US$3 million Option Exercise Payment from Sanofi

RNS Number : 4587G

Oxford Biomedica PLC

29 June 2012

 



Oxford BioMedica Announces US$3 million Option Exercise Payment from Sanofi

-- Sanofi acquires exclusive worldwide rights to develop and commercialise StarGen™ and UshStat^® --

Oxford, UK - 29 June 2012: Oxford BioMedica plc ("Oxford BioMedica" or "the Company") (LSE: OXB), the leading gene-based biopharmaceutical company, and Sanofi (EURONEXT: SAN and NYSE: SNY) today announced that Sanofi has elected to exercise its options to acquire two exclusive worldwide licences for further development, manufacture and commercialisation of StarGen™, a novel gene-based treatment for Stargardt disease, and UshStat^®, a novel gene-based treatment for Usher syndrome type 1B.  StarGen™and UshStat^® were designed and developed by Oxford BioMedica using the Company's proprietary LentiVector^® platform technology.

StarGen™ and UshStat^® are currently in Phase I/IIa development.  On the basis of pre-clinical data, it is anticipated that a single application of StarGen™ or UshStat^® to the retina could potentially either provide long-term or permanent therapeutic benefit for patients.  There are currently no approved treatments available for Stargardt disease or Usher syndrome type 1B and, as such, both products have received EU and US Orphan Drug Designation which brings development, regulatory and commercial benefits. 

Under the terms of the ocular agreement signed with Sanofi in April 2009, Oxford BioMedica will receive a total option exercise payment of US$3 million and is eligible for further development and commercialisation milestone payments and royalties on any future sales of the products.  Oxford BioMedica is currently conducting the two ongoing Phase I/IIa trials for StarGen™ and Ushstat^®.  The companies will continue to work together to plan the next stages of development and finalise the terms of the worldwide licence agreements.

John Dawson, Chief Executive Officer of Oxford BioMedica, said: "The success of our ocular programmes to date underlines our revolutionary approach to tackling diseases of the eye using LentiVector^® platform technology. Sanofi is a world-class partner and we are confident that their continued commitment will help ensure that StarGen™ and UshStat^® fulfil their significant potential."

"We are delighted that Sanofi will be licensing StarGen™ and UshStat^® gene therapies from Oxford BioMedica to continue advancing them through the clinical development pipeline," said Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. "Sanofi's commitment to these innovative gene therapies bolsters the opportunity to save vision in people with diseases for which there are no treatments."

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For further information, please contact:
Oxford BioMedica plc: Lara Mott, Head of Corporate Communications	Tel: [phone]
Media Enquiries: Mary Clark/Sarah Macleod/Claire Dickinson M:Communications	Tel: [phone]

Notes to editors

1. Oxford BioMedica

Oxford BioMedica plc (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 LentiVector^® gene delivery system, 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 with current partners and licensees including Sanofi, Pfizer, GlaxoSmithKline, MolMed, Sigma-Aldrich, Biogen Idec, Emergent BioSolutions and ImaginAb.  Further information is available at www.oxfordbiomedica.co.uk.

2. LentiVector^® gene delivery technology

Oxford BioMedica's LentiVector^® gene delivery 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. Oxford BioMedica has established a dominant intellectual property estate in the field of lentiviral-vector mediated gene delivery through its in-house research and from work conducted by the Company's co-founders at Oxford University.

3. Oxford BioMedica's agreement with Sanofi

Under the terms of the agreement signed with Sanofi in April 2009, Oxford BioMedica is responsible for the pre-clinical and initial Phase I/II studies of four lentiviral vector-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. Oxford BioMedica will receive committed funding of up to US$24 million over the initial phase of development. Oxford BioMedica granted Sanofi a license to develop the products and an option for further development, manufacture and commercialisation on a worldwide basis. At any time prior to or within a defined period after completion of each Phase I/II study, Sanofi can exercise its option to license the products. Sanofi also has rights to broaden its license to develop the four products in additional indications, and has rights of first refusal to license other lentiviral vector-based products for the treatment of ocular diseases.

4. Stargardt disease and StarGen™

Stargardt disease is the most common juvenile degenerative retinal disease which affects approximately 80-100,000 patients in the US and Europe.  The disease is caused by a mutation of the ABCR gene which leads to the degeneration of photoreceptors in the retina and vision loss. StarGen™ uses the Company's LentiVector^® platform technology to deliver a corrected version of the ABCR gene.  On the basis of pre-clinical data, it is anticipated that a single application of StarGen™ to the retina could potentially either provide long-term or permanent correction.  There are currently no approved treatments available for Stargardt disease.  StarGen™ has received European and US Orphan Drug Designation which brings development, regulatory and commercial benefits.  In the US, the current Phase I/IIa study is led by Professor David Wilson at the Oregon Health and Science University, Portland, Oregon.  In France, Professor Jose-Alain Sahel leads the study at the Centre Hospitalier National D'Opthalmologie des Quinze-Vingts, Paris.

5. Usher syndrome type 1B and UshStat^®

Usher syndrome is the most common form of deaf-blindness which affects approximately 30,000-50,000 patients in the US and Europe.  One of the most common subtypes is Usher syndrome type 1B. The disease 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 Company's LentiVector^® platform technology to deliver a corrected version of the MYO7A gene to address the vision loss associated with the disease.  On the basis of pre-clinical data, it is anticipated that a single application of UshStat^® to the retina could potentially either provide long-term or  permanent stabilisation of vision.  There are currently no approved treatments available for Usher syndrome type 1B. UshStat^® has received European and US Orphan Drug Designation which brings development, regulatory and commercial benefits.  The current Phase I/IIa study in the US is led by Professor Richard Weleber at the Oregon Health & Science University's Casey Eye Institute.

 

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