Eton Pharma Announces Licensing of Lamotrigine New Drug Application and Provides Pipeline Update

On Jun 13, 2019

Eton Pharmaceuticals, Inc. announced that the Company has entered into an agreement with Aucta Pharmaceuticals, Inc to acquire U.S. marketing rights for ET-105.

ET-105 is an innovative patent-pending formulation of lamotrigine that will be delivered to patients as an oral liquid. Aucta submitted the product’s New Drug Application (NDA) to the FDA in May 2019 and is seeking approval as an epilepsy treatment to be used as an adjunct therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients two years of age and older. Lamotrigine is currently only approved in tablet formulations, and Eton believes ET-105 will fulfill a significant unmet need for pediatric patients requiring precision dosing.

Lamotrigine is one of the most widely used anti-epilepsy drugs with sales exceeding $700 million annually. Initiation of epilepsy treatment with lamotrigine requires multi-week titration based on patient weight, and pediatric patients often require doses that are a fraction of the currently available tablet strengths. ET-105’s precision dosing delivery system allows for accurate measurements down to 1.0mg whereas the lowest strength tablet available on the market is 5.0mg.

The addition of ET-105 brings Eton’s emerging neurology franchise to a total of four high-value product candidates, two of which are now expected to launch in 2020. Eton plans to establish its neurology-focused sales force in early 2020 to support the anticipated launches of ET-105 in the first half of 2020, ET-104 in the second half of 2020, and ET-101 and ET-102 in 2021.

“We are excited to add ET-105 to our growing pipeline of near-term product launches and further strengthen our neurology franchise. There remains a significant unmet medical need for precision dosing for pediatric patients, and we believe that ET-105 has the potential to fill the need,” said Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals. “We look forward to working with Aucta to bring this important product to market as we gear up for its potential launch in the first half of next year.”

“Aucta is excited to be partnering with Eton. We look forward to working closely with Eton’s dedicated commercial team to bring this innovative treatment forward and to address the unmet medical need in epilepsy,” said Shoufeng Li, Chief Executive Officer of Aucta Pharmaceuticals.

Closing of the transaction is contingent upon Aucta’s NDA receiving an acceptance for review letter from the FDA. Under the terms of the agreement, Eton will pay to Aucta licensing milestones of up to $5 million, including $2 million upon closing of the transaction, $2 million upon FDA approval and product launch, and $1 million upon issuance of an Orange-book listed patent. Aucta will receive a low double-digit royalty on net sales and will be entitled to receive milestone payments of up to $18 million based on commercial success of the product, including:

$1 million when net sales exceed $10 million in a calendar year
$2 million when net sales exceed $20 million in a calendar year
$5 million when net sales exceed $50 million in a calendar year
$10 million when net sales exceed $100 million in a calendar year