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- Life Sciences
Covington offers one of the largest and most comprehensive life sciences industry-focused practices in the world. Our clients, spanning all industry sectors and ranging from startup ventures to multinational corporations and trade associations, trust us with their most challenging business problems. They know that they can rely on Covington for practical, efficient solutions rooted in a sophisticated knowledge of their business that only comes from deep immersion in the industry and decades of dedicated service.
We advise clients throughout a product’s life cycle, going beyond the traditional legal services offered by other firms to facilitate efficient and effective research and development, ensure successful launch and commercialization, and maximize the product’s franchise. Our multi-disciplinary "life cycle management" approach enables us to quickly assimilate our clients’ regulatory, intellectual property and commercial goals, identify potential issues and develop creative and novel approaches to maximize value for our clients.
Our team includes more than a hundred lawyers who devote substantially all of their time to work on behalf of pharmaceutical, biotech and medical device clients. Many of our lawyers have previously served in leadership positions with the major industry regulatory bodies (including several high-ranking officials with the FDA), in-house with major manufacturers (including two former life sciences General Counsel), or within industry trade associations. Our broad background and depth of experience ensures that when clients come upon a problem that they have not seen before or anticipated, chances are that we have.
HealthpointCapital in Acquisition and Exit of French Company
Represented HealthpointCapital in its minority investment in ScientX and subsequent acquisition of its France-based parent through a tender offer.
HealthSouth Senior Notes Offering
Represented HealthSouth Corporation in its public offering of $300 million of its 5.125% senior notes due 2023.
Horizon Discovery Group IPO on AIM
Represented Horizon Discovery Group plc in its £68.6 million initial public offering on AIM.
Illumina Decoding UK-based Human Genome
Represented Illumina on a strategic alliance with Genomics England for a four-year project to decode 100,000 human genomes in the UK.
Indivior $1.6 billion Demerger
Represented Indivior plc in its $1.6 billion demerger transaction from Reckitt Benckiser Group plc and listing on the LSE.
Investors in its Funding of Clinical Cancer Genomics Company
Advised Imperial Innovations, Cambridge Innovation Capital and Johnson & Johnson Development Corporation in a £4 million funding round for Inivata, a clinical cancer genomics company spun out from Cancer Research UK.
Life Sciences Investors in Series C Funding of Development Stage Biotech Company
Advised Imperial Innovations and SROne on a £25 million Series C funding round in portfolio company PsiOxus Therapeutics which is developing innovative oncolytic immuno-oncology treatments for cancer.
King Pharmaceuticals Acquisition by Pfizer
Representation of King Pharmaceuticals in its $3.6 billion acquisition by Pfizer.
Large commercial award for Merck
Representation of Merck in ad hoc London arbitrations against various insurers that produced a disclosed recovery of approximately US$590 million, plus US$45 million in fees and interest, for prescription drug liabilities — reportedly one of the largest commercial awards in Europe in recent years.
Abbot Laboratories - AbbVie de-merger
Advising Abbott Laboratories in relation to all privacy aspects of its global de-merger, involving the division of the company into a research-based business, AbbVie.
Acquisition of Leading Pharmaceutical Contract Development and Manufacturing Company
Represented Consort Medical plc on its £230 million acquisition, of Aesica Holdco Limited and its operating subsidiaries from Silverfleet Capital and management shareholders.
Advising Large Public Companies and Investors on Corporate Governance Matters
Represented boards in the pharmaceuticals, consumer goods, health insurance, home equipment, advertising, motor vehicles, network communications, and technology industries as well as hedge funds, public pension funds, and other investors with respect to corporate governance developments regarding board and committee composition, crisis management, cybersecurity, internal controls, shareholder proposals, proxy access, political spending, and other sensitive disclosures and similar matters.
AstraZeneca Acquisition of Diabetes Products
Represented AstraZeneca in its $4.3 billion acquisition of its diabetes collaboration from Bristol Myers Squibb.
