{"id":1606,"date":"2026-10-13T07:50:39","date_gmt":"2026-10-13T05:50:39","guid":{"rendered":"https:\/\/5mn.ch\/?p=1606"},"modified":"2026-10-13T10:37:12","modified_gmt":"2026-10-13T08:37:12","slug":"daily-brief-2026-10-13","status":"publish","type":"post","link":"http:\/\/5mn.ch\/de\/insights\/2026\/10\/13\/daily-brief-2026-10-13\/","title":{"rendered":"PolyPeptide, Formycon"},"content":{"rendered":"<div class=\"db-brief\">\n<p class=\"db-meta\">Daily Brief \u00b7 Tue 13 Oct 2026 \u00b7 2 stories<\/p>\n<h3 class=\"db-region\">Schweiz<\/h3>\n<article class=\"db-item\" id=\"polypeptide-samsung-offer-interim-result\">\n<p class=\"db-tags\"><span class=\"db-tone db-tone-neutral\">\u25cf Neutral<\/span><span class=\"db-tag\">PolyPeptide \u00b7 PPGN<\/span><span class=\"db-type\">Deal<\/span><\/p>\n<h4>PolyPeptide: Samsung Biologics&#8217; takeover offer clears its acceptance threshold<\/h4>\n<p>By the end of the main offer period on 12 October, 87.6% of PolyPeptide&#8217;s shares had been tendered into Samsung Biologics&#8217; cash offer of CHF 44.31 per share (equity value about CHF 1.46B), according to the provisional interim result. That is well above the two-thirds minimum acceptance condition, so the deal&#8217;s main hurdle is cleared, subject to the definitive result on 16 October. Still outstanding are some regulatory approvals and an extraordinary general meeting on 26 October to lift transfer and voting limits in the articles and elect Samsung&#8217;s board nominees. An additional acceptance period runs from 19 to 30 October; Samsung plans a squeeze-out and SIX delisting afterwards.<\/p>\n<details class=\"db-plain\">\n<summary>In plain words<\/summary>\n<p><strong>What happened.<\/strong> Samsung Biologics, which makes antibody drugs for other companies, offered CHF 44.31 in cash for each PolyPeptide share, about CHF 1.5 billion in total. Owners of almost 88% of the shares said yes, well above the two-thirds Samsung needed. The final count comes on 16 October.<\/p>\n<p><strong>Why it matters.<\/strong> This was expected: the largest shareholder, with over half of the shares, had promised to sell. PolyPeptide makes the active ingredients of peptide medicines for other drug companies; about two-thirds of its sales come from diabetes and obesity medicines. Some approvals and a shareholder vote on 26 October are still needed. PolyPeptide will then leave the Swiss stock exchange.<\/p>\n<\/details>\n<p class=\"db-context\"><span class=\"db-context-label\">Context<\/span> Expected: the largest shareholder, holding about 55.7% of the shares, had irrevocably committed to tender, and the board recommended the offer announced on 20 July. PolyPeptide makes peptide drug ingredients under contract for drug developers, with plants in Sweden, Belgium, France, the US and India; 68% of its H1 2026 revenue of \u20ac236.6M (+42%) came from metabolic peptides, the class that includes GLP-1 diabetes and obesity drugs. For Samsung Biologics, until now focused on antibody and ADC manufacturing, the deal adds peptide production capacity; closing is expected towards the end of 2026.<\/p>\n<\/article>\n<h3 class=\"db-region\">Deutschland<\/h3>\n<article class=\"db-item\" id=\"formycon-fyb206-bla-accepted\">\n<p class=\"db-tags\"><span class=\"db-tone db-tone-pos\">\u25b2 Positive<\/span><span class=\"db-tag\">Formycon \u00b7 FYB<\/span><span class=\"db-type\">Regulatory<\/span><\/p>\n<h4>Formycon: FDA accepts the filing for Keytruda biosimilar FYB206<\/h4>\n<p>The FDA has accepted for review the licence application for FYB206, Formycon&#8217;s proposed biosimilar of Merck&#8217;s cancer immunotherapy Keytruda (pembrolizumab), filed in Q3 2026. Formycon and its US partner Zydus say it is the first publicly announced FDA acceptance of a Keytruda biosimilar. The filing rests on a study showing the same blood levels as Keytruda, without a comparative efficacy trial, which the FDA agreed was not needed; such trials take one to three years and hundreds of patients, and Formycon puts the saving in the high double-digit millions of euros. A decision is expected in Q3 2027. Acceptance triggers an undisclosed milestone payment from Zydus, which holds US and Canadian rights; Formycon supplies the product and shares in its partners&#8217; gross profits.