PharmaTher Announces Update on FDA New Drug Application for Ketamine

Rhea-AI Summary

PharmaTher Holdings announced receiving satisfactory preliminary FDA responses regarding their Ketamine product's Abbreviated New Drug Application. The company canceled the post-complete response letter meeting scheduled for December 2, 2024, as no further discussion was needed. Following the FDA's Complete Response Letter from October 22, 2024, which cited MINOR deficiencies, PharmaTher plans to submit a MINOR AMENDMENT by January 2025. The FDA's requests focus on drug substance, product, manufacturing, and microbiology updates, with no concerns about stability or need for new clinical studies.

Positive

• FDA classified deficiencies as MINOR, indicating less significant concerns
• No new preclinical or clinical studies required by FDA
• Ketamine submission batches achieved 18 months stability without issues
• FDA responses were satisfactory requiring no further discussion

Negative

• FDA approval delayed due to Complete Response Letter requiring additional information
• Need for new and updated information related to drug substance, manufacturing, and microbiology

FDA provided preliminary responses to questions contained in the clarification only post-CRL meeting scheduled for December 2, 2024

PharmaTher has decided to cancel the meeting as the FDA preliminary responses were satisfactory and do not require further discussion

PharmaTher initiated activities to address the MINOR deficiencies cited in the CRL

TORONTO, Nov. 26, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the FDA provided preliminary responses (the “Responses”) to questions contained in the post-complete response letter clarification meeting (the “Meeting”) scheduled for December 2, 2024. PharmaTher has decided to cancel the Meeting as the Responses were satisfactory and do not require further discussion. The Company expects to resubmit information to address the deficiencies classified as MINOR in the complete response letter (“CRL”) by January 2025.

Fabio Chianelli, Chairman and CEO of PharmaTher, commented: “We are very pleased with the responses by the FDA to the clarification questions in our post-CRL meeting request. The FDA has addressed our questions, paving the way for our Ketamine product’s new drug approval. As such, we decided to cancel the meeting, and our team has already begun compiling the responses. We have also initiated additional tests to address the MINOR deficiencies in the CRL, and we expect to submit the MINOR AMENDMENT by January 2025.”

As previously announced, the Company requested the Meeting in response to the FDA issuing a CRL, dated October 22, 2024, for the Company’s Ketamine product’s Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024.

As noted by the FDA in the CRL, the resubmission to this CRL will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR. The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of the ketamine submission batches, which achieved 18 months of stability without issue, and no new preclinical and clinical studies were requested.

The Company will continue to provide updates as they occur.

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of KETARX™ (Ketamine) to fill the global unmet medical needs for anesthesia, sedation, 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”, 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 months ended August 31, 2024 dated October 24, 2024, 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

When will PharmaTher (PHRRF) submit the MINOR AMENDMENT for their Ketamine product?

PharmaTher plans to submit the MINOR AMENDMENT by January 2025.

What deficiencies did the FDA identify in PharmaTher's (PHRRF) Ketamine application?

The FDA requested new and updated information related to drug substance, drug product, manufacturing, and microbiology, classifying these as MINOR deficiencies.

What was the original GDUFA goal date for PharmaTher's (PHRRF) Ketamine application?

The original Generic Drug User Fee Amendments (GDUFA) goal date was October 29, 2024.

Did the FDA require new clinical studies for PharmaTher's (PHRRF) Ketamine product?

No, the FDA did not request any new preclinical or clinical studies.