AstraZeneca Investment in Respiratory Franchise
Represented AstraZeneca on its up to $2.1 billion transfer of rights to Almirall’s respiratory franchise for an initial consideration of $875 million on completion, and up to $1.22 billion in development, launch, and sales-related milestones.
NICE Challenge for Irish Biopharmaceutical Company
Advised the wholly owned Irish subsidiary of a major U.S. biopharmaceutical company on a negative recommendation from the UK's NHS reimbursement from the National Institute of Health and Care Excellence (NICE) on a treatment for obesity and an appeal against it.
Advised UK-based Clinical AI Company Sensyne Health
Advised Sensyne Health, a UK-based clinical AI company, on: a collaboration with Bayer to analyze patient data from the UK National Health Service using Sensyne’s clinical artificial intelligence platform and apply the findings to Bayer’s cardiovascular disease pipeline; Jefferson Health to evaluate the clinical and commercial potential of its GDm-Health™ system in the United States; novel strategic research and data processing; and agreements with the Chelsea and Westminster Hospital National Health Service (NHS) Foundation Trust, the Oxford University Hospitals NHS Foundation Trust, and the South Warwickshire NHS Foundation Trust.
Advice on the collection and use of employee data
Advised a major pharmaceutical client on the collection and use of its employees’ biometric information and social security numbers for internal purposes.
Binding Corporate Rules for global pharmaceutical company
Assisting GSK plc in its adoption of Binding Corporate Rules (BCRs) in order to permit the company to transfer personal data globally. We helped develop GSK’s privacy compliance program, obtain the UK data protection authority’s approval and continue assisting GSK during the subsequent implementation.
Q-Med Aktiebolag ITC Section 337 Investigation
Representation of Q-Med Aktiebolag in the ITC Section 337 Investigation: Injectable Implant Compositions, USITC Inv. No. 337-TA-515 (Respondent).
Bristol-Myers Squibb €1.15 billion Eurobond Offering
Represented Bristol-Myers Squibb in its €1.15 billion registered public offering of investment grade debt securities, and a cash “waterfall” tender offer for $500 million aggregate principal amount of certain of its outstanding debt securities.
Clinical Stage Cellular Therapeutics Company in Series B Funding
Advised Cell Medica Ltd. in its £50 million series B funding round. Cell Medica Ltd. is a cellular immunotherapy company which develops, manufactures and markets patient-specific products for the treatment of cancer and infectious diseases.
Data breach notification requirements
Advised a global pharmaceutical company on the data breach notification requirements in more than 80 countries, following a security breach affecting employees in Europe, Asia and the Americas.
Eli Lilly in €2.1 billion Euronotes Offering
Represented Eli Lilly and Company in its €2.1 billion notes offering consisting of €600 million 1.000% Notes Due 2022, €750 million 1.625% Notes Due 2026, €750 million 2.125% Notes Due 2030.
Global compliance
Conducted a detailed review of the human resources operations of a large pharmaceutical company to assess compliance with data protection and privacy laws and regulations in both the U.S. and EU, in anticipation of possible certification under the U.S.-EU Safe Harbor regime. Our extensive written report described potential compliance issues and recommended specific remedial actions.
Allergy Therapeutics on Alerpharma Acquisition and £20 Million Placing
Representation of Allergy Therapeutics plc, the AIM-listed specialty pharmaceutical company, in its acquisition of Alerpharma, S.A. a Spanish-based allergy immunotherapy company which previously spun out from Spanish biopharmaceutical company, Zeltia S.A. Covington also advised Allergy Therapeutics on its recent £20.8 million placing of ordinary shares with institutional investors. The proceeds of the placing are being used to progress the clinical development of the company’s lead product, Pollinex Quattro Grass, through to FDA approval and planned launch in the United States in 2019.
AstraZeneca/Bristol-Myers Squibb diabetes alliance
Representation of AstraZeneca in its strategic diabetes alliance with Bristol-Myers Squibb, including with respect to collaboration arrangements for the development and commercialization of Amylin Pharmaceuticals’ portfolio of diabetes products following BMS’s acquisition of Amylin in a deal valued at $7 billion (approximately half the cost of which was borne by AstraZeneca).
