Phathom Pharmaceuticals Announces Submission of Six-Month Stability Data in Support of Erosive GERD New Drug Application
21 Agosto 2023 - 9:00AM
Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical
company focused on developing and commercializing novel treatments
for gastrointestinal diseases, today announced it has submitted to
the FDA six-month stability data from its long-term and accelerated
stability program for its reformulated vonoprazan tablets. The
additional stability was required for the FDA to complete its NDA
review for vonoprazan, a novel first-in-class potassium-competitive
acid blocker (PCAB), for the treatment of Erosive GERD
(gastroesophageal reflux disease), also referred to as erosive
esophagitis.
With the submission of these data, Phathom has satisfied the
FDA’s request for additional data in response to the Complete
Response Letter (CRL) issued in February 2023 relating to
specifications and controls for a nitrosamine drug substance
related impurity, N-nitroso-vonoprazan (NVP). Phathom resubmitted
the NDA for vonoprazan for Erosive GERD in May 2023 on the basis of
three months of stability data and was assigned a PDUFA goal date
of November 17, 2023.
“We are happy to share that the six-month stability data
continue to demonstrate effective control of NVP, which is another
big step forward as we prepare for a planned launch in the fourth
quarter of this year,” said Terrie Curran, President and Chief
Executive Officer of Phathom. “The latest stability data confirm
that our minor product reformulation has limited the presence of
NVP, and we believe these data comfortably support the proposed
shelf life for vonoprazan tablets. We look forward to working with
the FDA as it completes its review.”
The long-term and accelerated six-month data from Phathom’s
stability program have demonstrated that the minor drug product
tablet reformulation is controlling NVP growth through six months
and keeping levels greater than tenfold below the acceptable daily
intake limit of 96 ng/day or 2.4 ppm based on the maximum approved
daily dose of 40 mg/day.
The NDA seeks regulatory approval for vonoprazan as a treatment
for the healing and maintenance of healing of Erosive GERD, and
relief of associated heartburn symptoms, and was previously
classified as a Class 2 resubmission with a six-month review
period. If approved, a combined U.S. commercial launch for Erosive
GERD and H. pylori is planned for the fourth quarter of 2023.
About Phathom PharmaceuticalsPhathom
Pharmaceuticals is a biopharmaceutical company focused on the
development and commercialization of novel treatments for
gastrointestinal diseases. Phathom has in-licensed the exclusive
rights in the United States, Europe, and Canada to vonoprazan, a
first-in-class potassium-competitive acid blocker (PCAB). For more
information about Phathom, visit the Company’s website
at www.phathompharma.com and follow the
Company on LinkedIn and Twitter.
Forward Looking StatementsThis press release
contains forward-looking statements. Investors are cautioned not to
place undue reliance on these forward-looking statements, including
statements about the potential of vonoprazan as a treatment for
Erosive GERD and H. pylori; Phathom’s expectations that the
stability data will support the requested shelf life of 24 months;
the timing of potential approval of the Erosive GERD NDA; and the
timing of a U.S. commercial launch for Erosive GERD and H. pylori
indications. 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 determine that the NDA resubmission
does not adequately address the deficiencies raised in the CRL;
future data generated from our stability program may be different
from the data generated to date and may not demonstrate that our
mitigation efforts will meet the acceptable intake (AI) of the
nitrosamine impurity, or reduce the impurity to an acceptable level
throughout the six-month period required by FDA or the shelf life
of the product, to obtain approval for its Erosive GERD NDA or to
bring vonoprazan to market for patients with Erosive GERD, if
approved, or for patients with H. pylori, if the pending prior
approval supplements to the convenience pack NDAs are approved;
risks associated with product manufacturing or formulation changes
required to be made in connection with achieving the AI; the FDA
may disagree that the existing safety and efficacy data, together
with additional data, is sufficient to approve the Erosive GERD NDA
or supplements to the H. pylori 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
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; 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.
MEDIA CONTACTNick
Benedetto1-877-742-8466media@phathompharma.com
INVESTOR CONTACTEric
Sciorilli1-877-742-8466ir@phathompharma.com
© 2023 Phathom Pharmaceuticals. All rights reserved.
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