Shire pipeline ‘advancing considerably’

Shire, the UK’s third largest pharmaceutical company, has said its product pipeline is advancing “considerably” after recent approval successes and new drug submissions.

The company has announced that it plans a new phase IIIb clinical trial to assess the safety and efficacy of guanfacine extended release, which Shire has decided to market as Connexyn.

Connexyn is indicated for the treatment of attention deficit-hyperactivity disorder (ADHD), a key sector in Shire’s product portfolio which includes existing ADHD treatments like Adderall XR.

The company has also stated that it has submitted a new drug application (NDA) to the FDA for Connexyn, which would be the first once-daily selective alpha-2A-adrenoreceptor agonist, if approved.

Matthew Emmens, chief executive of Shire, remarked: “The NDA submission of guanfacine extended release is another Shire milestone in the development of our ADHD portfolio, demonstrating further our ability to execute on our strategy for continued growth.”

“With this submission, as well as the recent approval and launch of Daytrana, the regulatory submission of SPD465, and the anticipated FDA response this October concerning NRP104, we have been successful in advancing our ADHD pipeline considerably,” he added.

Last week, Shire announced it had settled a patent dispute with Barr Laboratories, which admitted it had attempted to breach Shire patents by producing a generic version of Adderall XR.

The Evening Standard described the ruling as a “huge boost” to Shire, a FTSE 100 company.

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