(AOF) – Phase III Napoli 3 data demonstrates positive survival results for the investigational drug Onivyd in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). This is announced by the Ipsen laboratory, welcoming “a potential advance in an aggressive and difficult to treat cancer”. Ipsen announces that it plans to file an application for approval with the American regulatory authorities (the FDA).
“For the first time, a front-line clinical study to treat mPDAC has demonstrated superior overall survival and progression-free survival in an investigational treatment regimen compared to the standard treatment with nab-paclitaxel and gemcitabine. “said Zev Wainberg, MD, UCLA Professor of Medicine and Co-Director of UCLA’s Gastrointestinal Cancer Oncology Program.
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Key points
– 3rd specialized French biopharmaceutical, focused on innovation and specialty medicine, created in 1929;
– Turnover of €2.9 billion distributed between specialty medicine for 92% (of which oncology for 75%), neurosciences for 15%, rare diseases for 2% and the rest in family health (Smecta , Forlax, Fortrans, etc., division sold in 2022;
– International presence mainly in Europe (50.2%) and the United States (32%);
– Vision: to be a leading biopharmaceutical in drugs for oncology (Cabometyx, Decapeptyl, Onivyde, Somatuline), rare diseases (NutropinAct and Increlex) and neurosciences (Dysport) through R&D and scientific partnerships;
– Capital controlled by the founding Beaufour families (54% of the shares and nearly 70% of the voting rights) and by the Swabe family for 4.34%, Marc de Garidel chairing the 10-member board, David Loew being managing director;
– Solid balance sheet with, at the end of June, shareholders’ equity of €3.1 billion, debt leverage of less than 1 and cash of €1 billion, which will be reinforced by the sale of the family health division for €350 million €, financing the acquisition of Epizyme.
Challenges
– 2024 strategy capitalizing on specialty medicine with enhanced objectives: aiming for 4 to 6% annual growth in turnover, reduction of administrative and general expenses and increase in R&D efforts;
– Open innovation strategy, supported by R&D carried out in 3 centers (Oxford, Cambridge, Saclay and Shanghai) and financed by €3 billion in investments by 2024 (14.9% of revenues):
– resulting in the creation of a portfolio of 25 drugs including 3 registered
– accelerated by acquisitions (7 in 2021);
– “Generation Ipsen” environmental strategy:
– in 2030, 50% reduction (vs 2019) in CO2 emissions by infrastructure and the car fleet,
– 2024 progress report: 21% reduction in CO2 emissions, 24% reduction in water consumption and 20% increase in the volume of waste treated,
– integration since 2019 of ESG criteria in bond issues;
– Expansion of the range against rare diseases (NutropinAct and Increlex);
– Reinforcement in anti-cancer epigenetics after the merger with the American Epizyme.
Challenges
– Strong dependence on 3 drugs providing nearly 2/3 of sales: Dysport (Botox challenger, marketed in the United States), Decapeptyl and Somatuline;
– Postponement by the American authority -FDA- of the meeting scheduled for October 31 on palovarotene;
– Expected decisions: regulatory with Onivyde against lung cancer in the United States and clinical for Cabometyx-atezolizumab against liver cancer;
– Spin-offs from partnerships with Genfit around the drug Elifibranor, accompanied by an 8% stake and with Marengo Therapeutics;
– After a 9.5% increase in sales at the end of September, confirmed objectives of sales growth of +7% and an operating margin of +36%;
– Redemption of shares.
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Loss of speed in European research
European research is losing ground to American and Chinese research. In twenty years, Europe’s share has fallen from 41% to 31% in global R&D. China’s share jumped from 1% to 8%. As for the United States, which supplanted Europe, in 2001 it devoted only 2 billion euros per year more than Europe to R&D, whereas now this gap has reached 25 billion! Some experts accuse the European authorities of not having deployed effective policies. The financing of pharmaceutical research should therefore have been better targeted via the “Horizon 2020” programme. France only comes in eighteenth position in European funding despite the quality of its research. Conversely, the United States concentrates funding on Boston and a few centers of excellence.