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PharmaTher Announces Grant of U.S. Patent on Ketamine Formulation

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PharmaTher Holdings Ltd. announced the grant of U.S. Patent No. 11,213,495 for its KETABET™ formulation, combining FDA-approved ketamine with betaine anhydrous. This patent enhances the antidepressant effects while potentially reducing ketamine's side effects. The patent strengthens PharmaTher's intellectual property and global portfolio, with similar patents in Japan and Taiwan. The company plans to advance KETABET™ in Phase 2 clinical studies based on ongoing research. The patent protection for KETABET™ is expected to last until 2036.

Positive
  • Grant of U.S. Patent No. 11,213,495 for KETABET™, enhancing intellectual property.
  • Potential for KETABET™ to reduce ketamine's negative side effects.
  • Global patent protection, with existing patents in Japan and Taiwan.
  • Plans to advance KETABET™ into Phase 2 clinical studies.
Negative
  • None.

TORONTO, Feb. 16, 2022 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that the United States Patent and Trademark Office granted to the Company U.S. Patent No. 11,213,495, titled "Method and Composition for Decreasing the Psychotomimetic Side Effect and Addictive Disorder of Ketamine.” The patent refers to the combination formulation of FDA-approved ketamine and betaine anhydrous (“KETABET™”), which has been shown in research to enhance the antidepressant effect while potentially reducing the known negative side effects of ketamine significantly.

“We are extremely pleased about the grant of this patent in the U.S. as it further validates the potential of KETABET™, strengthens our intellectual property position, and highlights our commitment to innovation of ketamine for mental health, neurological and pain disorders,” said Fabio Chianelli, CEO of PharmaTher. 

The granted patent strengthens the Company’s global patent portfolio. It provides for broad potential of KETABET™ for uses in various mental health, neurological and pain disorders, and novel delivery forms, including the Company’s patented hydrogel-forming microneedle patch delivery system. 

In addition, granted patents of KETABET™ are issued in Japan (Patent no. 6967532) and Taiwan (Patent no. I648049). The Company expects to convert the current patent applications in Europe, Canada, Israel and China into granted patents. Patent protection is expected to expire in 2036.

The granted patents and published studies further validate the potential of KETABET™ and support the Company’s ongoing investigator-led observational studies evaluating the impact of betaine on the unwanted ketamine side effects seen post ketamine treatment for subjects with either depression or pain. Based on the outcome from the ongoing studies, the Company will advance the KETABET™ program with its microneedle patch technology in Phase 2 clinical studies.

The Company previously announced the publication of a scientific article demonstrating the potential of KETABET™ to prevent the potential adverse psychiatric effects of repeated ketamine treatment for depression and other indications, including suicidal ideation, substance abuse, post-traumatic stress disorder, and chronic pain. The article titled, "Betaine prevents and reverses the behavioral deficits and synaptic dysfunction induced by repeated ketamine exposure in mice,” is published in Biomedicine & Pharmacotherapy and can be found here.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of specialty ketamine pharmaceuticals for mental health, neurological, and pain disorders. 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 "could", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "aim", “may” 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 period of November 30, 2021 ("MD&A"), dated January 27, 2022, which is available on the Company's profile at www.sedar.com.

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 the significance of the U.S. Patent No. 11,213,495 for PHRRF?

The patent grants PharmaTher intellectual property rights for KETABET™, which combines ketamine and betaine, potentially enhancing its antidepressant effects while minimizing side effects.

How will the new patent impact PharmaTher's clinical studies?

With the patent granted, PharmaTher plans to advance KETABET™ into Phase 2 clinical studies based on ongoing research into its effects.

When does the patent protection for KETABET™ expire?

The patent protection for KETABET™ is expected to expire in 2036.

What other countries have granted patents for KETABET™?

Patents for KETABET™ have also been issued in Japan and Taiwan.

How does KETABET™ aim to improve ketamine treatment?

KETABET™ aims to enhance the antidepressant effects of ketamine while reducing its psychotomimetic side effects and addictive potential.

PHARMATHER HLDGS LTD

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