Brand of the Year: Januvia - Pharmaceutical Executive


Brand of the Year: Januvia

Pharmaceutical Executive

Fries with that?

In the spring of 2011, during a press tour of Merck's North Wales, Pennsylvania research laboratory and high-throughput screening outfit—where Pharm Exec's Brand of the Year, Januvia (sitagliptin) was discovered—Ann Weber, vice president and site lead for discovery chemistry at the research laboratory, and co-leader of the basic research team that discovered Januvia, made a subtle observation to assembled reporters. Weber noted that she'd recently seen a colleague's slide depicting parts of Asia and charting the expansion of McDonald's franchises, overlaid by a chart of Type 2 diabetes diagnoses in the same areas. Weber didn't make a definitive statement on the slide or the implied correlation, but said it raised her eyebrows.

In the past, it has been argued that globalization threatens the unique identities of native peoples and cultures by dimming the vibrancy of traditional dress, for example, resulting in a bland homogenization. But as the philosopher Kwame Anthony Appiah has argued, the fact that Coca-Cola and Guinness are served up in small African cites where many families don't have electricity in their homes doesn't mean these populations are being exploited; it means the opposite, since these products typically arrive in tandem with access to effective medicines and clean drinking water. Whatever cultural differences are lost due to globalization will be supplanted by new forms of difference, Appiah wrote in The New York Times in 2006, the same year Januvia received its first regulatory approval, in Mexico. "No one could say that the world's villages are becoming anything like the same."

That may be true, but what about the explosion of Type 2 diabetes in places where it was almost non-existent 30 years ago? In the face of data on the diabetes pandemic—the number of individuals with diabetes doubled, globally, between 1980 and 2008—it's hard to deny that globalization has had some adverse effects. But in general the benefits of globalization almost surely outweigh the negatives, even if some of the new medicines Appiah references are being used to treat conditions that are a result, at least in part, of ubiquitous access to products like Coca-Cola and Big Macs.

Armchair philosophizing won't lower a diabetic patient's blood sugar, though, and so the drug industry, government regulators, and health officials carry on dealing with the problem as best they can. An important part of that effort is educating the public about the importance of exercise and the dangers of an unhealthy diet, and offering medicine to help control diabetes once it has developed.

Merck, which unseated Pfizer last summer to become the number one pharmaceutical company in the United States in terms of total sales revenue, according to IMS Health, did a lot of things right when it came to developing and commercializing Januvia (sitagliptin), a first-in-class dipeptidyl peptidase-4 (DPP-4) inhibitor, along with its fixed-dose metformin/sitagliptin sibling, Janumet. In 2011, the company received approval for Juvisync, a sitagloptin/simvastatin combination for Type 2 diabetes and high cholesterol. Last year, FDA granted the approval of Janumet XR, a once-daily form of sitagliptin/metformin. In addition to growing its DPP-4 portfolio, the company continues to pump its diabetes franchise sales revenues at phenomenal rates, seven years after the initial Januvia approval. Merck is currently developing yet another DPP-4, known as MK-3102, to be administered once-weekly. That drug has entered Phase III trials, says Nancy Thornberry, Merck's senior vice president and franchise head, diabetes and endocrinology, and the biochemist who initiated and led Merck's DPP-4 project, which resulted in the discovery of Januvia. Thornberry says MK-3102 "is not a different formulation of Januvia but rather a different molecule entirely." As Thrornberry tells it, the drug's once-weekly oral administration "is a new paradigm for the treatment of Type 2 diabetes."


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