Comprehensive privacy policies
Assisted pharmaceutical companies in developing global comprehensive privacy policies aligned with federal (HIPAA, Food & Drug Administration, and National Institutes of Health) regulations, state and European law, and best practices.
Coordinated monitoring and advocacy at the multinational, international and national levels
A highly innovative pharmaceuticals company was concerned about the public debate and policy proposals made to address antimicrobial resistance, as these could seriously curtail its future business. Working together with external partners, we monitor and participate in discussions at the G7, WHO, EU and national levels (in the UK and Germany), with several successes already at proposing alternative solutions more favorable to our client.
Employment advice to AstraZeneca in major acquisition
Provided international employment law advice to AstraZeneca in relation to its acquisition of Bristol-Myers Squibb’s interests in the companies’ global diabetes alliance across 40 jurisdictions.
Employment aspects of life sciences-sector acquisition
Advised Consort Medical plc on employment and benefits issues arising from its £230 million acquisition of Aesica Holdco Ltd.
European data privacy
Represent an ad hoc consortium of U.S. and European pharmaceutical and medical device companies concerned about data privacy issues in Europe, including the Eastern European Member States such as Hungary, Poland, and the Czech Republic.
Hatch-Waxman settlement investigation and class action
AstraZeneca in an FTC investigation and private antitrust class action litigation concerning settlements of Hatch-Waxman patent litigation involving Nexium.
HR operations audit for multinational pharmaceutical client
Conducted a detailed review of the human resources operations of a large pharmaceutical company to assess compliance with data protection and privacy laws and regulations in both the US and EU, in anticipation of possible certification under the US-EU Safe Harbor regime. Our extensive written report described potential compliance issues and recommended specific remedial actions.
Lombard Medical IPO and Re-Domiciliation
Represented Lombard Medical in its $55 million initial public offering on Nasdaq and re-domiciliation.
Pepco on $6.6 billion in securities offerings
Represented Pepco Holdings, Inc. and its subsidiaries as corporate and securities counsel for over 25 years, including representation in over $6.6 billion of securities offerings since 2002.
Representing global pharmaceutical company in “test” case involving BCR and CBPR interoperability
Representing Merck in one of the first “test” cases involving interoperability between BCRs and APEC’s Cross-border Privacy Rules (CBPR). The case will establish a precedent for cross-border transfers of personal data for both the EU and Asia-Pacific Region.
Reviewing and amending Binding Corporate Rules
Reviewing and amending BCRs for a Swiss-based pharmaceutical company with the French data protection authority acting as the lead authority.
Sanofi in Series C Funding of Therapeutic Vaccine Product Development Company
Advised Sanofi-Genzyme Bioventures in a Series C round for Immune Design Corp., a company developing innovative technologies to strengthen patient-specific immune responses to potentially fight cancer and other chronic diseases.
AstraZeneca Transactions
Representation of AstraZeneca in relation to the creation of a $3.4 billion diabetes joint venture with BMS, and the subsequent acquisition of sole control over that venture; in its acquisition of the rights to Almirall’s respiratory franchise (for initial consideration of $875 million and up to $1.22 billion in development, launch and sales-related milestones); assisting in the acquisition of the Takeda respiratory portfolio; and in relation to the creation of an oncology joint venture with Fujifilm Kyowa Kirin Biologics (FKB).
Sanofi/Verily Life Sciences Transaction
Representation of Sanofi in connection with obtaining clearances from the European Commission and in China, Korea, Switzerland, Taiwan, Turkey and Ukraine for its collaboration with Google Life Sciences, Inc., now Verily, relating to diabetes management products and services.
Securities Counsel to Numerous Fortune 500 companies
Represent numerous Fortune 500 companies in the pharmaceuticals, consumer goods, health insurance, home equipment, advertising, motor vehicles, network communications, and technology industries with respect to the resolution of shareholder proposals concerning executive compensation, majority voting, proxy access, the right to call special meetings, political spending and lobbying disclosures, and a host of other topics.
