Company: PHAT
Filing Date: 2025-03-06
Form Type: 10-K
Source: 0000950170-25-034183
Chunk: 19

Company: Phathom Pharmaceuticals, Inc.
Filing Date: 2025-03-06
Form: 10-K
Item: Item 1
Chunk 19
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 with Non-Erosive GERD in adults. On July 17, 2024, the FDA approved VOQUEZNA 10 mg tablets for the relief of heartburn associated with Non-Erosive GERD, the largest category of GERD. Before we developed and obtained our initial approvals for VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK in the United States, vonoprazan was developed in markets outside of the United States by Takeda through an extensive clinical program, including 19 Phase 3 clinical trials. An estimate of over 60 million patients have received vonoprazan in Japan and other countries in Asia, Latin America and Russia since its launch. Vonoprazan received marketing approval in Japan in late 2014 and generated peak net sales of approximately $850 million and continues to achieve volume growth during its tenth full year on the market.  

Vonoprazan in GERD 

Based on the significant unmet medical need, previous Phase 3 trial results from Japan and elsewhere in Asia, and commercial potential, we prioritized the development and commercialization of vonoprazan in GERD, specifically for: 

•the healing of all grades of Erosive GERD and relief of associated heartburn in adults;  

•the maintenance of healing of all grades of Erosive GERD and relief of associated heartburn in adults; and

•the relief of heartburn associated with Non-Erosive GERD in adults. 

GERD Disease Overview 

GERD is one of the most prevalent diseases of any kind and is the most prevalent GI disease, affecting approximately 20% of the U.S. population and approximately 15% of the European population. We estimate there are approximately 65 million individuals with GERD in the United States and 50 million individuals with GERD in the EU5. GERD is a disease that develops when the reflux of acidic stomach contents into the esophagus causes troublesome symptoms and/or complications. The term covers a spectrum of diseases, the main categories of which are Erosive GERD, or EE, and Non-Erosive reflux disease, or Non-Erosive GERD. These diseases are detailed below: 

•Erosive GERD: Approximately 30% of GERD patients have Erosive GERD, which is classified by erosions in the esophageal mucosa caused by acidic reflux of stomach contents into the esophagus. Erosive GERD is