Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 65

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 65
---
 meets the criteria for orphan drug designation, for example because the product is sufficiently
profitable not to justify market exclusivity. Market exclusivity can be revoked only in very selected cases, such as consent from the
marketing authorization holder, inability to supply sufficient quantities of the product, demonstration of “clinically relevant
superiority” by a similar medicinal product, or, after a review by the Committee for Orphan Medicinal Products, requested by a
member state in the fifth year of the marketing exclusivity period (if the designation criteria are believed to no longer apply). Medicinal
products designated as orphan drugs pursuant to Regulation 141/2000 shall be eligible for incentives made available by the European Community
and by the member states to support research into, and the development and availability of, orphan drugs.

33

Regulatory Framework in Australia

The Therapeutic Goods Administration, through
the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations is responsible for the efficacy, quality, safety and timely availability
of drugs and medical devices in Australia. The mission statement of the TGA is “To ensure the safety, quality and efficacy of therapeutic
goods available in Australia at a standard equal to that of comparable countries, and that premarket assessment of therapeutic goods
is conducted within a reasonable time.”

The drug regulation process in Australia is complex
and resource intensive. It must be accountable in terms of the quality, safety and efficacy of drugs made available in Australia. This
accountability includes an acceptance of a balance between safety and efficacy. The approval process is a detailed evaluation of the
data supplied by the company sponsoring an application.

A drug may first come to the attention of the
TGA when an application for marketing is received or when an Australian clinical trial is being planned. For clinical trials, the sponsoring
company may submit preliminary data for evaluation to the TGA or notify the TGA that the trial has been approved by an institutional
Ethics Committee.

The drug evaluation process for new chemical
entities is as follows:

Application

    ●
    Check to see data complies with Australian guidelines.

    ●
    Invoice sponsor for 75% of evaluation fee.

Evaluation

    ●
    Evaluate pharmaceutical and chemical data.

    ●
    Evaluate animal pharmacology and toxicology data.

    ●
    Evaluate clinical data.

    ●
    Evaluation Unit reviews reports (coordinates external evaluations if
    used), prepares a summary and makes an initial recommendation.

    ●
    Pre ADEC consultation with sponsor.