Vonoprazan Fumarate

National TV and digital media campaign aims to motivate millions of people suffering from Erosive GERD to learn more about VOQUEZNA® (vonoprazan), the first and only FDA-approved potassium-competitive acid blocker (PCAB) A Media Snippet accompanying this announcement is available by clicking on this link. FLORHAM PARK, N.J., March 26, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announces the launch of its new broadcast ad and full-scale, Direct-to-Consumer (DTC) campaign, “VOQUEZNA Can Kick Some Acid,” to raise awareness of its powerful first-in-class treatment and encourage people to speak to their doctor about this new treatment option. VOQUEZNA (vonoprazan) is indicated for the healing and maintenance of healing of all severities of Erosive Esophagitis (EE), also referred to as Erosive GERD, and for the relief of related heartburn. VOQUEZNA represents the first major innovation to the U.S. Erosive GERD market in over 30 years.1 The multi-channel campaign delivers strong, compelling, and motivating efficacy and safety information to educate consumers about this new treatment option. It is currently live at VOQUEZNA.com and through Connected TV – streaming consumer content on popular platforms such as Prime Video, Hulu, and Peacock. The campaign will also be featured on consumer-facing platforms across Facebook, Instagram, waiting room TVs in doctor offices, and digital banner ads. Broadcast television promotion is anticipated to launch in the second quarter of 2024. By strategically utilizing a wide array of platforms, and leveraging advanced targeting, Phathom anticipates this campaign will reach the millions of Erosive GERD sufferers and motivate these patients to seek a new class of treatment that works differently than proton pump inhibitors (PPIs). “Phathom is excited to launch our first campaign directly to, and for, the people whose lives we strive to improve every day. Although Erosive GERD is a highly symptomatic condition that can have a detrimental impact on millions of patients, there has been little medical innovation in this category in decades, until now,” said Martin Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals. “We believe our new DTC campaign is accessible, memorable, and informative. Our goal is to connect with people unsatisfied with their current treatment options and empower them to explore the power of VOQUEZNA with their healthcare provider.” VOQUENZA, the first and only U.S. Food and Drug Administration (FDA)-approved treatment of its kind, helps to heal and maintain healing of acid-related damage to the lining of the esophagus, in addition to helping to provide 24-hour relief of associated heartburn in most adults. Its novel mechanism of action provides rapid, potent, and durable acid suppression in a way that is distinct from other prescription and over-the-counter medications.2 VOQUEZNA offers a novel therapeutic option with strong efficacy compared to standard of care PPI lansoprazole, demonstrated across a range of clinically important endpoints, including maintaining healing of Erosive GERD for all patients through six months. VOQUEZNA 20 mg demonstrated a strong healing rate of 93% compared to 85% for lansoprazole 30 mg. And of those healed, 79% stayed healed for 6-months on VOQUEZNA 10 mg compared to 72% taking lansoprazole 15mg.1 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.1 Further information on these Phase 3 results from Phathom’s pivotal clinical study is available at www.voquezna.com. Phathom is offering savings programs for eligible patients who face coverage or affordability issues, including a savings card program that allows for 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 that helps eligible patients find the most affordable option for filling their VOQUEZNA prescription. For more information, visit www.voquezna.com/savings. To view a video of the “VOQUEZNA Can Kick Some Acid” commercial, click here. If you are considering a new treatment option for Erosive GERD, you should speak to your healthcare provider to see if VOQUEZNA may be right for you. 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) 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. 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 Esophagitis include: stomach inflammationdiarrheastomach bloatingstomach painnauseaindigestionhigh blood pressureurinary 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. About Erosive GERD (gastroesophageal reflux disease)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.3 There are estimated to be over 65 million individuals with GERD in the U.S., of which approximately 30% have Erosive GERD.4,5,6 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.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 helps provide rapid, potent, and durable acid suppression.2 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 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 Erosive GERD and relief of related heartburn in adults, 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 StatementThis press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about the potential success of Phathom’s DTC campaign. 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, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PACK, 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; 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 obtain and maintain intellectual property protection and non-patent regulatory exclusivity for vonoprazan; 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. REFERENCES VOQUEZNA Prescribing Information, Phathom Pharmaceuticals, 2023.Laine L, Sharma P, Mulford DJ, et al. Pharmacodynamics and pharmacokinetics of the potassium-competitive acid blocker vonoprazan and the proton pump inhibitor lansoprazole in US subjects. Am J Gastroenterol. 2022;117(7):1158-1161.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.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.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.U.S. Census Bureau. U.S. and World Population Clock. Accessed May 2022. https://www.census.gov/popclock. MEDIA CONTACTNick Benedetto1-877-742-8466media@phathompharma.com INVESTOR CONTACTEric Sciorilli1-877-742-8466ir@phathompharma.com © 2024 Phathom Pharmaceuticals. All rights reserved. VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks of Phathom Pharmaceuticals, Inc. 3/24 US-VPZ-24-0136

