Achillion Pharmaceuticals: QuickView

With impressive single-dose ACH-3102 data, Achillion is back in the race to develop an all-oral, interferon (IFN)-free anti-HCV regimen. This would see its NS3 protease inhibitor, sovaprevir (ACH-1625), combined with ACH-3102, a NS5A inhibitor, with or without ribavirin (RBV). Achillion expects to initiate a Phase IIb trial of this combination in Q313; a Phase III trial starting in Q414 could, if successful, allow an NDA filing in Q216.

Promising ACH-3102 Phase Ib Data
A Phase Ib study in the harder-to-treat genotype 1a HCV-infected patients showed that a single dose of ACH-3102 (50 to 300mg QD) produced a mean maximum 3.74log10 reduction in HCV RNA. Significant HCV RNA reductions were also achieved in patients with resistant variants at baseline, including L31M (-3.4 log10) and Y93C (-4.4 log10) variants.

Matches Or Beats Other NS5As In Viral Load Reduction
These data suggest ACH-3102 could outperform other NS5A inhibitors, including BMS’s daclatasvir (-3.3 log10 on day one in GT1b after a single dose, 300mg), Gilead’s GS-5885 (-3.0 and -3.3log10 in GT1a and GT1b in a three-day study, 10mg), Abbott’s ABT-267 (-3log10 in GT1 in a three-day study, 200mg), GSK’s GSK-2336805 (-3log10 in GT1 in a single-dose study, 120mg) and Presidio’s PPI- 461 (-2.65 to -3.62log10 in a three-day study, 240mg). Preclinical studies showed ACH-3102 to be highly potent against NS5A variants that are resistant to other NS5A inhibitors, including daclatasvir.

IFN-Free Combinations
Achillion is one of a handful of companies developing IFN-free combinations including Gilead (sofosbuvir + RBV ± GS-5885), Vertex (ALS-2200 + RBV or ALS- 2200 + telaprevir), BMS (daclatasvir + asunaprevir+ BMS-791325), Boehringer Ingelheim (BI 201335 + BI 207127 ± RBV) and Abbott (ABT-450 + ritonavir + ABT- 267 ± ABT-333 ± RBV). Achillion’s combination (ACH-3102 + sovaprevir ± RBV) could be approved in 2016/17 but would be two to three years behind competitors.

Valuation: EV Of $773m
Achillion enjoys an EV of $773m, which has doubled since August on the back of positive ACH-3102 data. Its premium reflects market expectation about a partnership deal or M&A interest from large pharma companies.

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