16. Januvia

Merck & Co.
2015 sales: $3.99 billion
2020 projection: $4.52 billion

Merck's ($MRK) top-selling diabetes franchise has taken a few hits in recent years as questions about its safety arose and new competitors hit the market. But regulators and new data have eased many of those concerns, and as diabetes continues to burgeon in the U.S. and, increasingly, the developing world, the market for treatments is only growing.

Januvia and Janumet are mainstays of Type 2 diabetes treatment, used earlier in the disease than insulin treatments but typically after or alongside first-line metformin. Within the DPP-4 class it competes with AstraZeneca's ($AZN) Onglyza and Eli Lilly's ($LLY) Tradjenta, but it has dominated those drugs for years. It also competes with the GLP-1 drug class--which are also "incretin mimetics" like Januvia, but work in a different manner.

On the safety side, last year, Januvia's cardiovascular safety study TECOS unearthed no additional heart risks for patients using the drug, a positive signal that could increase sales. And in 2014, the FDA and European regulators joined forces to sweep aside some suspected links between Januvia and other incretin mimetics, and pancreatitis and pancreatic cancer.

Now, however, Januvia and Janumet face a new threat in the form of the SGLT2 drug class, which includes Johnson & Johnson's ($JNJ) Invokana and, importantly, Eli Lilly and Boehringer Ingelheim's Jardiance. The latter recently reported breakthrough data from a cardiovascular safety study showing that Jardiance actually reduced the risk of serious cardiovascular events--stroke, heart attack and CV-related death. The companies have asked the FDA to add that information to Jardiance's label, which could give it new edge in the market.

So far, Merck sees Jardiance pulling market share away from other SGLT2 drugs rather than cutting into other classes. But some analysts disagree. If Lilly and Boehringer win the CV label change, doctors might not switch their Januvia patients to a different med, but Jardiance could siphon away new patients.

Still, diabetes patients often need to try different drugs--or different combinations of drugs--as their disease progresses. "We individualize therapy," Merck VP of clinical research Peter Stein told FiercePharma after the Jardiance study was released. "It's not a one-size-fits-all situation. I'm going to reach for certain drugs for certain patients. The great thing about DPP-4 inhibitors like Januvia is that it's very well-tolerated, it's very simple to take, it's a daily-medication, it's weight neutral, and so it's got a very favorable profile."

Januvia and Janumet posted about $6 billion in 2015 sales, up 7% after backing out currency effects, $3.2 billion of that in the U.S. With key patents that don't expire till 2022, Januvia won't face generic rivals for several years, one reason why it's pegged at $7.5 billion in 2020 sales. And Januvia's heart-safety study, TECOS, could give the drug a 10% long-term boost, according to Bernstein analyst Tim Anderson. -- Tracy Staton (email | Twitter)

For more:
No exodus from DPP-4s on Jardiance CV data, but SGLT2 scripts are shifting: Merck
Jardiance and its CV data? They're no knockout punch for stalwart Januvia, Merck says
Merck's Januvia powerhouse could feel the heat from device challenger
No red flags in Januvia heart study means a big win for Merck

16. Januvia