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Such events could include introduction of new diagnostic tools (which might increase or decrease the patient pool), major competitors going off patent with an impact on pricing, and regulatory and market interventions which could restrict use. This analysis identified the major factors which could affect market penetration and commercial success. |
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In discussing the TPP, it was recognized that, on the basis of the biological data, PRIONIX might offer benefit as an anti-inflammatory agent and as a disease modifying agent or both. The team recognized that the minimum TPP for an anti-inflammatory agent and a disease modifying agent would be very different. PRIONIX could occupy different segments in the market. If the clinical benefit offered was solely anti-inflammatory efficacy, the TPP must identify features differentiating PRIONIX from the best alternative anti-inflammatory drugs currently marketed (NSAIDS) or in development. A review of the literature highlighted that these drugs offered prompt onset of anti-inflammatory and analgesic actions and variable patient response [2] and that some offered a convenient oral once daily dose regimen. It was noted that several agents were already generic and low priced. Important weaknesses were the poor tolerance of NSAIDs and, in particular, the poor gastrointestinal side effect profile. It was suggested by experts that the latter is class related (through modulation of an arachidonic acid cascade). Significant switching in prescribing of NSAIDs was evident, indicating patient dissatisfaction. |
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The team believed that PRIONIX with its novel mode of action, potentially, could offer key benefits over the NSAID class by providing consistent efficacy and better tolerability. These features were of more than sufficient benefit to the patient to offset a need for once daily oral dosing. The minimum competitive TPP chosen by the team would deliver a product with at least as good anti-inflammatory efficacy as NSAIDs but with a slower speed of onset (i.e., one month). The dose regimen was more frequent at t.i.d. than the many o.d./t.i.d. products on the market. However, it was considered that the key benefit of significantly improved GI tolerability provides a real breakthrough for patients and encourages long-term compliance. It was recognized that PRIONIX, in contrast to NSAIDs, probably would not offer benefit in many other nonrheumatoid inflammatory conditions. To crystallize its thinking, the team drafted the labeling statements it intended for PRIONIX. The clinical trials needed to support these labeling statements were carefully reviewed in considering trial size and powering. |
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Development plans were prepared, which included definition of clinical endpoints and the quantitative performance required. The planning work established that it would take five years to develop PRIONIX to registration. |
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