Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 64

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 64
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, CT2000, CT3000 or Channel’s future compounds will be harmed and its business, financial condition, results of operations and prospects will be adversely affected. While Channel plans to apply for orphan drug designation for CC8464 in the future, it may not effectively protect Channel from competition, and Channel may be unable to obtain similar designations for its future compounds. For instance, if Channel’s competitors are able to obtain orphan drug exclusivity for products that constitute the same drug and treat the same indications as Channel’s lead compounds before Channel, Channel may not be able to have competing products approved by the applicable regulatory authority for a significant period of time. To date, Channel has not submitted an application for orphan drug designation. In connection with the application for one of Channel’s two lead compounds, CC8464, for the treatment of EM and iSFN, Channel also plans to seek orphan drug designation from the FDA. As of the date of this information statement, Channel has not submitted an application for orphan drug designation for CC8464. Under the Orphan Drug Act of 1983, the FDA may designate a compound as an orphan drug if it is intended to treat a rare disease or condition, which is generally defined as having a patient population of fewer than 200,000 individuals in the United States, or a patient population greater than 200,000 in the United States 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 Channel does (regardless of its orphan drug designation), Channel will be precluded from receiving marketing approval for its product for the applicable exclusivity period. The applicable period is seven years in the United States. Even though Channel 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