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Re: Manufacturing Contract

7th Feb 2006 07:01

ReNeuron Group plc07 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 announcedthat it has signed a manufacturing contract with Angel Biotechnology Holdingsplc, the UK biopharmaceutical contract manufacturer. Under the contract, Angel will scale up ReNeuron's ReN005 stem cell line forHuntington's disease, initially producing a master cell bank to GoodManufacturing Practice (GMP) standards. ReNeuron has already generated positivepre-clinical efficacy data with this cell line in a Huntington's disease model,and the ReN005 programme is currently in pre-clinical development. TheCompany's lead ReN001 cell line for stroke has also been scaled up to GMPstandard with another contract manufacturer in the UK. Angel is a member of the consortium, led by ReNeuron, which was awarded a £2.2million bioprocessing grant by the UK Department of Trade and Industry inJanuary 2005. Angel is the manufacturing partner in this consortium,establishing the capability and technologies to scale up stem cell products toGMP 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 theReN005 Huntington's programme. Angel is an emerging leader in the out-sourcedGMP manufacture of cell-based therapies. Their capabilities play well to one ofReNeuron's key competitive strengths: the ability to generate stable andefficacious stem cell lines which are capable of rapid and early scale-up forthe clinic and beyond. We look forward to a continuing partnership with Angelboth 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 GMPcells for use in subsequent clinical trials. The technical transfer to Angel ofReNeuron's technology has gone extremely well and we look forward to furthercollaborations in the future. This contract moves Angel to the forefront ofstem cell manufacturing and is an endorsement of our MHRA1 licensed GMPfacilities in Edinburgh and the skill of the team at Angel. We also lookforward to continuing to work with ReNeuron in other directions as part of thestem cell bioprocessing consortium." 1. Medicines and Healthcare Products Regulatory Agency in the UK Enquiries: ReNeuronMichael Hunt, Chief Executive Officer Tel: 01483 302 560John Sinden, Chief Scientific Officer Financial DynamicsDavid Yates Tel: 020 7831 3113Sarah Macleod Notes to Editors About ReNeuron Group plc ReNeuron is a leading, UK-based adult stem cell therapy business. The Company isapplying its novel stem cell platform technologies in the development ofground-breaking stem cell therapies to serve significant and unmet or poorly-metclinical needs. ReNeuron has used its c-mycERTAM technology to generate genetically stableneural stem cell lines. This technology platform has multi-national patentprotection and is fully regulated by means of a chemically-induced safetyswitch. Cell growth can therefore be completely arrested prior to in vivoimplantation. The Company's lead stem cell therapy, ReN001 for chronic stroke disability, isin late pre-clinical development. The Company plans to file for approval tocommence initial clinical trials in stroke later this year, with trialscommencing as soon as possible thereafter. The Company has also generated positive pre-clinical efficacy data with itsReN005 stem cell therapy for Huntington's disease, a rare, genetic and fatalneurodegenerative disorder which affects around 1 in 100,000 people. Thisprogramme is in pre-clinical development. In addition to its stroke and Huntington's disease programmes, ReNeuron isdeveloping stem cell therapies for Parkinson's disease, Type 1 diabetes anddiseases of the retina. ReNeuron has also leveraged its stem cell technologies into non-therapeuticareas - its ReNcell range of cell lines for use in drug discovery applicationsin the pharmaceutical industry. The Company successfully completed its flotation on the London AIM market inAugust 2005, raising £9.5million before expenses. At flotation, the Companyalso issued warrants which, if exercised, will raise a further £5.7m for theCompany 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 atwww.reneuron.com. About Angel Biotechnology Holdings plc Angel Biotechnology Holdings plc is a fast growing biomanufacturing companyoffering process development services and cGMP manufacturing to supportbiotechnology and pharmaceutical companies worldwide. Angel's principalactivity is the manufacture and supply of materials for use in early stage drugdevelopment and pre-clinical studies, along with drug product and chemistrymanufacturing and control (CMC) documentation for Phases I, II and III clinicaltrials and the manufacture of licensed drugs or vaccines. Angel is managed by a team that has more than 100 years' combined experience inpharmaceutical and biopharmaceutical manufacture, gained in companies such asGlaxo, SmithKline Beecham and Serologicals Inc. Angel operates out of two sites in the UK, at Cramlington near Newcastle uponTyne and at Pentlands Science Park, near Edinburgh. Angel was established in 2000 and listed on the London AIM market in November2005, under the symbol ABH.L. This announcement contains forward-looking statements with respect to thefinancial condition, results of operations and business achievements/performanceof ReNeuron and certain of the plans and objectives of management of ReNeuronwith respect thereto. These statements may generally, but not always, beidentified by the use of words such as "should", "expects", "estimates","believes" or similar expressions. This announcement also containsforward-looking statements attributed to certain third parties relating to theirestimates regarding the growth of markets and demand for products. By theirnature, forward-looking statements involve risk and uncertainty because theyreflect ReNeuron's current expectations and assumptions as to future events andcircumstances that may not prove accurate. A number of factors could causeReNeuron's actual financial condition, results of operations and businessachievements/performance to differ materially from the estimates made or impliedin such forward-looking statements and, accordingly, reliance should not beplaced on such statements. The terms "ReNeuron" or "the Company" refer to ReNeuron Group plc and itssubsidiary undertakings. This information is provided by RNS The company news service from the London Stock Exchange

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