Distribution Agreement

RNS Number:7144X
Provalis PLC
19 April 2004


For Immediate Release                                            19 April 2004


       Provalis' Pharmaceuticals Business Appointed Exclusive Distributor
                      of Erdotin(R) in the UK and Ireland
                                        
Erdotin(R) is a new generation respiratory treatment for COPD with the potential
to replace the profits from Provalis' sales of the Dr Falk Pharma product range

Provalis plc (LSE: PRO; NASDAQ: PVLS), the Medical Diagnostics and
Pharmaceuticals Group, is pleased to announce that its Pharmaceuticals business
has entered into an agreement with Edmond Pharma SpA under which Provalis will
distribute Erdotin(R) in the UK and Republic of Ireland. The agreement is for a
minimum of 10 years, with Provalis the exclusive distributor for the first 5
years, and includes an option for Provalis to purchase the product, under
pre-agreed terms, after the end of the third year. Under the Agreement, Provalis
is to pay Euro200,000 to Edmond Pharma as a contribution towards development and
regulatory costs; this will be paid by instalments against certain regulatory
milestones.

Erdotin(R) (active ingredient erdosteine) is one of the latest generation of
mucolytic agents and has a wide application in a number of respiratory diseases.
Erdotin(R)'s major indication is as a treatment for chronic bronchitis or chronic
obstructive pulmonary disease (COPD) and will be promoted by Provalis'
representative sales force into the primary and secondary care markets.

Although products containing erdosteine have been available in a number of
European markets for some time, the lack of reimbursement in the UK made that
market unattractive. This changed when the UK authorities reinstated
reimbursement on mucolytic agents in March 2003. Erdotin(R) is currently
undergoing European MRP registration, and launch of the product is anticipated
at the beginning of 2005, which would make Erdotin(R) one of the first of this
next generation of products available in the UK.

Phil Gould, Chief Executive Officer of Provalis, commented, "We are pleased that
we have secured this new generation mucolytic product for Provalis. Over the
next 2 to 3 years, Erdotin(R) has the potential to replace the profits from
Provalis' sales of the Dr Falk Pharma product range, which it is to stop selling
at the end of 2004. This, together with other transactions in the pipeline, will
help us to further the success of our Pharmaceuticals business."


                                      END


Provalis' Internet Website ; http://www.provalis.com


"Safe Harbor" Statement under the US Private Securities Litigation Reform Act of
1995: Statements in this announcement that relate to future plans, expectations,
events, performances and the like are forward-looking statements as defined in
the US Private Securities Litigation Reform Act of 1995. Actual results of
events could differ materially from those described in the forward-looking
statements due to a variety of factors. Such factors include, among others: the
viability of the Group's products, which are at various stages of development;
the generation of sufficient operating cash flow by the Group's pharmaceutical
and medical diagnostic businesses to finance the ongoing development of these
businesses as well as the Group's research and development activities; the
success of the Group's research and development strategy and activities;
uncertainties related to future clinical trial results and the associated
regulatory process; the execution and success of collaborative agreements with
third parties; availability and level of reimbursement for the Group's products
from government health administration authorities or other third-party payors;
the rate of net cash utilisation within the Group and, hence, the Group's
possible need for additional capital in the short, medium and/or long term; the
Group's intellectual property position and the success of patent applications
for its products and technologies; the Group's dependence on key personnel;
general business and economic conditions; the impact of future laws, regulations
and policies; stock market trends in the Group's sector; and other factors
beyond the Group's control that may cause the Group's available capital
resources to be used more quickly than expected. These and other factors that
could affect the Company's future results are more fully described in its
filings with the US Securities and Exchange Commission, in particular the latest
20-F filing, copies of which are available from the Company Secretary at the
Company's registered address.


For further information:-

Dr Phil Gould, Chief Executive Officer, Provalis plc, Tel: 01244 833463
Mr Peter Bream, Finance Director, Provalis plc, Tel: 01244 833552
Mr Lee Greenbury, Company Secretary, Provalis plc, Tel: 01244 833402
Lisa Baderoon, Buchanan Communications, Tel: 020 7466 5000


Notes to Editors


Provalis plc (LSE: PRO; NASDAQ: PVLS) is a diversified healthcare group with two
operating businesses:-


* Medical Diagnostics - develops and sells to world markets
medical diagnostic products for chronic disease management. The business'
principal products are Glycosal(R) and Osteosal(R) in the areas of diabetes and
osteoporosis respectively.


* Pharmaceuticals - sells and markets its own, and third
party, branded, prescription medicines in the UK and Ireland to GPs and
hospitals through its own regionally managed sales force. The business'
principal product is Diclomax(R), a medicine for use in the treatment of
musculo-skeletal disorders, and it also sells products in the areas of
gastroenterology, osteoporosis, migraine and dermatology.


COPD


Chronic Obstructive Pulmonary Disease (COPD) is a group of slowly progressive
disorders characterised by air flow obstruction. COPD is primarily a disease of
cigarette smokers and is now the preferred term for the conditions in patients
that were previously diagnosed as having chronic bronchitis or emphysema, with
the primary symptom being breathlessness.


COPD is a major medical problem, exacting a massive toll in terms of patient
suffering and cost of care. 900,000 patients in the UK are diagnosed as having
COPD, but the British Thoracic Society believes that a further 2,700,000 are
actually undiagnosed. The condition accounts for about 30,000 deaths per year.
Respiratory diseases cost the NHS more than any other disease area. In 2000,
their total cost to the NHS was over #2,700m, with a cost to the primary care
sector alone of over #650m.


Although many clinicians hold the opinion that the course of COPD is fixed and
irreversible, increasing numbers of physicians are becoming aware that
aggressive use of drug therapies as part of a comprehensive disease management
program can significantly improve the lives of patients with COPD. This
heightened willingness to treat COPD holds promise for the growth of the
pharmaceutical market in this area, and so for drugs such as Erdotin(R).


Mucolytics


Mucolytic agents reduce the viscosity of bronchial secretions by breaking down
the structure of tenacious sputum (sticky mucus). They are typically used in
respiratory conditions exacerbated by mucus such as COPD in adults and glue ear
in children.


Erdotin(R)


Erdotin(R) (active ingredient erdosteine) is one of the latest generation of
mucolytic agents and has a wide application in a number of respiratory diseases.
Erdotin(R)'s major indication is as a treatment for chronic bronchitis or COPD,
assisting mucus breakdown and the production of sputum suitable for expulsion
through cough. This assists symptomatic improvement of COPD as well as assisting
the effectiveness of other COPD therapies.

Erdotin(R) was first introduced into France in 1993, and is now marketed in 7 EU
and 23 non-EU markets. Over 14 million adults and over 3 million children have
taken Erdotin over the period 1996-2002.

Dr Falk Products


Provalis currently markets and sells a number of gastro-intestinal products on
behalf of Dr Falk Pharma. Provalis agreed that the distribution agreement
between Dr Falk Pharma and Provalis would terminate at the end of December 2004,
with Provalis receiving up to #5m in staged compensatory payments. #3m of this
has already been received, with the final payment of up to #2m payable in
January 2005.


Edmond Pharma SpA


Edmond Pharma is a pharmaceutical research company based in Milan, Italy. It
also manufactures pharmaceutical products which are sold throughout the world by
distributors and licensees.






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

END
AGRILFLRSDIRLIS
Globaldata (LSE:DATA)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024