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Phase 3a trials would be powered to demonstrate at least as good efficacy as the selected NSAID comparative drugs with significantly reduced GI side effects. A good commercial opportunity was predicted. An enthusiastic commercial group was already starting to draft promotional copy PRIONIX - THE FIRST ANTI-INFLAMMATORY YOU WANTED TO STAY ON. |
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However, the minimum TPP for a true disease-modifying antirheumatic (DMARD) drug would be very different. The potential patient groups included adult and juvenile rheumatoid arthritis patients. Review of the marketed disease-modifying drugs revealed inconsistent delivery of efficacy and very significant side effects. The toxicities of these drugs resulted in their second-line positioning, and they were generally used only during active disease episodes. Benefit, when seen, was slow in onset. If PRIONIX was a true, disease-modifying agent, which retarded joint destruction, this would be a long awaited treatment breakthrough. In these circumstances, dose regimen convenience would not be critical in the TPP, though an oral disease modifying anti-rheumatic drug was highly desired. An intramuscular route of administration would be acceptable if adequate oral bioavailability did not prove achievable. The drug would likely be dosed even if side effects were evident but, depending on their incidence and severity, could be limited to second-line use with a more limited commercial potential. The team agreed on a minimum TPP for the DMARD. Table 1 compares key features of the minimum TPP for PRIONIX as an anti-inflammatory and as a disease-modifying anti-rheumatic agent. |
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A development plan was created. It was recognized that demonstrating disease-modifying activity convincingly would require extended clinical studies during which joint erosion would be carefully monitored. Development to the registration point as a DMARD agent would take six and a half years. The commercial group saw a strong opportunity to justify pricing in an area of clearly unmet medical need, where a strong pharmacoeconomics case could be made. |
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The potential vulnerability of the investment was recognized on two counts. First, this was a project for which heavy investment would be made prior to proof of its DMARD efficacy. Secondly vaccine and other novel anticytokine projects were in development ahead of PRIONIX. The internal research view of these competitor strategies was skepticalmuch promisednothing deliveredand advised that all the other players were long shotsother than PRIONIX! |
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The team considered the scenarios of PRIONIX as a DMARD with and without acute anti-inflammatory activity. This raised some important |
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