LONDON--(Marketwire - March 31, 2009) -
Lodotra™ Outlicensed by Nitec to Mundipharma in Europe
LONDON, UK, 31 March -- SkyePharma PLC (LSE: SKP) notes
the announcement earlier today by its partner Nitec Pharma AG ("Nitec")
that an exclusive license has been granted to Mundipharma International
Corporation Limited ("Mundipharma") for the distribution of Lodotra™
in Europe, excluding Germany and Austria which are licensed to Merck
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™, a
novel delayed-release, low-dose prednisone tablet, was recommended for
European regulatory approval for the treatment of rheumatoid arthritis
and associated morning stiffness in January 2009. Germany was the
reference member state for the Decentralised Procedure and Lodotra™
is now also considered approvable by the regulatory agencies of 14 other
countries. Lodotra™ is expected to be launched in Germany within the
next few weeks.
Dr. Ken Cunningham, CEO of SkyePharma said, "We are delighted by
this agreement between our two partners, Nitec and Mundipharma, for
the out-licensing of Lodotra™ in the remaining 14 European countries
due to approve the product under the Decentralised Procedure. Using
SkyePharma's Geoclock™ release technology, we believe Lodotra™ is
promising news for people suffering from the pain of rheumatoid
arthritis and the related morning stiffness."
For further information please contact:
SkyePharma PLC Ken Cunningham +44 20 7491 1777
Financial Dynamics Jonathan Birt +44 20 7831 3113
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 Group 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 (CCM), which can be taken
at bedtime. Lodotra™'s unique release mechanism releases the
glucocorticoid prednisone during the night around 2am enabling
suppression of the nocturnal proinflammatory cytokines. This results in
an effective relief of the early morning symptoms of RA, in addition to
the well established treatment effects of glucocorticoids.
This information is provided by RNS
The company news service from the London Stock Exchange