Eton Pharmaceuticals Announces Acquisition of U.S Marketing Rights to Pediatric Orphan Drug Alkindi Sprinkle

-Estimated Market Opportunity of Greater than $100 Million

-Alkindi Sprinkle NDA has been Assigned a September 29, 2020 Prescription Drug User Fee Act Date

-Alkindi Sprinkle has been Granted Orphan Drug Designation for Adrenal Insufficiency in Pediatric Patients

-Eton Executed $7.8 Million Equity Financing and $2.0 Million Amended Credit Facility to Support Alkindi Sprinkle Transaction

DEER PARK, Ill., March 27, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced that it has acquired U.S. marketing rights to Alkindi Sprinkle from Diurnal Group plc (AIM: DNL).

Alkindi Sprinkle’s New Drug Application (NDA) is currently under review with the U.S Food and Drug Administration (FDA) for approval as a replacement therapy for pediatric adrenal insufficiency (AI), including congenital adrenal hyperplasia (CAH) in patients from birth to less than 17 years of age. The application has been assigned a Prescription Drug User Fee Act (PDUFA) date of September 29, 2020.

“Alkindi Sprinkle represents a transformational acquisition for Eton and a major step forward on our journey to become a leader in pediatric rare disease products. This product represents the largest market opportunity within our pipeline and adds a major near-term product launch,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “We are excited to be partnering with Diurnal to bring Alkindi Sprinkle to pediatric patients, and we plan to immediately begin launch activities to ensure its commercial success.”

“We have been impressed by Eton’s enthusiasm and vision for the product throughout the Alkindi Sprinkle partnering process,” said Martin Whitaker, CEO of Diurnal Group plc. “If approved, Alkindi Sprinkle will provide a major breakthrough in the US as the only licensed treatment specifically designed for use in children with adrenal insufficiency, where there is a significant unmet patient need.”

Strategic Rationale

• Advances Eton’s leadership in pediatric rare diseases products. Alkindi Sprinkle is a strong strategic fit with Eton’s existing pediatric portfolio. Eton is committed to developing and bringing to market innovative products that are designed to address unmet needs for pediatric patients by improving product safety, efficacy, or treatment adherence through precision dosing and improved routes of administration.
• $100 million market opportunity. Eton estimates approximately 5,000 pediatric patients suffer from adrenal insufficiency in the United States, and current FDA-approved treatment options do not offer physicians the ability to properly dose and titrate for many of these pediatric patients.
• High-value product with strong intellectual property protection. Alkindi Sprinkle has been granted Orphan Drug Designation from the FDA and has been issued three U.S patents extending to 2034.
• Major near-term product launch. Alkindi Sprinkle’s NDA has been assigned a PDUFA date of September 29, 2020.

Alkindi Sprinkle Overview