PPL & Grifols Agreement
19 Juin 2003 - 5:17PM
UK Regulatory
RNS Number:5430M
PPL Therapeutics PLC
19 June 2003
Date: For immediate release: Thursday 19th June 2003
Contact: Geoff Cook, Chief Executive Officer
Lindsay Dunsmuir, Chief Financial Officer
PPL Therapeutics plc Telephone: 0131 440 4777
Alistair Mackinnon-Musson
Philip Dennis
Hudson Sandler Telephone: 020 7796 4133
Email: ppl@hspr.co.uk
PPL Therapeutics plc
PPL announces Fibrin I manufacturing Heads of Agreement with Instituto
Grifols-Probitas Pharma
Following yesterday's announcement regarding PPL's restructuring and the
Company's focus on Fibrin I, PPL Therapeutics plc (PPL) is pleased to announce
that it has today signed Heads of Agreement with Instituto Grifols S.A. (a
company member of the holding Probitas Pharma) to manufacture Fibrin I using
Grifols plasma derived fibrinogen. Under the agreement Grifols will scale up the
Fibrin I manufacturing process to industrial scale and supply Fibrin I to PPL
for clinical development and marketing.
This agreement represents a critical step forward in PPL's development of Fibrin
I as a surgical tissue sealant. Products in this class are used to seal tissue
during surgery to prevent fluid or air leaks and in particular to stop bleeding.
Fibrin I will offer a distinct competitive advantage in the rapidly growing
market for tissue sealants as it is being developed as a liquid which is ready
for the surgeon to use from the refrigerator, in contrast to existing fibrin
sealants which require significant preparation before use.
Grifols is a plasma products manufacturing company dedicated to the research,
development and production of therapeutic proteins from human plasma according
to the highest standards of quality and safety. Grifols uses the latest
technology for protein purification. Its modern facilities are organised
according to Good Manufacturing Procedures (GMP) and have been certified under
the FDA "Establishment License" since 1995. Grifols has a fractionation capacity
of over two million litres annually and is in the process of expansion which
will result in the company taking its place amongst the largest plasma
derivative companies in the world.
PPL and Grifols expect to announce the signing of the full agreement based on
these non-binding Heads of Agreement in the near future. The commercial terms of
the agreement remain confidential.
Geoff Cook, PPL's CEO said:
"We are delighted to be able to announce this agreement with one of the world's
leading and most respected plasma fractionators. Grifols quality standards and
regulatory record together with their technology capability mean that they are
the best possible partner for us in this area. In bringing any product to market
which is based on a component of human plasma, the rigorous application of
regulatory standards on quality and safety is critical. PPL, working together
with Grifols on Fibrin I, will be able to put together a world class dossier for
the regulatory authorities in Europe and the US."
Notes to editors
1. Fibrin I is based on a fibrin monomer that is mixed with a neutralising
buffer at the site of surgical application by means of a dual chamber syringe,
where it polymerises to stop bleeding and seal tissue. It will be supplied as a
liquid in pre-filled syringes and stored in the refrigerator, from where it is
ready to be used.
It is at least as effective as traditional fibrin sealants in sealing tissue and
promoting haemostasis. Preclinical data suggests that the product may promote a
more natural and rapid wound healing process than traditional fibrin sealants,
which may reduce the potential for the formation of post surgical adhesions.
An extensive patent portfolio provides comprehensive protection for the product
in major markets until 2015 in the fields of haemostasis, tissue sealing,
adhesion prevention and other biosurgery indications.
2. Further information about PPL, its products and technologies can be
found at: www.ppl-therapeutics.com
3. Further information about Grifols, its products and technologies
can be found at: www.grifols.com
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This information is provided by RNS
The company news service from the London Stock Exchange
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