Eton Pharmaceuticals has entered into a licensing and supply agreement with Esteve Pharmaceuticals, granting the latter exclusive commercial rights to the growth disorder treatment Increlex outside the US.
The agreement is for a period of up to 10 years.
It also provides Esteve with an option to acquire full international rights to the treatment at a future date.
Eton Pharmaceuticals CEO Sean Brynjelsen said: “Esteve has the global infrastructure and established presence necessary to successfully commercialise Increlex in countries outside the US.
“This transaction will allow Eton to focus its efforts on the Company’s compelling growth opportunities within the US, including its three rare disease product launches planned for 2025, and eliminates the need for significant infrastructure investments that would have been required to commercialise Increlex outside the US.”
Under the terms of the deal, Eton Pharmaceuticals will continue to manufacture and supply Increlex to Esteve Pharmaceuticals at a fixed transfer price. The arrangement does not alter Eton Pharmaceuticals’ financial forecast to achieve an annual revenue run rate of approximately $80m by the end of 2025.
Increlex is a biologic product intended for long-term treatment of children and adolescents aged between two and eighteen years diagnosed with severe primary insulin-like growth factor-1 deficiency (SPIGFD).
Patients affected by SPIGFD typically present with reduced levels of IGF-1, a hormone essential for normal growth.
Increlex received orphan medicine designation in 2006 and has been approved by both the US Food and Drug Administration and the European Medicines Agency. It is currently authorised for use in over 40 international markets.
Esteve Pharmaceuticals stated that the product represents its first biologic addition and aligns with the company’s strategic focus on treatments for rare conditions.
According to the company, this licensing agreement underscores its commitment to expanding in therapeutic areas that address high unmet medical needs.
Esteve Pharmaceuticals chief scientific and medical officer José María Giménez Arnau said: “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. 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 specialised treatments for high unmet medical and patient needs.”
Eton Pharmaceuticals currently markets seven rare disease treatments, including Increlex, Alkindi Sprinkle, Galzin, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous, and Nitisinone.
In addition, six late-stage development candidates remain in the company’s pipeline. These include ET-400, ET-600, Amglidia, ET-700, ET-800, and the ZENEO hydrocortisone autoinjector.
