Psyence Biomed Provides Progress Update on PsyLabs E.U. Good Manufacturing Practices (GMP) Certified Active Pharmaceutical Ingredient (API) Development
Psyence Biomedical (Nasdaq: PBM) has provided an update on its strategic acquisition of an equity stake in PsyLabs and the progress of PsyLabs' collaboration with a contract drug manufacturing organization (CDMO). This collaboration aims to advance the development of nature-derived psychedelic active pharmaceutical ingredients (APIs) towards E.U. Good Manufacturing Practices (GMP) certification.
Key points:
- PsyLabs has entered phase two of its development process, focusing on upscaling the purification process for commercial viability.
- The CDMO is working to validate that PsyLabs' high-purity psilocybin extraction methods can be replicated on a commercial scale.
- This progress is important for meeting global health regulator demands and advancing through Phase III clinical trials.
- Psyence Biomed's pending acquisition of PsyLabs aligns with its strategy to secure access to pharmaceutical-grade, naturally derived APIs for future clinical trials and FDA-approved drug development.
- PsyLabs has entered phase two of its development process, focusing on commercial viability of psilocybin production
- Collaboration with CDMO aims to achieve E.U. GMP certification for psychedelic APIs
- Psyence Biomed's pending acquisition of PsyLabs aligns with its strategy for securing high-quality APIs
- Progress towards producing GMP certified, nature-derived psychedelic APIs
- Exclusive worldwide licensing agreement with PsyLabs for pharmaceutical-grade psilocybin
- Acquisition of equity stake in PsyLabs is still pending and not finalized
- Commercial viability of the upscaled purification process is yet to be confirmed
- E.U. GMP certification for APIs has not been achieved yet
Insights
This update signals significant progress in PsyLabs' journey towards producing E.U. GMP certified psilocybin APIs, a important step for Psyence Biomed's drug development pipeline. The successful upscaling of the purification process at the CDMO is a critical milestone that validates the commercial viability of PsyLabs' extraction methodology.
The pending acquisition of an equity stake in PsyLabs positions Psyence Biomed as a vertically integrated developer of psilocybin-based therapeutics. This strategic move could potentially:
- Secure a consistent supply of high-purity, pharmaceutical-grade psilocybin
- Accelerate the development of treatments for Alcohol Use Disorder and other Substance Use Disorders
- Provide a competitive advantage in the rapidly evolving psychedelic therapeutics market
However, investors should note that while this progress is promising, the path to FDA approval and commercialization remains long and uncertain. The success of future clinical trials and regulatory hurdles will be important factors to monitor.
The psychedelic therapeutics market is gaining significant traction, with Psyence Biomed positioning itself as a key player. This update highlights several important market dynamics:
- Increasing demand for high-purity, naturally derived psychedelic compounds in pharmaceutical research
- Growing emphasis on GMP certification by regulatory agencies worldwide
- Potential for substantial market growth in mental health and addiction treatment sectors
Psyence Biomed's strategic moves, including the pending acquisition of PsyLabs and the exclusive licensing agreement, demonstrate a forward-thinking approach to capturing market share. The company's focus on Alcohol Use Disorder, a condition with significant unmet medical needs, could open up a lucrative market opportunity if clinical trials prove successful.
Investors should consider the potential long-term value creation from this vertically integrated model, while also being aware of the competitive landscape and regulatory challenges in this emerging field.
PsyLabs to exclusively supply Psyence Biomed with high purity, pharmaceutical grade psilocybin for its second development indication, Alcohol Use Disorder, as previously announced
NEW YORK, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) ("Psyence Biomed" or the "Company") is pleased to provide an update on its previously-announced pending strategic acquisition of an equity stake in PsyLabs, and progress with PsyLabs’ collaboration with its contract drug manufacturing organization (CDMO). This collaboration is key to advancing the development of PsyLabs' nature-derived psychedelic active pharmaceutical ingredients (APIs) towards E.U. Good Manufacturing Practices (GMP) certification.
In September 2024, Psyence Biomed entered into a worldwide, exclusive royalty-bearing IP licensing agreement with PsyLabs for pharmaceutical-grade, EU GMP certified, nature-derived psilocybin to be evaluated in future clinical trials as a potential treatment for Alcohol Use Disorder (AUD) and other Substance Use Disorders (SUDs), and for commercial supply, if approved.
Following the successful export of its psilocybin extract to its CDMO in the UK, PsyLabs has now entered phase two of its development process. The CDMO has commenced work on upscaling the purification process to validate its commercial viability, ensuring that the extraction methodology developed by PsyLabs can be efficiently scaled for larger production volumes. This critical phase will confirm that the methods used to achieve PsyLabs' high-purity psilocybin can be replicated on a commercial scale, setting the foundation for E.U. GMP certification.
