Oxford Biomedica Notes Positive US Regulator Feedback On AXO-Lenti-PD

LONDON (Alliance News) - Oxford Biomedica PLC on Thursday noted an announcement by Axovant ...

Alliance News 6 December, 2018 | 5:07PM
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LONDON (Alliance News) - Oxford Biomedica PLC on Thursday noted an announcement by Axovant Sciences Inc, which concerned US regulator feedback on Parkinson's therapy AXO-Lenti-PD.

Oxford Biomedia, a gene and cell therapy company, received USD30 million upfront, including a USD5 million pre-payment for manufacturing activities pertaining to AXO-Lenti-PD, then named OXB-102.

Once development milestones are achieved, Oxford Biomedica is eligible for a further USD55 million. Another USD757.5 million may be paid for regulatory and sales milestones, as well as between 7% and 10% tiered royalties on net sales of the therapy.

AXO-Lenti-PD is gene therapy for Parkinson's and delivers three genes. These genes code for a set of enzymes needed to make the hormone dopamine. People with Parkinson's do not produce enough dopamine as some of the cells needed to make it have died, which causes difficulty with movement.

Axovant, which is also a gene therapy company headquartered in Bermuda, said it was pleased by the feedback received from a face-to-face pre-investigational new drug meeting with the US Food & Drug administration regarding the therapy.

A phase two clinical trial of AXO-Lenti-PD, known as Sunrise-PD, began in the UK in the 2018 fourth quarter with the two patients dosed so far tolerating the surgical procedure well. Data from both of these patients is expected in March.

Feedback was received from the FDA on key features of the AXO-Lenti-PD development program, including that the ongoing Sunrise-PD study constitutes an early-phase exploratory trial and may support a future marketing application.

The FDA also encouraged Axovant to return for an end-of-phase two meeting once Sunrise is completes to study the available data.

"We believe we are well-positioned to continue to execute on the clinical trial as designed, manufacture drug product at scale, and activate clinical trial sites in the US," said Axovant Executive Vice President of Research & Development Gavin Corcoran.

Shares in Oxford Biomedica closed down 1.1% at 712.10 pence on Thursday.

By Anna Farley; annafarley@alliancenews.com

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Security Name Price Change (%) Morningstar Rating
Oxford BioMedica PLC 634.00 GBX -1.55 -
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