AEON Biopharma Announces Positive Outcome from FDA Biosimilar Advisory Meeting
Rhea-AI Summary
AEON Biopharma (NYSE: AEON) announced a positive outcome from its FDA Biosimilar Advisory Meeting for ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX® (onabotulinumtoxinA). The company is aligned with the FDA on the 351(k) regulatory pathway for approval. Key points include:
1. Comparative analytical studies are expected to start in Q4 2024.
2. A Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA is planned for 2025 to review results and confirm the proposed study package.
3. AEON aims to bring prabotulinumtoxinA to the U.S. market for all of BOTOX's approved and future therapeutic indications under a single approval.
4. The company anticipates conducting a Phase 3 program, subject to funding, to compare ABP-450 with BOTOX®.
Positive
- Alignment with FDA on 351(k) regulatory pathway for ABP-450 biosimilar approval
- Clear development path established with comparative analytical studies starting Q4 2024
- Potential for single approval covering all BOTOX's current and future therapeutic indications
- Opportunity to enter the U.S. market with a biosimilar to a well-established product (BOTOX)
Negative
- Need for additional funding to conduct required Phase 3 program
- Uncertainty regarding the necessity of comparative clinical studies pending FDA review of analytical assessment
- Extended timeline for potential market entry, with key meetings and studies planned through 2025
News Market Reaction
On the day this news was published, AEON gained 13.18%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
– Company is aligned with the FDA on next steps for a 351(k) regulatory pathway to approval for ABP-450 (prabotulinumtoxinA) as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product –
– Comparative analytical studies anticipated to commence in Q4 2024 –
– Expect to conduct a Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA in 2025 to review the results from the analytical studies and confirm remainder of proposed study package –
IRVINE, Calif., Sept. 30, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway, today announced receipt of the formal minutes from a recent Biosimilar Initial Advisory (BIA) Meeting with the U.S. Food and Drug Administration (FDA) for ABP-450 (prabotulinumtoxinA) injection as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product. The purpose of the meeting was to seek alignment with the FDA on proposed 351(k) regulatory pathway and determine the next steps in the development pathway.
The Company believes it is aligned with the FDA on key requirements, including additional analytical studies to be completed to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA). The Company is actively planning comparative analytical studies, which are expected to commence in Q4 2024. A Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA is planned for 2025 to discuss the outcome from these studies and determine the next steps in development, including a potential comparative clinical program.
“We are encouraged by the outcome from the recent FDA meeting and the opportunity to advance our development of prabotulinumtoxinA utilizing the 351(k) biosimilar regulatory pathway,” commented Marc Forth, AEON’s President and Chief Executive Officer. “We now have a clear path forward and plan to initiate analytical studies in Q4 2024. This biosimilar approach could potentially allow us to bring prabotulinumtoxinA to the U.S. market for all of BOTOX’s currently approved and future therapeutic indications under a single approval.”
As previously announced, the Company expects it will need to conduct, subject to securing funding, a Phase 3 program to compare ABP-450 (prabotulinumtoxinA) with BOTOX® (onabotulinumtoxinA) as the reference product. Under the 351(k) regulatory framework, comparative clinical studies are only required when it is necessary to address any residual uncertainty regarding biosimilarity following a comparative analytical assessment (CAA). The necessity of any specific comparative clinical studies will be determined after the FDA has reviewed the results from the CAA, which AEON currently anticipates in 2025.
About AEON Biopharma
AEON is a clinical stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions, with an initial focus on the neurosciences market. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada and European Medicines Agency. The product is approved as a biosimilar in Mexico and India. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. The Company has built a highly experienced management team with specific experience in biopharmaceutical and botulinum toxin development and commercialization. To learn more about AEON, visit www.aeonbiopharma.com.
Forward-Looking Statements
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance. For example, statements regarding meetings with the FDA, the timing of analytical studies and a potential Phase 3 comparative program, the securing of additional funding, the translation of clinical trial results into support for a BLA filing, and potential determination that ABP-450 is highly similar to the reference product for currently approved and future therapeutic indications are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements.
These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the outcome of any legal proceedings that may be instituted against AEON or others; (ii) AEON’s future capital requirements; (iii) AEON’s ability to raise financing in the future; (iv) AEON’s ability to continue to meet continued stock exchange listing standards; (v) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; and (vi) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov.
Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements.
Source: AEON Biopharma
FAQ
What is the outcome of AEON Biopharma's FDA Biosimilar Advisory Meeting for ABP-450?
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