Transmission and Compliance Monitoring of UK Patient Health Information
Represented a major global biopharmaceutical company on information governance requirements of the UK’s National Health Service with respect to the use and transmission of patient information collected using internet-enabled compliance monitoring tools.
Trusted Advisor to Fortune 100 Companies
Represent Fortune 100 companies in the consumer goods, health insurance, and technology industries with respect to sensitive, ongoing securities disclosure, and compliance matters.
Telehealth IT System Development
Represented a major global pharmaceutical company on negotiating arrangements with multiple suppliers for the development and operation of a complex state-of-the-art telehealth IT system.
Genetic diagnostics strategic alliance
Illumina in a strategic alliance with Genomics England for a four-year project to decode 100,000 human genomes.
Global health privacy advice
Advised pharmaceutical companies in the United States and Europe on data privacy issues, including questions relating to genetic testing programs and the development of genomics databases, the sourcing and handling of human tissue and biological samples for research purposes, patient outreach, and marketing activities.
Merck on €2.1 Billion Acquisition of Animal Health Company
Represented Merck & Co., Inc. in its €2.1 billion acquisition of Antelliq Group for approximately. Antelliq will be wholly owned and separately operated subsidiary within the Merck Animal Health Division.
Off-label promotion and reporting investigations
Representation of GlaxoSmithKline in global settlement of three investigations relating to off-label promotion, safety reporting and price reporting.
Specialty Pharma cross-border licensing agreement
Salix Pharmaceuticals in its licensing agreement with Alfa Wasserman S.p.A., by which Salix has licensed rights in the United States and Canada to an extended intestinal release (EIR) formulation of rifaximin.
Advice to Numerous Life Sciences Companies on Regulatory Compliance and Infrastructure
Advice to numerous pharmaceutical and medical technology companies on compliance with with pharmaceutical and medical device regulations. For pharmaceutical companies, this has included compliance with manufacturing and supply chain rules, pharmacovigilance, and other “GxP” requirements. We have advised device manufacturers on borderline, classification, conformity assessment and other quality system requirements, including in the digital health space. In both industries, we have advised extensively on the impact of, and preparations for Brexit.
GammaDelta Therapeutics on Strategic Collaboration with Takeda
GammaDelta Therapeutics Limited on a strategic collaboration with Takeda to develop GammaDelta Therapeutics’ novel T cell platform, which is based on the unique properties of gamma delta (γδ) T cells derived from human tissues.
Alkermes Global Pharmaceutical Portfolio
Managing the worldwide patent portfolios of Alkermes companies relating to sustained-release pharmaceutical formulations in products such as VIVITROL®, RISPERDAL® CONSTA®, and BYDUREON®. We obtained pivotal patents in Canada, China, Europe, Japan, and the United States covering the BYDUREON product, a sustained-release formulation indicated for the treatment of Type 2 diabetes.
UCB in Meizler Biopharma Majority Interest Acquisition
UCB S.A. in the acquisition of a majority interest in Meizler Biopharma, S.A., a Brazilian pharmaceutical company that commercializes a portfolio of in-licensed specialty products.
Advising a Pharmaceutical Company on a Collaboration with an Emerging Technology Company
Advising a pharmaceutical company on a collaboration with an emerging technology company for the development, licensing and commercialization of a connected drug delivery device.
Advising a Leading Health Service Provider on a Collaboration with an NHS Trust
Advising a leading health service provider on a collaboration with an NHS Trust to collaborate on the development of a range of AI-driven digital health solutions for patients.
Advising Client Efforts in Analysis of Patient Information
Advising clients in the life sciences, healthcare and technology sectors on collaborations with hospitals and hospital systems in respect of the analysis of patient information, including: advising on laws and regulations governing the collection and use of patient information; structuring, negotiating and drafting collaboration agreements between life sciences and technology companies; advising on data-driven revenue models; drafting and negotiating data processing agreements under GDPR and business associate agreements under HIPAA; advising on the regulation of the provision of healthcare services.
