ESTEVE signs a licensing agreement for a severe primary insulin-like growth factor 1 deficiency treatment

• It is a biologic product used to treat children and adolescents from 2 to 18 years-old who suffer from severe primary insulin-like growth factor 1 deficiency¹
• The acquisition of the treatment for this rare disease is an example of ESTEVE's commitment focused on growth opportunities in high unmet medical and patient needs.

BARCELONA, Spain, April 1, 2025 /PRNewswire/ -- ESTEVE has signed a license and supply agreement with Eton Pharmaceuticals with global rights for Increlex®, except for USA.

This biologic product, the first biologic in ESTEVE's portfolio, is used for the long-term treatment of growth failure in patients aged 2 to 18 years due to a condition known as 'severe primary insulin-like-growth-factor-1 deficiency' (SPIGFD). Patients with this condition have low levels of the hormone insulin-like growth factor-1 or IGF-1, which is required for normal growth.¹

"As a rare disorder, patients suffering SPIGFD, often face difficulties associated with receiving a late correct diagnosis, with consequent delayed treatment initiation with limited access to appropriate therapy. This has a considerable impact on the physical health and quality of life of these patients.² The disease awareness and the multidisciplinary approach are critical to improve those people's lives. This standard of care medicine is perfectly aligned with our strategy,focused on highly specialized treatments for high unmet medical and patient needs", confirms José María Giménez Arnau, Chief Scientific & Medical Officer of ESTEVE.

Increlex® was designated an 'orphan medicine' (a medicine used in rare diseases) in 2006.¹ It is approved by the U.S. Food and Drug Administration (FDA)³ and European Medicines Agency (EMA)¹ and authorized in 40 territories.

References

1. Increlex | European Medicines Agency (EMA)
2. Challenges in the care of individuals with severe primary insulin-like growth factor-I deficiency (SPIGFD): an international, multi-stakeholder perspective - PubMed
3. Drug Approval Package: Increlex (Mecasermin [rDNA origin]) NDA #021839

About ESTEVE

ESTEVE (www.esteve.com) is a global pharmaceutical company with a clear purpose: to improve people's lives. Founded in 1929 and headquartered in Barcelona, ESTEVE has a strong international presence with pharmaceutical affiliates in Spain, Portugal, Italy, Germany, France, the UK, and the USA.??

ESTEVE is focused on delivering highly specialized treatments that address significant unmet medical needs in several therapeutic areas. In addition, to our innovative pharma business, we offer comprehensive Contract Manufacturing services (CMO), specializing in the production of Active Pharmaceutical Ingredients (APIs) through world-class facilities in Spain, Mexico, and China.?

ESTEVE's strong commitment to its core values-people matter, transparency, and accountability-remains at the heart of everything it does.?

For more information:

Irene Simón, Head of Global External Communications & ESG, ESTEVE
Tel.[phone] - [e-mail]

Gemma Mestre, External & Digital Communications Manager, ESTEVE
Tel.[phone] - [e-mail]

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