If 2016 is to be Eli Lilly’s turnaround year, it needs several of its pipeline drugs to come good. Luckily for the company, one just has: ixekizumab, now known as Taltz, has got the FDA go-ahead for psoriasis.
Taltz is expected to be a near-blockbuster by 2020, so approval will come as a relief to Lilly, a company that has suffered more than most from patent expiries of its top sellers. But the group’s biggest pipeline hope, the Alzheimer’s candidate solanezumab, is a far more risky bet (see table below). Phase III failure would put Lilly back in the doldrums.
|Lilly’s top-five pipeline prospects (based on consensus forecasts)|
|Drug||Disease area||Class||Development phase||2020e sales ($m)|
|Solanezumab||Alzheimer’s||Anti-beta-amyloid MAb||Phase III||1,387|
|Baricitinib||Rheumatoid arthritis||JAK-1/2 inhibitor||Filed||1,002|
|Ixekizumab (Taltz)||Psoriasis||Anti-IL-17A MAb||Approved||971|
|Abemaciclib||Oncology||CDK 4 & 6 inhibitor||Phase III||820|
|Olaratumab||Oncology||Anti-platelet-derived growth factor alpha MAb||Phase III||215|
An anti-IL-17A MAb, Taltz has the same mechanism of action as Novartis’s Cosentyx, which was launched early last year.
Excitement over the new class of drug has cooled, however, after reports of suicidal ideation with brodalumab. Its forecasts have dwindled and Amgen abandoned it, but this did not stop Valeant picking up rights (Baffling Valeant strikes for troubled Astra psoriasis project, September 1, 2015).
Lilly will no doubt be watching for signs of suicidal thoughts with Taltz, but these are not mentioned in its label, which cites infection as the main potential serious side-effect.
|IL-17 inhibitors in late-stage development|
|Drug||Company||Status||2020e sales ($m)|
It is not just other IL-17-targeting agents that Taltz will go up against: the psoriasis market is becoming increasingly crowded with new classes of drugs in the pipeline, including anti-IL-23 MAbs like J&J and MorphoSys’s guselkumab (Next-generation psoriasis battle lures AbbVie, March 8, 2016).
But you have to be in it to win it, and Lilly has taken the first step to making Taltz a success.
Teva breathes easier
Teva also got some good news with the US approval of its intravenous drug for severe asthma reslizumab, now branded Cinqair.
It is not forecast to be a big seller, with EvaluatePharma consensus putting 2020 revenues at $337m. But the approval gives the company a reason to be cheerful following questions over its acquisition of Allergan’s generics unit. Although the deal has been approved by the European Commission, the US Federal Trade Commission has asked for more time to review it, pushing the expected completion date back to June.
Lilly and Teva both have bigger concerns, but for now they can celebrate. Lilly’s next big catalysts include an approval decision on its rheumatoid arthritis contender baricitinib, which it filed in January, and phase III data with sola, expected in late 2016 or early 2017.
A recent change in endpoints of the Expedition 3 pivotal trial of sola has not exactly inspired confidence. It has started well, but 2016 could yet go down as another disappointing year for the company.