By Oliver Haill
Date: Tuesday 31 Oct 2017
LONDON (ShareCast) - (ShareCast News) - Oxford Biomedica received a boost as Novartis announced that it has filed for approval of its Kymriah drug for a second blood cancer indication.
Kymriah is the main potential driver of revenues and profits for Oxford Biomedica through its deal as the sole manufacturer of the lentiviral vectors used to generate Kymriah.
Novartis said on Tuesday it had applied to the US Food & Drug Administration for Kymriah in adult patients suffering from a relapsed or refractory diffuse large B-cell lymphoma who are ineligible for an autologous stem cell transplant.
Kymriah was approved by the FDA in August in the smaller indication of paediatric acute lymphoblastic leukemia, which was the first-ever chimeric antigen receptor T cell (CAR-T) therapy approved by the US regulator.
Novartis also plans to apply to European authorities to market DLBCL this year.
Novartis noted that DLBCL is a significantly larger patient pool with US & EU relapsed/refractory DLBCL incidence of around 50,000 per year versus 2,200 for ALL.
Elsewhere, Oxford Biomedica got a second piece of good news as Sanofi chose not to exercise its option on Voyager's VY-AADC gene therapy product for Parkinsons, which is a potential competitor to OXB-102, Oxford BioMedica's own gene therapy pipeline candidate for Parkinsons.
According to reports, Sanofi's decision was due to the fact that its existing deal with Voyager did not include US rights.
Sanofi has a number of other existing gene therapy projects with Oxford BioMedica, noted analysts at Peel Hunt, also suggesting that further deals, whether for lentiviral vector supply and/or gene therapy partnerships, "are important potential catalysts for Oxford BioMedica and we await further updates with interest".