Ximency (Bristol-Myers Squibb) is a twice-daily fixed-dose combination of daclatasvir, a first-generation NS5A inhibitor; asunaprevir, an NS3 protease inhibitor; and beclabuvir, a non-nucleoside NS5B inhibitor. The combination is approved in Japan for the treatment of genotype 1 (GT-1) chronic hepatitis C virus infection. Ximency was previously in Phase III development in the US and EU; however, in July 2015, Bristol-Myers Squibb announced that it would not pursue the combination’s approval in these regions. This decision was likely due to Ximency’s lack of differentiation from its earlier-launched rivals, Harvoni ([sofosbuvir + ledipasvir]; Gilead) and Viekira Pak ([paritaprevir + ritonavir + ombitasvir] + dasabuvir; AbbVie), as well as its numerically inferior efficacy in GT-1a patients in the UNITY-1 and UNITY-2 studies.
As a fifth-to-market interferon-free regimen with an inconvenient twice-daily dosing schedule and a lack of differentiation based on efficacy or tolerability, Datamonitor Healthcare expects that Ximency will have a minimal impact on the market share of the earlier-launched once-daily regimens. The Japanese market is also entering a period of protracted decline due to falling patient numbers, further reducing Ximency’s commercial potential.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Ximency : Hepatitis C
LIST OF FIGURES
9 Figure 1: Ximency for hepatitis C – SWOT analysis
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of Ximency for hepatitis C
11 Figure 3: Datamonitor Healthcare’s drug assessment summary of Ximency for hepatitis C
13 Figure 4: Ximency sales for hepatitis C in Japan, 2017–26
LIST OF TABLES
5 Table 1: Ximency drug profile
6 Table 2: Key Phase III studies of Ximency in hepatitis C
13 Table 3: Ximency sales for hepatitis C in Japan ($m), 2017–26
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