CASE STUDY: Januvia's Hasty Arrival

Januvia's dramatic launch was all about speed.

Within 24 hours of approval, physician consultants began delivering talks to educate the medical community about the drug. Within 36 hours, reps began making their first sales calls. Within 48 hours, webcasts were broadcast to more than 1,000 scientific leaders.

Within eight days, pharmacies began to receive shipments of the drug, and an estimated 70 percent of target physicians had been brought up to speed on the product. And by mid-November, as Januvia passed its one-month anniversary on the market, the drug represented an impressive 14 percent of all new diabetes prescriptions and samples--in the same league as the category's market leaders.

Merck's new diabetes drug was lauded at its October 17 approval for ushering in a new treatment model. But after spending more than a decade to develop its blockbuster-to-be, the company had little time to celebrate--Novartis' competitor, Galvus, was nipping at its heels.

At the time, an approval for Galvus was expected within weeks--though FDA recently delayed its decision until February so Novartis could present more safety data.

Analysts predicted that the $6 billion race would come down to marketing--since there seems to be little else so far differentiating the two DPP-4 inhibitors--and being the first product out of the gate would create a sizeable advantage for Merck. Both Januvia (sitagliptin) and Galvus (vildagliptin) increase the body's own production of insulin in response to a rise in blood sugar--without causing the hypoglycemia and weight gain common with older drugs.

Speed was key to driving uptake, according to Peter Loescher, president of Global Human Health. But Merck is in no position to spend frivolously. Januvia is one of the first products launched under the company's new commercialization strategy, which executives adopted in 2005 as part of a five-year cost-cutting initiative.

It's a strategy that Loescher described as investing "to win" with each product launch--using fewer sales people, relying more heavily on alternative channels like the Internet, and putting new emphasis on getting health plans to cover the drug.

Education is the focus of the Januvia marketing campaign, which Merck is reportedly developing with agencies CommonHealth and Interlink. With only about two-thirds of diabetics in developed countries aware that they have the disorder, and of those on medication, 63 percent failing to reach goal, both diagnosis and treatment have a long way to go. "The patient need is so great," said spokesperson Amy Rose after the drug's launch. "That unmet need is driving us to move faster than in the past."

On the professional side, Merck had to work with a fixed head count on its sales force, and focused instead on e-detailing and Web-based channels.

Like Novartis, Merck is also building an arsenal of data to show that the drug can work in a multitude of patient populations. Studies are being undertaken to test the drug in hard-to-treat patient groups, as a monotherapy and add-on therapy, and as a way to prevent diabetes progression. The drug's versatility, a key part of its value proposition, is also being pitched to payers.

Merck is working with the American Diabetes Association and health-ed firm Healthy Interactions to train 9,500 "diabetes educators" over the next three years. "We intend to use the tools at our disposal to educate patients about the tools they have to treat diabetes," Rose said.

If approved, Galvus is likely to share some of Januvia's spoils since physicians and payers will already be primed to embrace the DPP-4 class. Novartis is also gearing up its own unbranded disease awareness campaign with Donovan McNabb of the Philadelphia Eagles.