Re: Manufacturing Contract
ReNeuron Group plc
07 February 2006
ReNeuron signs manufacturing contract with Angel Biotechnology for its ReN005
stem cell line for Huntington's disease
Guildford, UK, 7 February 2006: ReNeuron Group plc (LSE: RENE.L) today announced
that it has signed a manufacturing contract with Angel Biotechnology Holdings
plc, the UK biopharmaceutical contract manufacturer.
Under the contract, Angel will scale up ReNeuron's ReN005 stem cell line for
Huntington's disease, initially producing a master cell bank to Good
Manufacturing Practice (GMP) standards. ReNeuron has already generated positive
pre-clinical efficacy data with this cell line in a Huntington's disease model,
and the ReN005 programme is currently in pre-clinical development. The
Company's lead ReN001 cell line for stroke has also been scaled up to GMP
standard with another contract manufacturer in the UK.
Angel is a member of the consortium, led by ReNeuron, which was awarded a £2.2
million bioprocessing grant by the UK Department of Trade and Industry in
January 2005. Angel is the manufacturing partner in this consortium,
establishing the capability and technologies to scale up stem cell products to
GMP standards for clinical and commercial use.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
'We are delighted to be working with Angel as our manufacturing partner on the
ReN005 Huntington's programme. Angel is an emerging leader in the out-sourced
GMP manufacture of cell-based therapies. Their capabilities play well to one of
ReNeuron's key competitive strengths: the ability to generate stable and
efficacious stem cell lines which are capable of rapid and early scale-up for
the clinic and beyond. We look forward to a continuing partnership with Angel
both on this contract and with the stem cell bioprocessing consortium.'
Gordon Sherriff, Chief Operating Officer of Angel, said:
'Angel is delighted to have contracted with ReNeuron to provide them with GMP
cells for use in subsequent clinical trials. The technical transfer to Angel of
ReNeuron's technology has gone extremely well and we look forward to further
collaborations in the future. This contract moves Angel to the forefront of
stem cell manufacturing and is an endorsement of our MHRA1 licensed GMP
facilities in Edinburgh and the skill of the team at Angel. We also look
forward to continuing to work with ReNeuron in other directions as part of the
stem cell bioprocessing consortium.'
1. Medicines and Healthcare Products Regulatory Agency in the UK
Enquiries:
ReNeuron
Michael Hunt, Chief Executive Officer Tel: 01483 302 560
John Sinden, Chief Scientific Officer
Financial Dynamics
David Yates Tel: 020 7831 3113
Sarah Macleod
Notes to Editors
About ReNeuron Group plc
ReNeuron is a leading, UK-based adult stem cell therapy business. The Company is
applying its novel stem cell platform technologies in the development of
ground-breaking stem cell therapies to serve significant and unmet or poorly-met
clinical needs.
ReNeuron has used its c-mycERTAM technology to generate genetically stable
neural stem cell lines. This technology platform has multi-national patent
protection and is fully regulated by means of a chemically-induced safety
switch. Cell growth can therefore be completely arrested prior to in vivo
implantation.
The Company's lead stem cell therapy, ReN001 for chronic stroke disability, is
in late pre-clinical development. The Company plans to file for approval to
commence initial clinical trials in stroke later this year, with trials
commencing as soon as possible thereafter.
The Company has also generated positive pre-clinical efficacy data with its
ReN005 stem cell therapy for Huntington's disease, a rare, genetic and fatal
neurodegenerative disorder which affects around 1 in 100,000 people. This
programme is in pre-clinical development.
In addition to its stroke and Huntington's disease programmes, ReNeuron is
developing stem cell therapies for Parkinson's disease, Type 1 diabetes and
diseases of the retina.
ReNeuron has also leveraged its stem cell technologies into non-therapeutic
areas - its ReNcell range of cell lines for use in drug discovery applications
in the pharmaceutical industry.
The Company successfully completed its flotation on the London AIM market in
August 2005, raising £9.5million before expenses. At flotation, the Company
also issued warrants which, if exercised, will raise a further £5.7m for the
Company by February 2007. ReNeuron's shares are traded under the symbol RENE.L,
and its warrants are traded under the symbol RENW.L.
Further information on ReNeuron and its products can be found at
www.reneuron.com.
About Angel Biotechnology Holdings plc
Angel Biotechnology Holdings plc is a fast growing biomanufacturing company
offering process development services and cGMP manufacturing to support
biotechnology and pharmaceutical companies worldwide. Angel's principal
activity is the manufacture and supply of materials for use in early stage drug
development and pre-clinical studies, along with drug product and chemistry
manufacturing and control (CMC) documentation for Phases I, II and III clinical
trials and the manufacture of licensed drugs or vaccines.
Angel is managed by a team that has more than 100 years' combined experience in
pharmaceutical and biopharmaceutical manufacture, gained in companies such as
Glaxo, SmithKline Beecham and Serologicals Inc.
Angel operates out of two sites in the UK, at Cramlington near Newcastle upon
Tyne and at Pentlands Science Park, near Edinburgh.
Angel was established in 2000 and listed on the London AIM market in November
2005, under the symbol ABH.L.
This announcement contains forward-looking statements with respect to the
financial condition, results of operations and business achievements/performance
of ReNeuron and certain of the plans and objectives of management of ReNeuron
with respect thereto. These statements may generally, but not always, be
identified by the use of words such as 'should', 'expects', 'estimates',
'believes' or similar expressions. This announcement also contains
forward-looking statements attributed to certain third parties relating to their
estimates regarding the growth of markets and demand for products. By their
nature, forward-looking statements involve risk and uncertainty because they
reflect ReNeuron's current expectations and assumptions as to future events and
circumstances that may not prove accurate. A number of factors could cause
ReNeuron's actual financial condition, results of operations and business
achievements/performance to differ materially from the estimates made or implied
in such forward-looking statements and, accordingly, reliance should not be
placed on such statements.
The terms 'ReNeuron' or 'the Company' refer to ReNeuron Group plc and its
subsidiary undertakings.
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