Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical
company focused on developing and commercializing novel treatments
for gastrointestinal (GI) diseases, announced that the U.S. Food
and Drug Administration (FDA) has approved the Prior Approval
Supplement (PAS) for the reformulation of vonoprazan tablets for
both VOQUEZNA TRIPLE PAK (vonoprazan tablets, amoxicillin capsules,
clarithromycin tablets) and VOQUEZNA DUAL PAK (vonoprazan tablets,
amoxicillin capsules), for the treatment of Helicobacter pylori (H.
pylori) infection in adults. VOQUEZNA treatment regimens contain
antibiotics conveniently packaged with vonoprazan, a novel
potassium-competitive acid blocker (PCAB) and the first innovative
acid suppressant from a new drug class approved in the U.S. in over
30 years.
“We are very pleased with the FDA approval of our reformulated
vonoprazan tablets for both VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL
PAK, enabling Phathom to market two new first-line treatment
options that offer strong H. pylori eradication rates,” said Terrie
Curran, President and Chief Executive Officer at Phathom. “H.
pylori eradication failures are due to rising antibiotic
resistance, inadequate acid suppression, and complex treatment
regimens. We are excited about VOQUEZNA TRIPLE and DUAL PAKs, a new
class of acid suppression therapy, that has the potential to
address these issues and enhance H. pylori eradication. Our teams
are making the final preparations for a combined December 2023 U.S.
commercial launch for H. pylori along with the anticipated launch
of vonoprazan for Erosive GERD, if approved. Thank you to Phathom
employees and our manufacturing partners, Catalent and Evonik, who
contributed to today’s PAS approval.”
These initial product approvals were based on safety and
efficacy data from the Phase 3 PHALCON-HP trial, the largest U.S.
registrational trial ever conducted in H. pylori, randomizing
1,046 patients.1 In the modified intent-to-treat population,
both VOQUEZNA treatment regimens demonstrated non-inferiority to
lansoprazole triple therapy in patients without a clarithromycin or
amoxicillin resistant strain of H. pylori at baseline.
The H. pylori eradication rate was 84.7% with VOQUEZNA
TRIPLE PAK compared to 78.8% with lansoprazole triple therapy [95%
CI: -0.8, 12.6] and 78.5% for VOQUEZNA DUAL PAK compared to 78.8%
with lansoprazole triple therapy [95% CI: -7.4, 6.8]. VOQUEZNA
TRIPLE PAK and DUAL PAK demonstrated superior eradication rates
compared to PPI-based triple therapy (lansoprazole with amoxicillin
and clarithromycin) among all patients, including in patients with
clarithromycin resistant strains of H.
pylori.1 The H. pylori eradication rate with
VOQUEZNA TRIPLE PAK was 80.8% versus 68.5% with lansoprazole triple
therapy in the overall study population [95% CI: 5.7, 18.8] and in
patients who had a clarithromycin-resistant strain of H.
pylori, 65.8% vs. 31.9%, respectively [95% CI: 17.7, 48.1].1
H. pylori eradication rates for VOQUEZNA DUAL PAK were 77.2%
versus 68.5% with lansoprazole triple therapy in the overall study
population [95% CI: 1.9, 15.4] and in patients who had a
clarithromycin-resistant strain of H. pylori, 69.6% vs.
31.9%, respectively [95% CI: 20.5, 52.6].1
Adverse event (AE) rates for the vonoprazan-based regimens were
comparable to lansoprazole triple therapy in the trial.1 The
most common AEs (>2.0%) reported in the VOQUEZNA TRIPLE PAK,
VOQUEZNA DUAL PAK, and lansoprazole triple therapy arms,
respectively, were diarrhea (4.0%, 5.2%, 9.6%), dysgeusia (4.6%,
0.6%, 6.1%), vulvovaginal candidiasis (3.2%, 2.0%, 1.4%), abdominal
pain (2.3%, 2.6%, 2.9%), headache (2.6%, 1.4%, 1.4%), hypertension
(2.0%, 1.1%, 0.9%) and nasopharyngitis (0.3%, 2.0%, 0.9%).1
VOQUEZNA TRIPLE and DUAL PAKs are expected to be available in
the U.S. in December 2023 and marketed exclusively by Phathom
Pharmaceuticals, Inc. Phathom is planning for a combined U.S.
commercial launch of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK,
together with vonoprazan for Erosive GERD, if approved.
Phathom plans to host an investor conference call in November
2023, following FDA action on the pending Erosive GERD New Drug
Application, which has a PDUFA target action date of November 17,
to discuss the Company’s U.S. commercial launch plans.
