Huntington's Disease - ReNeuron Signs Manufacturing Contract With Angel Biotechnology For Its ReN005 Stem Cell Line

Main Category: Huntingtons Disease
Also Included In: Neurology / Neuroscience;  Pharma Industry / Biotech Industry
Article Date: 08 Feb 2006 - 12:00 PDT

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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 program 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 program. 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

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 program is in pre-clinical development.

In addition to its stroke and Huntington's disease programs, 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 http://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.

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