GSK and Pozen to develop novel migraine treatment

GlaxoSmithKline and Pozen have signed an agreement for the development and commercialisation of proprietary combinations of a triptan (5-HT1B/1D agonist) and a long-acting non-steroidal anti-inflammatory drug (NSAID) that may improve the effectiveness of acute treatment and provide sustained pain relief for migraine headaches.

The combinations covered by the agreement are among the combinations that Pozen has referred to as MT 400.

Under the terms of the agreement, GSK will have exclusive rights in the US to commercialise all combinations which combine either of GSK's currently marketed triptans, Imitrex (sumatriptan, sumatriptan succinate) or Amerge (naratriptan hydrochloride), with a long-acting NSAID. Pozen will be responsible for development, while GSK will provide formulation development and manufacturing. It is expected that the companies will commence Phase III trials under the agreement in 2004.

GSK will pay Pozen an upfront fee and an initial milestone payment totalling US$25m (€21m) in 2003 with potential milestone payments over the next few years of $55m (€47m) relating to development progress, regulatory submissions and approvals. GSK will also pay Pozen royalties on sales of marketed products, and potential sales performance milestones of up to $80m (€68m).

A Phase II clinical trial involving 972 patients showed that MT 400, using a marketed triptan and an NSAID, provided a greater than 50% improvement for sustained pain relief over triptan monotherapy with a similar side effect profile. Sustained pain relief is defined as patients achieving pain relief within two hours of dosing and neither relapsing nor using rescue medicine over the next 22 hours.