| Back-ground |
Phase 2 studies nearing completion on high potential GI drug. Cross functional product development team meets to plan for Phase 3 trial design prior to Pre Phase 3 FDA meeting. Cross functional team consists of Regulatory, clinical, Biostat, project management, clin ops, commercial and drug safety.
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| Challenges |
- Highly compressed time to initiate Phase 3 and progress towards commercialization
- Two formulations of drug requires multiple P3 trials and various indications
- Two competitors already on the market and one more on the way
- Lack of real world clinical and commercial experience in the drug category
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| Solution |
The commercial team compiled a variety of primary and secondary market research studies to derive insights on the market place and identify strategic opportunities. Commercial met with the product development team to share insights and propose the unique endpoint of Nighttime Heartburn Relief that would meet unmet medical needs and differentiate the product from the competition. The clinical team agreed and designed endpoints that could deliver the necessary data.
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| Result |
The product (pantoprazole) was successful in Phase 3 trials and demonstrated complete relief of Nighttime and Daytime Heartburn in erosive GERD patients. The successful Phase 3 design enabled the incorporation of key wording and data in the label which strongly supported the Nighttime Heartburn positioning of the product. Protonix (pantoprazole) reached maximum annual sales of $2.5 billion in the mid-2000s.
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(267) 441-3254