Will Galvus be DOA?

Will Galvus be DOA?

While Novartis (NYSE:NOV) anxiously awaits the FDA’s decision on Galvus, Merck (NYSE:MRK) continues to aggressively push their DPPIV Januvia. Yesterday Merck announced they had filed two supplemental New Drug Applications for Januvia and expects a decision by mid-October.

The problem for Novartis even if Galvus receives approval, which some expect in the very near future, will the successful launch of Januvia stymie Novartis efforts with physicians? Novartis sales reps are already dealing with questions from physicians as to why the drug has not received approval. These same physicians are curious why Galvus has shown some adverse events while Januvia has not. Many believed that the battle between Januvia and Galvus would be similar to the battle between Avandia and Actos. Both Galvus and Januvia are DPPIV’s and in clinical trials appeared to be almost mirror images of each other, just as Avandia and Actos or both TZD’s that produce almost identical outcomes. Obviously Januvia and Galvus are not the same as the FDA approved Januvia and Galvus is still awaiting approval.

Should Galvus receive approval Novartis faces an uphill battle in the field proving the drug is as safe and effective as Januvia. With the way the FDA has been handling approvals for nee drugs any further delays could effectively kill Galvus. Diabetic Investor does not expect any further delays but as was seen with Acomplia anything is possible.

Contributing to the problems for Galvus has little to do with the effectiveness of the drug or possible side effects, but the target market for the drug and the physicians who will be prescribing the drug. Targeted at type 2 patients who are treated by primary care physicians Novartis sales reps will be faced with the daunting task of explaining the differences between the drugs. As Diabetic Investor previously reported these physicians have multiple options for treating type 2 patients. The fact that Galvus and Januvia are from the same class it’s logical to believe Januvia would have the upper hand as to date there is no evidence it carries any of the issues associated with Galvus. Simply put Diabetic Investor does not the Januvia/Galvus battle being a split market as the Avandia/Actos battle has become. The longer it takes to get Galvus to the market the more likely this scenario becomes.

David Kliff
Diabetic Investor
847-634-4646 fax
224-715-3761 mobile