Shire gets go-ahead to market binge-eating medicine

Shire has received its second important regulatory breakthrough in two weeks after winning US approval for the first medicine to treat binge-eating disorder.

The UK-listed drugmaker received a go-ahead from the US Food and Drug Administration to market its Vyvanse drug for a condition estimated to affect more people than the better-known eating disorders anorexia and bulimia.

It came a week after the FDA gave its blessing to a treatment for the rare hormonal disorder hypoparathyroidism developed by NPS Pharmaceuticals, which last month agreed to be bought by Shire for $5.2bn.

The twin approvals will help increase confidence behind Shire's plan to double revenues to $10bn by 2020 - a goal set while the company was fending off a takeover approach from AbbVie of the US last year.

A takeover was eventually agreed but the deal collapsed, leaving Shire to chase its ambitious growth target as a standalone company.

Flemming Ornskov, chief executive, is mainly focused on expanding into treatments for rare diseases such as the Natpara drug acquired from NPS.

However, he hopes the Vyvanse approval, announced late on Friday, will eventually add several hundred millions of dollars in annual revenues to Shire's best-selling medicine.

Vyvanse, which generated $1.1bn of sales in the first nine months of last year, is one of the leading treatments for attention deficit hyperactivity disorder.

Shire last year abandoned trials to find out if the amphetamine-based drug might also work for depression but pressed ahead with its push to open a new market among the estimated 2.8m people in the US with binge-eating disorder.

The condition was officially recognised in 2013 by the US Diagnostic and Statistical Manual of Mental Disorders - known as the "psychiatric bible" - as "recurring episodes of eating significantly more food in a short period of time than most people would eat under similar circumstances, with episodes marked by feelings of lack of control".

In clinical trials, Vyvanse was shown to reduce the mean number of "binge days" per week from 4.79 to 0.78, compared with a reduction to 2.22 for those given a placebo.

Mitchell Mathis, director of the FDA's division of psychiatry drug products, said the approval provided physicians and patients with an effective option to curb a condition that "can cause serious health problems and difficulties with work, home, and social life".

Peter Welford, analyst at Jefferies, believes binge-eating disorder could add a peak of $500m to Vyvanse annual sales but others, including Ronny Gal at Bernstein, are more sceptical.

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