Eton Pharmaceuticals Announces Acquisition of Approved Orphan Drug Product Carglumic Acid

Rhea-AI Summary

Eton Pharmaceuticals has acquired U.S. marketing rights for carglumic acid tablets, a generic alternative to the high-cost treatment Carbaglu®. The FDA approved the Abbreviated New Drug Application on October 13, 2021. This move is expected to provide significant savings for patients, with Carbaglu® costing over $1 million annually. Eton plans to utilize its existing commercial framework for orphan drugs to enhance distribution and support for patients, aiming to save millions for both individuals and the U.S. healthcare system.

Positive

• Acquisition of U.S. marketing rights to a generic version of Carbaglu®, enhancing product portfolio.
• Expected substantial cost savings for patients and the healthcare system with the introduction of a lower-cost alternative.
• Strong existing infrastructure for orphan drugs to facilitate effective commercialization.

Negative

• None.

-Product is the first generic alternative to one of the highest priced pharmaceutical products in the world

DEER PARK, Ill., Oct. 28, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it has acquired U.S. marketing rights to carglumic acid tablets.

The product’s Abbreviated New Drug Application, which is owned by Novitium Pharma, was approved by the U.S. Food and Drug Administration on October 13, 2021. The product is an AB-rated, substitutable generic version of Carbaglu®.

“We are pleased to be offering patients a lower cost alternative to one of the most expensive treatments in the world,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “With our existing orphan drug commercial footprint and robust patient support services, we believe we are well positioned to commercialize this product. We look forward to working with Novitium to bring the product to patients later this year,” Brynjelsen added.

Carbaglu® is widely regarded as one of the highest priced pharmaceutical products in the world, with the annual cost of treatment estimated to exceed $1 million for many patients. The introduction of Eton’s lower cost alternative is expected to save patients and the U.S. healthcare system millions of dollars annually.

About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from five FDA-approved products, including ALKINDI® SPRINKLE, Biorphen®, Alaway® Preservative Free, Rezipres®, and carglumic acid, and has five additional products that have been submitted to the FDA.

Company Contacts:
Eton Pharmaceuticals
David Krempa
dkrempa@etonpharma.com
612-387-3740

 

FAQ

What is the significance of Eton Pharmaceuticals acquiring carglumic acid tablets?

The acquisition allows Eton to offer a much lower-cost generic alternative to Carbaglu®, potentially saving patients and the healthcare system millions.

When was the FDA approval for carglumic acid tablets received?

The FDA approved the Abbreviated New Drug Application for carglumic acid tablets on October 13, 2021.

How does carglumic acid compare to Carbaglu® in terms of cost?

Carglumic acid is expected to be a significantly lower-cost alternative, with Carbaglu® costing over $1 million annually for many patients.

What are the strategic benefits of Eton's existing infrastructure for this launch?

Eton's established orphan drug commercial footprint and patient support services position the company well for the successful commercialization of carglumic acid.