Eton Pharmaceuticals Expands Pediatric Endocrinology Portfolio With Increlex Acquisition

Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a leader in rare disease therapeutics, has announced a strategic out-licensing agreement with Esteve Pharmaceuticals, S.A., granting the latter exclusive rights to commercialize Increlex® (mecasermin injection) outside the U.S. for up to ten years.

This move allows Eton to focus on its growing U.S. market while leveraging Esteve’s global infrastructure to expand access to this critical treatment for severe primary insulin-like growth factor-1 deficiency (SPIGFD) in pediatric patients.

A Transformational Acquisition For Eton

Eton recently finalized its acquisition of Increlex from Ipsen S.A., marking a significant milestone in its mission to address rare endocrine disorders.

Increlex, a synthetic recombinant insulin-like growth factor-1 (IGF-1), is approved in 41 territories, including the U.S. and EU, for children aged 2 years and older with SPIGFD—a condition where the body fails to produce sufficient IGF-1, leading to growth failure.

The acquisition aligns with Eton’s expertise in pediatric endocrinology, complementing its existing rare disease portfolio, which includes ALKINDI SPRINKLE® and PKU GOLIKE®. Increlex is now available in the U.S. through AnovoRx, a specialty pharmacy dedicated to rare disease treatments.

Market Growth And Clinical Impact

The global Increlex market is projected to grow significantly, driven by rising diagnoses of childhood growth disorders and advancements in recombinant DNA technology.

Analysts forecast a steady CAGR, supported by increasing awareness and improved healthcare infrastructure in emerging economies.

Clinically, Increlex has demonstrated strong efficacy, with studies showing an increase in growth velocity from 2.8 cm/year pre-treatment to 8.0 cm/year in the first year of therapy.

However, it carries risks such as hypoglycemia, intracranial hypertension, and potential neoplasia, requiring careful patient monitoring.

Increlex Therapeutic Indication

For the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary IGFD).

Severe primary IGFD is defined by:

• height standard deviation score ? -3.0 and;
• basal insulin-like growth factor-1 (IGF-1) levels below the 2.5th percentile for age and gender and;
• growth hormone (GH) sufficiency;
• exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.

Severe primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signalling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.

About DengYueMed – HK Drug Wholesale Distributor

As a legally compliant drug import and export company, DengYueMed is certified by the pharmacy & poisons board of Hong Kong — you can verify our qualification on their official website.

Our efforts to improve the affordability of Mecasermin drug aim to ensure that more patients can benefit from this important medication.

HK DengYue provides detailed medicine information, transparent pricing, and responsive support to ensure a smooth and reliable buying experience.

Feel free to reach out anytime to discuss your needs or ask questions about the medicine. We welcome you to contact us for a consultation.