UK Life Sciences and Healthcare Newsletter
We are pleased to present the January 2022 issue of Dechert LLP’s UK Life Sciences and Healthcare Newsletter.
Legal Updates: Hot Topics
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 »
Notable Dechert-led Transactions
Dechert has recently been involved in advising on a number of significant life sciences and healthcare transactions, including advising:
- GIC, the sovereign wealth fund of Singapore, in connection with the US$17 billion acquisition of athenahealth, a leading provider of cloud-based enterprise software solutions for medical groups and health systems nationwide.
- Anne Arundel Dermatology Management, a portfolio company of Ridgemont Equity Partners, in connection with its partnerships with Academic Alliance in Dermatology, Atlantic Dermatology, Ball Dermpath and Dermatology Specialists of Augusta.
- Quilvest Capital Partners, the multi-strategy alternatives division of the Quilvest Group, in connection with its acquisition of a majority interest in UrgentMED, a premier network of urgent care clinics in Southern California.
- Quest Diagnostics, a leading provider of diagnostic information services, in connection with its definitive agreement to acquire Pack Health in an all-cash equity transaction.
Other Industry Events
- BIO-Europe Spring 2022, 28-30 March and 4-6 April. will bring together the life sciences community for global dealmaking in-person and digitally.
- Global Pharmaceutical Regulatory Affairs Summit, 6-13 April. Regulatory authorities and industry leaders provide insights into policy and real-world case studies to help achieve compliance goals.
- 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.
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.
This update was authored by partner Robert Darwin and associate Rose Limaye. The authors would also like to thank Thomas Deakin for his contributions to this newsletter.
- 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 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.
- Dechert authored the UK chapter in Lexology Getting The Deal Through's Pharmaceutical Antitrust Review 2021
- RHC Recommendations for the Reform of Medical Devices Regulation
- Revised FCA Rules for SPAC Listings
- Future Fund: Breakthrough
- Life Sciences Sector Vision
- A New Era for International Data Transfers: European Commission Adopts New Standard Contractual Clauses
- Medicinal Cannabis in the UK: Fund Structuring, Investment and Listing Considerations
- Guest Contributor Meriem Sefta, chief data and clinical solutions officer at Owkin: "Patient Data is Full of Potential, But Don’t “Data Grab” it too Tightly"
- COVID-19 Collaborations and EU Competition Law Compliance
- Equity Incentives: Single and Double Trigger Vesting
- Future Fund: Breakthrough
- Granting Incentives Under U.S. Plans to UK-based Executives
- Guest Contributor Charles Swingland, chairman of Vaxerna Limited: "COVID has Brought Unexpected New Approaches to Autoimmune and Allergic Diseases."
- Harnessing Big Data – Draft EU Data Governance Regulation Aims to Increase Innovators’ Access to Data
- Synthetic Warranties and W&I Insurance
- Committed Capital Podcast: A Strong Recovery? PE Life Sciences and Healthcare Investment Opportunities in 2021
- Guest Contributor David Miles, CEO of AKL Research and Development: "Are We Nearly There Yet? The Search for a Disease Modifying Drug for Osteoarthritis."
- Counterfeit Medicines: A Growing Threat to Consumers and Pharmaceutical Companies
- UK Government Launches Consultation into Potential Reform to Employee Non-compete Clauses
- Dechert Panel: How Does the Investment Landscape Look Post COVID-19? 12th Annual Healthcare Investor Conference
- Guest Contributor Linden Thomson, co-head of global equities at AXA IM Framlington: "All Eyes Were on Biotech in 2020: Some Investor Observations."
- UK National Security and Investment Bill
- A Brief Update on the Enterprise Management Incentive (EMI) Scheme
- Guest Contributor Kevin Cox, executive chairman at Biotaspheric Limited: "Antimicrobial Resistance (AMR) – A Personal Perspective."
- More Detail Announced on the Job Retention Bonus
- The Potential Impact of COVID-19 on EBITDA and Financial Covenant Calculations in Loan Agreements
- Guest Contributor Dr. Annalisa Jenkins, life sciences thought leader: "Led by Science: Protecting and Advancing Public Health – Is the Modern Day Regulatory System Fit for Purpose?"
- Dechert Q&A Guide in partnership with Practical Law: "Life Sciences Mergers and Acquisitions: Q&A."
- Life Sciences Investing Has Had A Good Bull Run – Will Covid-19 Upset That?
- Changes to Insolvency Rules Provide Breathing Space
- Guest Contributor Ben Howlett, managing director of Public Policy Projects: '“No-one is Listening”: The Failure to Recognise that Medicines and Medical Devices are for Patients.'
- COVID-19 – How Have Listed Companies Fared?
- Future Funds – Convertible Loans to Support Innovative Companies
- Foreign Direct Investment (FDI) Control in the United Kingdom