ESTEVE Pharmaceuticals has secured a license and supply agreement with Eton Pharmaceuticals for the global rights to Increlex®, excluding the United States market. The deal, announced on April 1, 2025, represents a significant expansion of ESTEVE's rare disease portfolio and marks the company's first entry into biologics.
Increlex® (mecasermin) is approved for the long-term treatment of growth failure in children and adolescents aged 2 to 18 years who suffer from severe primary insulin-like growth factor-1 deficiency (SPIGFD). The condition is characterized by abnormally low levels of insulin-like growth factor-1 (IGF-1), a hormone essential for normal growth and development.
A Critical Treatment for a Rare Condition
SPIGFD is a rare disorder that often presents significant challenges for patients, including delayed diagnosis and limited access to appropriate therapies. These challenges can substantially impact physical development and quality of life.
"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," explained José María Giménez Arnau, Chief Scientific & Medical Officer of ESTEVE. "This has a considerable impact on the physical health and quality of life of these patients. The disease awareness and the multidisciplinary approach are critical to improve those people's lives."
Increlex® received orphan drug designation in 2006 and has since been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The treatment is currently authorized in 40 territories worldwide.
Strategic Alignment for Both Companies
For Barcelona-based ESTEVE, the acquisition aligns perfectly with the company's strategic focus on specialized treatments addressing significant unmet medical needs. The addition of Increlex® to its portfolio demonstrates ESTEVE's commitment to expanding its presence in the rare disease space.
"This standard of care medicine is perfectly aligned with our strategy, focused on highly specialized treatments for high unmet medical and patient needs," Arnau added.
For Eton Pharmaceuticals, the out-licensing agreement allows the company to concentrate on its growth opportunities within the U.S. market, including three rare disease product launches planned for 2025.
"Esteve shares Eton's dedication to putting patients first and we're excited to partner with them to distribute this important treatment outside of the U.S.," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "Esteve has the global infrastructure and established presence necessary to successfully commercialize Increlex in countries outside the U.S. This transaction will allow Eton to focus its efforts on the Company's compelling growth opportunities within the U.S."
Terms of the Agreement
Under the terms of the agreement, Esteve will license the ex-U.S. rights for up to ten years and will receive an option to acquire the international rights in the future. Eton will supply the product to Esteve at a fixed transfer price. The transaction does not impact Eton's expectation to exit 2025 at an approximately $80 million annual revenue run rate.
About the Companies
ESTEVE, founded in 1929 and headquartered in Barcelona, is a global pharmaceutical company with a strong international presence through affiliates in Spain, Portugal, Italy, Germany, France, the UK, and the USA. The company focuses on delivering specialized treatments for unmet medical needs across several therapeutic areas. In addition to its pharmaceutical business, ESTEVE offers comprehensive Contract Manufacturing services, specializing in the production of Active Pharmaceutical Ingredients through facilities in Spain, Mexico, and China.
Eton Pharmaceuticals is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently has seven commercial rare disease products in its portfolio: INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. Additionally, Eton has six product candidates in late-stage development.
This licensing agreement represents a significant step for both companies in their commitment to addressing the needs of patients with rare diseases, particularly those suffering from severe primary insulin-like growth factor-1 deficiency.
