Going after a new way of treating a disease can be risky. There's no telling whether a new target might result in the desired changes without side effects. But taking the new road can also be very lucrative if the drug works, since there won't be any initial competition from drugs taking a me-too path.
In data from a phase 3 trial released today, dapagliflozin added to a generic drug, glimepiride, was markedly better than glimepiride alone. Dapagliflozin improved glucose levels using three different measurements.
Perhaps more importantly, patients taking dapagliflozin and glimepiride lost more weight than patients taking dapagliflozin alone. Being overweight is a complication for type 2 diabetes, so shedding pounds -- even if it is only three to five pounds over six months -- is an added benefit. Weight loss has been one of the selling points for Amylin Pharmaceuticals
Dapagliflozin is in a new class of drugs called SGLT inhibitors. The drug inhibits glucose filtered out by the kidneys from being reabsorbed into the bloodstream.
The drug is in stark contrast to Bristol-Myers and AstraZeneca's partnership on another diabetes drug, Onglyza, which works under the same mechanism as Merck's
Could dapagliflozin reach that kind of blockbuster level? It all depends on how the drug performs in its other phase 3 clinical trials. According to ClinicalTrials.gov, the drug is being tested in 12 more phase 3 trials. Patients taking the drug also seem to have an increased rate of genital infections, which might not be enough to keep it off the market, but could decrease sales.
Even with the added risk, investors should take a chance at innovation over stagnation.