The full Prescribing Information for VOQUEZNA TRIPLE PAK and
VOQUEZNA DUAL PAK can be found here.
INDICATION AND IMPORTANT SAFETY INFORMATION
What are
VOQUEZNA TRIPLE
PAK and VOQUEZNA
DUAL PAK?
- VOQUEZNA® TRIPLE
PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin
tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin
capsules) are co-packaged prescription medicines for the treatment
of a Helicobacter pylori (H. pylori) bacterial infection in
adults.
- It is not known if VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK
are safe and effective in children.
- To reduce the development of drug-resistant bacteria and
maintain the effectiveness of VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL
PAK and other antibacterial drugs, these products should be used
only to treat or prevent infections that are proven or strongly
suspected to be caused by susceptible bacteria.
Do not take
VOQUEZNA TRIPLE
PAK if you
- are known to have an allergy or be
sensitive to the components of VOQUEZNA TRIPLE PAK (vonoprazan,
amoxicillin, clarithromycin), macrolide antibiotics (such as
azithromycin and erythromycin), or penicillin.
- are taking:
- medicines that contain rilpivirine (Edurant, Complera,
Odefsey)
- pimozide
- colchicine, if you have kidney or
liver problems
- lomitapide, lovastatin, and simvastatin
- ergot alkaloids (ergotamine or dihydroergotamine)
- lurasidone
- have a history of yellowing of the
skin (jaundice) or liver problems when taking clarithromycin.
Do not take
VOQUEZNA DUAL
PAK if you
- are known to have an allergy or be
sensitive to the components of VOQUEZNA DUAL PAK (vonoprazan,
amoxicillin) or penicillin.
- are taking medicines that contain
rilpivirine (Edurant, Complera, Odefsey).
Before you
take VOQUEZNA
TRIPLE PAK or
VOQUEZNA DUAL
PAK, tell your
healthcare provider about all of your
medical conditions, including if you
- are breastfeeding. If breastfeeding, pump and discard breast
milk during treatment and for 2 days after treatment.
- have severe kidney disease.
- have moderate to severe liver
disease.
- have myasthenia gravis.
Additionally, do
not take
VOQUEZNA TRIPLE
PAK if:
- you are pregnant or plan to become pregnant. Clarithromycin, a
medicine in VOQUEZNA TRIPLE PAK may harm your unborn baby.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements. There can be serious side effects when some
are used in combination with this product. Serious adverse
reactions can occur with VOQUEZNA TRIPLE PAK due to drug
interactions of clarithromycin with colchicine, some lipid lowering
agents, some calcium channel blockers, and other drugs.
What are the possible side effects of VOQUEZNA TRIPLE PAK and
VOQUEZNA DUAL PAK? VOQUEZNA
TRIPLE PAK or
VOQUEZNA DUAL
PAK can cause
serious side
effects including:
- Allergic reactions
(hypersensitivity): Call your doctor right away if
you have rash, hives, or other skin changes, face swelling or
difficulty breathing.
- A
type of kidney
problem (acute tubulointerstitial
nephritis): Some people who take VOQUEZNA may
develop a kidney problem called acute tubulointerstitial nephritis.
Call your healthcare provider right away if you have a decrease in
the amount that you urinate or if you notice blood in your
urine.
- Severe
skin reactions: VOQUEZNA TRIPLE
PAK and VOQUEZNA DUAL PAK can cause severe skin reactions, such as
skin rash or allergic reaction on or in any part of your body.
Symptoms can also include, but are not limited to, fever, chills,
body aches or shortness of breath. If you experience any of these
symptoms, stop taking VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK
immediately and call your doctor right away.
- Severe diarrhea: Call your
doctor right away if you have watery stool, stomach pain, and fever
that does not go away while taking VOQUEZNA DUAL PAK or VOQUEZNA
TRIPLE PAK or after therapy is completed.
- Rash in patients with
mononucleosis: Amoxicillin (a component of VOQUEZNA TRIPLE
PAK and VOQUEZNA DUAL PAK) may cause a rash in patients who have
mononucleosis. Stop taking VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK
if you are diagnosed with mononucleosis and call your doctor right
away.
- Altered test
results for some tumors: VOQUEZNA TRIPLE
PAK and VOQUEZNA DUAL PAK lower stomach acid which can cause
increased levels of a certain protein (CgA) in your blood. When
this level is increased it may alter test results for detecting
some tumors. Notify your doctor of the use of VOQUEZNA TRIPLE PAK
or VOQUEZNA DUAL PAK prior to blood tests.
