Oxford Biomedica Receives Notice Of Allowance For Key US Patent Covering Parkinson's Disease Product, Prosavin(R)

Main Category: Parkinson's Disease
Article Date: 26 Jun 2006 - 1:00 PDT

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Oxford BioMedica (LSE:OXB), a leading gene therapy company, announced today that it has received a Notice of Allowance from the US Patent Office for a key patent application, which significantly extends the protection of ProSavin, the Company's lead product candidate for Parkinson's disease. It is expected that the patent will be issued during 2006. This patent describes the genetic composition of ProSavin, and as such is an important addition to the portfolio of patents that protect the product.

The product comprises the Company's LentiVector(R) gene delivery system carrying three genes that programme cells to produce dopamine, the neurotransmitter that is lost during the course of Parkinson's disease. The assembly and configuration of the three genes to achieve the optimal dopamine production were major technical achievements, and these form the basis of this key ProSavin patent.

Importantly, the claims allowed by the US Patent and Trademark Office are broad and not only cover the Company's LentiVector-based genetic configuration of ProSavin but also cover the basic gene constructs central to the development of ProSavin. In addition, the claims cover any LentiVector-based neurodegenerative disease product that uses the same general configuration with any therapeutic genes. Hence, the patent provides protection for new product candidates that the Company may develop for the treatment of other neurodegenerative conditions such as Alzheimer's disease.

ProSavin is the lead product in Oxford BioMedica's neurotherapy pipeline and has shown promising, long term efficacy in industry-standard preclinical models of Parkinson's disease. The Company has initiated regulatory consultation for the start of Phase I/II trials in patients with the disease.

Commenting on the news, Oxford BioMedica's Chief Executive, Professor Alan Kingsman said: "ProSavin is one of the major value drivers for Oxford BioMedica after TroVax. This patent secures our control of the intellectual property for the product, which has shown exceptional preclinical efficacy."

Oxford BioMedica plc

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of novel gene-based therapeutics with a focus on the areas of oncology and neurotherapy. The Company was established in 1995 as a spin out from Oxford University, and is listed on the London Stock Exchange.

Oxford BioMedica has core expertise in gene delivery, as well as in-house clinical, regulatory and manufacturing know-how. In oncology, the pipeline includes an immunotherapy and a gene therapy in multiple Phase II trials, and a preclinical targeted antibody therapy in collaboration with Wyeth. In neurotherapy, the Company's lead product is a gene therapy for Parkinson's disease, which is expected to enter clinical trials in 2006, and four further preclinical candidates. The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field.

The Company has a staff of approximately 70 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Sigma-Aldrich, Viragen, MolMed, Virxsys and Kiadis; and has licensed technology to a number of companies including Merck & Co, Biogen Idec and Pfizer.

ProSavin(R)

ProSavin is Oxford BioMedica's lead neurobiology candidate product for the treatment of Parkinson's disease. ProSavin uses a LentiVector(R) system to deliver the genes for three enzymes that are required for the synthesis of dopamine. The three genes are AADC (aromatic amino acid dopa decarboxylase), TH (tyrosine hydroxylase) and CH1 (GTP-cyclohydrolase 1). The product is administered locally to the striatum, where these genes are able to reprogramme transduced cells to manufacture and secrete dopamine. Gene expression is sustained over several months, a key requirement for the product to be clinically successful. This new endogenous source of the neurotransmitter replaces the patient's own lost source of dopamine.

The Company had demonstrated preclinical efficacy with ProSavin in an industry standard in vivo model of Parkinson's disease. The preclinical studies suggest that a single treatment with ProSavin has a therapeutic effect after two weeks, and restores almost normal movement after five to eight weeks, which is then maintained. This effect is seldom achieved in this model according to the literature. The clinical manufacturing process has been finalised and the Company has commenced regulatory consultation for the start of clinical trials of ProSavin.

Parkinson's disease

Parkinson's disease affects 1% of the over 50 population and about 10% of the over 60s. It is a progressive disease requiring care over a period of 10-15 years. The current worldwide market for Parkinson's disease products is about US$2 billion. None of the currently available products provide long-term relief from symptoms.

http://www.oxfordbiomedica.co.uk

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