VEbArYYm5wlyXspBQEqRDFfBuRaXMfv-exHst8ZMVQMOOiJWzQcv8mt8NJIdYlE2k5e0jAIbWcfnqacJtrLWNQMkPOnCEvg==\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><b>here<\/b><\/a>; a recording will be available on\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=QEsCA8puneyrrD8GWa3Veoc11rhEagQi9aJEWApwaBL5gzOYjiDlkKRYKWJneW9qbIPlfzSHTaOaEMeNNBaYc9UaiVeSH3JTsiehinLkI7oRalj6SvZFV4IPjimpIQySSQ-b0QrFaNYJ5YK0aIXYKOihBqRRFLVEuQg_ZkXZ0wmniposBxJbsVGCf3WQ-79ULV5lXHrgB-9yabfibhB0YR6OsZf7NHqBKpk-4whn8P-uQJORBbvO1hD5bLogffIDDKAsM5UlouNXsmFI_1ySsu03Fa6xpt1I1wTfDGwQ2ZedW26d_28HTyJR6m8YmQETdozJJwn3XiusMgeqgniQsHQ9QnRNMS66BhGliLUI6SCmNpvSNZqqJlBAteEFebIbXLab2Ifs3UqwCdsgCADykChy6uqFpn8ldf7u8Qija_TlR5Wz-6VUDUvEKYBDY5hPnh7X9EXFlOqCn1e8N9g1HH6EwCfEb50yfZ8ur1uvCo9BkL3VQyzoICG0XZ6RevYBsSMpnTOiDQEGcvtk_goJWVPpJNWF9V2OOtn3RqeMJknJPCkLeGZigpMDg6jVYOhn\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><b>ipsen.com<\/b><\/a>, while the webcast can be accessed\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=ZFkKd_5g8bvYudhpePc4SRvCkJbjkRgnFmGMb2v_cO9WSuTuKkOvOJH2wEWg-VVhIvojUWehq7C_x7Sddt8bSes4UCxweAEVDS6Tz5R7DIzRqAgnesleI6DGJbg_SEhcxTbk7oPtosjwvfN1e0LGHTjUxPVyxvZAuKtp5JTsibldingxWmcqDGfXa2L9ZioD0jryY6-MiA7g9TkfrICyUOsS356qBKUL23KbWW33dF925KWU4V7x3TB4Q9wlnSIB3wIWHHzMMTw73KS9QR4-YLhIxsNvVaqiJ84rU-M9IrdpOdDlv-C901E5YPVfd8viNs7G61s0GoYRKa9QlY2g6P4ANw6JAA4IO6uwg7Uwv4BLbLO7Q27vuDOixJ9w8VENaktHg5XE4oHKuWzy6wyO_W5h4UA0MZ0kv9qwQKARGjqt9TkzdXw-bVqwUBbHeTt486xxu0lED7F-UxhxiGSyov-x6ROtMWT1zb_pMUq5conVd4pM9DXZhmBhSJih2WelYqHTtVM2sMm2gtc7ggjOSqRD3CyOlqH5IHbV3fFg3etQV3R8saFaJLQKldtBOO575LmP1K-SM_osDJ3mNeos9A==\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><b>here<\/b><\/a>. The event ID is 7296852.<\/p>\n<p>1.\u00c0 l\u2019exception de la Chine, de Hong Kong, de Ta\u00efwan et de Macao, o\u00f9 Terns Pharmaceuticals d\u00e9tient la licence exclusive pour d\u00e9velopper et commercialiser elafibranor<br \/>\nELATIVE. Clinical Trials. Available at:\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=jzQtKZayZH20olMcVdwvGSRDj_fit18PWX4V0lji4ZHXVu0zlepbkCJwCdMX7VAQJzBuxuWxCxuFMmKSUqq5pWkBldJ_45DGeBxZIrTNmgWRwulnTIhElpBxzNzrRaT7orusaFz8SGdU9Xiglo6p4or18TecnS9U6FqD0pt9ao143jIz-FanXH6uU0YQnHvXjkKFi9fyU0CylvMFj9rWMHfNrr44GQyWR_Bbsu0lImFz6w7RFftDAhITpfYcG27f\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><b>https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04526665?term=ELATIVE&amp;draw=2&amp;rank=1<\/b><\/a><br \/>\n2.Schattenberg JM, et al. A randomized placebo-controlled trial of elfibranor in patients with primary bilary cholangitis and incomplete responses to UDCA.\u00a0<em>Journal of Hepatology.\u00a0<\/em>2021:74;1344-1354<br \/>\n3. GENFIT Press Release. 