In the contemplated transaction:
- Galapagos to transfer the Jyseleca® (filgotinib) business to Alfasigma, including the European and UK Marketing Authorizations and development activities, and approximately 400 positions in 14 European countries
- Alfasigma to pay Galapagos a €50 million upfront, potential milestone payments totaling €120 million and mid-single to mid-double digit royalties on European sales
- Galapagos to pay up to €40 million by June 2025 to Alfasigma for Jyseleca® related development activities
In the first half of 2023, Jyseleca®'s net sales in Europe totalled €54 million
Bologna, Italy - October 30, 2023, 21:01 CET - Alfasigma S.p.A. ("Alfasigma"), a global pharmaceutical company headquartered in Italy, announced today that it has signed a letter of intent to acquire the Jyseleca® business from Galapagos (Euronext & NASDAQ: GLPG), a global biotechnology company headquartered in Belgium, developing transformational medicines in immunology and oncology.
As part of the planned transaction, Galapagos will transfer Jyseleca®'s (filgotinib) business to Alfasigma, including the marketing authorizations in Europe and the UK, and associated commercial, medical and development activities. Jyseleca® is an oral once-daily JAK1 preferential inhibitor, a new class of drugs with innovative action mechanism and two approved indications: Rheumatoid Arthritis (launched in 2020) and Ulcerative Colitis (launched in 2021). Alfasigma will bring approximately 400 employees into its Group across 14 European countries with strong specialist and managerial skills in areas such as R&D, Medical Affairs, Market Access, Marketing and Sales.
The contemplated transaction will enable Alfasigma to add an innovative and specialty product to its portfolio. In addition, the transaction will strengthen Alfasigma’s pipeline, adding a new Phase 3 program aiming at expanding Jyseleca®’s label to a third indication. Overall, this transaction will be a key step to build on Alfasigma’s strategy and further support its growth aspirations.
With this planned transaction, Alfasigma expects to significantly expand its presence in the Northern European markets (Germany, UK & Ireland, Austria, Belgium, Netherlands, Denmark, Sweden, Norway, and Finland), where most of Jyseleca®'s sales are concentrated. In addition, the Group will strengthen its presence in Southern Europe (Italy, Spain, and France), where Alfasigma already has a significant presence.
Stefano Golinelli, Chairman of Alfasigma, commented: “The planned transaction announced today makes a concrete contribution to our company's growth strategy, consolidating and expanding our presence in several European markets. Additionally, the acquisition of Jyseleca® will further build our gastrointestinal portfolio while giving us access to the rheumatology market.”
Francesco Balestrieri, CEO of Alfasigma, added: “We are very pleased to have signed a letter of intent with Galapagos and are excited to acquire the Jyseleca® business. This transaction is an important development opportunity for both companies and represents another milestone in our journey of transformation and international growth, fitting into the core business areas of our company. We are delighted to welcome Galapagos' Jyseleca® team into Alfasigma following completion of the process and look forward to working together to continue our path of innovation.”
Dr. Paul Stoffels, CEO and Chairman of Galapagos, added: “We believe that the contemplated transaction with Alfasigma is the best possible outcome for our employees, patients, prescribers, our other stakeholders and Jyseleca®. I want to recognize the tremendous efforts and valuable contributions of our talented teams to successfully bring Jyseleca® to many patients across Europe. I am confident that they can thrive within Alfasigma.”
Process and timing
The completion of the intended transaction is subject to the execution of a definitive agreement and customary conditions, including regulatory approvals and consultations with works councils. There can be no assurance regarding the completion of the transaction. The letter of intent includes a customary break-up fee in the event either party does not proceed to a definitive agreement on terms consistent with the letter of intent.
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.
We are 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 highly unmet medical needs, we look to synergise 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 decentralised, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders. For additional information, please visit www.glpg.com or follow the company on LinkedIn or X (formerly Twitter).
About Jyseleca® /filgotinib
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.
 ‘Dr. Paul Stoffels’ should be read as ‘Dr. Paul Stoffels, acting via Stoffels IMC BV’