Print

Print


SMITHKLINE BEECHAM AND SKYEPHARMA SIGN AGREEMENT
TO DEVELOP ONCE DAILY REQUIP®

LONDON, 13 September 1999 - SmithKline Beecham (SB) and SkyePharma PLC
announced today that they have entered into a development and licensing
agreement for a once-daily version of SB’s anti-Parkinsonion drug, Requip
(ropinirole), using SkyePharma’s GEOMATRIX oral delivery technology. The new
formulation is expected to provide a simplified regime for patients on
Requip therapy thus improving patient convenience.

Under the terms of the agreement, SkyePharma will be responsible for all
development activities for Requip oral controlled release tablets up to
regulatory filing in collaboration with SB. The terms of the agreement
provide for:
- An equity investment by SB of $8 million in SkyePharma equity.
- SkyePharma to receive milestone payments at intervals up to product
approval, including an upfront payment. - On commercialisation of once-daily
Requip, SkyePharma will receive royalties on product sales.

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.

Requip 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 and is currently administered three times
daily. Requip has been proven effective in controlling tremors, muscle
stiffness and impaired balance associated with Parkinson’s disease.

A recent major five-year study shows that patients who completed the study
on Requip alone were 15 times less likely to produce the involuntary,
jerking movements (dyskinesias) that are a debilitating side effect of the
current standard treatment (L-dopa) for Parkinson’s disease. In all patients
both drugs were similarly effective in treating the underlying symptoms of
the disease.

Ian Gowrie-Smith, Chairman of SkyePharma said: "We are delighted that
SmithKline Beecham has entrusted the development of Requip oral controlled
release tablets to us. Their decision to take an equity position in
SkyePharma is a further validation of their confidence in our capabilities
in developing novel delivery profiles for products such as Paxil and now
Requip."

"We believe that in SkyePharma we have partnered with a company that has the
commitment and capability to develop a controlled release version of Requip
expeditiously, maximising the potential of this compound in Parkinson’s
disease, "said Dr Tachi Yamada, Chairman, R&D, SB Pharmaceuticals.

SmithKline Beecham - one of the world’s leading healthcare companies -
discovers, develops, manufactures and markets pharmaceuticals, vaccines,
over-the-counter medicines and health-related consumer products. For company
information, visit SmithKline Beecham on the World Wide Web at www.sb.com.

SkyePharma - one of the world’s leading drug delivery companies, develops
and manufactures advanced drug delivery solutions. Its technologies include
oral, injectable and inhalation controlled-release systems. For company
information, visit SkyePharma on the World Wide Web at www.skyepharma.com

© 1999 SmithKline Beecham
All rights reserved
September 13, 1999