RENE.L Regulatory News (RENE)

29 May 2008 07:00



ReNeuron signs contract with Angel Biotechnology to manufacture ReN001 stem cells for UK clinical trials in stroke

Guildford, UK, 29 May 2008: ReNeuron Group plc (LSE: RENE.L) today announces that it has signed a new manufacturing contract with Angel Biotechnology plc (LSE: ABH.L), a leading UK-based contract manufacturing organisation specialising in the production of clinical-grade material for cell-based therapies.

Under the contract, Angel will manufacture clinical-grade batches of ReNeuron's ReN001 stem cells in Angel's MHRA1-licensed facility in Scotland. The manufactured materials will be used to provide ReNeuron with further product data required for eventual clinical trial approval of ReNeuron's ReN001 stroke therapy by the UK regulatory authorities. Angel will become the approved UK clinical manufacturing partner for ReN001 as part of this regulatory process.

Michael Hunt, Chief Executive Officer of ReNeuron, said: 

"This new contract with Angel represents a further step forward in taking our ReN001 therapy for stroke towards its clinical phase of development, providing ReNeuron with clinical-grade product for subsequent clinical trials for ReN001 in the UK. We are happy to be working with Angel, whom we regard as an emerging leader in the scale-up and bulk manufacture of cell therapy products."

1. Medicines and Healthcare products Regulatory Agency

Enquiries:

About ReNeuron

ReNeuron is a leading, UK-based stem cell therapy business. It 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 proprietary, patented cell expansion 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. ReNeuron's clinically-tested cell encapsulation technology provides a method of protecting cells when transplanted, as well as reducing or eliminating the host immune response that might otherwise occur post-transplantation.

ReNeuron has filed for approval to commence initial clinical studies with its lead ReN001 stem cell therapy for chronic stroke disability. There are an estimated 50 million stroke survivors worldwide, approximately one half of which are left with permanent disabilities. The annual health and social costs of caring for these patients is estimated to be in excess of £5 billion in the UK and in excess of US$50 billion in the US. In addition to its stroke programme, ReNeuron is developing stem cell therapies for Parkinson's disease, Huntington'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 research and in drug discovery applications in the pharmaceutical industry. ReNeuron's ReNcell®CX and ReNcell®VM neural cell lines are marketed worldwide under license by Millipore Corporation.

ReNeuron's shares are traded on the London AIM market under the symbol RENE.L. Further information on ReNeuron and its products can be found at www.reneuron.com.

Data sources: UK Stroke Association; American Stroke Association.

About Angel Biotechnology Holdings plc

Angel Biotechnology Holdings plc is a 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 CMC documentation for Phases I, II and III clinical trials and the manufacture of licensed drugs or vaccines. Angel is managed by a team with wide ranging experience in biopharmaceutical manufacture, gained in companies such as Glaxo, Serologicals Inc. and PPL Therapeutics.

Angel was admitted to trading on AIM in November 2005.

More information about Angel can be found at www.angelbio.com.

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.