Phathom Pharmaceuticals Announces VOQUEZNA® (vonoprazan) Added to CVS Caremark Formularies for Commercially Insured Patients

• CVS Caremark, the largest pharmacy benefit manager (PBM) in the United States, added VOQUEZNA^® (vonoprazan) tablets to its national formularies for its more than 26 million commercially insured members

• Over 116 million commercially covered lives are now estimated to have access to VOQUEZNA, the first major innovation in Gastroesophageal Reflux Disease (GERD) treatment in over 30 years and the only FDA-approved treatment of its kind available in the U.S.

FLORHAM PARK, N.J., July 30, 2024 (GLOBE NEWSWIRE) -- 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 heartburn

related to gastroesophageal reflux disease include:

stomach inflammation	indigestion
diarrhea	constipation
stomach bloating	high blood pressure
stomach pain	urinary tract infection
nausea

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 Disease

Non-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 CONTACT

Nick Benedetto

1-877-742-8466

[email protected]

INVESTOR CONTACT

Eric Sciorilli

1-877-742-8466

[email protected]

© 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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US-VPZ-24-0175