UK Life Sciences and Healthcare Newsletter – January 2022 | Dechert LLP

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Life Sciences Mergers and Acquisitions: Questions and Answers

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

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Regulatory updates:

MHRA and HRA issue guidance on new Combined Examination Service

The Medicines and Healthcare Products Regulatory Agency (MHRA) and the Health Research Authority (HRA) published guidance on the Combined Review Service, formerly known as Combined Ways of Working, on January 6, 2022. Beginning January 1, 2022, all new clinical trial applications for investigational drugs will be prepared, submitted, and reviewed through the Combined Review Service.

DHSC launches review of bias in medical devices

On November 21, 2021, the Department of Health and Social Care (DHSC) announced a new independent study on the impact of potential systematic biases and risks in medical devices. The review will make recommendations, which could include regulatory changes, and examine emerging data based on algorithms and artificial intelligence tools. The first results are expected at the end of 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 fast-track delivery of medicines and medical products to the UK where international supply chains are disrupted or where there is a urgent need of these products.

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Market News:

Recent notable transactions in the sector:

  • AstraZeneca and Ionis Pharmaceuticals, Inc. have entered into a new global development and commercialization agreement for eplontersen, formerly known as IONIS-TTR-LRX, designed to treat hereditary and non-hereditary forms of TTR amyloidosis. The agreement provides for 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 SA and Oaktree Acquisition Corp. They have announced that they have entered into a definitive merger agreement. When completed, the combined company will have an implied initial enterprise value of approximately US$2.25 billion and its securities are expected to trade on NASDAQ under the symbol “ALVO”. The combined company is expected to continue investing in the growth of Alvotech’s biosimilars pipeline.
  • Merck (also known as MSD outside of North America) acquired Acceleron Pharma Inc. on November 19, 2021 for an approximate total net worth of US$11.5 billion. Acceleron is a publicly traded biopharmaceutical company. Its lead therapeutic candidate, sotatercept, has the potential to improve short- 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 assessment agreement for mRNA-based regenerative medicine research. Pantherna’s state-of-the-art mRNA platform and Astellas’ strong drug discovery capabilities will drive research into creating new programs in regenerative medicine and applying them to treatment.
  • CN Bio announced a research collaboration with the Infection Innovation Consortium, a global collaborative infectious disease R&D program, to validate the next generation of COVID-19 research tools. As part of the agreement, the Liverpool School of Tropical Medicine will independently validate CN Bio’s new lung and lung-liver models, designed to advance the discovery and development of new drugs against SARS-CoV-2
  • After owning shares of Roche for 20 years, Novartis has agreed to sell 53.3 million (approximately 33%) of Roche bearer shares in a bilateral transaction to Roche for $20.7 billion. The transaction is subject to the approval of Roche shareholders.
  • AstraZeneca has agreed to transfer its worldwide rights to Eklira and Duaklir to Covis Pharma. Both drugs are used for the treatment of chronic obstructive pulmonary disease. Under the agreement, AstraZeneca is eligible to receive US$270 million upon completion.
  • Ipsen and Accent Therapeutics have signed an exclusive worldwide collaboration agreement for the research, development, manufacturing and commercialization of Accent’s METTL3 preclinical program. Ipsen will pay up to US$446 million, comprising an upfront payment as well as preclinical, clinical, regulatory and sales-based milestone payments, as well as tiered sales royalties.

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

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