It will continue today… Ipsen – 23.01.2023 at 08:15

(AOF) – Phase III Napoli 3 data demonstrate positive survival results for investigational drug Onivyd in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). It heralds a “potential breakthrough in an aggressive and difficult-to-treat cancer” by Ipsen’s lab. Ipsen announces plans to submit an application to the US regulatory authorities (FDA) for approval.

“For the first time, a front-line clinical trial for the treatment of mPDAC demonstrated superior overall survival and progression-free survival in the study treatment regimen compared with 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 company, founded in 1929, focused on innovation and specialty medicine;

– EUR 2.9 billion turnover, 92% of specialty medicine (75% of which is oncology), 15% of neurology, 2% of rare diseases and the rest family health (Smecta, Forlax, Fortrans, etc., sold section) divided between in 2022;

– International presence mainly in Europe (50.2%) and USA (32%);

– Vision: To become a leading biopharmaceutical in oncology (Cabometyx, Decapeptyl, Onivyde, Somatuline), rare diseases (NutropinAct and Increlex) and neurology (Dysport) through R&D and scientific partnerships;

– Capital controlled by the founding Beaufour families (54% of the shares and about 70% of the voting rights) and the Swabe family with 4.34%, a board of 10 members, Marc de Garidel, managing director David Loew;

– A solid balance sheet with shareholders’ equity of €3.1 billion, debt leverage of less than 1 and cash of €1 billion at the end of June will be bolstered by the sale of the family healthcare unit for €350 million. , financing the acquisition of Epizyme.

Challenges

– 2024 strategy, capitalization of specialty medicine with improved goals: 4-6% annual increase in turnover, reduction of administrative and general expenses and increase of scientific-research works;

– An open innovation strategy supported by R&D implemented in 3 centers (Oxford, Cambridge, Saklay and Shanghai) and funded by 3 billion euros of investment until 2024 (14.9% of revenues):

– creation of a portfolio of 25 medicines, 3 of which are registered as a result

– accelerated by acquisitions (7 in 2021);

– “Generation Ipsen” environmental strategy:

– 50% reduction in CO2 emissions from infrastructure and vehicle fleet in 2030 (compared to 2019),

– 2024 progress report: 21% reduction in CO2 emissions, 24% reduction in water consumption and 20% increase in treated waste volume,

– integration of ESG criteria in bond issues from 2019;

– Expansion of the range against rare diseases (NutropinAct and Increlex);

– Enhancement in anti-cancer epigenetics after merger with American Epizyme.

Challenges

– Strong dependence on 3 drugs that account for about 2/3 of sales: Dysport (Botox competitor marketed in the US), Decapeptil and Somatulin;

– Postponement of the meeting scheduled for October 31 regarding Palovarotene by the American agency -FDA-;

– Expected decisions: US regulatory with Onivyde against lung cancer and clinical for Cabometyx-atezolizumab against liver cancer;

– additions from the partnership with Genfit around the Elifibranor drug accompanied by an 8% stake with Marengo Therapeutics;

– Confirmed +7% sales growth and +36% operating margin targets after 9.5% sales growth at the end of September;

– Redemption of shares.

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Loss of momentum in European studies

European studies are losing ground to American and Chinese studies. In twenty years, Europe’s share in global R&D has fallen from 41% to 31%. China’s share increased from 1% to 8%. As for the USA, which oppresses Europe, in 2001 it allocated only 2 billion euros per year from Europe to research and development, but now this gap has reached 25 billion! Some experts accuse the European authorities of not implementing an effective policy. Therefore, pharmaceutical research funding should be better targeted through the Horizon 2020 programme. Despite the quality of French research, it is only eighteenth in European funding. In contrast, the United States concentrates funding in Boston and a few centers of excellence.