~ Conference call for analysts to be held at 2:30pm BST / 9:30am ET (see details below)
Oxford, UK– 06 June 2018: Oxford BioMedica plc (LSE:Oxford Biomedica) (“Oxford BioMedica” or “the Group”), a leading gene and cell therapy group, today announces that it has entered into an exclusive worldwide licensing agreement with Axovant Sciences (NASDAQ: AXON) to develop and commercialise Oxford Biomedica-102, a gene therapy developed by Oxford BioMedica for Parkinson’s disease utilising the LentiVector® platform.
Under the terms of the agreement, Oxford BioMedica will receive a $30 million upfront payment (approximately £22 million) including $5 million as pre-payment for manufacturing activities related to Oxford Biomedica-102, now renamed, AXO-Lenti-PD. Oxford BioMedica is also eligible to receive $55 million upon the achievement of specified development milestones and $757.5 million upon the achievement of specified regulatory and sales milestones, with 7% to 10% tiered royalties on net sales of AXO-Lenti-PD.
Axovant Sciences, a clinical-stage biopharmaceutical company dedicated to advancing treatments for patients with life-altering neurologic conditions and a member of the Roivant family of companies, will fund all clinical development costs and manufacturing process development and scale-up activities for AXO-Lenti-PD. The agreement also allows for both parties to put in place a clinical and commercial supply agreement for GMP manufacturing of AXO-Lenti-PD at Oxford BioMedica. Roivant remains committed to Axovant’s success and are excited about the scientific potential of AXO-Lenti-PD. Axovant will be able to harness the full Roivant drug development platform to ensure its rapid development.
Axovant Sciences expects to initiate a Phase I/II dose escalation study of AXO-Lenti-PD in patients with advanced Parkinson’s disease by the end of 2018.
John Dawson, Chief Executive Officer of Oxford BioMedica, said: “We are delighted to sign this significant agreement which not only underlines our LentiVector® enabled platform and product development strategy but further demonstrates Oxford BioMedica’s ability to build multiple partnerships with leaders in their respective therapeutic fields. This agreement with Axovant also successfully demonstrates Oxford BioMedica’s pre-stated strategy to externalise product development beyond the end of the pre-clinical phase.
“Axovant’s expertise and focus on neurological disorders, which includes Parkinson’s disease, makes them an ideal development and commercialisation partner for this programme. Coupled with strong support from parent company Roivant, we believe Axovant is perfectly positioned to bring AXO-Lenti-PD to the market as quickly as possible to treat patients with Parkinson’s, a disease which still has a high unmet need.”
Commenting on the deal, Pavan Cheruvu, Chief Executive Officer of Axovant Sciences, said: “Axovant, together with our parent company Roivant, remains committed to developing innovative treatments for serious degenerative conditions such as Parkinson’s disease, and we are excited to partner with Oxford BioMedica, a recognised global leader in cell and gene therapy. Oxford Biomedica-102 is a potentially best-in-class gene therapy with the potential to transform Parkinson’s disease treatment. This is an area of significant unmet medical need and a major market opportunity. Advancing this high-quality candidate is a key priority for the team at Axovant and we very much look forward to working with Oxford BioMedica.”
-Ends-
Conference call for analysts:
A conference call and Q&A session for analysts will be held today at 2.30pm BST / 9.30am ET. The presentation will be available on the Group’s website at www.oxfordbiomedica.co.uk.
Please visit the website approximately 10 minutes before the conference call to download the presentation slides.
Conference call details:
Participant dial-in: 0800 376 7922
International dial-in: +44 (0) 207 192 8000
Participant code: 1857539
An audio replay file will be made available shortly afterwards via the Group’s website: www.oxfordbiomedica.co.uk
For further information, please contact:
Oxford BioMedica plc:
John Dawson, Chief Executive Officer
Stuart Paynter, Chief Financial Officer
Tel: +44 (0)1865 783 000
Financial and corporate communications enquiries:
Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal/Laura Thornton
Tel: +44 (0)20 3709 5700
Peel Hunt (Joint Corporate Brokers):
James Steel
Dr. Christopher Golden
Tel: +44 (0)20 7418 8900
WG Partners (Joint Corporate Brokers):
David Wilson
Claes Spång
Tel: +44 (0)20 3705 9321
Notes to editors
About Oxford BioMedica®
Oxford BioMedica (LSE:Oxford Biomedica) is a leading gene and cell therapy group focused on developing life changing treatments for serious diseases. Oxford BioMedica and its subsidiaries (the “Group”) have built a sector leading lentiviral vector delivery platform (LentiVector®), which the Group leverages to develop in vivo and ex vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology and CNS disorders. The Group has also entered into a number of partnerships, including with Novartis, Bioverativ, Sanofi, GSK, Orchard Therapeutics, GC LabCell and Immune Design, through which it has long-term economic interests in other potential gene and cell therapy products. Oxford BioMedica is based across several locations in Oxfordshire, UK and employs more than 320 people. Further information is available at www.oxfordbiomedica.co.uk.
About Oxford Biomedica-102 (AXO-Lenti-PD)
Oxford Biomedica-102, now known as AXO-Lenti-PD, is a lentiviral gene therapy with a clinically validated mechanism of action for the delivery of the three genes that encode the enzymes required for endogenous dopamine synthesis. Unlike current drug treatment, in which efficacy diminishes with long-term use, AXO-Lenti-PD is designed to provide patient benefit for multiple years following a single administration. AXO-Lenti-PD is a second-generation vector construct of Oxford Biomedica-101, also known as ProSavin®, with greater potency and increased transgenic expression observed in preclinical studies. Oxford BioMedica has successfully completed a Phase I/II study for Oxford Biomedica-101, which met its primary endpoint. The results, which were published in Lancet in 2014, demonstrate favourable safety and tolerability and a statistically significant improvement of motor function as measured by the UPDRS Part III score at 6 and 12 months following a one-time administration. This improvement was sustained in most patients for up to four years despite the progressively degenerative nature of Parkinson’s disease.
About Axovant Sciences
Axovant is a clinical-stage biopharmaceutical company dedicated to advancing treatments for patients with life-altering neurologic conditions. Axovant is committed to developing a pipeline of product candidates, and ultimately commercializing them, by identifying and developing novel treatments for unmet needs in neurology. For more information, visit www.axovant.com.
About Roivant Sciences
Roivant Sciences is a global biopharmaceutical company focused on reducing the time and cost of the drug development process to improve the lives of patients and their families. Roivant partners with innovative biopharmaceutical companies and academic institutions to ensure that important medicines are rapidly delivered to patients.
The Roivant family of companies includes Myovant (women’s health and prostate cancer), Axovant (neurology), Urovant (urology), Enzyvant (rare diseases), Dermavant (dermatology), Genevant (RNA therapeutics), Metavant (cardiometabolic diseases), Datavant (healthcare data), and Arbutus (hepatitis B). Today there are 24 investigational drugs in 11 therapeutic areas being tested in over 50 clinical trials and over 300 nonclinical studies across the Roivant family of companies.
For more information, please visit www.roivant.com