Case Challenging a Negative Reimbursement Decision before the Irish High Court
Advised U.S. pharmaceutical company PTC Therapeutics on the first ever challenge on a negative reimbursement decision by the Health Executive Ireland relating to ultra-orphan drug, Translarna.
LifeArc Royalty Monetization
Represented LifeArc (formerly, MRC Technology), a UK-based medical research charity, in the structured sale of a portion of its royalty interests in Keytruda for U.S. $150 million.
Product Recall Matter in Ireland
Advising on a product recall and related regulatory and consumer issues.
January 2021
Recapture of Excess COVID-19 Payroll Tax Credits Addressed in New Regs As the legal, regulatory, and commercial implications of coronavirus COVID-19 continue to evolve, our lawyers and advisors are helping clients navigate the complex considerations that companies around the world are facing and develop plans and strategies in response. Reach out to our ...
Brexit Task Force
January 2021
Since the beginning of the Brexit process in 2016, Covington’s Brexit Task Force–comprised of over 40 lawyers and former senior diplomats and policymakers, in London, Brussels, Frankfurt, Dublin, and Washington–has advised clients in a wide range of industries on the challenges and opportunities created by this historic event. While the EU-UK negotiations have ...
January 13, 2021
LONDON–Covington advised Sensyne Health plc, a UK clinical artificial intelligence company listed on the London AIM market, on its £27.5 million equity fundraising. The fundraise consisted of a placing with institutional investors, a subscription by directors and senior management, and an open offer to the company's existing shareholders. Covington also advised ...
January 2021, Covington Guide
The EU-UK Trade and Cooperation Agreement (EUTCA) reached on December 24th is a wide-ranging and complex agreement. Our Brexit Task Force offers these "bite-sized" recordings to give a snapshot of what you need to know in each area. Though the EUTCA provides the overall architecture of the future relationship in a number of areas, much of the detail must still ...
January 5, 2021, Law.com International
Louise Nash is quoted in Law.com International regarding the key life sciences and technology legal developments she expects to see in 2021. Ms. Nash senses there will be “high levels of activity across all areas, but particularly in life sciences and technology, which have generated a lot of corporate and regulatory work.” She adds, “Life sciences and ...
November 28, 2020, RTE
Maree Gallagher is quoted in RTE regarding the implications of Brexit on established food supply chains between Ireland and the UK, and the UK and the European continent. Ms. Gallagher says “until now you haven't had warehouses full of stock you have just in time delivery. So, if you run low on cheese or pizza or cauliflower an order goes in and it's delivered ...
August 8, 2020, Börsen-Zeitung
July 2020, Practical Law Life Sciences
July 2020, Practical Law Life Sciences
June 27, 2020
WASHINGTON—Covington represented Piramal Enterprises Limited (PEL) in the sale of a 20% stake in Piramal Pharma Limited (Piramal Pharma), a wholly owned subsidiary of PEL that will contain its pharmaceutical businesses, to CA Clover Intermediate II Investments, an affiliated entity of CAP V Mauritius Limited, an investment fund managed and advised by affiliated ...
Spring 2020, Covington Guide
As businesses across Europe prepare to reopen following the COVID-19 lockdown, Covington is providing practical resources and guidance on the broad array of issues companies face as employees return to the workplace, including employment, privacy, competition, policy, environmental and regulatory considerations at the EU level, with a focus on Germany and the ...
Covington Advises Sitryx on Licensing and Research Collaboration for Immunometabolic Medicines
April 1, 2020
LONDON—Covington represented Sitryx on an exclusive global licensing and research collaboration with Eli Lilly and Company. The collaboration will study up to four novel preclinical targets identified by Sitryx that could lead to potential new medicines for autoimmune diseases. Under the terms of the agreement, Sitryx will receive an upfront payment of $50 ...
February 2020
Covington's class action practice is pleased to launch a multi-part video series with insights on recent class action developments and trends. In our Navigating Class Actions series, partners Sonya Winner, Andrew Ruffino, Emily Henn, Henry Liu, Andrew Soukup, Ashley Simonsen, and Louise Freeman address: Class certifications Emerging issues and privacy ...
