Life Sciences Mergers and Acquisitions: Q&A

Dechert partnered with Practical Law on their Q&A guide to mergers and acquisitions (M&A) in the life sciences sector, with a focus on pharma and medicines. The second part of the Q&A provides a high-level overview of the factors affecting asset and share acquisitions in the sector and the key considerations for buyers and sellers. Read more

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Regulatory Updates:

MHRA and HRA publish guidance on the new combined review service

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) published guidance on 6 January 2022 on the combined review service, formerly called the Combined Ways of Working. From 1 January 2022, all new Clinical Trials of Investigational Medicinal Products applications will be prepared, submitted and reviewed via the combined review service.

DHSC launches review into bias in medical devices

On 21 November 2021, the Department of Health and Social Care (DHSC) announced a new independent review into the impact of potential systematic bias and risk in medical devices. The review will make recommendations, which may include changes to regulation, and consider emerging algorithmic-based data and artificial intelligence tools. Initial findings are expected in late January 2022.

DHSC launches International Express Freight Service to support medical supply chains

The Department of Health and Social Care has announced the launch of an International Express Freight Service to support the fast-track delivery of medicines and medical products to the UK where international supply chains are disrupted or where there is an urgent requirement for such products.

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Market News:

Recent notable industry transactions:

• AstraZeneca and Ionis Pharmaceuticals, Inc. have entered into a new global development and commercialisation agreement for eplontersen, previously known as IONIS-TTR-LRX, designed to treat both hereditary and non-hereditary forms of TTR amyloidosis. The agreement stipulates an upfront payment to Ionis of US$200 million and additional conditional payments of up to US$485 million following regulatory approvals. AstraZeneca will also pay up to US$2.9 billion in sales-related milestones, plus royalties
• Alvotech Holdings S.A. and Oaktree Acquisition Corp. II announced their entry into a definitive merger agreement. Upon completion, the combined company will have an implied initial enterprise value of approximately US$2.25 billion and its securities are expected to be listed on NASDAQ under the symbol "ALVO". The combined company is expected to continue investing in the growth of Alvotech’s biosimilar pipeline.
• Merck (also known as MSD outside North America) acquired Acceleron Pharma Inc. on 19 November 2021 for an approximate total equity value of US$11.5 billion. Acceleron is a publicly traded biopharmaceutical company. Its lead therapeutic candidate, sotatercept, has the potential to improve short-term and/or long-term pulmonary arterial hypertension, a progressive and life-threatening blood vessel disorder.
• Astellas Pharma and Pantherna Therapeutics have entered into a technology evaluation agreement for the research of mRNA-based regenerative medicine. Pantherna's leading mRNA platform and Astellas' high drug discovery capabilities will promote research on the creation of new programmes in the field of regenerative medicine and their application to treatment.
• CN Bio have announced a research collaboration with the Infection Innovation Consortium, a global collaborative infectious disease R&D programme, to validate the next generation of COVID-19 research tools. Under the agreement, the Liverpool School of Tropical Medicine will independently validate CN Bio’s novel lung and lung-liver models, designed to advance novel SARS-CoV-2 drug discovery and development
• After holding shares in Roche for 20 years, Novartis has agreed to sell 53.3 million (approximately 33 percent) Roche bearer shares in a bilateral transaction to Roche for US$20.7 billion. The transaction is subject to approval by the shareholders of Roche.
• AstraZeneca has agreed to transfer its global rights to Eklira and Duaklir to Covis Pharma. Both medicines are used for the treatment of chronic obstructive pulmonary disease. Under the agreement, AstraZeneca is eligible to receive US$270 million on completion.
• Ipsen and Accent Therapeutics have signed an exclusive worldwide-collaboration agreement to research, develop, manufacture and commercialise Accent's pre-clinical stage METTL3 programme. Ipsen will pay up to US$446 million, comprising an upfront payment as well as pre-clinical, clinical, regulatory and sales-based milestone payments, plus tiered sales royalties.

The authors would also like to thank Thomas Deakin for his contributions to this newsletter.