David Solomon, Chairman of the Board of Directors of Advicenna. (Photo credit: DR)
Update at 6:15 p.m. with an additional question. The European Commission has just granted marketing authorization to Sibnayal for the treatment of distal renal tubular acidosis (dRTA). This green fire makes Sibnayal the first and only drug approved for the treatment of dRTA in adults, adolescents and children one year and older. How will the next few months of biotech be organized? Interview with David Horn Solomon, President of Advicenna.
Boursorama: You have just obtained acceptance from the European Commission for Sibanayal in the dRTA, what are now the main stages and the timetable for the marketing of your treatment?
David Horn Solomon : In Europe, we will now look for industrial partners to market dRTA. Moreover, discussions are underway. We will follow a swift schedule to ensure our medicine reaches patients, working with our new partner.
Boursorama: Could this obtaining accelerate the development of your product across the Atlantic?
David Horn Solomon : The approval by the EMA gives us the certainty that the clinical studies carried out have been crowned with success. American investors will therefore see the risk decrease. We will communicate very soon on the schedule for the pivotal Phase III trials in dRTA and cystinuria in the United States.
Boursorama: Some investors had reacted badly to the abandonment of the application for obtaining orphan drug status, fearing that it would have an impact on the price of the treatment, what is your view on this specific point?
David Horn Solomon : Although the news of the abandonment of the orphan disease status may have seemed disappointing, we believe that at a lower price now, the sales volumes will be much higher and guarantee a good economic result for Advicenne.
Boursorama: Your approach to the commercial potential of Sibnayal is judged to be rather conservative by some analysts whereas, alongside certain hereditary causes, some patients also have dRTA acquired due to autoimmune diseases such as lupus or Sjogren’s Syndrome and that this patient pool would be underestimated today, what do you think?
David Horn Solomon : Of course, in all these indications, the number of patients can indeed be much greater. But at Advicenne, we prefer to remain conservative. We like to promise less and offer more for all of our shareholders.
Boursorama: Some critics point to the fact that the EMA does not recognize Advicenna’s assertion that Sibnayal will allow a better “standard of care” for patients, in particular because of “problems of robustness in the design of the study and its realization “(in the orphan disease designation retreat application). What can you say to that?
David Horn Solomon : First of all, this passage concerns an old request concerning the orphan designation (ODD) that we withdrew on our own initiative last March from the European Medicines Agency. Since then, this same agency very quickly gave us the green light for an MA. So quickly that we were taken aback with the suspension of our listing yesterday. I would simply remind you that the EMA, in its last report, clearly demonstrated the improvement in the quality of life of patients with dATRD by our ADV703 treatment, underlined its compliance, in particular for pediatric treatments. There is therefore no ambiguity about the efficacy and safety of our treatment.
Boursorama: Is finding a partner now the number one priority for Advicenne?
David Horn Solomon : Finding a business partner for Advicenne in Europe is indeed the top priority. We firmly believe that with the establishment of the AMM in Europe, the interest of the partners will now increase very quickly. And when it comes to the United States, we keep all the options in mind.
Boursorama: At the same time, Sibnayal is in phase II / III in cystinuria, how are you going to sequence the different developments? Is fundraising planned to accelerate the execution of the strategy?
David Horn Solomon : We will accelerate phase III cystinuria trials in both Europe and the United States. Additional fundraising is always possible, as we keep all options open to accelerate our strategy. We remain focused on ensuring great value creation for Advicenne shareholders.
Interview by Laurent Grassin ([email protected])