Bologna, 2 January 2024 - Alfasigma S.p.A today announced that it has signed an agreement with Galapagos NV (Euronext & NASDAQ: GLPG) to acquire the Jyseleca® (filgotinib) business for up to €170 million. The agreement follows the signing of a Letter of Intent as announced on 30 October 2023 and marks a significant milestone in Alfasigma’s ongoing growth strategy. With this transaction, Alfasigma will add an innovative and specialised product to its portfolio and significantly strengthens its pipeline, adding a new Phase 3 program aimed at expanding Jyseleca®’s label to a third indication. Furthermore, Alfasigma expects to significantly expand its presence in the Northern European markets whilst strengthening its presence in Southern Europe through this acquisition.
As previously announced, under the terms of the agreement, Alfasigma will acquire the entire Jyseleca® business, including the European and UK Marketing Authorizations, the commercial, medical affairs and development activities for Jyseleca® and approximately 400 Galapagos positions in 14 European countries. Galapagos will receive a €50 million upfront payment, potential milestone payments totalling €120 million and mid-single to mid-double-digit sales-based payments on European sales. Galapagos will contribute up to €40 million to Alfasigma by June 2025 for Jyseleca® related development activities.
In addition, subject to and as part of the closing, Michele Manto, Galapagos’ former Chief Commercial Officer, will join Alfasigma as Chief Commercial Officer Western Europe.
The transaction is subject to customary closing conditions and is expected to close in the first quarter of 2024.
Stefano Golinelli, Chairman of Alfasigma, stated: "With the acquisition of Galapagos' Jyseleca® business, Alfasigma strategically strengthens its position in the pharmaceutical sector, unlocking new avenues for growth and innovation. This deal marks an important step in our ongoing growth strategy, allowing us to enhance our portfolio in the gastrointestinal and rheumatological areas for the benefit of our patients".
Francesco Balestrieri, CEO of Alfasigma, commented: "This deal aligns with our commitment to advancing healthcare solutions, expanding our product portfolio, and solidifying our international presence. As we finalise the deal with Galapagos, we are ready to leverage our expertise to drive the success of Jyseleca®. Our focus now is to integrate the commercial, medical affairs, and development activities into our group’s wider framework, while preserving the business’ distinctive characteristics. This project also underscores our dedication to innovation bringing on board a robust Phase 3 programme, aimed at expanding Jyseleca's label to a third indication and further contributing to our growth as a company".
Filgotinib is marketed as Jyseleca® in Europe and Japan for the treatment of adults with moderate to severe active RA who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs. Filgotinib is also marketed as Jyseleca® in Europe and Japan for the treatment of adult patients with moderate to severe active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Jyseleca® 100mg and 200mg are registered in the above-mentioned territories. The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The Great Britain Summary of Product Characteristics for filgotinib can be found at www.medicines.org.uk/emc and the Northern Ireland Summary of Product Characteristics for filgotinib can be found at www.emcmedicines.com/en-GB/northernireland, respectively. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp.
Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies. Except for filgotinib’s approval as Jyseleca® for the treatment of moderate to severe active RA and UC by the relevant regulatory authorities in the European Union, Great Britain, and Japan, our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.
Alfasigma is one of Italy's leading pharmaceutical companies with a strong international positioning. The Group has a worldwide presence in over 100 countries where about 3000 people work in research, development, production and distribution. In Italy, Alfasigma is a leader in the prescription products market where, in addition to its strong focus on gastro-intestinal products, it is present in several primary care therapeutic areas. It is popular with the consumer public for a number of nutraceuticals & food supplements that respond to different needs, and that are well known and deeply rooted in the Italian families’ experience. Its historical headquarters is in Bologna, to which is added Milan, while the production sites are: in Italy, in Pomezia (RM), Alanno (PE), Sermoneta (LT) and Trezzano Rosa (MI) and abroad in Tortosa in Spain and in Shreveport (Louisiana) in the United States. The R&D laboratories are in Pomezia and in the Parco Scientifico Tecnologico Kilometro Rosso in Bergamo. Alfasigma's mission is to improve people's health and quality of life by offering caregivers and healthcare personnel therapeutic solutions according to the highest standards of quality and safety.
Is a global biotechnology company with operations in Europe and the US dedicated to developing transformational medicines for more years of life and quality of life. Focusing on high unmet medical needs, Galapagos synergizes the most compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, the company is committed to challenging the status quo and delivering results for patients, employees and shareholders.
  Austria, Belgium, Luxembourg, France, Germany, Netherlands, Nordics, Greece, Portugal, Spain, Switzerland, UK and Ireland.