Botulinum toxin(University of Texas Medical Branch)

– 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

CHONGQING, China, Sept. 25, 2024 /PRNewswire/ -- MingMed Biotechnology, an innovative company focused on the in-house discovery and development of novel drugs, recently announced that its partially owned subsidiary, Claruvis Pharmaceutical Co., has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for YY003, the world's first liquid formulation of recombinant BoNT/A, packaged in a pre-filled syringe, developed for the treatment of glabellar lines. "We are thrilled to receive FDA approval to advance the novel liquid formulation of rBoNT/A (YY003) into clinical development. This liquid-formulated recombinant BoNT/A, delivered via a prefilled device, represents a safer and more convenient option for users. The combination of a super-pure, highly effective product and its ease-of-use design offers BoNT/A users an optimized solution," said Dr. Wu Yang, Chief Scientific Officer of Claruvis, who has over 20 years of experience in botulinum toxin research and development. Claruvis Pharmaceutical, one of the few pioneering biotech companies in China, has developed the world's first recombinant BoNT/A product to reach clinical studies. The company recently completed its Phase III clinical trial for treatment of medium to severe glabellar lines and achieved all the study end points. The efficacy, safety and immunogenicity profiles demonstrated in the trial have set a remarkable milestone in the field of cosmetical use of BoNTs. On September 14th, the company has also successfully dosed the first patient in a phase II clinical trial for treatment of adult upper arm spasm in China, setting another new world record utilizing recombinant BoNT/A for the therapeutic indication. The company has started its first Biologics License Application (BLA) in China, backed by a comprehensive set of successful Phase I, II, and III clinical results. Dr. Yang added, "We believe the FDA's approval of YY003 for clinical evaluation is a significant milestone towards launching a high-quality product in the Botulinum toxin market." About MingMed MingMed Biotechnology Co., Ltd. is an innovative company dedicated to the in-house discovery and development of novel drugs that address global unmet medical needs. Our R&D team is led by global top-notch scientists and specialists. Leveraging our research and development capabilities and efficient operations, we have built an internally developed product portfolio with a diverse yet synergistic suite of four major therapeutic areas, namely recombinant botulinum toxin, ophthalmic drugs, immuno-oncology drugs and pet immune drugs. Our product pipelines include a number of first-in-class drug candidates, and the major products have moved forward to commercialization. About Claruvis Pharmaceutical Claruvis, a non-wholly owned subsidiary of MingMed Biotechnology, is strategically focus on the development, production and commercialization of botulinum toxin products utilizing recombinant protein technology. The R&D team is formed by top-notch global scientists and senior American Chinese scholars with in-depth knowledge and experience in botulinum toxin products. Marking a significant milestone, Claruvis has pioneered the development of the world's first recombinant type A BoNT product on a self-developed R&D platform. Excellent operational capability supported by a globally competitive R&D platform will continue to drive Claruvis' innovation and fast development in the rBoNT area to address the vast number of unmet aesthetic and therapeutic medical needs worldwide. Contact: [email protected] SOURCE MingMed Biotechnology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED