subslover
3 years ago
Eton Pharmaceuticals Announces FDA Approval of ZONISADEβ’ (Zonisamide Oral Suspension)
July 18, 2022 07:05 ET | Source: Eton Pharmaceuticals
...
DEER PARK, Ill., July 18, 2022 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved ZONISADEβ’ (zonisamide oral suspension).
βWe are proud to have another product approval from our teamβs development efforts. This is now the eighth product approval that our team has contributed to, and we are excited for Azurity to bring the product to patients. The proceeds from the launch milestone will be used to further grow our rare disease portfolio,β said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
ZONISADEβ’ was included in Etonβs multi-product neurology oral solution partnership with Azurity Pharmaceuticals announced in February of 2021. Under the agreement, Eton is entitled to receive an additional $5 million payment upon the launch of ZONISADEβ’, royalty on net sales, and up to $15 million of commercial milestones tied to the combined sales of all three products in the partnership. Azurity Pharmaceuticals will be responsible for the commercialization of ZONISADEβ’, and no marketing expenses will be incurred by Eton.
About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The product currently commercializes ALKINDI SPRINKLE® and Carglumic Acid tablets and has two additional rare disease products under development, dehydrated alcohol injection and the ZENEO® hydrocortisone autoinjector. In addition, the companyβs royalty segment is entitled to receive milestone payments or royalties on six different products.
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 Etonβs business strategy, Etonβs plans to develop and commercialize its product candidates, the safety and efficacy of Etonβs product candidates, Etonβs plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Etonβs 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 Etonβs 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 Etonβs development programs and financial position are described in additional detail in Etonβs filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on
stockguard
4 years ago
Attention Biotech Investors: Mark Your Calendar For September PDUFA Dates
Eton's In-licensed Pediatric Adrenal Insufficiency Drug Awaits FDA Clearance
Company: Eton Pharma
Type of Application: NDA
Candidate: Alkindi Sprinkle
Indication: pediatric adrenal insufficiency
Date: Sept. 29
Eton acquired U.S. marketing rights to Alkindi Sprinkle from AIM-listed Diurnal Group plc in late March. Alkindi Sprinkle, a taste neutral sprinkle or granule formulation of hydrocortisone, is being evaluated as a replacement therapy for pediatric adrenal insufficiency, including congenital adrenal hyperplasia in patients from birth to less than 17 years of age.
The product, which is approved in Europe, is to be available strengths 0.5mg, 1mg, 2mg, and 5mg to provide pediatric atients with optimal precision and flexibility.
Eton estimates the market opportunity of Alkindi Sprinkle to be $100 million annually.
BioSpecialist
6 years ago
great buying opportunity indeed , lots of big news around the corner . And EM-100 still likely to be approved in Q1-Q2 2020 its a light crl .
ET-202. Eton has initiated launch preparations for ET-202, Etonβs ready-to-use injectable formulation of phenylephrine. If approved on its PDUFA date of October 21, 2019, Eton anticipates launching the product in the fourth quarter of 2019. Eton believes the addressable phenylephrine market for ET-202 is more than 10 million units annually.
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.
ET-203. The NDA for ET-203, a ready-to-use formulation of a high-volume injectable product, is expected to be submitted by Etonβs 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.