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news.SkyePharma, a drug delivery company, has announced that its partner Nitec, a specialty pharmaceutical company, has received the final assessment report from the German BfArM, 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 European Medicines Agency's decentralized procedure.
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The first national launch of Lodotra is expected to take place in 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 manufacturing the product at its plant in Lyon, France.
Using SkyePharma’s 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.
Nitec is also seeking approval for Lodotra in the US and a second pivotal Phase III trial is ongoing in preparation for the filing of the new drug application with the FDA. Lodotra is also being developed by Nitec for the treatment of severe asthma and polymyalgia rheumatica.
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.”