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Vyvanse leads the charge at Shire in Q1

ADHD drug boosts increase in sales of 24 per cent

Shire has taken a step closer to meeting its goal of strong earnings growth in 2012, with a healthy set of first-quarter results including operating profit up 18 per cent to $362m.

Product sales rose 24 per cent to $1.1bn, with a strong showing from attention-deficit hyperactivity disorder (ADHD) product Vyvanse (lisdexamfetamine dimesylate), with which grew 29 per cent to $290m and also increased its market share to around 17 per cent from a little over 15 per cent a year ago.

Shire is in the process of setting up a head-to-head trial to compare Vyvanse to Johnson & Johnson's Concerta (methylphenidate) as it gears up to launch the drug "on a global basis", said the firm's chief executive Angus Russell on a conference call. 

Shire is now hoping to expand the Vyvanse into non-ADHD applications, and reported positive data in a phase II study in binge eating disorder, with Vyvanse achieving a significant reduction in the number of days binging per week compared to placebo.

The company is now planning to move ahead with a phase III programme in binge eating, and is also looking at the drug in major depressive disorder (phase III), negative symptom schizophrenia and excessive daytime sleepiness.

Meanwhile, another ADHD drug - Intuniv guanfacine) - also performed well in the quarter, with sales up 63 per cent to $69m and prescriptions rising 54 per cent in volume terms.

Shire is also working towards launching both Vyvanse and Intuniv in Europe and Japan, where stimulant-based treatment for ADHD is less common than in the US.

Turning to its rare disease business, Shire reported robust gains for Replagal (agalsidase alfa) for Fabry disease, up 28 per cent to $134m, and although growth going forward will be held back by the decision to withdraw its marketing application for the drug in the US, it is capturing an estimated 80 per cent of the ex-US market.

Hereditary angioedema treatment Firazyr (icatibant) also performed well since its launch in the US towards the end of last year, adding $20m in first-quarter sales, a rise of 272 per cent. Meanwhile, Elaprase (idursulfase) for Hunter syndrome and Gaucher disease treatment Vpriv (velaglucerase alfa) both grew 20 per cent-plus to $126m and $72m, respectively.

In its emerging regenerative medicine business, Shire noted that recently-acquired regenerative medicine product Dermagraft contributed $49m in the quarter, up 10 per cent on the same period of 2011. Dermagraft is due to receive its first significant ex-US launch - in Canada - before the end of the year.

The firm recently added to its portfolio in this area by acquiring Pervasis Therapeutics, including its Vascugel therapy for vascular repair in patients on haemodialysis which is in phase II.

"We've made a strong start to the year and reiterate our expectation of good earnings growth in 2012," said Russell.

27th April 2012

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