Important News Due From FDA Tomorrow Afternoon -- J&J's Invokana®, Januvia® Competitor?

Late in the afternoon tomorrow, after the markets have closed early -- for Good Friday -- we ought to learn whether the full Commission of the US FDA has voted to approve J&J's canagliflozin candidate, a first-in-class SGLT2 inhibitor, for Type II diabetis treatment.

In January 2013, the Advisory Panel voted to recommend approval, to the full Commission.

To be branded as Invokana^®, the J&J drug -- if approved -- will go head-to-head with Merck's Januvia^® franchise. That overall diabetis market -- worldwide -- is estimated at about $24 billion this year, growing to $36 billion by 2017. At present, the Januvia/Janumet franchise generates about $5.8 billion worldwide, in annual sales for Merck. If approved, over the next 24 months, I would expect to see Merck's sales flatten out, and perhaps even begin to decrease a bit -- back to around the $5 billion a year level, as Invokana ramps up -- to about $500 million per year in sales by mid-2014 or so. Longer term, and this is simply a guess, Invokana could be a $4 billion a year franchise for J&J -- into 2016 and beyond.

Why? Because earlier, Invokana soundly beat Januvia in a 10,000 patient head to head trial, for efficacy. It must also be noted, however though, that another maker's drug, in this new class of SGLT2 inhibitors, showed a cardio-vascular safety signal. Thus far, that signal hasn't appeared in any significant way in J&J's Invokana candidate. So, it will be an interesting horse race, as Invokana seems not to be associated with the weight gains diabetics experience -- while on Januvia (and the rest of the current class of medicines).

We will -- of course -- cover the full FDA's decision, right here, tomorrow afternoon.