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23 Sep 2019
Lupus Momentum Building – AstraZeneca, Roche and Alexion with Lupus indications – big market potential, big pharma approach – how will this fit with Lupuzor™?
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Lupus Momentum Building – AstraZeneca, Roche and Alexion with Lupus indications – big market potential, big pharma approach – how will this fit with Lupuzor™?
ImmuPharma plc (IMM:LON) | 2.2 0 (-3.7%) | Mkt Cap: 9.33m
- Published:
23 Sep 2019 -
Author:
Dr. Navid Malik -
Pages:
7
The Lupus field continues to experience renewed upward momentum, especially in the past few days with a new update from Roche for its drug Obinutuzumab in Lupus Nephritis, an organ specific complication of Lupus. This follows AstraZeneca’s announcement (29/08/2019) of having met its primary and secondary endpoints in its second Phase III study in Lupus with antibody product Anifrolumab in the TULIP II study (see TLSD research report dated: 09/09/2019). We note in a recent broker call with the CEO of AstraZeneca, Pascal Soriot, stated that AstraZeneca was excited about the opportunity to file for Anifrolumab with the FDA. This is despite having completed the Phase III TULIP II study with an endpoint that we believe is not generally accepted by FDA – he went on to state that AstraZeneca was yet to discuss next steps with US FDA, however, he believed the ‘chances of approval on existing data are good, considering the unmet medical need and the limitations of current treatment’ (read: Benlysta). We believe that AstraZeneca will rely on presenting all its data from the TULIP II study, as well as a previous Phase II study that was successful. We await data from both the TULIP I and TULIP II studies – And re-iterate this situation is not dissimilar to ImmuPharma for its novel drug Lupuzor™.