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Eton Pharmaceuticals Announces Submission to FDA of New Drug Application for ET-400 (Hydrocortisone Oral Solution)

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Eton Pharmaceuticals submitted a New Drug Application (NDA) for ET-400, a hydrocortisone oral solution with patent protection through 2043. The company expects potential approval by Q1 2025, aiming for combined peak sales of over $50 million annually.

Eton Pharmaceuticals ha presentato una Nuova Domanda di Autorizzazione (NDA) per ET-400, una soluzione orale di idrocortisone con brevetto protetto fino al 2043. La società prevede una possibile approvazione entro il primo trimestre del 2025, con obiettivi di vendite massime combinate di oltre 50 milioni di dollari all'anno.
Eton Pharmaceuticals ha presentado una Nueva Solicitud de Medicamento (NDA) para ET-400, una solución oral de hidrocortisona con protección de patente hasta 2043. La compañía espera una posible aprobación para el primer trimestre de 2025, con ventas máximas combinadas previstas de más de 50 millones de dólares anuales.
Eton Pharmaceuticals는 2043년까지 특허 보호를 받는 하이드로코르티손 경구 용액 ET-400에 대한 신약 허가 신청(NDA)을 제출했습니다. 이 회사는 2025년 1분기까지 승인을 기대하며, 연간 최대 5000만 달러 이상의 매출을 목표로 하고 있습니다.
Eton Pharmaceuticals a soumis une Nouvelle Demande d'Autorisation (NDA) pour ET-400, une solution orale d'hydrocortisone protégée par un brevet jusqu'en 2043. La société s'attend à une approbation potentielle d'ici le premier trimestre 2025, visant des ventes annuelles cumulées de plus de 50 millions de dollars.
Eton Pharmaceuticals hat eine Neue Medikamentenzulassung (NDA) für ET-400 eingereicht, eine orale Hydrocortison-Lösung mit Patentschutz bis 2043. Das Unternehmen rechnet mit einer möglichen Genehmigung bis zum 1. Quartal 2025 und zielt auf kombinierte Spitzenumsätze von über 50 Millionen Dollar jährlich.
Positive
  • ET-400 NDA submission made to FDA for potential approval by Q1 2025.

  • ET-400 and Alkindi Sprinkle® project combined peak sales exceeding $50 million annually.

  • ET-400 patent protection in place until 2043.

Negative
  • None.

Insights

The submission of a New Drug Application (NDA) by Eton Pharmaceuticals for ET-400, a hydrocortisone oral solution, represents a critical milestone in the company's strategic plan. If approved by the FDA, ET-400, alongside Alkindi Sprinkle®, has the potential to generate significant revenue streams for Eton Pharmaceuticals. The anticipation of a 10-month review process suggests that investors can expect pivotal news regarding market entry by the first quarter of 2025.

From a financial perspective, the estimation of more than $50 million in potential combined peak sales annually is ambitious yet plausible, given the market's demand for pediatric medications and treatments for rare diseases. Patent protection until 2043 further strengthens the competitive moat Eton is building around its products, which could deter competitors and support long-term revenue generation.

The patent aspect of Eton Pharmaceuticals' strategy is vital for its potential market exclusivity and ability to set pricing without immediate generic competition. Patent protection for over two decades is exceptional and could result in sustained profitability for Eton if ET-400 is approved. Investors should be cognizant of the importance of intellectual property in the pharmaceutical industry, especially for smaller companies like Eton that focus on niche markets.

While patent issuance is positive, investors should also monitor ongoing patent applications, as they could further reinforce the company's intellectual property portfolio and provide additional layers of protection and value.

From a clinical standpoint, the unique formulation of a hydrocortisone oral solution, tailored for children with rare diseases, addresses an unmet medical need. Success in the pharmaceutical market is not just about invention but also about market demand and the medication's impact on patient care. The confidence expressed by Eton in strong demand from patients, caregivers and physicians for ET-400, indicates a well-vetted market need.

Investors should consider the therapeutic benefits and patient populations when evaluating Eton's potential market success post-approval. Future clinical data and real-world efficacy will be the true test of ET-400's market viability and, consequently, its impact on the company's financial health.

- Company anticipates 10-month review for potential approval in Q1 2025 -
- Eton expects ET-400 and Alkindi Sprinkle® to achieve potential combined peak sales of more than $50 million annually -
- Product has patent protection through 2043 -

DEER PARK, Ill., April 30, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of ET-400, Eton’s proprietary patented formulation of hydrocortisone oral solution. The Company expects the application to be assigned a 10-month FDA review, allowing for potential approval and launch in the first quarter of 2025.

“With the completion of the NDA submission for ET-400, we are one step closer to bringing this critical medication to children in need. We continue to see very strong demand from patients, caregivers, and physicians, and are confident that ET-400, once approved, and Alkindi Sprinkle can achieve potential combined peak sales of more than $50 million annually,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

Eton has been issued a patent by the U.S. Patent and Trademark Office on ET-400, which expires in 2043 and has additional patent applications under review.

About Eton Pharmaceuticals

Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has five commercial rare disease products: ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.

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 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 development programs and financial position 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.

Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Source: Eton Pharmaceuticals.


FAQ

What did Eton Pharmaceuticals announce?

Eton Pharmaceuticals announced the submission of a New Drug Application (NDA) for ET-400 to the FDA.

What is ET-400?

ET-400 is Eton's proprietary patented formulation of hydrocortisone oral solution.

When does the company expect potential approval for ET-400?

Eton Pharmaceuticals anticipates potential approval for ET-400 in the first quarter of 2025.

What is the projected peak sales for ET-400 and Alkindi Sprinkle®?

The company projects combined peak sales of over $50 million annually for ET-400 and Alkindi Sprinkle®.

How long is the patent protection for ET-400?

ET-400 has patent protection through 2043.

Eton Pharmaceutcials, Inc.

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