GlaxoSmithKline and partner Pozen Pharmaceuticals have been dealt another blow by the US Food and Drug Administration in their bid to get approval for the migraine drug Trexima.
Pozen said that the agency has completed its initial review of the firms’
response to an approvable letter issued in June for Trexima (sumatriptan
plus naproxen). The FDA feels the reply “is not yet complete” and has
“requested additional analyses and supporting information.”
On receipt of the approvable letter in the summer, Pozen plunged over 60%, but since then the stock has rallied. However, news of the latest missive from the FDA sent the shares down over 9%, although they recovered to finish just 2% down on Wednesday at $16.09.
Pozen and GSK were upbeat, saying that they will submit the revised
response before the end of 2006 so that the FDA can more fully assess the
relative safety profile of Trexima, which combines GSK’s Imitrex (sumatriptan) with the nonsteroidal anti-inflammatory, naproxen sodium, and uses Pozen’s RT Technology allowing drugs to quickly dissolve in the stomach.
In a conference call, John Plachetka, Pozen’s chief executive, said that
the problem centred around the way that the new data was presented as
opposed to any issue of safety. GSK and Pozen concluded by saying that
they continue to believe that the data for Trexima “demonstrate superior
efficacy and a safety profile comparable to sumatriptan” and they remain
hopeful of a launch in the third quarter of 2007.
New Tykerb study initiated
On a more positive note, GSK said it has initiated a Phase III study,
called TEACH, to investigate whether adjuvant treatment with its
experimental drug Tykerb (lapatinib) will improve disease-free survival in
women with early-stage HER2(ErbB2)-positive breast cancer. Approximately 3,000 women will be enrolled from more than 450 centres in more than 30 countries.
Tykerb has been filed in the USA and Europe for use in combination with Roche’s Xeloda (capecitabine) for advanced breast cancer in women who have already received other treatments. Many observers see the drug as a potential rival to Roche’s blockbuster breast cancer drug Herceptin
(trastuzumab), with the advantage of being an orally-active drug while
Herceptin is dosed by injection. Both block the HER-2 receptor, while
Tykerb also has activity against the epidermal growth factor receptor