Eton Pharmaceuticals Announces Licensing of Lamotrigine New Drug Application and Provides Pipeline Update
- Unique patent-pending formulation of lamotrigine addresses significant unmet need in pediatric epilepsy patients
- NDA was submitted in
May 2019; product launch anticipated in 1H 2020
- Lamotrigine market currently exceeds
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
Lamotrigine is one of the most widely used anti-epilepsy drugs with sales exceeding
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
“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
“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
Closing of the transaction is contingent upon Aucta’s NDA receiving an acceptance for review letter from the
$1 millionwhen net sales exceed $10 millionin a calendar year $2 millionwhen net sales exceed $20 millionin a calendar year $5 millionwhen net sales exceed $50 millionin a calendar year $10 millionwhen net sales exceed $100 millionin a calendar year
Eton also provided an update on its pipeline product candidates:
EM-100. EM-100, Eton’s preservative-free ophthalmic solution for allergic conjunctivitis has been assigned a target action date of
ET-202. Eton has initiated launch preparations for ET-202, Eton’s ready-to-use injectable formulation of phenylephrine. If approved on its PDUFA date of
DS-300. Due to a third-party approval of another NDA product containing DS-300’s active ingredient, the
ET-203. The NDA for ET-203, a ready-to-use formulation of a high-volume injectable product, is expected to be submitted by Eton’s partner by the end of the third quarter of 2019.
ET-104. The bioequivalence study for ET-104, a patent-pending oral suspension pursuing a neurological indication, is ongoing. Eton expects study results in September and, if successful, plans to submit the NDA in the fourth quarter of 2019.
ET-103. The bioequivalence study for ET-103, a liquid formulation of levothyroxine, is ongoing. Eton expects study results in September and, if successful, plans to submit the NDA in the fourth quarter of 2019.
DS-100. Eton has an
ET-101. Development activities are ongoing for ET-101, an innovative oral liquid neurology product. Eton currently expects to submit the product’s NDA in 2020
ET-102. Development activities are ongoing for ET-102, an innovative oral liquid neurology product. Eton currently expects to submit the product’s NDA in 2020
ET-201. Development activities are ongoing for ET-201, an injectable product currently approved in
About Eton Pharmaceuticals
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 Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’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 Eton’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 Eton’s business, development programs, and financial condition are described in additional detail in Eton’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. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Source: Eton Pharmaceuticals