Strategic Progress Toward Commercial Viability
This milestone represents significant progress in PsyLabs' journey to produce E.U. GMP certified APIs. The ability to scale the extraction process while maintaining high purity levels is essential for meeting the rigorous demands of global health regulators and advancing through Phase III clinical trials. PsyLabs’ collaboration with its CDMO is designed to ensure that PsyLabs’ APIs are commercially viable and meet the highest quality standards, providing a faster route to market for psychedelic-based therapies.
Enhancing Psyence Biomed's Investment Value
Psyence Biomed’s pending acquisition of an equity stake in PsyLabs continues to align with its strategy of securing access to pharmaceutical-grade, naturally derived APIs that can serve as the foundation for future clinical trials and FDA-approved drug development. This update marks another important step in solidifying a consistent supply of high-purity psilocybin.
Looking Ahead
As this next phase progresses, Psyence Biomed remains confident that PsyLabs is on track to produce GMP certified, nature-derived psychedelic APIs. These developments underscore Psyence Biomed’s commitment to innovation and leadership in the psychedelic sector. PsyLabs’ proprietary methods, combined with strategic collaborations like the one with its CDMO, will continue to provide Psyence Biomed with a competitive edge in bringing next-generation mental health treatments to market.
“Our strategic acquisition of an equity stake in PsyLabs, when completed later this year, will transition Psyence Biomed into a fully vertically integrated developer of psilocybin-based therapeutics that address significant unmet needs in mental health and addiction,” said Dr. Neil Maresky, Chief Executive Officer of Psyence Biomed. “PsyLabs’ continued progress toward the production of E.U. GMP certified APIs is a critical step going forward, and we are very pleased with their progress to date. We look forward to a long and mutually beneficial partnership with PsyLabs as we advance a psilocybin-based therapeutic as a potential treatment for AUD.”
Tony Budden, Chief Executive Officer of PsyLabs, said “We believe our proprietary extraction process will create the highest purity psilocybin available on the market, at a time when regulatory agencies around the world are placing greater emphasis on purity in psychedelic-based drug development programs.
About Psyence Biomed
Psyence Biomedical Ltd. (Nasdaq: PBM) is one of the world’s few biopharmas with a focus on psychedelic-based pharmaceutical therapeutics. As the first life science biotechnology company developing nature-derived (non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq, Psyence is initially working to address the unmet needs of patients who suffer from mental health disorders in the context of Palliative Care. The name “Psyence” combines the words “psychedelics” and “science” to affirm Psyence Biomed’s commitment to an evidence-based approach to innovation as it works to develop safe and effective, FDA-approved, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Learn more at www.psyencebiomed.com and on LinkedIn.
Contact Information
Email: ir@psyencebiomed.com
Media Inquiries: media@psyencebiomed.com
General Information: info@psyencebiomed.com
Phone: +1 416-477-1708
Investor Contact:
Jeremy Feffer
Managing Director
LifeSci Advisors
jfeffer@lifesciadvisors.com
Forward Looking Statements
This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to future operations, products and services; and other statements identified by words such as "will likely result," "are expected to," "will continue," "is anticipated," "estimated," "believe," "intend," "plan," "projection," "outlook" or words of similar meaning.
Forward-looking statements in this communication include statements regarding the fulfilment of the conditions to the closing of the strategic acquisition of an equity stake in PsyLabs (the "Acquisition"), access to the capital and liquidity required for Psyence Biomed to execute on the AUD strategy and PsyLabs' ability to successfully deliver its intended drug product. These forward-looking statements are based on a number of assumptions, including the assumptions that the parties will obtain all such regulatory, corporate, shareholder and other approvals as may be required to implement the Acquisition, the continuation of PsyLabs' product development strategy as referred to in this news release on schedule, and the safety and effectiveness of psilocybin as a treatment option for AUD.
There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others: (i) the inability to complete the Acquisition; (ii) the inability to recognize the anticipated benefits of the Acquisition (iii) the ability of PsyLabs to execute its obligations in respect of its product development objectives; (iv) changes in applicable laws which may impact drug development, clinical trials and/or the conducting thereof; (v) Psyence Biomed’s ability to obtain regulatory approval for the proposed product candidate, and any related restrictions or limitations of any approved products; (vi) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; and (vii) volatility in the price of the securities of Psyence Biomed due to a variety of factors, including changes in the competitive and highly regulated industries in which Psyence Biomed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence Biomed’s business and changes in Psyence Biomed’s capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of the final prospectus (File No. 333 276973) filed with the Securities and Exchange Commission on August 30, 2024 and other documents filed by the Company from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such information. Nothing in this communication 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. Except as required by law, the Company does not intend to update these forward-looking statements.
The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.
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