Eton Pharmaceuticals Expands Pediatric Care with Increlex

Eton Pharmaceuticals Completes Increlex Acquisition

Eton Pharmaceuticals, Inc., an innovative player in the pharmaceutical industry, has successfully concluded its acquisition of Increlex® (mecasermin injection). This strategic move significantly enhances Eton's portfolio within the realm of pediatric endocrinology, reaffirming the company’s dedication to addressing rare diseases. With this acquisition, Increlex® will be distributed through AnovoRx, a specialty pharmacy designed to cater to patients battling rare and chronic illnesses.

Key Benefits of Increlex

Increlex® stands as a critical biologic solution for treating pediatric patients aged two years and older suffering from severe primary insulin-like growth factor 1 deficiency (SPIGFD). The effectiveness of Increlex® in replenishing IGF-1 levels—which are pivotal for growth—has been well documented, making it a pioneering treatment in its category. Now that Increlex® is available in the U.S., Eton aims to leverage its existing sales infrastructure to raise awareness about SPIGFD, ensuring more children receive the treatment they need.

CEO Perspective on Acquisition

Sean Brynjelsen, CEO of Eton Pharmaceuticals, expressed enthusiasm over the acquisition, stating, "Closing this deal marks a transformative chapter for Eton. Increlex's alignment with our focus on pediatric endocrinology and our specialized sales team positions us to enhance the treatment landscape for SPIGFD significantly." He emphasized the importance of making Increlex® accessible without disruptions, thus supporting patients globally.

Expanding Access Through Specialty Pharmacy

With Increlex® now in the capable hands of AnovoRx, Eton Pharmaceuticals is working closely with the pharmacy to implement the Eton Cares Program. This initiative offers comprehensive support to patients, including prescription fulfillment, educational resources, insurance benefit evaluations, and financial support programs tailored for qualifying families. Notably, the program also provides copay assistance allowing qualifying patients to access medications without any out-of-pocket expenses.

Global Distribution Strategy

For patients outside the United States, Ipsen will manage the distribution of Increlex® for a six-month transition period. Following this, Eton will assume full commercial responsibilities. The acquisition was made possible through Eton's cash reserves and an extension of its existing credit facility, showcasing the company's readiness to advance its mission despite changing market dynamics.

Understanding SPIGFD and Its Challenges

SPIGFD is a rare condition characterized by insufficient production of IGF-1, critical for a child's growth and development. In the U.S. alone, approximately 200 children are diagnosed with SPIGFD, while the number in Europe ranges between 900 to 1,000. Given its rarity and the complexities surrounding diagnosis and treatment, Increlex® represents an invaluable lifeline for affected families seeking effective management of this condition.

Safety Information and Monitoring

As with any medication, Increlex® comes with specific safety considerations. Adverse reactions such as hypoglycemia, hypersensitivity, and tonsillar hypertrophy are among the noted side effects. Healthcare providers must closely monitor children’s health, particularly watching for signs of hypoglycemia and other serious reactions, especially during the initial stages of treatment. Regular check-ups and communication between clinicians and caregivers are essential for optimizing treatment outcomes.

About Eton Pharmaceuticals

Eton Pharmaceuticals is dedicated to producing innovative solutions for rare diseases, having developed several products that are now commercially available. In addition to Increlex®, other products in their portfolio include ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. With ongoing development of new treatment options like ET-400 and ET-600, Eton remains at the forefront of pharmaceutical advancements in addressing unmet medical needs.

Frequently Asked Questions

What is Increlex® used for?

Increlex® is used for treating severe primary insulin-like growth factor 1 deficiency in pediatric patients aged two years and older.

How does the Eton Cares Program work?

The Eton Cares Program assists patients by providing educational support, insurance benefit evaluations, and offers financial assistance for eligible patients to minimize out-of-pocket expenses.

Who is eligible for Increlex treatment?

Pediatric patients diagnosed with severe primary IGF-1 deficiency are eligible for treatment with Increlex®.

What are the common side effects of Increlex®?

Common side effects include hypoglycemia, local and systemic hypersensitivity, and tonsillar hypertrophy.

How can healthcare providers prescribe Increlex®?

Clinicians can e-prescribe Increlex® through AnovoRx or send a referral form by fax.

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