Novartis is awaiting FDA approval for Galvus (vildagliptin), a breakthrough drug for type-2 diabetes that's poised to go head-to-head with Merck's recently approved Januvia (sitagliptin). The company suffered a significant blow in mid-November, when about two weeks before Galvus' expected approval date, FDA said it would take three more months to review new data submitted about the proposed dosing regimen and indications. Novartis isn't faltering, though. A company spokesperson said Novartis does not consider the delay a setback, but rather, just what FDA says it is—a delay.
Pharm Exec talked with Ebeling before news broke about Galvus' delay. But judging from his evident competitive spirit, a few extra months—and a viable competitor with an increasingly sizeable head start—are not about to changed his primary focus: He wants to win.Pharm Exec: How will you manage the competition with Januvia?
THOMAS EBELING: First of all, to have a competitor launching a drug in the same class is actually helpful because two companies and two different compounds can basically create a lot of buzz for that new class. It's actually quite positive that we are simultaneously launching similar drugs.
It's really important for our strategy to manage this kind of competition. If we compare Galvus to the competitor's product, we believe we have, in simple words, a more efficacious drug that is safer and more tolerable.
In terms of the source of business, the class initially will be used as an add-on to metformin. From there it will compete against TZDs and sulfonylureas, which are currently used as add-on therapies. It's really important that the new class and Galvus successfully replace TZDs and sulfonylureas first, then outperform our competitor second. It's more important that the new class gain share of the diabetes market rather than a small segment share. But in the end, we still want to be the leader.
Galvus is one of the first two drugs in a new class known as DPP-IV inhibitors. How significant is this for people with type-2 diabetes?
It's always great when a new mechanism is launched. Galvus is part of this new therapeutic class of DPP-IV inhibitors and it's very powerful in its ability to reduce HbA1c [glycosylated hemoglobin]. The main advantage of this drug is its efficacy—tolerability is high. Where a lot of the current agents to treat type-2 diabetes have side effects like edema, weight gain, and raised blood pressure, from the way it looks now, Galvus is to a large degree free of such side effects. Therefore, it's very safe and easy to use. And what's most important about Galvus is that it doesn't cause weight gain. A lot of agents that treat diabetes have this side effect, so this is a key point for the drug.
Like in hypertension where most physicians need between two and four drugs to treat a patient, we believe that it's the same situation for diabetes in the future. One needs to assume that doctors will use two or three agents to get the HbA1c under control, and given the profile of Galvus, we believe this drug can definitely be a part of it.