Oxford BioMedica provides update on RetinoStat?

RNS Number : 7159F

Oxford Biomedica PLC

29 April 2014

 



Oxford BioMedica provides update on RetinoStat^® Programme

Oxford, UK - 29 April 2014: Oxford BioMedica plc (LSE: OXB), ("the Company") the leading gene based biopharmaceutical company, announces that it will regain the worldwide rights to RetinoStat^®, a treatment for wet age-related macular degeneration ("Wet AMD"). Sanofi has notified Oxford BioMedica that due to pipeline prioritisation they will not be taking up the option to continue development of RetinoStat^® beyond the currently ongoing Phase I study.  Sanofi has confirmed that this decision is not linked to unexpected results based on an analysis of the data from the study.

On 7 April 2014, Oxford BioMedica announced that it had successfully completed the recruitment and dosing of the Phase I trial of RetinoStat^®. Interim analysis of patient data from the ongoing open-label study, which has been designed to assess the safety and aspects of biological activity of RetinoStat^® in the eye, has demonstrated safety and signs of efficacy.  Indicative results from the study are expected towards the end of 2014.

There is considerable interest in therapies for Wet AMD which is currently treated with Lucentis^® and Eylea^® (global 2013 sales ~ $6.0 billion, source: Novartis/Roche/Regeneron) and the Company has previously received expressions of interest in RetinoStat^® from both large pharmaceutical/biotech companies and financial investors in the event of Sanofi not exercising its option.  The Company is therefore confident that once the indicative results from the study are available there will be significant demand for what will then be a Phase II-ready product for a major ocular indication.

Commenting on the announcement, John Dawson, Chief Executive Officer of Oxford BioMedica, said: "RetinoStat^® has the potential to provide long-term or even permanent treatment of a major ocular disease from a single dose, and therefore offers a major step forward for patients.  Whilst I am disappointed that Sanofi, who has been a good partner during the collaboration and paid for the Phase I development to date, has decided to take forward only StarGen^™ and UshStat^® and not RetinoStat^® I am excited to regain control over a product which will soon be Phase II-ready.  Over the past two years, since we published interim data at The Association for Research in Vision and Ophthalmology conference, we have been approached on a number of occasions by third parties interested in investing in RetinoStat^® in the event that Sanofi would chose not to exercise their option.  So, we are confident that once we have the indicative results from the full study, we will be in a position to re-partner the product with terms that enhance shareholder value given the Phase-II ready nature of this asset."

Soraya Bekkali, VP, Ophthalmology Unit Head of Sanofi Fovea, said:

"Sanofi has accepted to give back the rights of RetinoStat^® but we firmly believe in the potential of the LentiVector^® platform.  We look forward to continuing to work with Oxford BioMedica on StarGen^™ and UshStat^®. Based on the data seen to date, RetinoStat^® has the potential to be effective in Wet AMD."

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For further information, please contact:
Oxford BioMedica plc: John Dawson, Chief Executive Officer Tim Watts, Chief Financial Officer	Tel: [phone]
Media Enquiries: Mary-Jane Elliott/Emma Thompson/Jessica Hodgson/Matthew Neal Consilium Strategic Communications	Tel: [phone]

Notes for editors

1. Information about RetinoStat^® and the ongoing open-label study

The industry standard treatments for wet AMD and other related ocular conditions achieved global sales in excess of US$6.0 billion in 2013¹. On the basis of pre-clinical data, it is anticipated that RetinoStat^® may require only a single administration. If confirmed, this would give the product a significant advantage over currently available treatments in the market that require frequent, repeated administration.

The ongoing open-label study is evaluating three dose levels, in four cohorts, to assess safety and aspects of biological activity in the eye. Analysis of patient samples has shown a substantial increase above baseline levels of both endostatin and angiostatin proteins in the eye following a single administration of RetinoStat^®; protein expression has been sustained to 12 months (the longest time-point assessed to date in the first three cohorts); and a clear proportional dose response has been seen. All patients are being regularly followed up and indicative results from the study are expected towards the end of 2014.  For further information see www.clinicaltrials.gov.

¹ source: Novartis/Roche/Regeneron

2.  About 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 range of partners and licensees including Sanofi, Pfizer, Novartis, GlaxoSmithKline, MolMed, Sigma-Aldrich, Biogen Idec, Emergent BioSolutions, ImaginAb and Immune Design Corp. Further information is available at www.oxfordbiomedica.co.uk and www.oxbsolutions.co.uk.

 

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