Additionally, VOQUEZNA
TRIPLE PAK can
cause:
- Irregular
heartbeats: Clarithromycin may cause irregular
heartbeats. Call your doctor right away if you feel faint,
light-headed, or feel your heart beating irregularly.
- Liver
problems: Call your doctor right away if you have
any of the following symptoms: weight loss, yellowing of the skin
and eyes (jaundice), dark urine, rash, or pain on the right side of
your abdomen.
The most
common side
effects may
include:
- diarrhea
- temporary changes in sense of taste
- vaginal yeast infection
- stomach pain
- headache
- high blood pressure and
- cold-like symptoms
These are not all of the possible side effects of VOQUEZNA
TRIPLE PAK and VOQUEZNA DUAL PAK. Call your healthcare provider for
medical advice about side effects.
General information
about the safe
and effective
use of
VOQUEZNA.Medicines are sometimes prescribed for
purposes other than those listed in a Patient Information leaflet.
Do not use VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK for a condition
for which it was not prescribed. Do not give VOQUEZNA TRIPLE PAK or
VOQUEZNA DUAL PAK to other people, even if they have the same
symptoms you have. It may harm them.
For more information, ask your healthcare provider or
pharmacist.
You are
encouraged to
report suspected
adverse reactions
by contacting
Phathom Pharmaceuticals
at 1-888- 775-PHAT (7428) or FDA at
1-800-FDA-1088 or
www.fda.gov/medwatch.
Please see
full Prescribing
Information for
VOQUEZNA TRIPLE
PAK AND VOQUEZNA
DUAL PAK.
About Helicobacter
pylori (H.
pylori) infectionH. pylori is a
bacterial pathogen that is estimated to infect nearly 115 million
individuals in the United States.1 If left untreated, H.
pylori infection can lead to serious complications, such as peptic
ulcer disease and non-cardia gastric cancer.2 Approximately 50% of
the world and 36% of the U.S. population is estimated to be
infected with the bacterium. As a result of the chronic
inflammation induced by H. pylori infection, infected
patients may develop a range of pathologies including dyspepsia,
peptic ulcer disease, non-cardia gastric cancer, and
mucosa-associated lymphoid tissue (MALT) lymphoma. Studies
have found that roughly 1 in 4 patients treated for H.
pylori will fail first-line therapy when using PPI-based
clarithromycin triple therapy.3
About VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL
PAK®VOQUEZNA® TRIPLE PAK® (vonoprazan, amoxicillin,
clarithromycin) and VOQUEZNA® DUAL PAK® (vonoprazan, amoxicillin)
contain vonoprazan, an oral small
molecule potassium-competitive acid blocker (PCAB) co-packaged
with antibiotics. PCABs are a novel class of medicines that block
acid secretion in the stomach. Vonoprazan has shown the potential
to provide acid suppression that can achieve pH levels that are
important in enhancing antibiotic effectiveness. Phathom
in-licensed the U.S., European, and Canadian rights to vonoprazan
from Takeda, which markets the product in Japan and numerous other
countries in Asia and Latin America.
About Phathom Pharmaceuticals, Inc.Phathom
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 timing of the commercial launch of convenience
packs containing vonoprazan for H. pylori infection, the potential
of vonoprazan-based therapies to address declining H. pylori
eradication rates in the U.S., and statements regarding the PDUFA
goal date and the timing of a U.S. commercial launch for vonoprazan
for Erosive GERD. 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: future data generated from our stability program
may be different from the data submitted to the FDA to date and may
not demonstrate that our mitigation efforts will continue to
maintain the level of the nitrosamine impurity below the acceptable
intake (AI) level throughout the shelf life of products containing
vonoprazan, which could result in market action or shelf life
reduction; 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; 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.
VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, Phathom
Pharmaceuticals, and their respective logos are registered
trademarks or trademarks of Phathom Pharmaceuticals, Inc.
10/23
US-VPZ-23-0153
1 Chey et al. ACG Clinical Guideline: Treatment of Helicobacter
pylori Infection. Am J Gastroenterol. 2017;112:212.2 Malfertheiner
et al. Management of Helicobacter Pylori Infection—the Maastricht
V/Florence Consensus Report. Gut. 2017;66-6.3 Mertz et al.
Helicobacter pylori Treatment & Eradication Rates in Department
of Defense Patients from 2016-2018. Am J Gastroenterol.
2020;115:S664.
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