Shire eyes huge sales from new Vyvanse uses

NEW YORK Wed May 11, 2011 1:15pm EDT

NEW YORK (Reuters) - British drugmaker Shire (SHP.L) hopes to generate "multiple billions of dollars" of extra sales from expanded use of the hyperactivity drug Vyvanse into new indications, such as schizophrenia and depression, the company's CEO said on Wednesday.

Since Vyvanse is a stimulant, some analysts have questioned how willing regulators will be to see its use extended into wider population groups.

However, Shire Chief Executive Angus Russell told the Reuters Health Summit that the U.S. Food and Drug Administration was backing the company's moves to test the medicine among patients who had failed on standard therapy. Early tests have shown promise, he said.

"We've been in to discuss those findings with the FDA and we've found them incredibly supportive. They want us to develop these drugs," Russell said.

Britain's third-largest drug company reported a 31 percent increase in Vyvanse sales to $202 million in the first quarter. The drug is used to treat attention deficit hyperactivity disorder (ADHD).

Russell believes the ADHD business could be dwarfed in future by new uses for the drug, including treatment for binge eating and daytime sleepiness.

"The summation of these additional indications is a multiple factor bigger than the size of the ADHD business we've had historically," he said.

"Each one is a $1 or $2 billion opportunity, something in that range certainly, and we've said there are three or four indications."

Shire last month reported encouraging findings from a study of Vyvanse in schizophrenia, which showed it reduced the "negative" symptoms of the disease -- including apathy and poor social functioning -- without increasing the "positive" symptoms, such as hearing voices. The result surprised some experts who had thought a stimulant might aggravate the situation.

Russell said the potential to use Vyvanse in schizophrenia was potentially the biggest opportunity among the new uses, given the limited options for treating the negative symptoms of the disease.

Shire and other makers of stimulant drugs used for ADHD received a boost last month when the FDA said it saw no need to change labels after the initial findings of a review of cardiovascular risks from the drugs.

In addition to its ADHD business, Shire has a significant presence in biotechnology drugs to treat rare diseases, following its purchase of TKT six years ago.

Shire has capitalized for the last 18 months on production problems at Genzyme, the U.S. rare disease specialist recently bought by Sanofi (SASY.PA).

Shire is also working on developing new products within the rare-diseases division. Russell said he is particularly excited about a novel intrathecal pump system to deliver medicine to the brain via spinal fluid. The company expects the system to be in clinical tests for Hunter and two other rare diseases by the end of the year, he said.

"This would be unique to Shire. No one else is doing this intrathecal delivery ... and we think it is patentable and protectable," he said.

(Reporting by Ben Hirschler; editing by John Wallace)