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Merck's Januvia has a head start, but Novartis isn't sitting idle.
Merck's new oral diabetes drug, Januvia, unexpectedly beat Novartis' version, Galvus, to the FDA finish line, but marketing efforts will determine the real winner in what's expected to be a $6 billion market.
Assuming Galvus (vildagliptin) gets the nod--which is expected to happen before the end of 2006--the struggle between Merck and Novartis will be one of creating brand loyalty for drugs that are not only the first in a brand new class, but that also have seemingly interchangeable competition.
"There's not a huge amount to differentiate them other than marketing," said Donny Wong, a research analyst at Decision Resources.
Januvia (sitagliptin) and Galvus represent the first two oral drugs known as DPP-4 inhibitors, and are being touted as the first major advance in type-2 diabetes in a decade.
With Januvia setting the bar, Novartis said its FDA application would include a more comprehensive data package that shows the drug's efficacy in hard-to-treat patient groups, like minorities, the elderly, and the obese.
Still, many observers had the reaction of Wong, who called the products "nearly identical."
"I think they'll split the market," Wong added, valuing the market for both drugs at $6 billion a year.
DPP-4 inhibitors are activated by a rise in blood sugar, and increase insulin production. In clinical trials, they worked as well as older TZD drugs, without hypoglycemia or weight gain.
Merck is reportedly working with CommonHealth and Interlink on marketing and medical education, but neither the company nor the agencies confirmed the relationships.
"Now that the drug has been approved, we're embarked on a full-fledged education effort to physicians," said Merck spokesperson Amy Rose.
She noted that DTC efforts would begin "at the appropriate time," and would include tactics such as Internet-based marketing.
Yet while Merck might have the lead, Novartis doesn't intend to sit idle. It is pushing ahead with its GALIANT trial, which involves primary care physicians at 800 US research centers. The purpose of the study is to test the drug in the "real world," since most diabetics are treated in a primary care setting, according to Marjorie Gatlin, MD, Novartis's vice president of US clinical development and medical affairs for cardiovascular and metabolic diseases.
So far, Novartis's message has focused on hard numbers attesting to Galvus' efficacy in a range of patient populations.
"There is no patient type for whom this drug is not indicated," Gatlin said. "What we have done is provided a robust data set to allow [physicians] to select the best therapy based on the data."
Novartis has also unveiled an unbranded diabetes awareness campaign with Donovan McNabb of the Philadelphia Eagles.
Merck, for its part, is also studying the drug in hard-to-treat patients, as well as in combination-pill form with metformin.
Pricing issues might be another factor in uptake. The launch of the DPP-4 class, which can be used either as a monotherapy or an add-on to current drugs, moves diabetes care from "somewhat expensive to extremely expensive," said Michael Russo, a partner at consulting firm The Bruckner Group.
Merck has priced Januvia at $4.86 per tablet for the once-daily drug. Novartis has not released its price yet, but it is expected to be comparable.
"Though overt competitive pricing is rarely done, competitive rebate negotiation can be a backdoor for such a tactic," Russo noted.
Another variable is Eli Lilly/Amylin's Byetta (exenatide injection), which also is part of DPP-4 class. Wong expects the current version of Byetta--now a $750 million product--to take a hit as patients are switched to the more user-friendly oral formulation. But he noted that a weekly dosing version of the injection could prove to be a billion-dollar competitor.
"There really is a lot of room for blockbusters in this category," Wong said.