<\/p>\n<details class=\"db-plain\">\n<summary>In plain words<\/summary>\n<p><strong>What happened.<\/strong> The US drug regulator (FDA) will review Formycon&#8217;s request to sell a copy of Keytruda, Merck&#8217;s cancer drug and the world&#8217;s best-selling medicine. Such copies of biological drugs are called biosimilars. A decision is expected in the third quarter of 2027.<\/p>\n<p><strong>Why it matters.<\/strong> Keytruda sold $31.7 billion in 2025; Formycon expects \u20ac60\u201370 million of revenue this year. The FDA agreed that Formycon did not need a large patient trial, which can take one to three years. US sales also depend on Keytruda&#8217;s patents, the main one running until December 2028.<\/p>\n<p><strong>What it means for others.<\/strong> Rivals working on Keytruda copies, such as Sandoz, Celltrion and Samsung Bioepis, have not yet filed in the US, so Formycon is ahead for now.<\/p>\n<\/details>\n<p class=\"db-context\"><span class=\"db-context-label\">Context<\/span> Largely anticipated: Formycon finished clinical development in July and had called the filings its top priority; the FDA normally decides within 60 days of submission whether to accept a file. Keytruda is the world&#8217;s best-selling drug, with sales of $31.7B in 2025, compared with Formycon&#8217;s 2026 revenue guidance of \u20ac60\u201370M from its three marketed biosimilars (of Lucentis, Stelara and Eylea). Keytruda&#8217;s main US compound patent runs to December 2028, with related patents into 2029, and the companies say launch also depends on resolving IP issues.<\/p>\n<p class=\"db-cross\"><span class=\"db-cross-label\">Read-across<\/span> Raises the bar for Sandoz (SDZ, SIX), whose pembrolizumab biosimilar GME751 was in Phase 1 as of mid-2026, and for Celltrion (068270, KRX) with CT-P51 and Samsung Bioepis with SB27, which have so far filed only in Korea.<\/p>\n<\/article>\n<aside class=\"db-also\"><h3>From the other side of the pond<\/h3><ul><li><strong>BMS<\/strong>: Ph. 3 results in IPF \u2014 <span class=\"db-tone db-tone-neg\">\u25bc Negative<\/span> read-across for Vicore (VICO)<\/li><li><strong>First Tracks<\/strong>: positive Ph. 1b data in celiac disease \u2014 <span class=\"db-tone db-tone-pos\">\u25b2 Positive<\/span> read-across for argenx (ARGX)<\/li><\/ul><\/aside>\n<aside class=\"db-coming\"><h3>Coming up<\/h3><ul><li>14 Oct \u2014 AB Science web conference on H1 2026 results<\/li><li>Mid-Oct \u2014 Newron: enrolment completion expected in ENIGMA-TRS 1 (topline Q1 2027)<\/li><li>16 Oct \u2014 PolyPeptide: definitive interim result of Samsung Biologics&#8217; offer<\/li><li>17\u201320 Oct \u2014 UEG Week, Barcelona; Abivax ABTECT maintenance 44-week data (oral presentation 19 Oct)<\/li><li>19\u201330 Oct \u2014 PolyPeptide: additional acceptance period<\/li><li>22 Oct \u2014 ADC Therapeutics: PIPE closing<\/li><li>26 Oct \u2014 PolyPeptide extraordinary general meeting<\/li><\/ul><\/aside>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>PolyPeptide: Samsung Biologics\u2019 takeover offer clears its acceptance threshold; Formycon: FDA accepts the filing for Keytruda biosimilar FYB206.<\/p>","protected":false},"author":2,"featured_media":1607,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[3],"tags":[37,38,19],"class_list":["post-1606","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-daily-brief","tag-formycon","tag-polypeptide","tag-switzerland"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - 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