RNS Number:3891M
Skyepharma PLC
16 June 2003


For Immediate Release                           16 June, 2003


                   FDA approves Sanofi-Synthelabo's Uroxatral


LONDON, ENGLAND, June 16, 2003 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)
announced today that the US Food and Drug Administration (FDA) has approved
Sanofi-Synthelabo's New Drug Application (NDA) for alfuzosin hydrochloride
extended-release tablets, to be marketed in the US as UroXatral. The 10 mg
once-daily extended-release formulation was developed for Sanofi-Synthelabo by
SkyePharma and involves SkyePharma's proprietary Geomatrix oral
controlled-release drug drug delivery technology. SkyePharma earns a royalty on
Sanofi-Synthelabo's global sales of the once-daily formulation of alfuzosin.


Alfuzosin is indicated for the treatment of the signs and symptoms of benign
prostatic hyperplasia (BPH). Alfuzosin selectively blocks alpha1-adrenergic
receptors in the lower urinary tract. Blockade of these adrenoreceptors can
cause smooth muscle in the bladder neck and prostate to relax, resulting in an
improvement in urine flow and a reduction in the symptoms of BPH. BPH is a very
common disorder, leading to urinary symptoms of varying severity. The resulting
symptoms affect 22% of men aged 50-59 years, but up to 45% of men aged 70-80
years. These symptoms may have an impact on men's day-to-day activities and may
ultimately lead to serious complications such as acute urinary retention.


Clinical efficacy data for alfuzosin from placebo-controlled trials have
demonstrated efficacy compared to placebo in urinary flow improvement and in
improvement in urinary symptoms without the need for dose titration. In the
clinical trials, the most common side effects occurring more frequently than
placebo were dizziness, upper respiratory tract infection, headache and fatigue.


Alfuzosin is marketed in more than 80 countries throughout Europe, Latin
America, Africa and Asia. Outside of the United States, the once-daily
formulation (Xatral OD) is registered in 70 countries worldwide and is currently
marketed in 14 countries in Europe and in more than 35 other countries. Total
sales of alfuzosin reached 182 million euros in 2002 and 49 million euros in the
first quarter of 2003.


Sanofi-Synthelabo has indicated that the launch of UroXatral in the United
States will occur in the second half of 2003.


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 Geomatrix


Geomatrix oral 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 drug's 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 rates of swelling, gelling and
erosion.


About Sanofi-Synthelabo


Sanofi-Synthelabo is a major global research-based pharmaceutical group with
32,500 employees in more than 100 countries. The company is headquartered in
Paris and listed in Paris (Euronext: SAN) and in New York (NYSE: SNY). With
consolidated sales of EUR 7.4 billion in 2002, Sanofi-Synthelabo ranks 7th in
Europe and among the world's top 20 pharmaceutical companies. With an R&D
portfolio of 52 compounds in development, Sanofi-Synthelabo is focused on a core
group of four therapeutic areas: cardiovascular disease and thrombosis; diseases
of the central nervous system; internal medicine; and oncology.



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
MSCILFERRSIRLIV