Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical
company focused on developing and commercializing novel treatments
for gastrointestinal (GI) diseases, today announced the U.S.
commercial availability of VOQUEZNA® (vonoprazan). VOQUEZNA is now
available for the treatment of adults with Erosive Esophagitis,
also known as Erosive GERD (gastroesophageal reflux disease), and
the relief of heartburn associated with Erosive GERD.1 As the first
and only approved potassium-competitive acid blocker (PCAB) in the
U.S., this milestone brings the power of a new class of acid
suppression treatment to a disease with high unmet need.
“We are thrilled to announce the commercial availability of our
first-in-class medication, VOQUEZNA, now available for the millions
of people in the U.S. suffering from Erosive GERD,” said Martin
Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals. “For
over three decades, there has been no major innovation in this
category. We are excited to introduce VOQUEZNA to patients and
healthcare providers, as it has been shown to provide rapid,
potent, and durable acid suppression and has the power to help heal
Erosive GERD for patients seeking a new and effective treatment
option.”
The U.S. Food and Drug Administration (FDA) recently approved
VOQUEZNA for the healing of all severities (grades) of Erosive
GERD, maintenance of healing of all severities of Erosive GERD, and
relief of heartburn associated with Erosive GERD in adults.1 Its
novel mechanism of action (MOA) provides rapid, potent, and durable
acid suppression in a way that is distinct from other prescription
and over-the-counter medications.2 Additionally, VOQUEZNA does not
have the burden of mealtime dosing, whereas most PPIs must always
be taken with food.1
In a Phase 3, randomized clinical study, VOQUEZNA 20 mg met the
primary endpoint of non-inferiority for complete healing by Week 8
in patients with all severities of Erosive GERD, demonstrating a
strong healing rate of 93% compared to 85% for lansoprazole 30 mg,
with superior rates of healing demonstrated in a secondary endpoint
in patients with moderate-to-severe disease at Week 2 compared to
lansoprazole (70% for VOQUEZNA 20 mg and 53% for lansoprazole 30
mg). In the maintenance phase of the study, VOQUEZNA 10 mg was
superior to lansoprazole 15 mg in maintaining healing at six months
in all randomized patients (79% for VOQUEZNA 10 mg, compared to 72%
for lansoprazole 15 mg).
The most common side effects of VOQUEZNA for the treatment of
Erosive GERD include stomach inflammation, diarrhea, stomach
bloating, stomach pain, nausea, indigestion, high blood pressure,
and urinary tract infection.
“Erosive GERD is a highly prevalent condition affecting over 20
million people in the U.S.,3,4 many of whom experience troubling
symptoms, including painful heartburn. When not properly treated,
Erosive GERD can lead to complications such as scarring, narrowing
of the esophagus, and bleeding,4” said Colin Howden, M.D.,
Professor Emeritus, University of Tennessee College of Medicine.
"With many patients unsatisfied with their current therapy,5 the
introduction of VOQUEZNA provides healthcare providers and patients
with an important new treatment option that offers a novel
mechanism of action and has demonstrated superiority in comparison
to a standard-of-care PPI across several clinically meaningful
endpoints.2"
Prescriptions for VOQUEZNA may be filled at major retail
pharmacies and through BlinkRx, an end-to-end digital fulfillment
channel. Phathom is offering programs for eligible patients who
face coverage or affordability issues, including co-pay assistance
for patients with commercial insurance. For more information,
please visit www.voquezna.com/savings.
In addition, VOQUEZNA® TRIPLE PAK® (vonoprazan tablets,
amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL
PAK® (vonoprazan tablets, amoxicillin capsules), two treatment
regimens for adults with H. pylori infection, are expected to be
commercially available in mid-December 2023. VOQUEZNA TRIPLE PAK
and VOQUEZNA DUAL PAK each contain 14-days of VOQUEZNA-based
treatment co-packaged with antibiotics in convenient blister
packs.
VOQUEZNA is marketed exclusively by Phathom Pharmaceuticals,
Inc. Please visit www.voquezna.com to learn more about
VOQUEZNA.