January 31, 2020, Covington Alert
This evening, at 11:00 p.m. GMT, the UK will leave the European Union. Brexit day marks a beginning, not an end. The UK today embarks on a complex process of negotiating new arrangements for trade and cooperation with the EU and partners around the world. Regulatory divergence seems inevitable, given that the UK will want to make its own decisions on existing ...
January 17, 2020
WASHINGTON—Covington represented Piramal Enterprises Limited in itsdefinitive agreement to sell Decision Resources Group to Clarivate Analytics plc, in a deal valued at $950 million. The $950 million purchase price includes $900 million in cash and approximately $50 million in Clarivate ordinary shares to be issued following the one-year anniversary of ...
January 16, 2020
London—Covington represented Illumina on its partnership with Genomics England, to sequence up to 500,000 whole genomes for the NHS Genomic Medicine Service. This partnership is part of the wider ambition to analyse up to 5 million genomes by 2024, to enable the UK to maintain its position as a global leader in genomics. Under this partnership and guided by ...
December 9, 2019
WASHINGTON—Covington represented Merck & Co., Inc. in its definitive agreement under which Merck, through a subsidiary, will acquire ArQule for $20 per share in cash for an approximate total equity value of $2.7 billion. ArQule is a publicly traded biopharmaceutical company focused on kinase inhibitor discovery and development for the treatment of patients with ...
October 15, 2019
LONDON—Covington has advised BenevolentAI on its $90 million investment from Temasek, a Singapore-headquartered investment company. BenevolentAI aims to improve the lives of patients suffering from diseases with no effective treatment. The Benevolent Platform® is used by scientists and technologists to find new ways to treat disease, improve the efficacy, and ...
July 30, 2019, Covington Alert
On July 29, 2019, the Court of Justice of the European Union (“CJEU”) issued its judgment in Case C-359/18 P, Shire Pharmaceuticals Ireland v. EMA, dismissing the European Medicines Agency’s (“EMA”) appeal and reconfirming the position set by the General Court. Covington represented Shire Pharmaceuticals Ireland (“Shire”), which was recently acquired by Takeda.
May 21, 2019
WASHINGTON—Covington advised Merck & Co., Inc., in its definitive agreement under which Merck, through a subsidiary, will acquire privately held Peloton Therapeutics, Inc. in exchange for an upfront payment of $1.05 billion in cash. In addition, Peloton shareholders will be eligible to receive a further $1.15 billion contingent upon successful achievement of ...
May 20, 2019
NEW YORK—Covington advised LifeArc, a UK-based medical research charity, on its monetization of a portion of its royalties relating to Keytruda® for $1.297 billion (approximately £1 billion). This royalty monetization is the largest single-product royalty monetization ever done by a non-profit. The transaction closed on May 10, 2019, the culmination of efforts ...
The Brexit Headaches Keeping Partners Awake At Night
March 28, 2019, Legal Week
Bart Van Vooren is quoted in Legal Week regarding the potential decrease in work for law firms in the UK following Brexit. He says, “A general impression is that small and medium-sized enterprises don’t have enough resources to prepare, while our clients – large worldwide pharmaceutical companies – have invested millions into this. Many have done their homework, ...
February 6, 2019
NEW YORK—Covington has advised Sensyne Health, the British clinical AI technology company, on its agreement with Jefferson Health to evaluate the clinical and commercial potential of its GDm-Health™ system in the United States. GDm-Health is a direct patient-to-clinician blood glucose monitoring management system specifically designed for the management of ...
August 17, 2018
LONDON—Covington has advised Sensyne Health on medical device regulatory and data protection matters in connection with its £60 million IPO on London’s AIM market. The firm also represented Sensyne Health in negotiating strategic research and data processing agreements with the Chelsea and Westminster Hospital NHS Foundation Trust, the Oxford University ...
August 9, 2018
WASHINGTON—Covington advised Emergent BioSolutions in its $270 million acquisition of PaxVax. PaxVax is majority owned by an affiliate of Cerberus Capital Management. Emergent is a global life sciences company focusing on providing specialty products for civilian and military populations that address public health threats. PaxVax is a company focused on ...
