Shire's plans to sell its blockbuster attention deficit hyperactivity disorder drug Vyvanse in Europe has advanced with the news that the drug, to be called Venvanse, has been accepted for review.
The company announced the acceptance for review of Venvanse (lisdexamfetamine dimesylate) by the UK's Medicines Healthcare products Regulatory Agency. The MHRA will act as the reference member state for the decentralised procedure which will initially include eight European countries.
Shire's application follows the successful completion of a European Phase III study of the drug in children and adolescents with ADHD last year. Sales of the long-acting prodrug stimulant in the third quarter rose 32% to just shy of $200 million and it is currently commercialised in the USA, Canada and Brazil.
Mike Yasick, head of Shire’s ADHD business unit, said the regulatory submission in Europe is an important milestone for the company and for physicians "who are seeking alternative treatments to help their patients diagnosed with ADHD".
Meantime, analysts at Credit Suisse have issued a research note saying that “Shire remains our favoured name". Their enthusiasm for the stock is based on continued growth in the adult ADHD market "and continued supply issues for competitor Sanofi in the enzyme replacement market".
The broker added that it continues to assume full generic competition to Vyvanse predecessor Adderall XR (mixed amphetamine salts) in 2011 but acknowledge this may not appear until 2014.