INDICATION AND IMPORTANT SAFETY INFORMATION
What is
VOQUEZNA?VOQUEZNA® (vonoprazan) is a prescription
medicine used in adults:
- for 8 weeks to heal acid-related
damage to the lining of the esophagus (called Erosive Esophagitis
or Erosive Acid Reflux) and for relief of heartburn related to
Erosive Acid Reflux.
- for up to 6 months to maintain
healing of Erosive Acid Reflux and for relief of heartburn related
to Erosive Acid Reflux.
It is not known if VOQUEZNA is safe and effective in
children.
Do not take VOQUEZNA if you:
- are allergic to vonoprazan or any
of the other ingredients in VOQUEZNA. Allergic reaction symptoms
may include trouble breathing, rash, itching and swelling of your
face, lips, tongue, or throat.
- are taking a medicine that contains rilpivirine (EDURANT,
COMPLERA, JULUCA, ODEFSEY, CABENUVA) used to treat HIV-1 (Human
Immunodeficiency Virus).
Before taking VOQUEZNA, tell your healthcare provider about all
your medical conditions, including if you:
- have low magnesium, calcium, or potassium in your blood, or you
are taking a medicine to increase urine (diuretic).
- have kidney or liver problems.
- are pregnant, think you may be pregnant, or plan to become
pregnant. It is not known if VOQUEZNA will harm your unborn
baby.
- are breastfeeding or plan to breastfeed. It is not known if
VOQUEZNA passes into your breast milk. You and your healthcare
provider should decide if you will take VOQUEZNA or breastfeed. You
should not do both.
Tell your healthcare provider about all the medicines
you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Keep a list of them to
show your healthcare provider and pharmacist when you get a new
medicine.
VOQUEZNA may affect how other medicines work, and other
medicines may affect how VOQUEZNA works. Especially tell your
healthcare provider if you take medicine that contains rilpivirine
(EDURANT, COMPLERA, JULUCA, ODEFSEY, CABENUVA).
What are the possible side effects of
VOQUEZNA?
VOQUEZNA may
cause serious
side effects
including:
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.
Diarrhea caused
by an infection
(Clostridioides
difficile) in
your intestines: Call your
healthcare provider right away if you have watery stools, stomach
pain, and fever that does not go away.
Bone fractures
(hip, wrist, or
spine): Bone fractures in the hip, wrist, or spine
may happen in people who take multiple daily doses of another type
of medicine that reduces acid in your stomach known as proton pump
inhibitors (PPI medicines) for a long period of time (a year or
longer). Tell your healthcare provider if you have a bone fracture,
especially in the hip, wrist, or spine.
Severe skin
reactions: VOQUEZNA can cause rare, but severe
skin reactions that may affect any part of your body. These serious
skin reactions may need to be treated in a hospital and may be life
threatening:
- Skin rash which may have blistering, peeling, or bleeding on
any part of your skin.
- You may also have fever, chills, body aches, shortness of
breath, or enlarged lymph nodes.
- If you experience any of these symptoms, stop taking VOQUEZNA
and call your healthcare provider right away. These symptoms may be
the first sign of a severe skin reaction.
Low vitamin B-12 levels: VOQUEZNA lowers the
amount of acid in your stomach. Stomach acid is needed to absorb
Vitamin B12 properly. Tell your healthcare provider if you have
symptoms of low vitamin B12 levels, including irregular heartbeat,
shortness of breath, lightheadedness, tingling or numbness in the
arms or legs, muscle weakness, pale skin, feeling tired, or mood
changes. Talk with your healthcare provider about the risk of low
vitamin B12 levels if you have been on VOQUEZNA for a long
time.
Low magnesium levels in the body can happen in
people who take VOQUEZNA. Tell your healthcare provider right away
if you have symptoms of low magnesium levels, including seizures,
dizziness, irregular heartbeat, jitteriness, muscle aches or
weakness, or spasms of hands, feet, or voice.
