Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 69

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 69
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 where there is no reasonable expectation that
the cost of developing the drug will be recovered from sales in the United States.

Generally,
if a compound with an orphan drug designation receives the first marketing approval for the indication for which it has such designation,
the product is entitled to a period of marketing exclusivity, which precludes the FDA from approving another marketing application
for a product that constitutes the same drug treating the same indication for that marketing exclusivity period, except in limited
circumstances. If another sponsor receives such approval before we do (regardless of our orphan drug designation), we will be
precluded from receiving marketing approval for our product for the applicable exclusivity period. The applicable period is seven
years in the United States.

40 

Even
though we may obtain orphan drug exclusivity for CC8464, that exclusivity may not effectively protect the compound from competition
because different drugs can be approved for the same condition. In the United States, even after an orphan drug is approved, the
FDA may subsequently approve another drug for the same condition if the FDA concludes that the latter drug is not the same drug
or is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care. In the
European Union, marketing authorization may be granted to a similar medicinal product for the same orphan indication if:

    ●
    the second applicant
    can establish in its application that its medicinal product, although like the orphan medicinal product already authorized,
    is safer, more effective or otherwise clinically superior;

    ●
    the holder of the
    marketing authorization for the original orphan medicinal product consents to a second orphan medicinal product application;
    or

    ●
    the holder of the
    marketing authorization for the original orphan medicinal product cannot supply enough quantities of orphan medicinal product.

If
we are not able to secure an orphan drug designation, or if the exclusivity associated with such designation does not effectively
protect us from competition, our business, financial condition, results of operations and prospects will be adversely affected.

FDA
designations to expedite drug development and review, including “orphan drug” designation, Breakthrough Therapy designation,
and/or Fast Track designation, even if granted for any of our compounds, may not lead to a faster development, regulatory review
or approval process and do not increase the likelihood that any of our compounds will receive marketing approval in the United
States.

As
with any future application for “orphan drug” designation for CC8464