Thoughtleader: Thomas Ebeling, Novartis
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.
Januvia was approved in October. Does that create a disadvantage for Novartis?
It clearly would have been better if we had launched first—it's always our ambition to be first in the market. But what really matters is which drug has the better profile, and us having the better profile will definitely help us to compensate for the eight weeks.
Will Novartis run awareness ads to highlight this new class of drugs, or will you stick with branded ads that mention only Galvus?
At this point I don't want to give you a specific answer. We ultimately have to wait and see what to do in terms of our advertising. We first need to discover what is our product profile, what is our perceived differentiation [from the] competition, and what is our competitor doing? For the time being, we are keeping both options open.
Diabetes is becoming an oppressive epidemic, especially here in the United States. What does the future of treatment look like?
The next level of diabetes treatment really involves developing more fixed-dose combinations. Patients who very often have concomitant diseases have to take a lot of pills a day. These patients very often are not really fully compliant, and the availability of powerful fixed-dose combinations will ensure a better outcome based on better efficacy and better compliance of patients. That is a very critical element.
Ideally the future will hold diabetes drugs that lower HbA1c and that reduce weight gain as one of its side effects. Most scientific approaches will aim to address those two unmet medical needs.
Is diabetes becoming a rising problem or is there just more awareness now?
It will become a real problem here and beyond the US. There are articles about Europe now, articles that say Europe is becoming an obese continent. There is also more discussion of this topic in Asia, too. Given the lifestyle we all have, which is a lot of bad food and too little exercise, I expect this epidemic to continue.
Can new drugs really fix diabetes, or does it require social change?
It's a very interesting question. To some degree, lifestyle changes should be highly recommended to complement pharmaceutical therapy regarding diabetic patients. Even if you have a genetic predisposition for such a disease, you still can mitigate the intensity of the impact by adjusting your lifestyle.
Drug analysts are calling DPP-IV inhibitors the next blockbuster class. How do you go about creating this new class of drugs? What do you look for?
What we really know and have experienced already is that the key opinion leaders are very excited about the new class. That's always the first step—you have to make sure that KOLs are enthusiastic. I see a good level of this in the medical community for the new classes, and we have to continue to nurture that excitement. This can be achieved by providing new clinical data, developing fixed-dose combinations, and exploring if any new drugs can slow down the progression of diabetes. There is a lot we expect to deliver over the next few years, which will continue to increase this level of excitement.
Direct-to-patient initiatives, which educate patients and communicate that there's a great treatment that can help them, are really the next key step. This is certainly a category that can be built on, not only driving awareness with key opinion leaders, but driving awareness among patients as well.
What has been the reaction from doctors and clinicians about Galvus, and in general about this new drug class?
Novartis has one of the most exciting, if not the most exciting, late-stage pipelines, and doctors and clinicians are responding to that. We have done significant clinical studies with a lot of patients being enrolled, and we're very comfortable about the efficacy and safety profile of Galvus. It's always great to have a new class where the drug is safe.
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