PharmaTher Unveils KetaVault™: A First-of-Its-Kind Portal to Accelerate Ketamine Research and Commercialization
- Strategic launch timing with upcoming FDA approval goal date of June 4, 2025
- Access to extensive proprietary data can accelerate partners' regulatory approvals and clinical trials
- Multiple FDA Orphan Drug Designations already secured for various conditions
- Potential for additional revenue streams through partnerships and data access
- Offers end-to-end solution including cGMP-compliant ketamine manufacturing
- Success depends on securing partnerships and platform adoption
- FDA approval for ketamine product still pending
- Revenue impact from KetaVault™ platform remains uncertain
KetaVault™ to Provide Partners Unprecedented Access to PharmaTher's Extensive Regulatory, Manufacturing, and Clinical Ketamine Data, Aiming to Expedite New Therapies and Market Entry
TORONTO, May 14, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on the research and commercialization of ketamine for unmet medical needs, today announced the launch of KetaVault™. This innovative, world-first portal offers pharmaceutical and biotech companies, academic and clinical researchers, and government agencies to partner with PharmaTher for direct access to its comprehensive proprietary data on ketamine. KetaVault™ is strategically designed to streamline and accelerate clinical trials, regulatory submissions, and commercialization initiatives for ketamine-based therapies.
The launch of KetaVault™ is strategically timed with the Company’s anticipated FDA approval for its ketamine product, which has an approval goal date of June 4, 2025. This dual milestone underscores PharmaTher's commitment to leading innovation in the ketamine space. KetaVault™ is positioned to be a pivotal catalyst, empowering partners to leverage PharmaTher's deep expertise and data to unlock new therapeutic avenues for ketamine in areas of high unmet medical need and for emergency use applications, potentially revolutionizing treatment paradigms.
Fabio Chianelli, Chairman and CEO of PharmaTher, commented:
"PharmaTher is committed to revolutionizing patient care through ketamine. With KetaVault™, PharmaTher isn't just sharing data; we're igniting a new era of collaborative ketamine innovation. This platform is a bold step toward unlocking the full potential of ketamine, empowering our partners with unprecedented access to our years of dedicated work, rich proprietary insights, and collectively accelerating the journey towards novel treatments for patients in critical need. As we near our FDA approval goal date for ketamine, KetaVault™ will serve as a critical tool to expand ketamine's therapeutic reach and solidify PharmaTher's leadership in the market for ketamine, creating significant value for our partners and shareholders.”
KetaVault™: A Gateway to Expedited Ketamine Development
Accessible at KetaVault.com, KetaVault™ provides partners with a significant competitive advantage by offering insights derived from years of dedicated research. This can directly support:
- Expedited Regulatory Pathways: Leverage existing data to potentially streamline investigational new drug applications and emergency use authorizations.
- De-risked Clinical Development: Inform trial design, safety and efficacy data, and identify promising indications based on robust existing research.
- Enhanced Commercial Strategy: Gain insights into manufacturing, control, and product development for market readiness.
Key Proprietary Information Available in KetaVault™ Includes:
- Regulatory Filings: Investigational New Drug (IND) Applications.
- Comprehensive Drug Information: Investigator’s Brochures.
- Manufacturing Insights: Chemistry, Manufacturing, and Control (CMC) data.
- Clinical Research & Data: In-depth clinical study protocols and research data for indications including Parkinson’s disease.
- Orphan Drug Designations: Access to information supporting FDA Orphan Drug Approvals for Amyotrophic Lateral Sclerosis, Rett Syndrome, Complex Regional Pain Syndrome, Status Epilepticus, and ischemia/reperfusion injury during solid organ transplantation.
- Novel Delivery Systems: Product development programs and regulatory filings for PharmaTher's ketamine microneedle patch and subcutaneous wearable pump.
Beyond Data: Comprehensive Partnership Support
In addition to data access, PharmaTher offers to support partners' clinical and commercialization initiatives with a reliable supply of ketamine, manufactured in the USA under the FDA’s stringent cGMP guidelines. This integrated offering positions PharmaTher as an end-to-end partner in the rapidly growing ketamine market.
KetaVault™ underscores PharmaTher’s leadership in the ketamine space, fostering high-value partnerships that could drive revenue growth and expand market opportunities. With FDA approval on the horizon and a robust portfolio of intellectual property, PharmaTher is well-positioned to capitalize on the increasing demand for innovative mental health, neurological, and pain management therapies.
PharmaTher is poised to significantly impact patient lives by expanding access to ketamine globally. KetaVault™ is a cornerstone of this strategy, fostering the innovation and collaboration necessary to realize the immense therapeutic potential of ketamine.
For partnering opportunities, visit KetaVault.com.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the research and commercialization of KETARX™ (Ketamine) to fill the unmet medical needs for surgery, pain, mental health, neurological, and medical countermeasures indications. Learn more at PharmaTher.com.
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “closer”, "could", “confident”, "would", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "aim", “may”, “plan”, “proposed”, “lead”, “toward”, “anticipate”, “provide”, and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in Company's management's discussion and analysis for the three and nine months ended February 28, 2025 dated April 24, 2025, which is available on the Company's profile at www.sedarplus.ca.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.
FAQ
What is PharmaTher's KetaVault™ platform and when was it launched?
When is PharmaTher (PHRRF) expecting FDA approval for its ketamine product?
What type of data does PharmaTher's KetaVault™ platform provide access to?
What conditions has PharmaTher received FDA Orphan Drug Designations for?
How does KetaVault™ benefit potential partners of PharmaTher (PHRRF)?
