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Novartis breakthrough feeds Oxford BioMedica hopes

Good news on the regulatory front for the Swiss giant could mean the London group's facilities investment pays off
April 18, 2017

Followers of biotech group Oxford BioMedica (OXB) will be well aware of the drug development programme it's working on with Swiss giant Novartis (ch:NOVN). The two are working together to develop a drug called CTL019, which is designed to treat cancer patients suffering from a specific kind of lymphoma and leukaemia. The drug is due to be submitted for regulatory approval before the end of this year - and the US Food and Drug Administration (FDA) just handed Novartis a golden ticket.

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The regulator has given Novartis and CTL019 what's known as a "breakthrough" tag for a second time. The drug was awarded an original tag for its use in B-cell acute lymphoblastic leukaemia in paediatric and young adult patients, and thus was given a priority review at the end of March. This second tag could also speed up the regulatory process for its use in relapsed/refractory diffuse large B-cell lymphoma cases. Novartis said the latest breakthrough designation is based on data from a second-phase study, which is looking at the efficacy and safety of CTL019 in adult patients. That trial data isn't available to the public yet, but company bosses say it will be officially presented at an upcoming medical conference.

This decision is particularly pertinent given the competition Novartis faces from Kite Therapeutics, a specialist US biotech group working on very similar treatments. Kite is particularly keen to get its KTE-19 drug on the market as the first CAR-T therapy for patients with aggressive non-Hodgkin lymphoma. In December 2015 this drug received a "breakthrough" label from the FDA for diffuse large B-cell lymphoma, transformed follicular lymphoma and primary mediastinal B-cell lymphoma. If approved, Kite plans to commercially launch the new treatment this year.

Why should this matter to Oxford BioMedica? The London-listed group has worked with Novartis on the drug's delivery system via its LentiVector technology platform, and there's a royalty agreement in place based on future sales of the drug. Although the Novartis deal has sent the Oxford's revenues soaring, the company has spent a significant amount of money on expanding its Oxford-based laboratory to fulfil the contract terms.