Shire of the UK reported robust gains for its attention deficit hyperactivity disorder franchise in the third quarter, despite safety questions about its flagship Adderall XR brand and other ADHD therapies.
Sales in the third quarter rose 25% to $386 million, while total revenues were up 19% to $449 million. The performance swung Shire into a profit of $7 million, compared to a loss of $631 million a year ago as a result of write-off costs associated with its acquisition of Transkaryotic Therapies.
Shire is now forecasting 2006 revenue growth between 12% and 14%, up from earlier predictions of low-double-digit revenue growth.
Shire’s ADHD franchise grew by 28% to $224 million, with Adderall XR (mixed amphetamine salts) sales up 25% to $208 million. The company now claims a 29% share of the US prescription market for ADHD drugs, helped by the launch of ADHD patch product Daytrana (methylphenidate) which added $10 million in sales in its first quarter on the market.
Meanwhile, future growth for the franchise seems assured with three new products due for launch in 2007, including NRP104, partnered with New River Pharmaceuticals, which is awaiting labelling and scheduling approval before it can be launched in the USA.
Shire is also set to launch two other new ADHD products next year, namely SPD465 (an extended version of Adderall XR which can provide up to 16 hours of efficacy) and SPD503 (guanfacine) a novel alpha-2A-adrenoceptor agonist which would be a first-in-class non-stimulant product.
The good performance comes against a backdrop of increased scrutiny of the safety of SDGD drugs. In March this year, a US Food and Drug Administration (FDA) advisory committee recommended that new warnings be added to the labelling of drugs for ADHD to draw attention to the risk of potential adverse reactions, but stopped short of recommending a ‘black-box’ warning – the strongest available on medicine labelling – for fear of alarming patients and preventing those who could benefit from the products from receiving treatment.
But there was also good news for Shire’s non-ADHD products in the third-quarter results, with Fosrenol (lanthanum carbonate) for high blood phosphate levels seeing sales up 25% to $12 million in the quarter. The product is also capturing additional market share, according to Shire, with 9% of the US market, 15% in Sweden and 10% in Ireland. Additional launches in Europe are in the offing.
Recently launched Elaprase (idursulfase) for Hunter syndrome made its first contribution in the quarter, bringing in $4.3 million.
“Unlike its larger peers, Shire is delivering strong momentum from its pipeline, with a large number of launches next year including [anaemia drug] Dynepo in Europe,” commented analyst Navid Malik of Collins Stewart.
