- Surpassing Expectations: Over a span of six months, our stability data emerges triumphant, boasting levels more than 10 times below the threshold set by the discerning U.S. Food and Drug Administration (FDA). This remarkable achievement not only cements our commitment to excellence but also reinforces the longevity of our sought-after product on the shelves. The journey continues, guided by the beacon of outstanding quality!
- “Triumph on the Horizon: With the submission of our robust six-month stability data, Phathom achieves a resounding victory, fulfilling the stringent requirements for our Erosive GERD New Drug Application (NDA) for the remarkable vonoprazan. Mark your calendars for November 17, 2023, as we set our sights on the Prescription Drug User Fee Act (PDUFA) goal date, a moment that holds the promise of transformation in the realm of healthcare innovation.”
“FLORHAM PARK, N.J., Aug. 21, 2023 (GLOBE NEWSWIRE) — Brace yourselves for groundbreaking news as Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a trailblazing biopharmaceutical powerhouse, strides forward with a resounding declaration. Focused intently on revolutionizing the landscape of gastrointestinal well-being, the company unveils a pivotal chapter in its journey.
Today, a crescendo of anticipation fills the air as Phathom announces the submission of an invaluable gift to the FDA—a treasure trove of six-month stability data. These data, meticulously cultivated from the crucible of a long-term and accelerated stability program, encompass the soul of innovation encapsulated within reformulated vonoprazan tablets.
With these remarkable strides, the stage is set for the FDA to embark on the final leg of its NDA review for vonoprazan. This pioneer among potassium-competitive acid blockers (PCABs), a true first-of-its-kind, holds the key to transforming the realm of Erosive GERD treatment. Let the era of healing innovation unfold!”
“In a triumph that resonates with the promise of transformation, Phathom emerges as a beacon of innovation. With unwavering determination, the company rises to meet the FDA’s call for evolution, sculpting a saga that started with a Complete Response Letter (CRL) issued in February 2023. The spotlight now shines on the virtuosity of these newly submitted data, a testament to Phathom’s prowess in steering the course of progress. Navigating through the intricate landscape of specifications and controls, Phathom has harnessed the power to rein in N-nitroso-vonoprazan (NVP), a nitrosamine drug substance related impurity that once stood as a challenge.
The narrative unfolds further as Phathom’s resubmission of the NDA for vonoprazan finds its anchor in the realm of three months of stability data. A symphony of scientific ingenuity finds resonance in the resolute strides taken by the company, etching a path towards the coveted Prescription Drug User Fee Act (PDUFA) goal date of November 17, 2023.
Terrie Curran, the visionary President and Chief Executive Officer of Phathom, encapsulates the sentiment, expressing jubilation in the continuous victory over NVP. “Our voyage through innovation has revealed an even brighter horizon,” she exclaims, her words echoing the excitement of a planned launch in the fourth quarter of the year.
Amidst this journey, the orchestra of data crescendos with profound revelations. The reformulated tablets stand as guardians, vigilantly curbing the growth of NVP through a span of six months. A masterstroke of scientific prowess, these tablets maintain levels impressively more than tenfold below the daily intake limit. Here, science dances with purpose, mirroring the company’s commitment to excellence.
And what of the ambitious vision? The New Drug Application (NDA) dances at the crossroads of healing and restoration, seeking approval to mend and soothe the wounds of Erosive GERD. A chorus of heartburn relief joins this symphony of healing, promising solace to those in need. Classified as a Class 2 resubmission, the anticipation mounts, painting a portrait of a combined U.S. launch that beckons in the fourth quarter of 2023.
In the grand tapestry of healthcare evolution, Phathom Pharmaceuticals takes center stage, its brilliance illuminating the path to a healthier future.”
About Phathom Pharmaceuticals
Enter the realm of medical innovation with Phathom Pharmaceuticals, a dynamic force dedicated to reshaping the landscape of gastrointestinal health. Our journey unfolds with a singular focus: crafting revolutionary treatments that defy convention. Meet vonoprazan, the herald of change—a true pioneer among potassium-competitive acid blockers (PCABs). With exclusive rights spanning the United States, Europe, and Canada, Phathom holds the key to a new chapter in healthcare evolution. Step into a world where healing knows no boundaries.
Forward Looking Statements
“Step into the realm of future possibilities, but tread with mindful curiosity. Amidst the grand tapestry of our ambitions lie forward-looking statements that beckon us to envision the road ahead. As we cast our gaze towards the horizon, remember that these statements—while brimming with potential—should not be taken as promises etched in stone.
Within these words lies a mosaic of aspirations: the promise of vonoprazan’s potential in addressing Erosive GERD and H. pylori, the anticipation that stability data will stand strong for a coveted 24-month shelf life, and the hopes for timely FDA approval and a commercial launch that will change lives. Yet, the twists and turns of reality shape our journey.
Uncertainties dance in the shadows, for the FDA’s discerning eye may deem our resubmission insufficient, altering our trajectory. The intricate interplay of data from our stability program holds the potential for surprises, the kind that might redefine our path towards conquering the nitrosamine impurity challenge. The very essence of clinical development poses its own challenges, from manufacturing intricacies to unexpected side effects.
Gaze into the crystal ball, and one finds the stage of intellectual property protection, regulatory landscapes, and partnerships that sculpt our voyage. The pages of history remind us of the evolution of our journey, etching their mark on our Annual Report on Form 10-K and SEC filings.
The essence of our story lies not in fortune-telling, but in the realization that the journey itself is our true treasure. As we navigate these waters, remember that these words are like stars in the sky—guiding yet subject to change. The future unfolds with a tapestry woven from both ambition and humility, under the watchful gaze of the Private Securities Litigation Reform Act of 1995’s embrace.”