Company: PHAT
Filing Date: 2025-03-06
Form Type: 10-K
Source: 0000950170-25-034183
Chunk: 146

Company: Phathom Pharmaceuticals, Inc.
Filing Date: 2025-03-06
Form: 10-K
Item: Item 1A
Chunk 146
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5 and two H. pylori Phase 3 dual therapy (with amoxicillin) studies in 2026. Outside the U.S., Cinclus, via their local partner, received a 2024 approval in GERD for linaprazan glurate in China--facilitating a potential launch in 2025. No other registration activities are noted for linaprazan glurate. In Europe, Cinclus agreed to a pediatric investigation plan with the European Medicines Agency and received regulatory advice on Phase 2 and Phase 3 study designs. Lastly, there are two additional PCABs with registrations outside the U.S.—Jiangsu Carephar’s keverprazan which launched in China and Jeil’s zastaprazan which launched in South Korea. To the best of our knowledge, none of the above compounds have demonstrated superiority to PPIs in a Phase 3 clinical trial. 

Additionally, we are aware of two PPIs in territories outside of the U.S. that if developed and approved in our licensed territories may compete with vonoprazan. These include Dexa Medica’s DLBS-2411, launched in the Philippines and in Phase 3 in Indonesia and Sihuan Pharmaceutical’s anaprazole, launched in China.

In July 2012, the Food and Drug Administration Safety and Innovation Act was passed, which included the Generating Antibiotic Incentives Now Act, or GAIN Act. The GAIN Act is intended to provide incentives for the development of new, qualified infectious disease products. In December 2016, the 21st Century Cures Act was passed, providing additional support for the development of new infectious disease products. These incentives may result in more competition in the market for new antibiotics and may cause pharmaceutical and biotechnology companies with more resources than we have to shift their efforts towards the development of product candidates that could be competitive with vonoprazan or any future product candidates.

Many of our competitors have significantly greater financial, technical, manufacturing, marketing, sales and supply resources or experience than we do. We will face competition for our current products and any future product candidates based on many different factors, including the safety and effectiveness of our products, the ease with which our products can be administered and the extent to which patients accept relatively new routes of administration, the scope of regulatory approvals for these products, the availability and cost of manufacturing, marketing and sales capabilities, price, reimbursement coverage and patent position. Competing products could present superior treatment alternatives, including by