Re: Clickhaler Agreement

RNS Number:6561S
M.L. Laboratories PLC
01 December 2003


Embargoed until 0700                                             1 December 2003



 KEY REGULATORY FILING OF BUDESONIDE CLICKHALER TRIGGERS SIGNIFICANT MILESTONE
                                 PAYMENT TO ML
                                      and
               FORMOTEROL CLICKHALER REGULATORY FILING IN CANADA

ML Laboratories PLC's (MLB.L) respiratory division, Innovata Biomed ("IB"),
announces today the filing of the first application for marketing authorisation
for budesonide Clickhaler in Europe.

This filing triggers a significant milestone payment to IB by its licensee. The
first launch of budesonide Clickhaler is planned for 2005 which will trigger a
further significant milestone payment.

IB will earn double digit royalties on sales of this new presentation of
Clickhaler which will compete in a valuable market worth in excess of #450
million per annum. Currently sales of budesonide inhalers are predominantly dry
powder inhaler devices ("DPI's"). Clickhaler offers important advantages over
the other budesonide DPI's and is expected to be welcomed by prescribers.

IB also announces the regulatory filing of formoterol Clickhaler in Canada,
which is an important step towards globalisation of the Clickhaler platform.

Commenting for IB, Paul Ballington, Managing Director, said, "These are two
important steps forward for IB in addressing the valuable areas of the asthma
market. Budesonide is a popular medication and Clickhaler is a great dry powder
inhaler, and the combination represents a significant opportunity. These
achievements, expand the Clickhaler range and demonstrate, once again, that the
Clickhaler platform is suitable for a wide range of asthma medications."


For further information please contact:-
ML Laboratories PLC                                               01925 844700
Stuart Sim, Executive Chairman

Innovata Biomed                                                   01727 837341
Paul Ballington, Managing Director

Weber Shandwick Square Mile                                      020 7067 0700
Kevin Smith /Cass Helstrip

Note to editors:-

Clickhaler

Clickhaler is a proven, industrialised dry powder inhaler with many established
advantages over standard inhalers. The Clickhaler has been designed to meet the
needs of patients and to satisfy the most stringent regulatory standards. The
product has achieved regulatory approval in the EU and is already marketed with
standard asthma therapies (salbutamol and beclomethasone) in UK, Ireland and
France.

IB is a leading independent provider of inhaled drug delivery technologies to
the pharmaceutical industry. IB's proven delivery technologies are already
commercialised in some markets and available for proof of principle testing as
"fast-to-market" drug delivery solutions.

ML Laboratories PLC

ML is a pharmaceutical product development company with a track record of
successful clinical development, regulatory approval and licensing of
pharmaceutical products and a pipeline of future products targeted at specialist
markets. ML's activities are supported by a growing income stream from marketed
products it has successfully developed and licensed to other pharmaceutical
companies, which include Baxter, Shire and Celltech.

New therapeutic products in clinical development include cancer treatments, a
pain management compound prepared to enter Phase III studies, a preventative of
sexually transmitted infections, including HIV, and a phosphate binder to assist
the management of kidney failure. ML's portfolio of early stage development
projects includes unique polymer/drug molecules to provide safer and more potent
cancer chemotherapy and technologies for use in the discovery and manufacture of
biotechnology products.

In addition ML provides inhaled drug delivery solutions to the global
pharmaceutical industry through its dedicated respiratory subsidiary Innovata
Biomed.

More information about ML Laboratories PLC can be found at www.mllabs.co.uk



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

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