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.

Articles

Merck plays 'to win' in one of its first launches since implementing a new cost-cutting model.

CASE STUDY: Januvia's Hasty Arrival

Eli Lilly is one of the first companies to help fund a campaign that thanks clinical trial participants for their "heroism."

At a time when pipelines are drying, approvals are taking longer, and the total cost of bringing a drug to market is skimming the billion-dollar mark, drug companies are struggling to find ways to reduce the time, expense, and risk of the R&D process. But they're being stymied before they even begin, with four out of five clinical trials delayed because sponsors can't enroll enough eligible volunteers. Spending on recruitment now costs the industry about $500 million each year.

The problem, according to the Center for Information and Study on Clinical Research Participation (CISCRP), is that Americans don't believe that participating in a trial is a noble thing to do. When the group asked 1,000 people to identify who makes the "greatest contribution to mankind"--among an organ donor, blood donor, marathon runner raising money for a disease, and a clinical trial participant--the study volunteer came in last.

With the initial funding from Eli Lilly, CISCRP is set to roll out phase one of its "Everyday Heroes" campaign early this year, and the group hopes other companies will join the cause. "The idea here is to really focus on pre-education," said CISCRP chairman Kenneth Getz, who is also a senior research fellow at the Tufts Center for the Study of Drug Development. "We believe it's not negative media [that's creating misperceptions]--it's minimal to no coverage."

The lack of awareness has contributed to a "dramatic" decline in the response rate to recruitment materials, and companies are reporting that the responses are far below what they were seeing five years ago, he noted.

Jim Kremidas, director of global enrollment optimization at Eli Lilly, called recruitment the "biggest bottleneck" in the R&D process.

"We can influence it, but we can't really control it," he said. "Where the real wild card is is in the enrollment period. It's a very, very hot topic."

The first ad features a taxi driver stopped in traffic on a busy street. The light on top of his cab reads "HERO." "Medical heroes can be found in ordinary places," the copy reads. "Together we can make a difference through medical research." Viewers are then directed to the Web site smartparticipant.org and a CISCRP phone number. CISCRP has raised about 25 percent of the $1 million it plans to spend on the campaign in its first year. FDA has expressed interest in having its logo on the ad, according to Getz.

The ads, which were created pro bono by clinical trial recruitment firm Fast4wD Ogilvy, are slated to run in consumer publications like 

, on search-engine and health-info Web sites, and on billboards and buses in cities such as New York, Chicago, and Los Angeles. The scope and timing of the campaign are contingent on fundraising efforts.

CISCRP will measure the success of the campaign on follow-up research to see whether opinions of clinical trial participation have changed. A separate study from Thomson CenterWatch found that while 79 percent of study volunteers say that they're motivated to participate by a desire to advance science, their top concerns are convenience and risk.

Multi-company campaign hopes to cast clinical trial participants as 'heroes.'

Returning the Favor

FDA is so snowed under by the drug industry's prolific marketing materials that its approach to nabbing rule-breakers amounts to little more than playing pin the tail on the donkey, a government report accuses. The study released last month fingers a 2002 policy change--intended to give FDA more teeth to police drug ads, but which made the agency slower, clumsier, and less efficient. It also calls on FDA to establish a system for prioritizing which marketing materials to review and for tracking them through the process.

Senators Herb Kohl (D-WI) and Bill Frist (R-TN) requested the report from the Government Accountability Office. Its findings may serve as extra ammunition for the new Congress as it attempts to add drug-safety reforms to a reauthorized 2007 Prescription Drug User Fee Act.

The 37-page report found that, compared to four years ago, FDA is issuing fewer warning letters to pharma companies that violate direct-to-consumer advertising rules, and is taking longer to send them out--so much longer, in fact, that about half of violators are getting warned about material that is no longer in circulation. "Given the length of time it takes FDA to issue regulatory letters and the potential for repeated use of violative claims, we are concerned about FDA's effectiveness at limiting consumers' exposure to false or misleading DTC advertising," wrote Marcia Crosse, GAO's director of healthcare.

The GAO blames a 2002 rule requiring FDA to have all warning letters approved by its Office of Chief Counsel, three attorneys who also have responsibility for a host of legal issues, including those relating to new drug approvals. Since FDA has little enforcement power of its own to act on ad violations, the policy was meant to warn manufacturers that the agency is willing to take legal action, when necessary.

But at the same time that the oversight process became more cumbersome--including back-and-forth negotiations between the DTC Review Group and the legal team before letters were sent--FDA saw a big jump in the number of ad materials it received. In 2005, reviewers faced a mountain of about 16,000 pieces of marketing material--nearly double what piled up on their desks three years earlier.

Of course, most of those materials--which range from prime-time broadcast spots to waiting-room brochures--never even get a perfunctory once-over. But GAO slammed the FDA for having no effective system either to prioritize which ad materials to review or to keep track of which--or even how many--pieces it monitors.

The Department of Health and Human Services (HHS), which oversees FDA, begged to differ. The agency claimed that it does have a system in place for prioritizing ads: It looks at broadcast spots first, since these have the largest audience potential, and then moves on to pieces that haven't run yet, as a way to stop problems before they start.

HHS also insisted that its enforcement efforts are about quality not quantity--and aimed at getting industry to voluntarily comply with its marketing rules. "Recognizing that the agency's credibility would suffer if it was considered a paper tiger, the department ultimately determined that a change was necessary and desirable," HHS officials wrote. "Instead of multiple letters, one letter now suffices."

FDA, however, does seem to be saving its bigger bite for the worst offenders. Of the 98 letters it issued from 1997 through 2001, only six, representing about 6 percent, were the most serious "warning letters;" in contrast, eight of the 37 letters (22 percent) issued between 2002 and 2005 were warning letters.

GAO also had a finger wag for pharma, noting that it takes an offender an average of five months to fix a violation, attributing the delay to lengthy compromise and negotiation between the company and FDA on new materials. About 42 percent of drugs receive multiple warnings for ads that continue to break the rules, it added.

Government report paints picture of ineffectual FDA buried by avalanche of ads.

Pharmaceutical Executive-01-03-2007

CASE STUDY: Januvia's Hasty Arrival

Returning the Favor

Lost in the Sauce