Shire is taking aim at Johnson & Johnson’s ($JNJ) Concerta. The Irish drugmaker is sponsoring two head-to-head trials pitting its ADHD drug Vyvanse against the J&J product as a treatment for adolescents with the disorder. But it’s not just J&J’s branded product in Shire’s sights. Generic versions of Concerta are already on the market, and if Shire can’t make a better case for Vyvanse, then it stands to lose sales to those cheaper rivals.

Head-to-head trials are always a gamble; just think of AstraZeneca’s ($AZN) Crestor-vs.-Lipitor trial, Saturn, in which the AZ drug failed to beat Pfizer’s ($PFE) on the primary endpoint. Or Merck’s test of Vytorin against Zocor in Enhance, which also backfired. Shire does have some indication Vyvanse could edge out Concerta. It recently wrapped up an 8-week Vyvanse trial with a Concerta reference arm, and even though the study wasn’t designed to compare the two drugs–it was placebo-controlled–“the data do suggest … further investigation,” the company said in a statement. See :

One of the planned trials will be dose-optimized, and the other will use a fixed-dosing schedule. Together, they’ll comprise 1,000 patients, with results forthcoming by the second half of next year. “These studies are important to further our understanding of the possible differences in efficacy between Vyvanse and Concerta in treating adolescents with ADHD,” Dr. Jeffrey Jonas, senior VP of R&D, said in a statement.

For 2011, Vyvanse turned in $805 million in sales. Concerta brought in $1.4 billion in 2010, its last full year without generic competiton. Besides looking for an edge in ADHD, Shire is studying Vyvanse as an add-on treatment for depression, and it’s pushing the drug into new markets, with a regulatory filing in Europe (under the brand name Venvanse) and a launch in Brazil (also as Venvanse).

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