Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 40

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 40
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 years, the marketing authorization
holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their
authorization, are held to bring a significant clinical benefit in comparison with existing therapies. Even if a compound is considered
to be a new active substance so that the innovator gains the prescribed period of data exclusivity, another company may market
another version of the product if such company obtained marketing authorization based on a MAA with a complete independent data
package of pharmaceutical tests, preclinical tests and clinical trials. 

The
criteria for designating an “orphan medicinal product” in the EEA are similar in principle to those in the United
States. Under Article 3 of Regulation (EC) 141/2000, in the EEA a medicinal product may be designated as orphan if it meets the
following criteria (1) it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating
condition; and (2) either (a) such condition affects no more than five in 10,000 persons in the EEA when the application is made,
or (b) it is unlikely that the product, without the benefits derived from orphan status, would generate sufficient return in the
EEA to justify the investment needed for its development; and (3) there exists no satisfactory method of diagnosis, prevention
or treatment of such condition, or if such a method exists, the product will be of significant benefit to those affected by the
condition. Orphan medicinal products are eligible for financial incentives such as reduction of fees or fee waivers and are, upon
grant of a marketing authorization, entitled to ten years of market exclusivity for the approved therapeutic indication. During
this ten-year orphan market exclusivity period, no marketing authorization application shall be accepted, and no marketing authorization
shall be granted for a similar medicinal product for the same indication, although similar, is safer, more effective or otherwise
clinically superior than the authorized product; (ii) the marketing authorization holder of the authorized product consents to
a second orphan medicinal product application; or (iii) the marketing authorization holder of the authorized product cannot supply
enough orphan medicinal product. An orphan product can also obtain an additional two years of market exclusivity in the EEA for
pediatric studies. The ten-year market exclusivity may be reduced to six years if, at the end of the fifth year, it is established
that the product no longer meets the criteria for orphan drug designation,