(AOF) – Ipsen has announced the results of analyzes from the Phase 3 study which demonstrated sustained benefits in terms of survival and response rates, as well as improved health-related quality of life for Cabometyx (cabozantinib) in combination with Opdivo (nivolumab) compared to sunitinib in the first-line treatment of advanced renal cell carcinoma (RCC). These latest results will be the subject of two poster presentations at the American Society of Clinical Oncology Symposium on Genitourinary Cancers (ASCO GU), February 17-19, 2022.
LEXICON
Clinical trials (Phases I, II, III)
Phase I: small-scale testing of the molecule on humans to assess its safety, tolerance, metabolic and pharmacological properties. Phase II: evaluation of tolerance and efficacy on several hundred patients to identify side effects. Phase III: evaluation of the overall benefit/risk ratio with several thousand patients.
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=/ Key points /=
– 3rd French laboratory specialized in peptides and toxins, created in 1929;
– Turnover of €2.6 billion distributed between specialty medicine for 92% (neuroendocrine tumors with Somatuline, prostate cancer with Decapeptyl, kidney with Cabometyx, pancreas with 0nivyde and the rest in family health (Smecta, Forlax, Fortrans, etc.);
– International presence mainly in Europe (39% + 5% in the United Kingdom) and the United States (34%);
– New business model in 4 pillars: maximization of the specialty medicine portfolio and strategic review of the family health activity, reorganization of R&D targeted towards differentiated drugs in oncology, rare diseases and neurosciences, industrial efficiency and environmental commitment and social;
– Capital controlled by the founding Beaufour families (66.54% of voting rights), Marc de Garidel chairing the 14-member board, David Loew being managing director;
– Solid balance sheet with net debt reduced to €525 million, i.e. a leverage effect of 0.6 and free cash flow of €647 million.
=/ Issues /=
– 2022 strategy capitalizing on specialty medicine and the integration of Clementia targeting €3.2 billion in revenue and over 32% operating margin;
– Innovation strategy supported by R&D equal to 15% of sales carried out in 3 centers (Oxford, Cambridge, Saclay), €1 billion of investment being devoted to botulinum and recombinant toxins, having resulted in the creation of a portfolio 21 products, including 3 registered (Dysport wrinkles de la gabelle, Dysport PUL Spasticity, Somatuline acromegale) and 6 in phase 3 (cabometyx in combination with 6 other products, decapeptyl 3 M, Onivyde 1L and 2L, Dysport solutions);
– Environmental strategy:
– reduction, between 2015 and 2020, of 5% in energy consumption and CO2 emissions and 30% in water consumption.
– integration since 2019 of ESG criteria in bond issues;
– Partnerships with the German company Schwabe, with Oncodesign, a specialist in pharmaco-imaging and the possession of biomarkers; and, in oncology, with the Canadian center IRICoR;
– Commercial benefits of the Cabometyx-rivumab protocol against renal cell carcinoma, approved by the European Commission;
– Decisions expected by the end of 2021: regulatory with Onivyde against lung cancer in the United States and Palovarotene against FOP, clinical for Cabometyx-atezolizumab against liver cancer;
– Waiting for acquisitions, with a strike force of €1.3 billion.
=/ Challenges /=
– Strong dependence on 3 drugs, providing nearly 2/3 of sales – Dysport (Botox challenger), marketed in the United States, Decapeptyl and Somatuline;
– In France, regulatory environment hostile to local drugs, such as Smecta, less well reimbursed than its Chinese competitor since February 2021;
– Impact of the pandemic: 11% increase in half-year revenues;
– 2021 target raised: revenue growth of +8% and operating margin around 32%;
– 2020 dividend of €1.
Boost for French pharmacy
At the end of a recent CSIS, the French authorities announced an amount of credits (7 billion euros) never reached: 1.5 billion for hospital-university research, 2 billion for investment in health via bpi france , 1.5 billion in aid for the relocation of industrial projects, and 2 billion to strengthen investment in three sectors of the future (bioproduction, digital medicine, and pandemic preparedness). In addition, the annual growth in drug expenditure reimbursed by Medicare will be 2.4%, which should generate growth of at least 0.5% in the turnover of laboratories,
Above all, the normal drug marketing procedure will be accelerated (up to 500 days saved) if the medical benefit rendered is sufficient.