Stomach growths
(fundic gland
polyps): A certain type of stomach growth called
fundic gland polyps may happen in people who take another type of
medicine that reduces acid in your stomach known as proton pump
inhibitors (PPI medicines) for a long time. Talk with your
healthcare provider about the possibility of fundic gland polyps if
you have been on VOQUEZNA for a long time.
The most common side effects of VOQUEZNA for treatment
of Erosive Acid Reflux include:
- stomach inflammation
- diarrhea
- stomach bloating
- stomach pain
- nausea
- indigestion
- high blood pressure
- urinary tract infection
These are not all the possible side effects of VOQUEZNA. For
more information, ask your healthcare provider or pharmacist. Call
your healthcare provider for medical advice about side effects.
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 Patient Information
and full Prescribing Information
for VOQUEZNA.
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.
- 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 Erosive GERDErosive GERD, also referred
to as Erosive Esophagitis or Erosive Acid Reflux, is a major type
of GERD that affects over 20 million people in the U.S. and is
characterized by erosions in the gastric mucosa caused by acidic
reflux of stomach contents into the esophagus.3 There are estimated
to be over 65 million individuals with GERD in the U.S., of which
approximately 30% have erosive GERD.4,6,7 In addition to
experiencing troubling heartburn symptoms and painful erosions,
patients with inadequately treated erosive GERD may progress to
more severe diseases including Barrett’s esophagus and esophageal
cancer.4
About VOQUEZNA®VOQUEZNA® (vonoprazan) tablets
contain vonoprazan, an oral small
molecule potassium-competitive acid blocker (PCAB). PCABs are
a novel class of medicines that block acid secretion in the
stomach. Vonoprazan provides rapid, potent, and durable acid
suppression. 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 U.S., 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 X
(formerly Twitter).
Forward Looking StatementThis press release
contains forward-looking statements. Investors are cautioned not to
place undue reliance on these forward-looking statements, including
statements about the size of the Erosive GERD patient population
and the potential of vonoprazan to satisfy the large unmet medical
need. 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: we may not be
able to successfully commercialize VOQUEZNA which will depend on a
number of factors including coverage and reimbursement levels from
governmental authorities and health insurers as well as market
acceptance by healthcare providers; 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 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, Phathom Pharmaceuticals, and their respective logos
are registered trademarks or trademarks of Phathom Pharmaceuticals,
Inc.
11/23 US-VPZ-23-0227
1 VOQUEZNA Prescribing Information, Phathom Pharmaceuticals,
2023.2 Laine L, DeVault K, Katz P, et al. Vonoprazan Verses
Lansoprazole for Healing and Maintenance of Healing of Erosive
Esophagitis: A Randomized Trial. Gastroenterology. October 10,
2022. https://doi.org/10.1053/j.gastro.2022.09.0413 Dickman R,
Maradey-Romero C, Gingold-Belfer R, Fass R. Unmet Needs in the
Treatment of Gastroesophageal Reflux Disease. J Neurogastroenterol
Motil. 2015 Jul 30;21(3):309-19. doi: 10.5056/jnm15105.4 Savarino
E, de Bortoli N, De Cassan C, et al. The natural history of
gastro-esophageal reflux disease: A comprehensive review. Dis
Esophagus. 2017;30(2):1-9.5 Vaezi MF, Brunton S, Mark Fendrick A,
et al. Patient journey in erosive esophagitis: real-world
perspectives from US physicians andpatients. BMJ Open
Gastroenterology 2022;9:e000941. doi: 10.1136/bmjgast-2022-0009416
Machicado J.D., Greer J.B., Yadav D. (2020) Epidemiology of
Gastrointestinal Diseases. In: Pitchumoni C., Dharmarajan T. (eds)
Geriatric Gastroenterology. Springer, Cham.
https://doi.org/10.1007/978-3-319-90761-1_7-1.7 U.S. Census Bureau.
U.S. and World Population Clock. Accessed May 2022.
https://www.census.gov/popclock.
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