Xevinapant

Debiopharm and ITM announced a licensing deal for a ​​radiopharmaceutical treatment that’s being investigated in several cancers. Debiopharm, which is based in Switzerland, is eligible for upfront, development and regulatory milestone payments of about €300 million, or about $331 million, along with commercial milestones and low double-digit royalties on potential future sales. In exchange, the German radiopharma biotech gets exclusive global development and commercialization rights to Debiopharm’s peptide-based theranostic pair, which is a combination of the therapeutic compound Debio 0228 and diagnostic imaging agent Debio 0328. The combo is currently in the Phase 1/2 GaLuCi trial in clear cell renal cell carcinoma, pancreatic ductal adenocarcinoma and colorectal cancer. According to the companies, the treatment combo targets the carbonic anhydrase IX surface protein, which plays a role in promoting tumor survival, growth and metastasis. “Adding a clinical stage theranostic pair that targets the critical CA IX protein aligns seamlessly with our mission to expand access to innovative radiopharmaceuticals on a global scale,” ITM CEO Andrew Cavey said in a statement. Debiopharm CEO Bertrand Ducrey added in a statement that Debio 0328’s “outstanding potential as a stand-alone imaging agent has also boosted our confidence for the upcoming evaluation of Debio 0228, the therapeutic agent.” Back in June , Merck KGaA decided to wind down Phase 3 trials for a cancer drug called xevinapant that it licensed from Debiopharm in 2021 after a failure.

Disclosure of inside information pursuant to Article 17 of Regulation (EU) No 596/2014 Darmstadt, Germany, July 26, 2024 – Based on a very strong second quarter of 2024 with net sales of EUR 5.352 bn resulting in an EBITDA pre1 of EUR 1.509 bn and an EPS pre1 of EUR 2.20, Merck KGaA, Darmstadt, Germany, (the "Company") has raised its guidance for the entire group for fiscal 2024.  The main driver is a very strong operating performance of Healthcare and Electronics compared to consensus. The performance of Life Science is within expectations. The strong operating performance of Healthcare more than offset the provision equal to a mid-double-digit million euro amount associated with xevinapant. The Company now projects net sales of approx. EUR 20.7 - 22.1 bn (previously EUR 20.6 – 22.1 bn). EBITDA pre1 is anticipated to grow to approx. EUR 5.8 – 6.4 bn for the Group (previously "EUR 5.7 – 6.3 bn"). EPS pre1 is projected to amount to approx. EUR 8.20 – 9.30 (previously "EUR 8.05 – 9.10"). The Company will publish Q2 / 2024 figures as scheduled on 1 August 2024. 1 EBITDA pre and EPS pre are alternative performance measures not defined by international accounting standards, used by the Company to improve the comparability of business performance over time and within the industry. EBITDA pre means earnings before interest, income tax, depreciation and amortization as well as adjustments ( Ergebnis vor Zinsen, Ertragsteuern, Abschreibungen und Anpassungen ). EPS pre means profit after tax including adjustments per theoretical shares outstanding (see Merck KGaA, Darmstadt, Germany, Annual Report 2023). About Merck KGaA, Darmstadt, Germany Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. Around 63,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2023, Merck KGaA, Darmstadt, Germany, generated sales of € 21 billion in 65 countries. The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group website. In case you are a resident of the USA or Canada, please go to www.emdgroup.com/subscribe to register for your online, change your selection or discontinue this service.