Tuesday, January 06, 2015

UpdatesPlus Psoriasis - Leo continues to defend its Taclonex brand by filing NDA for foam formulation of calcipotriene/betamethasone dipropionate

  • Leo has submitted an NDA for calcipotriene/betamethasone dipropionate aerosol foam (0.005%/0.064%), LEO 90100 as a treatment of psoriasis [link]
  • This is the first aerosol foam formulation of a fixed combination calcipotriene/betamethasone dipropionate
  • The NDA is supported by the Phase 3a PSO-FAST efficacy/safety and Phase 2 MUSE safety studies
  • Regulatory filings in Europe and other countries are planned in 2015/2016

Comments:  Leo has previously marketed calcipotriene/betamethasone dipropionate ointment but the FDA approved Tolmar's generic in Jan 2014 which was launched in partnership with Sandoz on April 1st 2014.  Tolmar's 180d period of exclusivity started at launch and expired Sept 28th 2014.  Perrigo subsequently received approval for a second generic in Dec 2014.  Leo's defense against generic calcipotriene/betamethasone ointments has been to launch a gel formulation which is claimed to be preferred by patients over ointment formulations.  Foam formulations may offer further benefits of improved application without requiring rubbing onto the skin which may reduce irritation to large and sensitive skin surfaces.  We suspect that the gel formulation may be focused on scalp psoriasis, while the foam will be targeted to other areas.  Of note a further Phase 3 study completed enrollment in Dec 2014 and is expected to reach its primary endpoint this month.  This study has an active control arm (contrasting with PSO-FAST which was placebo controlled).  We suggest that this study will be included in the EU regulatory dossier

This alert is from our UpdatesPlus-Psoriasis service.  UpdatesPlus offers A unique and affordable combination of information monitoring and expert analysis across 14 therapy areas [further information]

To access our most recent 121 slide report on recent advances in psoriasis please contact fiona.watts@leaddiscovery.co.uk


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