Johnson & Johnson's new diabetes drug Invokana, previously known as canagliflozin, is the first FDA-approved treatment in a new class. That's something of a double-edged sword. It offers the promise of a novel approach to diabetes treatment, but because it's new, doctors may be in wait-and-see mode for a while. And J&J ($JNJ) will have to spend a pretty penny on detailing and advertising to make a dent in the market.
After all, Invokana is entering a field already crowded with plenty of long-proven alternatives, including Merck's ($MRK) top-selling Januvia, Sanofi's ($SNY) Lantus, Novo Nordisk's ($NVO) Victoza--not to mention old, off-patent standbys like metformin. And all these drugs are known quantities, with familiar side-effect profiles.
Not so much with the new SGLT-2 class in general, and Invokana in particular, as Matthew Herper points out in Forbes. Citing Wells Fargo analyst Lawrence Biegelson, Herper says a worrisome rate of fungal infections may be a roadblock for Invokana. "[W]e have modest expectations for Invokana and the SGLT-2 class because the drug and class are associated with a relatively high rate of genital infections which will limit uptake," Biegelson wrote.
Other safety worries hit Forxiga, another SGLT-2 drug from Bristol-Myers Squibb ($BMY) and AstraZeneca ($AZN). It was rejected by FDA last year on concerns about side effects but won approval in Europe. Recently, the cost-effectiveness gatekeepers in the U.K. voted Forxiga down, saying they weren't convinced it works any better than other drugs already in use.
Biegelson says his firm expects Invokana's worldwide sales to hit $122 million this year and $667 million by 2016. Not too shabby, but not close to the multibillion-dollar Januvia or Lantus.
Meanwhile, as Medical Marketing & Media recently noted, launching a diabetes drug these days can be expensive. Overall market spending on non-insulin treatments grew to about $1.6 billion last year, MM&M notes, making the diabetes market one of the most expensive in which to launch a new drug. The new SGLT-2 drugs may boost spending by hundreds of millions, with $200 million to $300 million in detailing, advertising and sampling during their first year on the market.
When BMS and AstraZeneca launched Forxiga, they talked about adding the drug to their portfolio of diabetes treatments spanning different stages of the disease. And it's true that diabetes patients often have to change meds to keep control of their blood sugar. The SGLT-2 drugs will play a role in that, no doubt. And with diabetes incidence mushrooming around the globe, they can ride a growing market. They just may not match the mega-sales of their predecessors.
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