LONDON, UK, 7 January 2009 -- SkyePharma PLC (LSE: SKP) today 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.
Phase III studies were carried out on 288 patients in 26 European centres. The primary endpoint of the studies was to show significantly reduced morning stiffness. The results were published and, in an article in The Lancet (Lancet 2008; 371: 205-214), Buttgereit et al. concluded ‘‘... that modified release prednisone provides an improvement with respect to conventional glucocorticoids for the treatment of rheumatoid arthritis.’’
Nitec is also seeking approval for Lodotra in the U.S. and a second pivotal Phase III trial is ongoing in preparation for the filing of the New Drug Application with the U.S. Food and Drug Administration. Lodotra™ is also being developed by Nitec for the treatment of severe asthma and polymyalgia rheumatica.
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.”
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new formulations of existing products to provide a clinical advantage and life-cycle extension. The Company has twelve approved products in the areas of oral, inhalation and topical delivery. The Group’s products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com.
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. Prednisone belongs to a therapeutic class known as glucocorticoids. Glucocorticoids are used to suppress various autoimmune, inflammatory and allergic disorders by inhibiting the production of pro-inflammatory cytokines. Glucocorticoids bind to a well-characterized intercellular receptor known as the glucocorticoid receptor. Upon binding of the glucocorticoid to the receptor, this complex binds to specific DNA sequences and blocks the transcription of genes that encode for various pro-inflammatory cytokines, such as interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-a). By synchronizing prednisone delivery time with the sufferer’s elevated cytokine rhythm, Lodotra™ takes effect at a physiologically optimal point to inhibit cytokine production and thus significantly reduce symptoms.
About Nitec Pharma AG
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. Nitec’s most advanced product is Lodotra™, a circadian cytokine modulator (CCM) for the treatment of rheumatoid arthritis (RA). Nitec was originally founded in 2004 as a spin-out of Merck KGaA and is headquartered in Reinach/Basel in Switzerland. Nitec is financed by Atlas Venture, Global Life Science Ventures, NGN Capital, TVM Capital, and a principal investing arm of Deutsche Bank AG, London. For further information about Nitec Pharma please visit www.nitecpharma.com.