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Merck to create spin off for women’s health and biosimilars Posted 21/02/2020

US pharma giant Merck is to create a spin-off company for its women’s health, biosimilars and legacy products, allowing the main company to focus on blockbuster cancer drug Keytruda (pembrolizumab).

Merck announced in February 2020 that it will create a new company to focus on women’s health care, as well as its biosimilars and legacy products. This (as yet unnamed) company will represent around 15% of Merck’s total sales and half of its human medicines. The company will be headed by Kevin Ali who has held a number of leadership roles at Merck over the last three decades, most recently leading its enterprise portfolio strategy initiative.

The new company ‘will help people around the world live healthier lives, with a special focus on investing in innovations for the distinct healthcare needs of women’, Mr Ali said. ‘We are committed to becoming a leader in Women’s Health driven by organic and inorganic opportunities fuelled by our portfolio of trusted legacy brands and our commitment to growing our rapidly expanding biosimilars business’, he added.

The company will market Nexplanon (etonogestrel implant), a birth control implant, and biosimilars of infliximab, etanercept and trastuzumab, to be sold in partnership with Samsung Bioepis. Merck made a deal to develop and commercialize biosimilars with Samsung Bioepis back in 2013 [1]. Other products to be managed by the new company include anti-cholesterol drugs Zetia (ezetimibe) and Vytorin (ezetimibe/simvastatin). The company will be headquartered in New Jersey with an estimated 10,000−11,000 employees.

The new company should be created by the first half of 2021 and is expected to save Merck over US$1.5 billion by 2024. The majority of its sales will be generated from outside the US.

The creation of this new company will enable Merck to focus on its oncology products, in particular Keytruda (pembrolizumab), an antibody treatment for melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma and stomach cancer. Keytruda was approved by the US Food and Drug Administration in September 2014 and by the European Union in July 2015 [2]. However, despite being one of the world’s top selling drugs, sales have so far not met analysts’ estimates.

Merck will also retain its animal health business, drugs for acute care in hospitals such as Bridion (sugammadex) which is used to bring people round following anaesthesia, and its diabetes range.

Merck’s Chief Executive, Ken Frazier, explained that separation into two companies aims to bring growth. ‘By optimizing our human health portfolio, Merck can move closer to its aspiration of being the premier research-intensive biopharmaceutical company, while also properly prioritizing a set of products at [the new company] that are important to public health and the patients who rely on them, and which present real opportunities for growth.’

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References
1. GaBI Online - Generics and Biosimilars Initiative. Merck makes biosimilars deal with Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 21]. Available from: www.gabionline.net/Biosimilars/News/Merck-makes-biosimilars-deal-with-Samsung-Bioepis
2. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003

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Source: Merck

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