Eton Pharmaceuticals Enters Into License Agreement for Two Branded Hospital Product Candidates
Transaction adds an additional potential 2019 product launch to Eton’s pipeline
ET-202 NDA was submitted in
ET-203 NDA expected to be submitted by Q3 2019
The licensed product candidates provide Eton with two high-volume, near-term product launch opportunities. The NDA for ET-202 was submitted to the
Both products are innovative ready-to-use formulas of existing injectable products that Eton believes to be two of the highest volume compounded products in the hospital setting. The existing
- Longer shelf-life
- Elimination of compounding errors due to incorrect drug or concentration
- Significantly higher level of sterility assurance
- More consistent supply
FDA reviewed for safety and efficacy- Time and cost savings compared to in-house compounding
- Elimination of regulatory risk associated with in-house compounding
Eton estimates the combined addressable market for the products to be in excess of 10 million units annually. The company believes that, if approved, the compelling potential benefits of these ready-to-use products would enable it to take a significant share of the market.
“We are very excited to partner with Sintetica and add an additional 2019 product launch opportunity to our pipeline,” said
“Sintetica, a recognized leader in innovative formulations, is very pleased to have entered into a partnership with
Under terms of the agreement, Sintetica will supply product to Eton at its direct costs and profit from Eton’s commercial sales will be shared equally by both parties. Eton will pay Sintetica
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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 potential benefits of Eton’s 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, potential delays in regulatory filings and approvals, the risk that the
Company Contact:
dkrempa@etonpharma.com
847-805-1077
Investor Contact:
Stern Investor Relations, Inc.
Julie.Seidel@sternir.com
212-362-1200
Source: Eton Pharmaceuticals