Eli Lilly/Daiichi Sankyo: Prasugrel Dose Adjustments Lead to Uncertainty
Posted on: Thursday, 25 October 2007, 15:00 CDT
Eli Lilly and Daiichi Sankyo have suspended patient enrolment for two Phase II trials for their anti-clotting agent prasugrel after a pharmacokinetic analysis indicated that "dose adjustment may be appropriate for various sub-populations." Although the extent of the problem will not be known until Phase II data is published, any approval delays could damage the drug's commercial potential.
According to Eli Lilly, the amendments are strictly protocol-related and do not provide a basis for inferring overall outcomes of other prasugrel trials. Lilly/Sankyo are conducting the Phase III TRITON-TIMI 38 trial and trial results are expected at be presented at the American Heart Association meeting in November 2007.
Prasugrel is a platelet aggregation inhibitor under development for the treatment of thromboembolism and will be a direct competitor to Plavix (clopidogrel), Bristol Myers Squibb/Sanofi-Aventis's highly successful drug. The drug is the active metabolite of clopidogrel and was expected to have a competitive advantage after displaying greater specificity and a higher degree of platelet aggregation inhibition. The drug also showed activity in the 25% of patients who are clopidogrel 'non-responders'.
Dosing changes to two small Phase II trials would not normally warrant an announcement if no effect on the overall outcomes of the program was expected, when Phase III trial data is imminent. It can only then be inferred that these dose changes will have a material impact on safety and efficacy data for the drug.
The companies had hoped that an NDA would be filed for the drug by the end of 2007 and uncertainty over dosing will focus attention on the strength of the data presented in November. The success of prasugrel will be highly dependent on the launch date as sales will need to be maximized before generic versions of clopidogrel become available in the US in November 2011.
Datamonitor has predicted peak sales of prasugrel in the seven major markets of $1 billion. The full impact of the dose adjustment on this forecast will not be known until the publication of the Phase III trial data. However, any problems with the prasugrel program will provide heart to Bristol Myers Squibb/Sanofi-Aventis, in their defense of Plavix sales, and to the developers of the next generation of platelet aggregation inhibitors ticagrelor and cangrelor, AstraZeneca and The Medicines Company.
Source: Datamonitor
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