SkyePharma PLC announces that its partner Nitec has received the Final Assessment Report from the German BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), concluding that Lodotra is approvable for the treatment of rheumatoid arthritis and associated morning stiffness, in 15 European countries, including Germany as the Reference Member State, under the EMEA's Decentralised Procedure.
Marketing Authorisations are granted following this procedure on a country by country basis. The first national launch of Lodotra is expected to take place in H1 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 specially formulated tablet which, once ingested, does not release the active ingredient, prednisone, until approximately four hours later. Lodotra 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. This night-time release formulation is especially suited to the treatment of early morning stiffness, which is associated with rheumatoid arthritis, caused by the marked release of inflammatory cytokines, including interleukin-6 (IL-6), in the early hours of the morning.
Dr Ken Cunningham, CEO of SkyePharma said, "We are delighted to announce the approval of Lodotra, the first Geoclock product. This is good news for sufferers of rheumatoid arthritis who we hope will receive significant reductions in pain and early morning stiffness through the use of Lodotra. It is also good news for SkyePharma and its shareholders as it validates the potential of our proprietary Geoclock technology for making good drugs better."
Using its proprietary drug delivery technologies, SkyePharma develops new formulations of existing products to provide a clinical advantage and life-cycle extension.
Lodotra is a circadian cytokine modulator, a novel single-pulse night-time release formulation of low dose prednisone, a proven and effective compound for the treatment of rheumatoid arthritis, severe asthma and polymyalgia rheumatica, which is safe at low doses.
Nitec Pharma is a Switzerland-based specialty pharmaceutical company focused on the development and commercialisation of innovative medicines and effective treatment solutions for chronic inflammation and pain-related diseases.