Shire plc ADHD Drug Elvanse Close to Europe Approval

Shire Plc (SHP) won backing to sell its attention deficit drug Vyvanse in eight European countries, paving the way for the company’s top-selling treatment in the U.S. to be marketed in Europe. The U.K., Denmark, Finland, Germany, Ireland, Norway, Spain and Sweden have recommended approval for Vyvanse as a treatment for children aged six years and over with attention deficit hyperactivity disorder, who don’t respond adequately to Novartis AG (NOVN)’s Ritalin, Dublin-based Shire said in a statement today. The drug will be sold as Tyvense in Ireland and as Elvanse in the other countries. The eight nations are expected to formally approve the drug within one month to three months, and negotiations with pricing and reimbursement authorities will be required in some countries, Shire, which has management offices in Basingstoke, England, said in the statement. Vyvanse earned Shire $805 million last year, or 19 percent of sales. It may reap $2.2 billion by 2017, according to the average of five analyst estimates compiled by Bloomberg. “We will now work closely with the pricing and reimbursement authorities in the respective countries to ensure that Elvanse is made available to patients as soon as possible,” Angus Russell, Shire’s chief executive officer, said in the statement.