Achillion recently announced that its partner, Janssen, has fully enrolled its 365-patient Phase IIb trial testing the triple combination of ALS-022335, simeprevir and odalasvir (together known as JNJ-4178) to treat hepatitis C patients, with results expected in H217. Importantly, the trial will be testing six- and eight-week treatment durations (the current standard treatment duration is 8-12 weeks). Achillion also recently initiated patient dosing in a Phase II trial of ACH-4471 in treatment naïve PNH patients.
Following positive data in which the combination of ALS-022335, simeprevir and odalasvir for the treatment of genotype 1 hepatitis C virus (HCV) achieved a 100% sustained virologic response at 12 weeks post treatment (SVR12) in all patients (n=60) for both six- and eight-week treatment durations, Janssen decided to move forward with a 365-patient Phase IIb, which is now fully enrolled. Data is expected in H217 and advancement to Phase III is currently expected in 2018 (previously estimated to be 2017).
Merck recently announced that it is taking a $2.9bn asset impairment charge on MK-3682, which is part of its triple combination regimen with grazoprevir and elbasvir to treat HCV, leaving $240m in intangible asset value. It had been the main reason for its $3.9bn acquisition of Idenix. While Merck is continuing to develop the triple combination, this may be a signal that the company’s expectations are low.
Besides advancing ACH-4471 into Phase II for PNH, Achillion will be moving the drug into Phase II to treat C3 glomerulopathy (C3G) in H217. Additionally, a nextgeneration oral factor D inhibitor should enter Phase I and an ophthalmic factor D inhibitor should be selected for clinical development by the end of 2017.
We have lowered our valuation from $2.75bn or $20.15 per basic share to $2.41bn or $17.64 per share, mainly because our estimated launch date for JNJ-4178 is now 2020 (previously 2019) due to the new expectation for a 2018 Phase III start, as well as the removal of genotype 3 patients from our model as JNJ-4178 will not be developed for that subgroup of patients. Achillion ended Q117 with $386.6m in cash and investments, which we expect to be sufficient to reach profitability, currently expected to occur in 2020.