With the addition of these product candidates, Eton now has three product candidates submitted with the FDA and expects to submit two additional NDAs by the third quarter of 2019.

The licensed product candidates provide Eton with two high-volume, near-term product launch opportunities. The NDA for ET-202 was submitted to the FDA in December 2018 and Eton expects to receive a fourth quarter 2019 Prescription Drug User Fee Act (PDUFA) date. The NDA for ET-203 is expected to be submitted by the third quarter of 2019.

Both products are innovative ready-to-use formulas of existing injectable products that Eton believes to be two of the highest volume compounded products in the hospital setting. The existing FDA-approved products are only available in concentrated versions that must be diluted prior to administration to patients. 

 

Eton believes that if approved, ET-202 and ET-203 will offer significant benefits to hospitals over the current compounded products, including:

Longer shelf-life
Elimination of compounding errors due to incorrect drug or concentration
Significantly higher level of sterility assurance
More consistent supply
FDA reviewed for safety and efficacy
Time and cost savings compared to in-house compounding
Elimination of regulatory risk associated with in-house compounding

Eton estimates the combined addressable market for the products to be in excess of 10 million units annually. The company believes that, if approved, the compelling potential benefits of these ready-to-use products would enable it to take a significant share of the market.

“We are very excited to partner with Sintetica and add an additional 2019 product launch opportunity to our pipeline,” said Sean Brynjelsen, chief executive officer of Eton Pharmaceuticals. “These potentially high volume hospital product candidates are an ideal strategic fit with Eton’s ongoing mission to bring safe, approved pharmaceutical products to markets that are currently reliant on compounded and unapproved products. We plan to immediately begin launch preparation activities in order to facilitate successful commercialization of these important products if approved.”

“Sintetica, a recognized leader in innovative formulations, is very pleased to have entered into a partnership with Eton Pharmaceuticals.  The combination of high quality manufacturing and dynamic product development at Sintetica, and Eton’s energy and experience in the American market make this great for all stakeholders,” said Pasquale Mitidieri, director of the Global Division of Sintetica S.A.