Bye Bye Galvus

Bye Bye Galvus

In what could be the final blow to Galvus from Novartis (NYSE:NVS) the FDA has requested further studies to show Galvus safety and efficacy in patients with kidney impairment. As Diabetic Investor has been reporting all along this most recent delay has nothing to do with skin lesions. Just how long it will take Novartis to complete the requested studies is anyone’s guess although most believe that should Novartis proceed it would delay Galvus for at least a year.

This latest delay continues an incredible streak of luck for Merck (NYSE:MRK) and their DPPIV Januvia. Many analysts expected Januvia and Galvus to be approved at about the same time and split the market for this new class of drugs, both of whom were expected to hit blockbuster status. Already off to a strong start this latest news on Galvus has sent shares of Merck soaring up almost 4% today.

Diabetic Investor isn’t quite convinced that Januvia is home free just yet. While it is true that Januvia will be the only DPPIV on the market for quite some time, reports from the field on the drugs performance is less than impressive. The main benefit of Januvia isn’t that the drug performs better than the current crop of oral medications used to treat type 2 diabetes; the main benefit is that Januvia works as well but with few adverse events. Yesterday at the ADA Postgraduate conference in NY, Robert Ratner, MD gave a detailed presentation entitled “Incretin-Based Therapies for Type 2 Diabetes: Clinical Utility”. During this presentation Dr. Ratner reviewed data on Januvia, Galvus and Byetta. Not surprisingly Dr. Ratner pointed out that Januvia is most effective when used in combination with metformin. Citing one study which showed almost 50% of the patients taking a Januvia metformin combination reaching an A1C level of 7% or lower. (The ADA defines good control when a patient maintains an A1C level of 7% or lower.)

Taken at face value this would appear to put Januvia in the driver’s seat and well on it’s way to becoming the next multi-billion type 2 drug. After speaking with several leading diabetologists at the conference Diabetic Investor believes Merck could be in for a rude awakening. While many remained concerned over the lack of data on long term usage of Januvia another problem is the high percentage of non-responders. Diabetic Investor defines non-responders as patients who see no improvement to their A1C after taking Januvia. Since the drug has been on the market for more than three months physicians are now just beginning to run A1C tests for their patients they put on Januvia and the results are surprising. One leading diabetologist told Diabetic Investor that 70% of the patients put on Januvia have not seen any change in their A1C levels.

Diabetic Investor also heard concerns, since reinforced by the news on Galvus, that not enough is known about long term usage of DPPIV’s. While it is possible that Januvia is problem free and nothing will become evident in the months ahead, we’re not so sure. As we indicated previously we have been down this road before and remain skeptical. Hopefully for Merck and the patients now on Januvia the concerns of these leading diabetologists will prove unfounded. However as the news on Galvus points out, sometimes when there is smoke a fire does develop.

Until that time Merck has open field running with their nearest competitor hurt badly and unlikely to recover. The question remains will Merck’s luck with Januvia continue or will the horseshoe flip over and the luck begin to run out?

David Kliff
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