Is this the beginning of the end for Galvus

Is this the beginning of the end for Galvus

This morning Novartis (NYSE:NVS) released results from a two-year trial that showed Galvus, their DPP-4 for the treatment of type 2 diabetes which is awaiting approval from the Food and Drug Administration (FDA), produced results inferior to metformin. In this study Novartis tested Galvus as a stand alone therapy and in combination with other medications. Data from the study showed that patients using Galvus showed a 1.1% drop in A1C while patients on metformin experienced a 1.5% reduction in A1C.
According to James Shannon, head of Novartis research and development, the company won’t try and market Galvus as a replacement for metformin, but as add-on therapy. Given that the FDA has yet to approve Galvus and Januvia Merck’s (NYSE:MRK) DPP-4 is already approved and in the marketplace, these study results couldn’t have come at worse time form Novartis and strengthens Merck’s first to market advantage.

As Diabetic Investor pointed out yesterday neither Januvia nor Galvus produce better outcomes than currently available treatment options. There main selling point has been they produce similar results with fewer side effects. Armed with this data it is highly unlikely that physicians will choose Galvus over Januvia should the drug receive FDA approval.

Prior to the approval of Januvia, all available data appeared to indicate that Galvus and Januvia where almost identical, not surprising as they are both DPP-4’s. While there were small differences between the drugs there was nothing in the data that would have lead one to believe that Januvia would be approved and Galvus would be delayed. It should be noted that Bristol-Myers Squibb (NYSE:BMY) also has a DPP-4 under-development which has also had issues with skin irritation similar to the issues that have delayed Galvus at the FDA. According to Merck they have not seen any skin issues with Januvia.

While it is unclear why Galvus and Bristol’s DPP-4 have shown skin issues and Januvia has not, Diabetic Investor does not believe the DPP-4 category is any danger at the moment. Surprisingly little attention has been paid to the possibility that DPP-4’s may increase the possibility of promoting cancer cell growth. An issue that was highlighted in the study by Masur, et al entitled “DPPIV inhibitors extend GLP-2 mediated tumour promoting effects on intestinal cancer cells” published earlier this year.

With the race has just beginning Merck is off to a strong start and could build a substantial lead while Galvus remains bogged down at the FDA. Diabetic Investor remains just a bite skeptical and is not yet convinced that the DPP-4 category is as safe as the companies make them out to be.

David Kliff
Diabetic Investor
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