Phathom Pharmaceuticals' commercial stars an animated, superherolike character (think: a blue-skinned, nose-less Mr. Incredible, small enough to fit inside an esophagus) who takes viewers into an erosive esophagitis patient’s stomach to pinpoint exactly where Voquezna can “kick some acid.” Just a few months after earning FDA approval for Voquezna in erosive esophagitis and associated heartburn, Phathom Pharmaceuticals has launched a direct-to-consumer campaign to support the indication, which is also known as EE or erosive GERD. The campaign—which happens to be Phathom’s first-ever full-scale DTC effort—has already gone live with a Voquezna-branded website and, as of this week, paid advertisements on social media and a commercial that’ll be pushed out to streaming audiences, according to Martin Gilligan, Phathom’s chief commercial officer. The “next phase” of the rollout will come in April, Gilligan said in an interview with Fierce Pharma Marketing. That’ll bring the commercial first to the TVs in doctors' offices' waiting rooms and then, finally, to regular broadcast television. Just as the campaign expands to more media in that “stepwise approach,” so too will its designated audience grow, Gilligan said, noting that the streaming service ads, in particular, will “target households where erosive GERD has a diagnosis code and/or [proton pump inhibitor] utilization—so we’ll start out super targeted before we go broad.” Those audience-targeting efforts will also play into how Phathom assesses the success of the campaign: To start, the metrics will be more “qualitative,” the exec said, with the company focused on making sure its ads are “reaching the right people” and the message is “resonating.” As time goes on, Phathom will be able to add in the quantitative side of things, looking at how many patients are inspired to contact their physicians about Voquezna and how many doctors go on to prescribe the drug. “We’ve done a lot of market research here; we did a lot of testing, both with physicians and with patients, and what we know is that the ad and the campaign is different,” Gilligan said. “And, more important than being different, it’s motivational.” The commercial stars an animated, superherolike character (think: a blue-skinned, nose-less Mr. Incredible, small enough to fit inside an esophagus) who takes viewers into an EE patient’s stomach to pinpoint exactly where Voquezna can “kick some acid.” The character—who is currently nameless, so as to keep the focus on the Voquezna name, per Gilligan—goes on to highlight that the drug is “the first and only FDA-approved treatment of its kind” and that Voquezna healed 93% of patients in a clinical trial after two months, 79% of whom remained EE-free after six months, and can provide 24-hour heartburn relief to boot. As the one-minute spot continues, the requisite list of side effects and contraindications plays out over a scene of the patient attending a kickball game and then ordering from a food truck, after which the character returns to the man’s stomach to urge viewers with EE to talk to their doctors about the drug, alongside information about Voquezna’s cost-savings plan and out-of-pocket payment support options. Phathom took inspiration for its new pint-sized star from Voquezna itself, according to the commercial chief. The mascot’s muscular physique, for example, channels the strength and power of the drug, which provides “rapid, potent and durable acid suppression.” Its “bold and unique” appearance, meanwhile, symbolizes Voquezna’s novel status in an indication that hasn’t seen any new innovation in 30 years, nor any promotion in at least 10, Gilligan said. Rounding out the design process was a desire to make the character “cool and enthusiastic" and able to “really communicate what the product does,” he said, explaining that the mascot’s blue skin and outfit suggest “healing and symptom relief” when juxtaposed against the vibrant red of the stomach lining. The “Voquezna Can Kick Some Acid” campaign follows shortly after the drug’s approval in November and pharmacy launch later that month, a fast-paced timeline Phathom chose to follow “because there is so much dissatisfaction” among EE patients, Gilligan said. Though the pace has now picked up, Phathom did hit a few setbacks on its way to FDA approval. Voquezna was originally approved to treat Helicobacter pylori infection in 2022, but, after trace levels of a potential cancer-causing agent were found in commercial batches of the drug, Phathom had to pause its rollout plans, while the FDA also delayed its review of Voquezna for EE. Ultimately, last spring, the regulator asked Phathom to resubmit applications for both indications, then issued back-to-back approvals in the fall. Now, however, the Takeda spinout is off to the races: Though the ads currently target Voquezna’s use in treating erosive GERD—as well as its ability to provide 24-hour relief for associated heartburn, which Gilligan cited as “the most important point” of the campaign—the company is hoping to eventually expand its reach to the overall GERD market; a PDUFA for Phathom’s application to expand the drug into non-erosive GERD is now slated for July 19, he said.