2019\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=jzQtKZayZH20olMcVdwvGYMYsKc_VsbjwvRqxQq__NrrF8gO7OvgQPcu1ZBbHSl5oa5k43duQ3OQjrQr71h4XzokdVABr-eH51y6TeHPh3wA2v7rM_We_M9YegN6t340wSKfZCMQYcnPQeZatkzXB49gH2Ja4VXpyYEYMMVBlKKK72YJGE6CboJsOOIntLsQd724K6xxElBqTdhMJjJF0KFvsZk68oVIi07FF-5KVn4eqo3iGWfNISFU3pvwo0MQSRZOHZzovjenUhuNLe0tqx-jzLW4bsVrgTh44vAP3ssz4mulqId3pPrMGYPDQJgfdtJyIdTA6B1i2bQ9Bip0nRGxdffwZfDsv-LFiL6ATleFrwelkvLJsR-QhjKKN-D-Vh8H7opmNNemwyKeGdQe96fI9FEad5V8s2sfEgUKyhc=\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><b>https:\/\/www.genfit.com\/press-release\/genfit-announces-fda-grant-of-breakthrough-therapy-designation-to-elafibranor-for-the-treatment-of-pbc\/<\/b><\/a><br \/>\n4. European Medicines Agency. 2019.\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=jzQtKZayZH20olMcVdwvGRUOfDm54us5pKNwQfHTQyWiwooTOBVw6cyCPy15m9DnnJkyHGFL0oaKQNQyIP8QUpfGkalozieM3OEknS_ExPkeNBwQbtyRQeQ00inhbT5SvCTh0_32MWdVYt6OKIyYTIHxyBwZqENNRjlr_U3F55InU2cZcedobPuwfwjF3v-msA7ktU_a-eek1n_MMb27szN_1aLHoXKcyvXAwZTw1Yg=\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><b>https:\/\/www.ema.europa.eu\/en\/medicines\/human\/orphan-designations\/eu3192182<\/b><\/a><br \/>\n5. Kimagi T, Heathcote EJ. Orphanet\u00a0<em>J Rare Dis<\/em>. 2008; 3:1<br \/>\n6. NHS. Primary Biliary Cirrhosis. <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=jzQtKZayZH20olMcVdwvGYHr-aI7gveq2f-c2rMLk4m7zxS2boDb-ajX0w-Ek8Kg6VKkK3LAdpwrlBHmBADauzzS45tbg5FklfF1avM_5wPpbUMjayzQpTqKRc-jBCPsydKh04j989q1I_c7EzD8AEic6-cDBDRC0POWW792ALfu9IF4UsTPeQeBrWDvYpIrnqLzNWeJbLtrag8BNJITgQ==\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\">https:\/\/www.nhs.uk\/conditions\/primary-biliary-cirrhosis-pbc\/<\/a><\/p>\n<p id=\"gnw_attachments_section-header\">\n    <strong>Attachment<\/strong><\/p>\n<ul id=\"gnw_attachments_section-items\">\n<li>\n        <a target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=we1Xhn0hcmEy4zndoZDAkCLZ3kAKHK4uxVxdQEUMWtYwacQzmWUTs_g3C3RHsL3vgComuEIgO-_WAU9kt0_Pe908HqscDPE6wK3ADkWKroqFHuslsYdTCdeGiNC61ptAsWtQiSKUiLb_nxD3TPz4urBaDWGnPOL5OnhIVKHho9ixKkgdDedlVEIDo_Uho8TvFJ7pzLFpQq3GnoZbaQ1o0A==\" title=\"Ipsen-Genfit-Collaboration-17-December-2021\" rel=\"nofollow noopener\">Ipsen-Genfit-Collaboration-17-December-2021<\/a><\/li>\n<\/ul>\n<p><img src='https:\/\/ml-eu.globenewswire.com\/media\/YThkYWZlMmUtNzZmNC00NDc5LWEzZmItN2QwMDI4MGExM2NiLTEwMTA5NDM=\/tiny\/Ipsen-SA.png' \/><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"template":"","categories":[1763,1769,149],"tags":[],"class_list":["post-36096","press_release","type-press_release","status-publish","hentry","category-corporate-pressrelease","category-partnering-pressrelease","category-pressrelease","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Exclusive Licensing Agreement with GENFIT | Ipsen Global<\/title>\n<meta name=\"description\" content=\"Discover the exclusive licensing agreement between Ipsen and GENFIT as part of a long term global agreement.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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