Item 8.01 Other Events.
On January 3, 2023, Phathom Pharmaceuticals, Inc. ("Phathom" or the "Company")
announced that the U.S. Food and Drug Administration (the "FDA") has advised the
Company that the FDA will not be taking any action on or prior to the
January 11, 2023, Prescription Drug User Fee Act ("PDUFA") target action date
for the New Drug Application (the "NDA") for the use of vonoprazan as a
treatment for adults for the healing of all grades of erosive esophagitis
("EE"), maintenance of healing of all grades of EE, and relief of heartburn
associated with EE.
In addition, while an acceptable daily intake limit for the nitrosamine
impurity, N-nitroso-vonoprazan ("NVP"), previously identified by the Company in
commercial batches of vonoprazan has now been established by the FDA at 96
ng/day, the FDA has requested additional stability data demonstrating that
levels of NVP remain below that limit throughout the proposed shelf life of the
product. The Company is actively in the process of both generating additional
stability data and discussing with the FDA the nature and extent of such
requested data. As a result, Phathom no longer expects product launches for H.
pylori or erosive esophagitis in the first quarter of 2023.
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
Phathom's expectations to generate additional data to support the launch and
proposed shelf life of vonoprazan and the potential approval of our EE NDA and
anticipated product launches in H. pylori and erosive esophagitis and the timing
thereof. 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 report due to the risks and
uncertainties inherent in Phathom's business, including, without limitation:
Phathom may be unable to generate the required data to meet the acceptable
intake limit of NVP, or may be unable to reduce the NVP intake levels to an
acceptable level throughout the shelf life of the product, to obtain approval of
its EE NDA or to bring the product to market for its EE NDA, if approved, or its
approved H. Pylori NDAs; risks associated with product manufacturing or
formulation changes required to be made in connection with the required intake
limit; the FDA may disagree that the existing safety and efficacy data, together
with additional data, is sufficient to approve the EE NDA; the potential for the
FDA to delay taking action related to the EE NDA following the FDA's decision
not to do so on or prior to the PDUFA target action date; 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 access
additional capital under its term loan facility and royalty interest finance
agreements is subject to certain conditions; 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 ongoing spread of the COVID-19
coronavirus, including delaying or otherwise disrupting its clinical trials,
manufacturing and supply chain, and other risks described in the Company's prior
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.
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