Since being named CEO of Novartis Pharma in 2000, Thomas Ebeling has witnessed tremendous financial and scientific growth
at the company. Until recently, the most significant milestone of Ebeling's tenure was one that caught him by surprise. Gleevec,
a drug originally intended for just 6,500 chronic myeloid leukemia patients, went on to gain additional indications and blockbuster
status. Ebeling is on the brink of his next major milestone, but this time, he sees it coming from a mile away.
Thomas Ebeling is CEO of Novartis Pharma, responsible for Novartis' pharmaceutical business worldwide. CEO since 2000, Ebeling
has been with the company since 1997, when he joined from Pepsi-Cola Germany, where he served as general manager. During his
tenure, Ebeling has helped Novartis gain double-digit income, driven by strong performances in the medical nutrition business.
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
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
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
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.