Novartis' strategy for launching its dipeptidyl peptidase IV inhibitor Galvus will be to position the antidiabetic as an option against other existing therapeutic classes, not head-to-head against Merck's DPP-IV Januvia .

"Our target is not to fight within the class. Our major target is to try to get patients onto a better tolerated drug and to get better outcomes," Novartis Head of Pharmaceutical Development James Shannon said at the Goldman Sachs Global Healthcare Conference in California June 13.

"Our initial positioning will be as combination with metformin, but trying to take patients who would normally be starting or being added on metformin with either sulfonylurea or TZD, so our targets, at least initially at launch, [are] the TZDs and the sulfonylureas," he said. The firm later plans to transition towards earlier use (see ¹ Also see "Novartis’ Outcome Program May Prove Galvus A GLORIOUS First-Line Therapy" - Pink Sheet, 19 June, 2006. ).

Galvus (vildagliptin) and Januvia (sitagliptin), both under review at FDA, are in competition to be the first DPP-IV to market; Januvia has a mid-October user fee date, while Galvus' deadline falls in late November (² Also see "OSI DPP-IV Inhibitor Is A “Sensible Approach” To Diabetes Dosing, Firm Says" - Pink Sheet, 20 March, 2006., p. 21).

Given the DPP-IV inhibitors' comparable efficacy compared to other type 2 diabetes treatments, Merck and Novartis are likely to base promotions on safety; both firms released data at the American Diabetes Association Annual Scientific Sessions June 13 emphasizing the drugs' favorable side effects.

In particular, both companies highlighted weight loss side effects of their DPP-IV inhibitors versus standard therapies, which commonly cause weight gain.

Merck reported that patients receiving Januvia 100 mg daily in a non-inferiority study versus glipizide experienced "significant weight loss" (mean -1.5 kg from baseline at 52 weeks) compared to those treated with the sulfonyurea (mean +1.1 kg).

However, despite the contention that Novartis would not target Januvia directly, Shannon argued during the analyst call that "the rest of the program did not show any weight loss compared to placebo. Actually, placebo showed greater weight loss than Januvia. I think this may be a little bit optimistic, on one study to claim the drug has weight loss."

For its part, Novartis announced study results of two trials, comparing Galvus to rosiglitazone and looking at Galvus in combination with pioglitazone. In the overall population of a six-month, 700-person trial, Galvus patients experienced 0.3 kg of weight loss versus a 1.6 kg increase with rosiglitazone. In the six-month, 592-patient pioglitazone combo trial, obese patients (BMI>30) receiving Galvus and pioglitazone gained 0.4 kg less than those treated with pioglitazone alone.

Beyond the weight effects, other safety advantages are also being highlighted for the DPP-IV inhibitors. Noting that existing treatments "are pretty good as far as efficacy is concerned," Shannon pointed to other side effect advantages with Galvus - such as "minimal hyperglycemia [and] no GI intolerability."

Merck stressed a lower rate of hypoglycemia with Januvia. Patients receiving glipizide in the 793-person study had a 32% incidence of hypoglycemia, versus 4.9% for Januvia. "This very dramatic difference in the rise of hypoglycemia between a sulfonylurea and the DPP-IV inhibitors with the same degree of improvement in glucose control, I think, is going to be a tremendous advantage with this class," Merck scientific consultant Edward Horton (Joslin Diabetes Center) said.

One advantage that Galvus may have over Januvia is dose adjustment, Shannon indicated. The Novartis drug does "not have any limitations or dose adjustments based on different populations - hepatic, elderly, renal - [whereas] Merck...said they would actually have to move to 25 [mg] or 50 [mg] depending on the renal function of the patient, and that, at least for me, is a little bit of a complication."

"We see no such limitations for Galvus....We don't need to adjust the dose. We don't need to restrict population. It can be used anywhere," he noted.

Both Merck and Novartis are also touting the ease of use associated with Galvus' and Januvia's once-daily tablet formulations.

In terms of efficacy, 65% of patients receiving the combination of Galvus and pioglitazone achieved the ADA-defined HbA1c goal of less than or equal to 7% versus 42.5% and 42.9% of those being treated with Galvus and pioglitazone, respectively. In the Januvia trial, 63% of patients on sitagliptin achieved the A1c goal at 52 weeks, compared to 59% for glipizide, meeting the goal of non-inferiority.

Novartis Takes Aim: Galvus Promotions To Target Other Classes, Not Januvia

More from Archive

More from Pink Sheet