Tag Archives: Invokana J and J New Drug Diabetis Type II Januvia Janumet New DrugJanuary 9 2010 February 28 June 9 2012 January 10 March 28 2013

J&J’s Invokana® Approved By FDA; “First In Class” Drug For Type II Diabetics

Now we wait to see where Merck opens, on the NYSE, on Monday. My very strong hunch here is that Invokana® will be a perhaps $5 billion franchise by 2016 or so. Some of that will logically come from Merck’s Januvia®/Janumet® franchise.

UPDATE: I should make it plain that my estimates for early uptake of Invokana are perhaps as much as ten times higher than those being bandied about by most of the people whose day job is stock analysis. While there have been safety concerns with other candidates in this class, I think the post-marketing studies are going to vindicate Invokana. In addition to the superior efficacy profile here, the reported “side effect” — of weight loss — makes a pretty compelling uptake case. I think this drug will be called for by name, by the vast majority of Americans with obesity-triggered Type II diabetis. That’s called patient pull-through — and when it occurs, the sales ramp accelerates significantly.

Stay tuned — but here is Larry Huston — writing for Forbes:

. . . .The FDA said today that it had approved canaglifozin (Invokana, Johnson & Johnson), the first of a new class of diabetes drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Canaglifozin is indicated to improve glycemic control in adults with type 2 diabetes in conjunction with diet and exercise. The drug has been studied as monotherapy and in combination with other common treatments for type 2 diabetes including metformin, sulfonylurea, pioglitazone, and insulin. . . .

Have a safe and peaceful holiday weekend.

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Interesting Merck NYSE Chart Action — Around 11 AM EDT Today

We will see where Merck closes, but at the moment, it is off a fair bit — from yesterday’s NYSE close.

This may be a bit immodest, but throughout the mid-morning hours this morning, Merck had been steadily rising on the NYSE, and on pretty solid volume, too.

Then, at 10:55 a.m. local New York time, I published the FDA/J&J Invokana® speculation, in the immediately-below post. The $5.8 billion franchise Merck runs — in Januvia®/Janumet® — would clearly be impacted, and as soon as the next quarter, should FDA vote to approve Invokana, tomorrow evening.

Now look at the day’s chart (thus far), courtesy Yahoo! stocks:

I have searched, and seen no earlier — or contemporaneous — mention of the likely Merck/Januvia impact, here. In addition, my traffic spiked in the 11 am to Noon time frame, Eastern — much of it from in and around Manhattan. I’ll name no names — but all the usual Wall Street firms’ IP backbones were well-represented. Highly entertaining.

Now, we wait for tomorrow’s FDA approval action — or complete response letter.

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

MRK-Inkovana-2013 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.