UK drugmaker Shire has posted a mixed bag of results for the third quarter of the year as strong growth of its core products was masked by plummeting sales of its attention-deficit hyperactivity disorder drug Adderall XR.

The revenue stream from the firm’s flagship drugs swelled 20% (or +23% at constant exchange rates) to $532 million for the period, driven by solid performances from: ADHD therapy Vyvanse (lisdexamfetamine dimesylate), up 34% to $129 million; Lialda/Mezavant (mesalazine) for ulcerative colitis, +62% to $65 million; Elaprase (idursulfase) for Hunter syndrome, +16% to $91 million (+20% at CER); and Fabry disease treatment Replagal (agalsidase alfa), +8% to $48 million (+15% at CER).

On the down side, however, sales of Shire’s one-time big earner Adderall XR continued to take a beating from generic competition, dropping 74% to $71 million, and this, coupled with a much higher investment in R&D in the quarter - including an up-front payment of $6.5 million to Santaris for technology access and R&D funding in August - drove operating income down 52% to $134 million.

Nevertheless, the company, which closed the third quarter with cash of $372 million in its back pocket – an increase of $124.6 million over the year-ago period – remains optimistic about the year ahead, and with good reason, as a spate of expected launches in 2010 could help to bolster sales and overcome the loss of Adderall revenues.

First off the block, the firm is preparing to launch its new ADHD drug Intuniv (guanfacine) Extended Release Tablets in the US this week after receiving the regulatory green light for the treatment of the disorder in children and adolescents aged six to 17 years back in September.

In addition, European regulators have recently extended the license for the phosphate binder Fosrenol – sales of which were up 11% to $47.7 million in the quarter - to include the control of hyperphosphataemia in patients who are not receiving dialysis, further expanding its market potential.

And looking forward, Shire is expecting approval of its enzyme replacement therapy velaglucerase alfa for the treatment of Gaucher disease on both sides of the Atlantic as well as Replagal (agalsidase alfa) for Fabry disease in the US in 2010. Both these drugs are already available ahead of launch on a pre-approval basis in certain territories to help fill the void left by severe shortages of Genzyme’s drugs for these disorders, after viral contamination of a bioreactor forced the temporary shut down of its manufacturing plant.

Growing ADHD portfolio
Furthermore, the group also anticipates further expanding its ADHD franchise next year with the launch of Daytrana (methylphenidate) for adolescents in the US in 2010, Vyvanse in ex-US and ex-EU regions and the further introduction of Equasym (methylphenidate) in Europe, as well as the continued roll out of Mezavant for ulcerative colitis in certain EU and rest of world countries and Firazyr (icatibant) for the symptomatic treatment of acute attacks of HAE (a potentially life-threatening genetic disease characterised by spontaneous and recurring attacks of oedema) in certain European and Latin American regions.

Commenting on the Shire’s results for the period and outlook for the year, chief executive Angus Russell said the group’s performance reflects its transformation 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”, and that growth of its core products “and continued pro-active cost management are positioning us well to deliver on our unchanged guidance framework for 2009 and our aspiration of growing sales in the mid-teens range on average between 2009 and 2015”.