Johnson & Johnson’s (NYSE:JNJ) diabetes therapy Invokana needs a strong result in its cardiovascular outcomes trials this year if it is to hold off the threat of Lilly (NYSE:LLY) and Boehringer Ingelheim’s rival SGLT2 inhibitor Jardiance (see table).
But with J&J not giving anything away about the timing of the Canvas and Canvas-R readouts during its fourth-quarter call, some analysts have become less optimistic about the chance of a positive outcome. Wells Fargo Securities noted that, “while pure speculation on our part, it’s possible that J&J has seen more of the Canvas/Canvas-R data since the Q3 call and feels less confident in the outlook”.
During the call J&J’s Chief Executive Alex Gorsky would only say there were “very important, very promising trials coming up in Invokana this year”. This was a contrast to the previous quarter when William Hait, head of R&D at Janssen, said the two trials would read out in mid-2017, and that he was confident that the data would look similar to those seen in the Empa-Reg Outcome study of Jardiance.
The Canvas program should be completed in early 2017, and J&J plans to evaluate Canvas and Canvas-R together in one net analysis. The company will not say when or where the results would be reported, but Wells Fargo Securities analysts speculate that they could be presented at the American Diabetes Association meeting in San Diego in June. When asked during the third-quarter call, Mr. Hait did not disclose whether the company would release the topline results before this.
The primary endpoint of Canvas is a composite of major adverse cardiovascular events, including CV death, non-fatal myocardial infarction and non-fatal stroke. Canvas-R looks at renal outcomes, specifically the number of participants with progression of albuminuria; impaired renal function and urinary tract infections are known side effects of these medicines, which work by increasing the excretion of glucose in the urine.
Both trials have enrolled patients with type 2 diabetes and a history or high risk of cardiovascular events.
Invokana will need to come close to the 14% reduction in cardiovascular events seen with Jardiance in the Empa-Reg Outcome trial or risk being overtaken – something that will happen by 2022, according to EvaluatePharma's sellside consensus.
There are signs that a slowdown is already happening: Jardiance’s market share is growing. Boehringer will not report its financials until April, but Lilly’s portion of Jardiance sales surged by over 200% in 2016, which the company put down to growth in the SGLT2 class in general and increased market share for the product specifically.
The impact of Jardiance’s new cardiovascular label, which was approved in the US in December and Europe in January, is only just being felt. Lilly expects an uptick in new patient starts “right away”, Enrique Conterno, president of its diabetes unit, said this month. Up to 30% of patients with type 2 diabetes also have established cardiovascular disease, he estimates.
J&J will be hoping that Jardiance’s cardiovascular benefit is a class effect for the SGLT2 inhibitors – as will AstraZeneca (NYSE:AZN), which will have to wait until 2019 for its CV outcomes data with Farxiga. If it is not, both will be doomed to stay in Jardiance’s shadow.