SECURITIES AND EXCHANGE COMMISSION
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|Item 8.01|| |
On September 8, 2021, Phathom Pharmaceuticals, Inc. (the “Company”), announced that it has submitted new drug applications (“NDAs”) with the U.S. Food and Drug Administration (“FDA”) for vonoprazan in combination with amoxicillin and clarithromycin (“vonoprazan triple therapy”) and vonoprazan in combination with amoxicillin (“vonoprazan dual therapy”) for the treatment of H. pylori infection in adults. Due to unresolved quality issues at an aseptic (sterile) drug product manufacturing at Takeda’s manufacturing facility located in Hikari, Yamaguchi (the “Hikari Facility”), the Company did not include the Hikari Facility as a manufacturer in the NDAs.
The FDA has previously designated vonoprazan triple therapy and vonoprazan dual therapy as qualified infectious disease products (“QIDP”) and awarded them Fast Track designation, in each case, for the treatment of H. pylori infection. In connection with the NDA submissions, the Company requested Priority Review, which if granted will shorten the review period from 10 months to 6 months following FDA acceptance of the submissions for filing.
If the NDAs are accepted for filing and approved, the Company expects a commercial launch of vonoprazan triple therapy and vonoprazan dual therapy in the second half of 2022.
Forward Looking Statements
Phathom cautions you that statements contained in this report regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential acceptance and approval by the FDA of the NDAs; and the Company’s plans to commercially launch vonoprazan triple therapy and vonoprazan dual therapy in the second half of 2022, if the NDAs are approved. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom’s business, including, without limitation: the FDA may disagree that the existing safety and efficacy data is sufficient to accept or approve the NDAs; the inherent risks of clinical development of vonoprazan; Phathom’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Phathom’s ability to obtain and maintain intellectual property protection for vonoprazan; Phathom’s ability to comply with its license agreement with Takeda; Phathom’s ability to maintain undisrupted business operations due to the COVID-19 coronavirus, including delaying or otherwise disrupting its manufacturing and supply chain; and other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (“SEC”), including under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|PHATHOM PHARMACEUTICALS, INC.|
|Date: September 8, 2021||By:|
|General Counsel and Secretary|