Aucta Pharmaceuticals Announces Licensing of Lamotrigine New Drug Application

Piscataway, New Jersey, UNITED STATES

PISCATAWAY, N.J., June 27, 2019 (GLOBE NEWSWIRE) -- Aucta Pharmaceuticals, Inc. (Aucta), a technology based company focusing on the development and commercialization of Branded Specialty Products, today announced that the Company has entered into an agreement with Eton Pharmaceuticals, Inc. to License U.S. marketing rights for AUC025.

AUC025 is an innovative patent-pending formulation of lamotrigine that will be delivered to patients as an oral liquid form. Aucta submitted the product’s New Drug Application (NDA) to the FDA in early 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 forms, and Aucta believes AUC025 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 with more than 15 million prescriptions in U.S. 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.  The dosing flexibility and patient friendly nature of the oral liquid form makes AUC025 a great addition to treat epilepsy. 

“We are 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.

“Eton is excited to add AUC025 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 AUC025 has the potential to fill the need,” said Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals. “Eton looks 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.”

About Aucta Pharmaceuticals

Aucta Pharmaceuticals, Inc. is a research and technology based pharmaceutical company focusing on the development and commercialization of niche generic and branded specialty products.  The company’s corporate strategy is to focus on proven molecules, and, through innovation, create new therapeutics with lower scientific risk that fulfill unmet medical needs. Aucta’s specialty division has a therapeutic focus in CNS, Dermatology, and Pediatrics.

About Eton Pharmaceuticals

Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative products utilizing the FDA’s 505(b)(2) regulatory pathway. Eton is primarily focused on liquid dosage forms including injectables, oral liquids and ophthalmics. Eton has a diversified pipeline of high-value product candidates in various stages of development and therapeutic areas, including multiple product candidates currently pending regulatory approval with the FDA.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Aucta to undertake certain activities and accomplish certain goals and objectives.  These statements include but are not limited to statements regarding Aucta’s business strategy, Aucta’s plans to develop and commercialize its product candidates, the safety and efficacy of Aucta’s product candidates, Aucta’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Aucta’s product candidates.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Aucta’s current expectations and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.  These and other risks concerning Aucta’s business, development programs, and financial condition are described in additional detail in Aucta’s filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made.  Aucta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Patricia Yang