Mechelen, Belgium; 31 January 2024, 22:01
CET; Galapagos NV (Euronext & NASDAQ: GLPG)
today announced the successful completion of the transaction to
transfer its Jyseleca® (filgotinib) business to Alfasigma
S.p.A.
As previously announced, the transfer includes
the entire Jyseleca® business, including the European and UK
Marketing Authorizations, and the commercial, medical affairs and
development activities for Jyseleca®. In connection with the
completion of the transaction, approximately 400 Galapagos
positions in 14 European countries transferred to Alfasigma to
support business continuity and ongoing patient access. Michele
Manto, former Chief Commercial Officer of Galapagos, also joins
Alfasigma to lead the Jyseleca® business.
“I sincerely thank Michele and our dedicated
teams joining Alfasigma for the key role they have played in
bringing Jyseleca® to more than 20,000 patients in Europe, and I am
confident they will help ensure a successful next chapter for the
business alongside the Alfasigma team,” said Dr. Paul
Stoffels1, CEO and Chairman of Galapagos. “Galapagos is moving
forward with increased focus and resources to drive investments in
our key technology platforms and strategic therapeutic areas. We
will leverage this momentum to deliver value across our pipeline
with the aim to bring transformational medicines to patients around
the world.”
Francesco Balestrieri, CEO of Alfasigma,
added: “We are excited to welcome the talented Galapagos team
to Alfasigma. The acquisition of Galapagos' Jyseleca® business,
including a Phase 3 clinical program, strategically strengthens our
position in the pharmaceutical sector and opens new avenues for
growth and innovation. We are ready to expand and harness the
synergies of Alfasigma and Jyseleca®, and we look forward to
working with our new colleagues to further expand our healthcare
business in Europe.”
Galapagos will receive a €50 million upfront
payment, potential sales-based milestone payments totaling €120
million and mid-single to mid-double-digit royalties on European
sales. Galapagos will contribute up to €40 million to Alfasigma by
June 2025 for Jyseleca® related development activities.
Galapagos expects to realize substantial savings
ranging between €150 million and €200 million in connection with
the transaction and will prioritize investments in its existing
technology platforms of small molecules, CAR-T cell therapies and
biologics, as well as the scale-up of its innovative decentralized
CAR-T manufacturing network. In addition, Galapagos plans to invest
in licensing and acquisition opportunities ranging from late
preclinical to mid-stage clinical assets in its strategic
therapeutic areas to drive value across its pipeline.
Van Lanschot Kempen and Morgan Stanley served as
financial advisors to Galapagos, and Baker McKenzie acted as the
company’s legal advisor.
About filgotinib
Filgotinib is currently approved for the
treatment of moderate to severe active RA and UC by the relevant
regulatory authorities in the European Union, Great Britain, and
Japan. It 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.
About GalapagosWe 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 high unmet medical needs,
we synergize 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, 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 us
on LinkedIn or X (formerly Twitter).
About AlfasigmaAlfasigma 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.
Contact
Media
inquiries: Marieke Vermeersch +32 479 490
603 media@glpg.com |
Investor
inquiries: Sofie Van Gijsel +1 781 296
1143 ir@glpg.com Sandra
Cauwenberghs ir@glpg.com |
Forward-looking statements
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended. These statements are often, but not
always, made through the use of words or phrases such as “will,”
“expect,” “anticipate,” “may,” and any similar expressions.
Forward-looking statements contained in this release include, but
are not limited to, statements related to the transaction between
Galapagos and Alfasigma, including potential payments and
royalties, statements related to Galapagos’ expected cost savings
and efficiencies resulting from the foregoing, and statements
related to Galapagos’ anticipated future research and development
and business development activities. Forward-looking statements are
subject to risks, uncertainties and other factors that could cause
actual results to differ materially from those referred to in the
forward-looking statements and, therefore, the reader should not
place undue reliance on them. These risks, uncertainties and other
factors include, without limitation, , the risk that Galapagos’
expected cost savings and efficiencies from the transaction will
not be realized, the risk that Galapagos will not successfully
achieve its anticipated future research and development and
business development activities, as well as those risks and
uncertainties identified in its Annual Report on Form 20-F for the
year ended 31 December 2022 and its subsequent filings with the
Securities and Exchange Commission. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. The forward-looking statements
contained herein are based on Galapagos management’s current
expectations and beliefs and speak only as of the date hereof, and
Galapagos makes no commitment to update or publicly release any
revisions to forward-looking statements in order to reflect new
information or subsequent events, circumstances or changes in
expectations, unless required by law or regulation.
1 Throughout this press release, ‘Dr. Paul Stoffels’ should be
read as ‘Dr. Paul Stoffels, acting via Stoffels IMC BV’.
- GLPG Alfasigma Closing of the Transaction Press Release_Final
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