Shire is celebrating the news that approvals in eight European states are imminent for its attention deficit/hyperactivity disorder blockbuster Vyvanse, which will be marketed as Elvanse.
The company has announced a positive outcome from the European decentralised procedure for Elvanse (lisdexamfetamine dimesylate). The UK Medicines and Healthcare products Regulatory Agency acted as the reference member state on behalf of seven other European countries - Denmark, Finland, Germany, Norway, Spain, Sweden and Ireland; the drug will be sold in the latter country as Tyvense.
Specifically, Elvanse is indicated "as part of a comprehensive treatment programme" for ADHD in children aged six and over when response to previous methylphenidate treatment is considered inadequate. Product labelling has been agreed by the aforementioned eight countries, which will now issue their national approvals in the next one to three months.
Angus Russell, Shire's chief executive, noted that "as all ADHD patients are different and will vary in their responses to the available treatments, we believe introducing Elvanse will provide physicians with a broader range of options". He added that "we will now work closely with the pricing and reimbursement authorities in the respective countries to ensure that Elvanse is made available to patients as soon as possible".
The UK thumbs-up, which is based on two European Phase III studies in children and adolescents with ADHD and is further supported by data from the USA, will boost the drug's already-sizeable sales. In the third quarter, Vyvanse turnover soared 24% to $247.1 million - it is the biggest-selling branded prescribed ADHD drug in the USA.
Orphan disease pact with Arrowhead
Meantime, Shire has also entered into a collaboration with the USA's Arrowhead Research Corp to develop and commercialise targeted peptide-drug conjugates. Pasadena-based Arrowhead will receive research funding and could be eligible for milestone payments of up to $32.8 million for each development candidate, plus additional milestone payments for a second indication and royalties.
Phil Vickers, head of R&D at Shire HGT (the firm's unit focused on genetic diseases), said that with this novel platform technology, the company has "the potential to move into a wider range of orphan diseases".