Oxford BioMedica announced today that it has entered into a new collaboration with sanofi-aventis to develop novel gene-based medicines, utilising the Company's LentiVector® gene delivery technology, for the treatment of ocular diseases

Oxford, UK | April 29, 2009 | Oxford BioMedica (LSE: OXB) announced today that it has entered into a new collaboration with sanofi-aventis to develop novel gene-based medicines, utilising the Company's LentiVector® gene delivery technology, for the treatment of ocular diseases. Oxford BioMedica will receive an upfront payment of US$26 million (£18 million) and committed funding of up to a further US$24 million (£16 million) over three years. In addition, sanofi-aventis has an exclusive option for a worldwide licence to develop and commercialise four ocular products. If successful, Oxford BioMedica will receive further undisclosed license fees, milestone payments and royalties on product sales, the terms of which are consistent with other deals of this size and scope.

The initial payment from sanofi-aventis significantly strengthens Oxford BioMedica's financial resources. As a result, with pro forma net cash1 as at 31 December 2008 of approximately £51 million, the Directors estimate that current cash is sufficient to support the Company's operations into 2012.

Dr Marc Cluzel, Senior Vice President, Research and Development of sanofi-aventis, said: "Oxford BioMedica is a highly valued partner, and we respect their scientific expertise and highly skilled personnel. Our new collaboration in the field of ophthalmology complements our pipeline and overall strategy of developing innovative treatments for inadequately treated disease. The ability of Oxford BioMedica's LentiVector technology to deliver genes into retinal cells efficiently and stably makes it a valuable system for gene-based approaches to ocular diseases. This collaboration is a key step in our strategy to expand our efforts in this field."

Commenting on the deal, Oxford BioMedica's Chief Executive, John Dawson, said: "We are delighted to have entered a new collaboration with sanofi-aventis for the treatment of ocular diseases, which enables us to accelerate and expand our development activities in this area. This multi-product collaboration, combined with the encouraging data emerging from the Phase I/II trial of ProSavin® in Parkinson's disease, validate the tremendous potential and value of our LentiVector platform across many indications. The broad scope of our new partnership is in line with the Company's strategy of reducing risk and maximising the value of our assets. By strengthening our financial resources, we are well-positioned for further growth and will continue to build the Company through in-house and collaborative drug development."

Dr Stephen Rose, Chief Research Officer of the Foundation Fighting Blindness, which is collaborating with Oxford BioMedica, said: "The Foundation Fighting Blindness, which is committed to driving research that can save and restore sight, is delighted that sanofi-aventis, as a major pharmaceutical company, is investing in the field. This new collaboration between Oxford BioMedica and sanofi-aventis gives even greater hope to patients and their families that novel gene-based therapies may soon be developed to treat their debilitating ocular diseases. We will continue to work closely with Oxford BioMedica and hope to contribute to the successful development of these exciting product opportunities."

The new agreement covers four LentiVector-based product candidates in the field of ophthalmology: RetinoStat® for wet age-related macular degeneration, StarGen™ for Stargardt disease, UshStat™ for Usher syndrome 1B and EncorStat™ for corneal graft rejection. The four products are addressing key unmet medical needs. There are currently no existing treatments for Stargardt disease, Usher syndrome and corneal graft rejection. Oxford BioMedica has granted sanofi-aventis a license to develop the products, and an option for further development, manufacture and commercialisation on a worldwide basis.

Oxford BioMedica will be responsible for preclinical development and for conducting initial Phase I/II studies. Under the joint development plan, the companies aim to advance all four product candidates into Phase I/II development within three years. At any time prior to or within a defined period after completion of each Phase I/II study, sanofi-aventis can exercise its option to license the products and will then assume responsibility for ongoing activities. Sanofi-aventis also has rights to broaden its license to develop the four products in additional indications, and has rights of first refusal to license other LentiVector-based products for the treatment of ocular diseases.

1. Cash, cash equivalents and current financial assets

Analyst meeting: An analyst briefing will be held at 10:00 am at the offices of Buchanan Communications, 45 Moorfields, London EC2Y 9AE.

1. Oxford BioMedica plc

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company developing innovative gene-based medicines and therapeutic vaccines that aim to improve the lives of patients with high unmet medical needs. The Company's technology platform includes a highly efficient gene delivery system (LentiVector®), which has specific advantages for targeting diseases of the central nervous system and the eye; and a unique tumour antigen (5T4), which is an ideal target for anti-cancer therapy. Through in-house and collaborative research, Oxford BioMedica has a broad pipeline. Partners include sanofi-aventis, Sigma-Aldrich and Wyeth. Technology licensees include GlaxoSmithKline, Merck & Co, Open Biosystems and Pfizer. Further information is available at www.oxfordbiomedica.co.uk

2. Sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

3. LentiVector®

The LentiVector technology is one of the most advanced gene delivery systems currently available, which has many applications in product development and discovery research. It is the system of choice for gene-based treatments addressing chronic and inherited diseases, and it has specific advantages for targeting diseases of the central nervous system or the eye. In these settings, a single administration of a LentiVector-based gene therapy could achieve permanent therapeutic benefit.

4. RetinoStat® for Wet Age-related Macular Degeneration

RetinoStat uses the LentiVector system to deliver two anti-angiogenic genes, endostatin and angiostatin to block aberrant growth of leaky and disruptive blood vessels in the retina, associated with neovascular "wet" age-related macular degeneration (AMD) and diabetic retinopathy (DR). Age-related macular degeneration is a major cause of blindness, affecting an estimated 25 to 30 million people in the Western world. Wet AMD accounts for 90% of all severe vision loss from the disease. The current leading treatment, Lucentis® (Genentech), achieved sales in the USA of US$875 million in 2008 but requires repeated injections directly into the eye. RetinoStat could require only a single or infrequent administration, and could also provide a safer and more efficient means of inhibiting angiogenesis.

5. StarGen™ for Stargardt Disease

Stargardt disease is caused by a mutation of the ABCR gene which leads to the degeneration of photoreceptors in the retina. StarGen uses the LentiVector system to deliver a corrected version of the ABCR gene. Stargardt disease is the most common juvenile degenerative retinal disease with approximately 50,000 cases in the USA and EU. Oxford BioMedica is collaborating with Foundation Fighting Blindness (FFB) for the development of StarGen and has received valuable funding from individuals associated with the FFB, notably Paul and Diane Manning.

6. UshStat™ for Usher Syndrome

Usher syndrome 1B is caused by a mutation of the gene encoding myosin VIIA (MY07A), which leads to progressive retinitis pigmentosa combined with a congenital hearing defect. UshStat uses the LentiVector system to deliver a corrected version of the MYO7A gene. Approximately 70,000 people in the USA and EU have Usher syndrome, which is the most prevalent form of deaf-blindness. Approximately 8,000 have Usher syndrome 1B.

7. EncorStat™ for Corneal Graft Rejection

Corneal grafting arises from a need to remove and replace pathology arising in the cornea causing 'clouding'. Although one of the most successfully transplanted tissues, a significant number of grafts are rejected due to vascularisation. EncorStat uses the same genetic payload as RetinoStat but differs in the way gene expression is controlled, in order to block vascularisation and to prevent graft rejection. Approximately 60,000 corneal transplants are performed in the USA and EU each year.

SOURCE: Oxford BioMedica plc

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