Ipsen acquires Albireo to accelerate growth in rare diseases – 09/01/2023 08:20

(AOF) – Ipsen and Albireo announced that they have entered into a definitive merger agreement whereby Ipsen will acquire Albireo, a leading innovator in bile acid modulators for the treatment of cholestatic liver disease in children and adults. Thus, the planned acquisition will enable Ipsen to strengthen its portfolio of marketed products and products in R&D in rare diseases.

The lead drug in Albireo’s pipeline is Bylvay (odevixibat), a potent, nonsystemic, once-daily oral ileal bile acid transport inhibitor.

Bylvay was approved in 2021 in the United States for the treatment of pruritus in patients three months of age and older with progressive familial intrahepatic cholestasis (PIHC), and in the European Union for the treatment of CIFP in patients six months of age and older. .

Pruritus is one of the most important and problematic clinical manifestations of the disease, often causing a sharp decrease in the quality of life of patients. Bylvay benefits from orphan exclusivity for indications approved for the treatment of CIFP in the United States and within the European Union.

“We welcome the potential that the acquisition of Albireo offers in terms of assets and scientific expertise, and we believe this is a solid growth opportunity for Ipsen,” said David Löw, CEO of Ipsen.

“In addition to being the first drug approved for the treatment of CIFP, it has two other indications under investigation in rare liver conditions with high unmet need, thus strengthening our franchise in the disease. In addition, the bile acid transport inhibitors from Bylvay and the new clinical and preclinical portfolio of Albireo have shown their potential in the treatment of liver diseases. completes our portfolio.

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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.