Phase III Clinical Trials
June 27 2003 - 2:00AM
UK Regulatory
RNS Number:8498M
Skyepharma PLC
27 June 2003
For Immediate Release 27 June, 2003
SkyePharma Announces Initiation of Phase III
Clinical Trial for GlaxoSmithKline Requip(R) OCR
LONDON, ENGLAND, June 27, 2003 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) today
announces the initiation of Phase III clinical trials of the oral controlled
release formulation of GlaxoSmithKline's Requip(R) (Ropinirole HCl). The new
once daily formulation for Parkinson's disease has been developed utilizing
SkyePharma's GeomatrixTM technology. Requip(R) OCR is expected to simplify the
treatment regime for patients using this drug, thus improving patient
convenience and compliance.
Michael R.D. Ashton, SkyePharma's chief executive officer commented: "The
initiation of the Phase III study represents a significant milestone in the
development of Requip(R) and validation of the therapeutic advances obtained by
formulating major drugs with our GeomatrixTM oral drug delivery platform.
Moreover, it brings yet another SkyePharma improved formulation closer to
commercialization."
Requip(R) is indicated for the treatment of Parkinson's disease, both as initial
monotherapy in early stage patients and as adjunct therapy, with L-dopa, to
control motor fluctuations. It was first launched in 1997 in the US and most
European countries. Requip(R) has been proven effective in controlling tremors,
muscle stiffness and impaired balance associated with Parkinson's disease.
Parkinson's disease is a chronic, progressive disease in which the degeneration
of nerve cells in the brain eventually impairs the ability to control body
movements. The primary symptoms are tremors in the arms, legs, hands and face;
rigidity or stiffness of the limbs and torso; slowness of movement; and impaired
balance and co-ordination.
Notes to Editors
About SkyePharma
SkyePharma PLC uses its world-leading drug delivery technology to develop
easier-to-use and more effective formulations of drugs. The majority of
challenges faced in the formulation and delivery of drugs can be addressed by
one of the Company's proprietary technologies in the areas of oral, injectable,
inhaled and topical delivery, supported by advanced solubilisation capabilities.
For more information, visit http://www.skyepharma.com.
About GeomatrixTM
GeomatrixTM controlled release systems control the amount, timing and location
of drug release into the body. This is achieved by constructing a tablet with
two basic components: a core containing the active drug or drugs, and one or two
additional barrier layers that control the drugs' diffusion out of the core.
Tablets with a wide range of predictable and reproducible drug release profiles
can be made by combining different chemical components in the core and barrier
layers, each with a different rate of swelling, gelling and erosion.
About GlaxoSmithKline
GlaxoSmithKline, one of the world's leading research-based pharmaceutical and
health care companies, is committed to improving the quality of human life by
enabling people to do more, feel better and live longer. For further information
visit: http://www.gsk.com.
This press release may contain forward-looking statements regarding SkyePharma
PLC and its technologies. Actual results may differ materially from those
described in the press release as a result of a number of factors, including but
not limited to the following: There can be no assurance that SkyePharma will
exercise its option to sign a technology access and license agreement for
micro-encapsulation technology, nor that any product will be successfully
developed incorporating micro-encapsulation technology, or that final results of
human clinical trials will result in the regulatory approvals required to market
products, or that final regulatory approval will be received in a timely manner,
if at all, or that patient and physician acceptance of these products will be
achieved. The Company undertakes no obligation to revise or update any such
forward-looking statement to reflect events or circumstances after the date of
this release.
For further information please contact:
SkyePharma PLC +44 207 491 1777
Michael Ashton, Chief Executive Officer
Peter Laing, Director of Corporate Communications
Sandra Haughton, US Investor Relations +1 212 753 5780
Buchanan Communications +44 207 466 5000
Tim Anderson / Nicola How
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCEAXKKAEPDEFE