SkyePharma PLC (LSE: SKP; Nasdaq: SKYE) today announces positive results of a Phase III clinical trial for Lodotra(TM), a new, modified-release tablet that has been
developed in partnership with Nitec Pharma to optimize the efficacy of
orally administered low-dose prednisone in Rheumatoid Arthritis (RA).
Lodotra uses SkyePharma's proprietary GEOCLOCK(TM) technology and has been
filed with regulatory authorities in August by Nitec Pharma AG, which is a
specialist pharmaceutical company focused on the treatment of chronic
inflammatory diseases.
Lodotra provides all the benefits of standard immediate release (IR)
prednisone but has the additional, clinically important advantage of
significantly reducing morning symptoms combined with a convenient dosing
regimen.
The diurnal rhythm in RA is characterised by elevated night time levels
of inflammatory cytokines such as IL6, which leads to extreme stiffness and
pain in the hours immediately after waking. It has been established that
these morning symptoms can be addressed with prednisone administered at
2am. However, until now this has been impossible without disturbing sleep.
Lodotra is an oral medication that has a unique delivery system ensuring
rapid release of the prednisone from the tablet core about 4 hours after
ingestion. Administration of Lodotra at bed time results in a release of
prednisone at about 2am for a more effective treatment of the morning
symptoms of RA.
The trial involved 288 patients in 26 centres in Europe, and was a
randomized, double-blind, active-controlled, parallel-group Phase III
study. The study compared the efficacy and safety of Lodotra given to
patients before sleep the evening before, with standard immediate-release
(IR) prednisone (following the current recommended regimen where prednisone
is administered in the morning at 8am) over a period of 12 weeks. The
duration of morning stiffness (the primary clinical endpoint of the study)
was significantly reduced in the Lodotra group while under standard IR
prednisone no change in morning stiffness was shown. In half the patients a
reduction of more than one hour or one third was observed and those
patients also showed a reduction in pain of one third. Lodotra was also
shown to be well tolerated and just as safe as the standard regimen.
Importantly, IL6 levels were shown to be reduced in the Lodotra group but
remained constant in the standard prednisone group indicating that this
reformulation of prednisone was exerting a specific inhibitory action on
what is thought to be a key biological marker of the inflammatory process
in RA.
Frank Condella, CEO, SkyePharma said:
"We are extremely pleased with this validation of our GEOCLOCK(TM)
technology in this area of high unmet need, through these successful Phase
III trials and the filing in the EU. Lodotra(TM) should be the first
commercial exploitation of our GEOCLOCK(TM) technology which has the
potential to be applied across a wide range of therapeutic needs."
Prof. Frank Buttgereit, Charite Berlin; principal investigator in the
study commented:
"These results confirm the hypothesis that the adaptation of the timing
of oral glucocorticoids to the circadian rhythms in RA could lead to a more
effective therapy without increasing the dose of prednisone. The benefit of
Lodotra results in a clinically relevant reduction of morning stiffness
added to all known therapeutic effects of IR prednisone. The new
administration mode is also convenient for the patient and was well
tolerated."
Jochen Mattis, co-founder and Head of Marketing of Nitec Pharma said:
"We are delighted to have such positive results in a Phase III trial
and have already submitted a dossier for marketing authorisation in Europe
in August. We also plan to seek marketing authorisation for North America
and the Far East. We will also be seeking marketing partners to realise the
commercial value of Lodotra worldwide, in addition to the agreement we
already have with Merck KGaA in Germany and Austria."
Lodotra has originally been developed through a partnership between
SkyePharma and Merck KGaA until 2004 when Nitec Pharma was spun out of
Merck.
About SkyePharma
SkyePharma PLC develops pharmaceutical products benefiting from world-
leading drug delivery technologies that provide easier-to-use and more
effective drug formulations. There are now twelve approved products
incorporating SkyePharma's technologies in the areas of oral, injectable,
inhaled and topical delivery, supported by advanced solubilisation
capabilities. For more information, visit skyepharma.
About Nitec Pharma AG
Nitec Pharma is a specialist pharmaceutical company created in 2004 in
a spin out from Merck KGaA, financed by Atlas Venture and Global Life
Science Ventures. Lodotra was originally developed by Merck in cooperation
with SkyePharma using SkyePharma's proprietary GEOCLOCK(TM) technology.
Certain statements in this news release are forward-looking statements
and are made in reliance on the safe harbour provisions of the U.S. Private
Securities Litigation Act of 1995. Although SkyePharma believes that the
expectations reflected in these forward-looking statements are reasonable,
it can give no assurance that these expectations will materialize. Because
the expectations are subject to risks and uncertainties, actual results may
vary significantly from those expressed or implied by the forward-looking
statements based upon a number of factors, which are described in
SkyePharma's 20-F and other documents on file with the SEC. Factors that
could cause differences between actual results and those implied by the
forward-looking statements contained in this news release include, without
limitation, risks related to the development of new products, risks related
to obtaining and maintaining regulatory approval for existing, new or
expanded indications of existing and new products, risks related to
SkyePharma's ability to manufacture products on a large scale or at all,
risks related to SkyePharma's and its marketing partners' ability to market
products on a large scale to maintain or expand market share in the face of
changes in customer requirements, competition and technological change,
risks related to regulatory compliance, the risk of product liability
claims, risks related to the ownership and use of intellectual property,
and risks related to SkyePharma's ability to manage growth. SkyePharma
undertakes no obligation to revise or update any such forward-looking
statement to reflect events or circumstances after the date of this
release.
SkyePharma PLC
skyepharma
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