Shire of the UK has received a boost with the announcement that the European Commission has granted marketing approval to Elaprase for the long-term treatment of patients with the rare genetic disorder Hunter syndrome.
The company noted that Elaprase (idursulfase), which was launched in the US last July, is the only enzyme replacement therapy for Hunter, a disorder that causes mucopolysaccharide to build up and deposit in the tissues. It is characterised by growth problems, facial deformity and abnormal organ function and can also cause mental retardation, and in severe cases patients do not tend to live beyond 20.
Currently more than 100 patients in Europe already receive Elaprase through pre-approval access programmes and the treatment will be launched across most of the continent in 2007.
Analysts at Collins Stewart said that Shire will have peak sales for Elaprase of around $400 million by 2015, and $200 million by the end of this decade, noting that “there is a very limited chance of any competition arriving for the drug.” The broker also pointed out that more drug approvals for Shire are likely in the near future, with Mesavance (mesalamine) for ulcerative colitis likely to get the green light in the USA this month.
By the second quarter, Collins Stewart also expects Shire to have full US approval for its new attention deficit hyperactivity disorder drug Vyvanse (lisdexamfetamine dimesylate), formerly known as NRP104, the heir to Adderall XR (mixed amphetamine salts), the firm’s earnings driver which becomes genericised in 2009.
The analysts concluded by claiming that Shire would be ripe as an acquisitions target “given the heavy M&A seen within the European mid-cap pharma sector last year.”