Sarah Crowder Named to GIR's "Women in Investigations"
July 17, 2018
LONDON—Global Investigations Review has named Covington’s Sarah Crowder to the second edition of “Women in Investigations,” highlighting 100 female practitioners from across the globe. Nancy Kestenbaum and Mythili Raman were selected to the list’s first edition in 2015. The survey highlights a variety of women not previously recognized by the magazine—from ...
May 22, 2018, The American Lawyer
Michael Labson is quoted by The American Lawyer in an article regarding Covington's presence in Ireland. "We were focused on whether it’s a strategic fit with the firm’s overall strengths,” says Labson. “With Brexit, we saw the Irish office would be of growing importance. A lot of large pharmaceutical companies have significant operations in Ireland and large ...
May 9, 2018
FRANKFURT—Covington advised Adiuva Fund II GmbH & Co. KG, a private equity fund advised by Adiuva Capital GmbH, on the acquisition of nt-trading from private equity investor INVICTO Invest GmbH and various co-investors. Adiuva Capital is a Hamburg-based independent investment firm focused on investing in mid-sized enterprises. nt-trading is headquartered in ...
April 20, 2018
LONDON—Covington advised BenevolentAI on an £80 million equity investment by new and existing investors, including Woodford Investment Management, at a pre-money valuation of £1.4 billion. The firm also recently advised BenevolentAI on its acquisition of Proximagen Limited, a Cambridge, UK-based drug discovery and development company, for an undisclosed ...
April 2018, Digital Health Legal
Brian Kelly and Raj Gathani are quoted in a Digital Health Legal article regarding a report published by the UK’s Care Quality Commission on "The state of care in independent online primary health services." According to Kelly and Gathani, “The report illustrates some of the teething problems in the inspection system, particularly when applied to online ...
March 22, 2018, Covington Alert
European General Court confirms that a new medicinal product containing the same active substance as a company’s existing medicinal product may be entitled to its own period of orphan exclusivity.
March 8, 2018, Biotech and Money
James Gubbins, Lucinda Osborne, and Brian Kelly are quoted in a Biotech and Money article providing an overview of Covington's Life Sciences practice and discussing the legal implications of issues facing the sector. “Having an international practice, having a team in London, on [the U.S.] East Coast and West Coast, and in Asia, who encompass that regulatory ...
January 31, 2018, Covington Alert
In the EU, a sponsor can obtain an “orphan designation” for a medicinal product pursuant to Regulation 141/2000. Adopted in December 1999, the regime aims to encourage investment in R&D for treatments for rare diseases. The most important incentive is the 10-year market exclusivity for designated products. Other incentives include protocol assistance and fee ...
Covington Represents Autifony Therapeutics in Collaboration and Option Deal with Boehringer Ingelheim
December 21, 2017
LONDON—Covington represented Autifony Therapeutics Limited in connection with an option and asset purchase agreement with Boehringer Ingelheim (BI), with respect to Autifony's Kv3.1/3.2 positive modulator platform. This agreement provides BI with an exclusive option to acquire Autifony’s Kv3.1/3.2 positive modulator platform, including Autifony's lead compound ...
European approvals face delay from agency move
October 25, 2017, EP Vantage
Grant Castle is quoted in an EP Vantage article examining how the move of the European Medicines Agency from London will impact European drug approvals. According to Castle, the main consequence of lower staff numbers could be longer waiting times to file drugs. “Because of the regulatory timetable there isn’t a huge amount of scope for delaying reviews, but ...
October 10, 2017, EurActiv
Peter Bogaert is quoted in a EurActiv article regarding EU Commissioner for Health and Food Safety Vytenis Andruikaitis' remarks in support of drug innovation. "The incentives which are built in the pharmaceutical regime and especially the SPCs and the regulatory exclusivity aim to work as a stimulus to develop new products in order to basically continue the ...
