Keywords: Shire, Third quarter 2009 results, Adderall

Shire’s new drugs offset slumping Adderall in 3rd quarter 2009

Article | 2 November 2009

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Shire, the UK’s third largest drugmaker, posted revenues from continuing operations for the three months to September 30, 2009 down 14% to $667.0 million (2008: $778.6 million), due to the decline in branded Adderall XR (amphetamine and dextroamphetamine), used to treat narcolepsy and attention deficit hyperactivity disorder (ADHD), following the launch of an authorized generic version by Teva in April 2009. However, core product sales increased by 20% to $531.6 million, noted the company, which saw its share price rise 4.7% to £10.72 on the day of the announcement, October 30.

Non GAAP operating income decreased 52% to $133.6 million. Increased revenues from core products, combined with lower selling, general and administrative expenses achieved through continued focus on cost management partially offset the impact of lower revenues from Adderall XR and increased investment in R&D, in part reflecting the Santaris collaboration up-front costs and the acceleration of the velaglucerase program, said Shire.

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Product sales including Adderall XR, were down 15% to $603 million, as the Adderall range slumped 74% $71 million. Vyvanse (lisdexamfetamine) turnover jumped 34% to $129 million, Lialda/Mezavant (mesalamine) was up 62% to $65 million, Elaprase (idursulfase) increased 16% to $91 million and turnover of Replagal (agalsidase alfa) advanced 8% to $48 million.

Angus Russell, chief executive, commented: “Shire continues to deliver excellent growth from its core products, which were up 20% over an exceptionally strong third quarter 2008. This performance reflects our transformation in the past few years into a global biopharmaceutical company with a proven differentiated strategy and a balanced portfolio of new products which is protected by strong exclusivity and patent protection.”

He added: “Following US approval of Intuniv (guanfacine), our new ADHD treatment, we are preparing for the US launch next week. Intuniv adds a new choice of treatment for physicians and patients within our market-leading branded portfolio of ADHD products. We have also continued to grow Vyvanse’s market share which is now 13.4%, benefiting from both the ‘back to school’ season and strong 10% ADHD market growth.”

“Our HGT business continues to deliver; a New Drug Application for velaglucerase alfa, for Gaucher disease, was filed with the Food and Drug Administration at the end of August. Velaglucerase alfa is available ahead of its commercial launch in the USA via a treatment protocol and elsewhere on a pre-approval access basis. We are supporting the Fabry disease community with a stronger uptake of Replagal in Europe. In the USA, a treatment protocol has been approved, enabling immediate access to the drug. In addition we plan to file a Biologics License Application with the FDA for Replagal by the end of the year,” Mr Russell stated.