Skyepharma PLC announces European Product Approval

First GeoclockTM Product, LodotraTM, Approved in Europe

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 fur Arzneimittel und Medizinprodukte),
concluding that LodotraTM 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 GeoclockTM technology, LodotraTM takes
the form of a specially formulated tablet which, once ingested, does not
release the active ingredient, prednisone, until approximately four
hours later. LodotraTM 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.
LodotraTM 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 LodotraTM, the first GeoclockTM 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 LodotraTM. It is also good news for SkyePharma and
its shareholders as it validates the potential of our proprietary
GeoclockTM technology for making good drugs better."

For further information please contact:

SkyePharma PLC       Ken Cunningham  +44 20 7491 1777

During office hours  Peter Grant

Financial Dynamics   David Yates     +44 20 7831 3113

Outside office hours Jonathan Birt

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.

About LodotraTM

LodotraTM 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, LodotraTM 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 LodotraTM, 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.


                    This information is provided by RNS
          The company news service from the London Stock Exchange

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