RNS Number:5740R
Skyepharma PLC
3 November 2003


For Immediate Release                                3 November, 2003



                                 SkyePharma PLC



                Sanofi-Synthelabo launches Uroxatral(R) in USA



LONDON, ENGLAND, November 3, 2003 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)
announces that Sanofi-Synthelabo (Euronext: SASY; NYSE: SNY) has launched
Uroxatral(R) (alfuzosin hydrochloride) in the US market for the relief of
urinary symptoms associated with benign prostatic hypertrophy ("BPH"), a common
condition affecting middle-aged males. Uroxatral(R) was approved by the US Food
& Drug Administration ("FDA") on 16 June. The 10 mg once-daily extended-release
formulation was developed for Sanofi-Synthelabo by SkyePharma and involves
SkyePharma's proprietary GeoMatrixTM oral controlled-release delivery
technology. SkyePharma receives a royalty on Sanofi-Synthelabo's global sales of
the once-daily formulation of alfuzosin (known as Xatral(R) OD outside the
USA).



Michael R.D. Ashton, SkyePharma's chief executive officer, commented "We are
excited by the launch of Uroxatral(R) representing another product being
introduced into the US market utilising SkyePharma's GeomatrixTM drug delivery
technology.  The market for products for the effective relief of the signs and
symptoms of BPH, already a common condition, is increasing due to an ageing
population. Alfuzosin is an effective treatment with a low incidence of
side-effects and the once-daily formulation we developed for Sanofi-Synthelabo
has enabled a significant increase in Xatral(R)'s share of market outside the
US, we therefore see a great opportunity for this important new product in the
US. Rising royalty income from Xatral(R) OD and Uroxatral(R) will be a key
part of moving SkyePharma closer to its goal of having the greater proportion of
our earnings derived from product-related revenues."



BPH is a common chronic condition that typically first affects males in middle
age. Thereafter the incidence rises steeply with age. Gradual enlargement of the
prostate gland causes progressive obstruction of the urethra. Patients feel the
need for frequent micturition but this results in incomplete emptying of the
bladder. The urinary symptoms of BPH affect 22% of men aged 50-59 but 45% of men
aged 70-80. Alfuzosin is not a primary treatment for enlarged prostate but
addresses the urinary symptoms by selectively blocking alpha-1 adrenergic
receptors in smooth muscle of the urinary tract, causing smooth muscle in the
bladder neck and prostate to relax and thereby improving urine flow. Extensive
clinical studies conducted by Sanofi-Synthelabo have demonstrated that alfuzosin
has a high degree of selectivity for urinary tract smooth muscle, resulting in a
low incidence of vasodilatory side-effects such as postural hypotension and
syncope (fainting) that can affect patients treated with competing less
selective alpha blockers. In addition alfuzosin has a low risk of sexual
side-effects whereas impotence and ejaculatory disorders are well-recognized
side-effects of some other alpha-blockers (and also of alternative treatments
for BPH). Alfuzosin is also in late-stage clinical trials for a second related
indication, acute urinary retention. Alfuzosin is the only alpha-1 blocker that
has been shown in clinical trials to result in a significant decrease in
post-void residual urine volume, a known risk factor for acute urinary
retention.



IMS estimates that the US market for treatments for BPH is currently in excess
of US$1.0 billion, two-thirds of which comes from sales of alpha-blockers.  A
2002 analysis by Theta Reports estimated that by 2006 approximately 115 million
men in the 50+ age bracket will suffer from BPH and that even though BPH is not
life-threatening, the rising incidence will drive the value of the global market
to nearly $10 billion. Sanofi-Synthelabo has marketed alfuzosin as Xatral(R) 
outside the USA since 1988. Xatral(R)  was initially introduced as a three times
a day formulation and subsequently a twice-daily formulation was marketed.
Xatral(R) OD, the once a day formulation developed by SkyePharma for
Sanofi-Synthelabo, was launched in Europe in April 2000 and is now on the market
in Europe and certain territories in Africa, the Middle East, Asia, Latin
America and Canada. For the first nine months of 2003, Sanofi-Synthelabo's sales
of Xatral(R) in all forms outside the USA were Euro156 mn. No version of
Xatral(R) has previously been marketed in the USA.



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 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 rate of swelling, gelling and erosion.



About Sanofi-Synthelabo

With 2002 annual sales in excess of $8.4 billion and 33,000 employees in more
than 100 countries, Sanofi-Synthelabo ranks among the world's top 20
pharmaceutical companies and the top seven pharmaceutical companies in Europe.
World headquarters are in Paris, France. The Sanofi-Synthelabo group is a major
player on the world's pharmaceutical market, especially in four fields of
expertise: cardiovascular/thrombosis, central nervous system, internal medicine
and oncology. For further information, visit http://www.sanofi-synthelabo.com.



Except for the historical information herein, the matters discussed in this news
release include forward-looking statements that may involve a number of risks
and uncertainties. Actual results may vary significantly based upon a number of
factors, which are described in SkyePharma's 20-F and other documents on file
with the SEC. These include without limitation risks in obtaining and
maintaining regulatory approval for existing, new or expanded indications for
its products, other regulatory risks, risks relating to SkyePharma's ability to
manufacture pharmaceutical products on a large scale, risks that customer
inventory will be greater than previously thought, risks concerning SkyePharma's
ability to manage growth, market a pharmaceutical product on a large scale and
integrate and manage an internal sales and marketing organization and maintain
or expand sales and market share for its products, risks relating to the ability
to ensure regulatory compliance, risks related to the research, development and
regulatory approval of new pharmaceutical products, risks related to research
and development costs and capabilities, market acceptance of and continuing
demand for SkyePharma's products and the impact of increased competition, risks
associated with anticipated top and bottom line growth and the possibility that
upside potential will not be achieved, competitive products and pricing, and
risks associated with the ownership and use of intellectual property rights.
SkyePharma 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 / Mark Court




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

PRLWUGMCUUPWGMG