Nitec Pharma and technology partner SkyePharma are celebrating after receiving a recommendation for European regulatory approval for Lodotra for the treatment of rheumatoid arthritis and associated morning stiffness.

Nitec, which is based in Switzerland, noted that Lodotra (delayed-release prednisone) developed using SkyePharma’s Geoclock technology, has demonstrated a significant long-term reduction “in the most disabling symptom of RA”, namely morning stiffness of the joints and a simultaneous reduction in interleukin 6. Lodotra is taken at bedtime and its unique release mechanism releases prednisone at around 2am enabling suppression of the nocturnal proinflammatory cytokines.

Nitec chief executive Anders Harfstrand said the positive recommendation to approve Lodotra “is the achievement of ten years of challenging scientific work”. He added that the firm recently raised 24 million Swiss francs and is well-positioned to focus on Lodotra’s commercialisation in Europe “as well as its ongoing development in the USA, and label extension into severe asthma.”

The first national launch of Lodotra is expected to take place in the first half of 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 making the product at its plant in Lyon, France.

Ken Cunningham, SkyePharma’s chief executive, said the recommendation is good news for the firm and its shareholders “as it validates the potential of our proprietary Geoclock technology for making good drugs better”.