Eton Pharmaceuticals to Acquire Increlex® from Ipsen

Eton Pharmaceuticals Announces Acquisition of Increlex® to Enhance Pediatric Endocrinology Portfolio

DEER PARK, Ill., Oct. 03, 2024 — Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a forward-thinking pharmaceutical company dedicated to developing and marketing treatments for rare diseases, has announced a significant development. Eton has entered into an asset purchase agreement to acquire Increlex® (mecasermin injection) from Ipsen S.A. The acquisition is projected to be finalized by the end of 2024.

Eton’s CEO, Sean Brynjelsen, emphasized the alignment of Increlex with the company's mission to provide transformative medicines for patients suffering from ultra-rare conditions. Increlex is essential for treating severe IGF-1 deficiency, a condition that fits seamlessly with Eton’s focus on rare diseases. Brynjelsen highlighted Eton's strong ties within the pediatric endocrinology community and their commitment to raising awareness about this underdiagnosed condition. He also expressed eagerness to collaborate with Ipsen to ensure that patients continue to receive uninterrupted care and a consistent medication supply globally.

Increlex is a biologic therapy specifically for children and adolescents aged 2 to 18 years who have severe primary insulin-like growth factor 1 deficiency (SPIGFD), a condition where the body fails to produce adequate IGF-1. It is approved in 40 regions, including the U.S. and EU. There are approximately 200 patients in the U.S. and between 900 and 1,000 patients in Europe with SPIGFD. Increlex holds the distinction of being the only treatment approved by both the U.S. FDA and the EMA for this condition.

Post-acquisition, Eton will take over the commercialization of Increlex in the U.S. without disrupting patient supply. Outside the U.S., Ipsen will manage the distribution during a six-month transition period, after which Eton will assume full responsibility.

The transaction will be funded through Eton’s available cash and an expansion of its existing credit facility with SWK Holdings. Ipsen reported global sales for Increlex at €17.3 million in 2023.

Increlex has several safety considerations. It is contraindicated in patients with hypersensitivity to mecasermin or any inactive ingredients, closed epiphyses, or active neoplasia. Precautions include monitoring for hypoglycemia, intracranial hypertension, lymphoid tissue hypertrophy, slipped capital femoral epiphysis, scoliosis progression, and cardiomegaly. There have been postmarketing reports of malignant neoplasms in pediatric patients treated with Increlex, especially at higher doses. The drug is not recommended for infants due to the risk of serious adverse reactions, including "gasping syndrome".

Common adverse reactions to Increlex include hypoglycemia, hypersensitivity reactions, and tonsillar hypertrophy.

In the U.S., Increlex is indicated for treating growth failure in pediatric patients aged 2 years and older with severe primary IGF-1 deficiency or hormone gene deletion with neutralizing antibodies to GH. It is not a substitute for GH in patients with secondary forms of IGFD.

In the EU, Increlex is for long-term treatment of children and adolescents from 2 to 18 years with confirmed severe primary IGF-1 deficiency, defined by specific clinical criteria and exclusion of secondary IGFD forms.

About Eton Pharmaceuticals

Eton is a pharmaceutical company dedicated to developing and commercializing treatments for rare diseases. It currently markets five products for rare diseases and has three additional product candidates in late-stage development.

This strategic acquisition aims to solidify Eton’s commitment to addressing the needs of patients with ultra-rare conditions, particularly in the field of pediatric endocrinology.