?Geoclock's delayed release product gains approval in Europe
SkyePharma partner Nitec has received the Final Assessment Report from the German Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM), concluding that Lodotra is approvable for the treatment of rheumatoid arthritis and associated morning stiffness, in 15 European countries.
SkyePharma partner Nitec has received the Final Assessment Report from the German Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM), concluding that Lodotra is approvable for the treatment of rheumatoid arthritis and associated morning stiffness, in 15 European countries.
Germany will be the Reference Member State, under the EMEA's Decentralised Procedure. The first national launch of Lodotra is expected to take place in 2009 in Germany by Merck KGaA, Nitec's partner for that region.
SkyePharma will receive a mid- single digit percentage royalty on net sales and is manufacturing the product at its plant in Lyon, France.
Using SkyePharma's proprietary Geoclock technology, Lodotra takes the form of a tablet that, once ingested, does not release the active ingredient, prednisone, until approximately four hours later. The drug has been designed so that maximum plasma levels are reached six hours after intake. This enables a patient to swallow the tablet at 10pm before going to sleep, with the dose of prednisone not being released until 2am, reaching maximum plasma levels at 4am, which is regarded as the optimal timing to relieve the stiffness and pain on waking.
The night-time release formulation is especially suited to the treatment of early morning stiffness associated with rheumatoid arthritis, caused by the marked release of inflammatory cytokines, including interleukin-6 (IL-6), in the early hours of the morning.