Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical
company focused on developing and commercializing novel treatments
for gastrointestinal diseases, announces that effective
immediately, CVS Caremark has added VOQUEZNA® (vonoprazan) tablets
to its commercial formularies. VOQUEZNA is approved for the relief
of heartburn associated with Non-Erosive GERD and for the treatment
of all severities of Erosive Esophagitis, commonly referred to as
Erosive GERD, and relief of related heartburn. VOQUEZNA is the
first and only FDA-approved potassium-competitive acid blocker
(PCAB) available in the United States. Over 116 million
commercially covered lives are now estimated to have access to
VOQUEZNA.
“We are extremely pleased to have secured widespread commercial
coverage for VOQUEZNA while still in the early stages of our
product launch,” said Martin Gilligan, Chief Commercial Officer of
Phathom. “Today's positive news with the nation’s largest PBM is a
significant development for millions of GERD patients seeking an
effective new treatment option. Since our last report, an estimated
77% of total commercial lives now have access to our first-in-class
GERD treatment. The inclusion of VOQUEZNA on CVS Caremark’s
national commercial formularies, requiring only a single step
through a generic prescription proton pump inhibitor (PPI),
directly aligns with our market access strategy. This achievement
underscores our commitment to enhancing patient access and
advancing treatment options for those living with acid-related
disorders.”
Phathom is offering savings programs for eligible patients who
face coverage or affordability issues, including a savings card
program that allows eligible patients with commercial insurance to
pay as little as $25 for their VOQUEZNA prescription. The company
has also partnered with BlinkRx, an end-to-end digital fulfillment
channel to help eligible patients find the most affordable option
for filling their VOQUEZNA prescription. For more information,
visit www.voquezna.com/savings.
VOQUEZNA is available by prescription only and marketed
exclusively by Phathom Pharmaceuticals. For more information about
VOQUEZNA visit voquezna.com.
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) and for relief of heartburn
related to Erosive Esophagitis.
- for up to 6 months to maintain healing of Erosive Esophagitis
and for relief of heartburn related to Erosive Esophagitis.
- for 4 weeks for relief of heartburn related to gastroesophageal
reflux disease (GERD).
- for 14 days with the antibiotics amoxicillin and clarithromycin
to treat an infection caused by bacteria called Helicobacter pylori
(H. pylori).
- for 14 days with the antibiotic amoxicillin to treat an
infection caused by bacteria called H. pylori.
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) 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).
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 the 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 Esophagitis and/or relief of
heartburnrelated to gastroesophageal reflux
disease include:
The most common side effects of VOQUEZNA when used with
antibiotics for treatment of H. pylori infection
include:
- diarrhea
- temporary changes in sense of taste
- vaginal yeast infection
- stomach pain
- headache
- high blood pressure
- cold-like symptoms
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.
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. VOQUEZNA is approved in the U.S. for the treatment of
adults with Erosive Esophagitis, also known as Erosive GERD, the
relief of heartburn associated with Erosive GERD, the relief of
heartburn associated with Non-Erosive GERD, and for the treatment
of H. pylori infection in combination with either amoxicillin or
amoxicillin and clarithromycin. Phathom in-licensed the U.S. rights
to vonoprazan from Takeda, which markets the product in Japan and
numerous other countries in Asia and Latin America.
About Non-Erosive Gastroesophageal Reflux
DiseaseNon-Erosive GERD is the largest category of GERD
and is characterized by reflux-related symptoms in the absence of
esophageal mucosal erosions. There are over 65 million U.S.
patients living with GERD, and it is estimated that approximately
70% of this population have Non-Erosive GERD. Symptoms of
Non-Erosive GERD may impact overall quality of life and can include
episodic heartburn, especially at night, regurgitation, problems
swallowing, and chest pain.
About Erosive GERD Erosive GERD, also
referred to as Erosive Esophagitis (EE), is a subtype of
gastroesophageal reflux disease (GERD) characterized by erosions in
the gastric mucosa caused by acidic reflux of stomach contents into
the esophagus. There are estimated to be over 65 million
individuals with GERD in the U.S., of which approximately 30% have
Erosive GERD. In addition to experiencing troubling heartburn
symptoms, patients with inadequately treated Erosive GERD may
progress to more severe diseases including Barrett’s esophagus and
esophageal cancer.
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 to vonoprazan, a first-in-class potassium-competitive acid
blocker (PCAB) that is currently marketed in the United States as
VOQUEZNA® (vonoprazan) tablets for the treatment of heartburn
associated with Non-Erosive GERD in adults, the healing and
maintenance of healing of Erosive GERD in adults and associated
heartburn, in addition to VOQUEZNA® TRIPLE PAK® (vonoprazan
tablets, amoxicillin capsules, clarithromycin tablets) and
VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for
the treatment of H. pylori infection in adults. For more
information about Phathom, visit the company’s website at
www.phathompharma.com and follow on LinkedIn and X.
Forward-Looking Statements Phathom cautions you
that statements contained in this press release 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 patient access and continued
expansion in commercial coverage with other payers; and the
Company’s estimates of the number of patients with GERD and its
estimates of the commercially covered lives who have access to
VOQUEZNA. 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: Phathom’s
estimates regarding patient population and commercial coverage
could prove to be inaccurate; 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; 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 and non-patent
regulatory exclusivity 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 most recent 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
© 2024 Phathom Pharmaceuticals. All rights reserved.VOQUEZNA,
VOQUEZNA DUAL PAK, VOQUEZNA TRIPLE PAK, Phathom Pharmaceuticals,
and their respective logos are registered trademarks of Phathom
Pharmaceuticals, Inc.
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