September 26, 2017, The Pink Sheet
A blog post by Miranda Cole is referenced in a Pink Sheet article regarding the Advocate General's Opinion in Hoffmann-La Roche vs Autorità Garante della Concurrenza e del Mercato. Cole write, if the opinion was followed by the full court it could have "significant implications for market definition in relation to pharmaceutical products, and potentially for ...
August 10, 2017
NEW YORK—Covington is representing IFM Therapeutics in its sale to Bristol Myers Squibb for $300 million in cash and the right to receive contingent payments upon achievement of specified milestones that could total in excess of $1 billion for each of its two oncology programs. Prior to closing, IFM will spin off its inflammation program to a newly-formed ...
Covington Represents Australian Medical Research Institute in Landmark Royalty Monetization
July 27, 2017
NEW YORK—Covington advised The Walter and Eliza Hall Institute of Medical Research (WEHI), Australia's oldest medical research institute, in its landmark monetization of a portion of its royalties relating to the cancer drug Venetoclax. The purchaser, a wholly owned subsidiary of Canada Pension Plan Investment Board, paid US$250 million upfront, and agreed to ...
June 16, 2017
LONDON—Euromoney Legal Media Group has selected three Covington lawyers for its annual “Europe Women in Business Law Awards.” The awards honor women in the legal sector across Europe. The Covington lawyers recognized are: Louise Nash, Best in Mergers & Acquisitions. Ms. Nash focuses on M&A and other transactional matters for clients in the consumer brands, ...
June 1, 2017, MLex
Robin Blaney is quoted in an MLex article regarding pleas from the EMA urging UK drugmakers to relicense their products in another EU country before Brexit. According to Blaney, the transfer of authorizations is "primarily an administrative exercise," and there is no legal obstacle to using a shell company in the European Economic Area to hold marketing ...
May 11, 2017, PaRR
Bart Van Vooren is quoted in PaRR's "Brexit Club" column regarding the two-part approach to the Brexit negotiation process, following the publication of draft negotiating directives for “phase one” of the talks. According to Van Vooren, there are real legal problems with this two-part approach, regardless of the parties' up-front negotiating positions. One ...
April 12, 2017, Covington Alert
On April 11, 2017, the Cyberspace Administration of China (“CAC”) released a draft of the Measures on Security Assessment of Cross-border Data Transfer of Personal Information and Important Data (“the Draft Measures”) for public comment (official Chinese version available here; Covington’s translation of the Draft Measures is appended at the end of this alert).
GDPR Planning and Preparation Conference for Employers
March 30, 2017, Business Forums International Ltd.
March 17, 2017
LONDON—Covington advised AstraZeneca on its strategic collaboration with Circassia Pharmaceuticals plc, a respiratory biopharmaceutical company, for the development and commercialisation of Tudorza and Duaklir* in the U.S. Tudorza and Duaklir are inhaled respiratory medicines for the treatment of chronic obstructive pulmonary disease (COPD). Tudorza was ...
February 3, 2017, Global Investigations Review
Ian Hargreaves and David Lorello are quoted in a Global Investigations Review article regarding Hargreaves’ recent arrival to Covington. According to Hargreaves, the firm’s “pre-eminence in dispute resolution, and its immense strength and global recognition as a market-leader in white-collar crime matters and investigations” fueled his decision. Lorello says, ...
January 31, 2017
LONDON—Ian Hargreaves has joined Covington as a partner in the firm’s European Dispute Resolution practice resident in London. Mr. Hargreaves’ arrival follows that of litigation partners Craig Pollack, Greg Lascelles, Elaine Whiteford, and Louise Freeman over the past six months. Mr. Hargreaves advises on major European white collar and related civil and ...
December 7, 2016, Covington Alert
In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, seeds, flowers, viruses, fragrances, flavonoids, essential oils, enzymes, yeasts, and so on. So far, compliance by companies is progressing slowly due to ...
November 4, 2016, EU Food Law
Brian Kelly is quoted in an EU Food Law article regarding the UK High Court ruling requiring its government to have Parliamentary approval before triggering Article 50. According to Kelly, the decision added uncertainty around Brexit, although it did also present a lobbying opportunity for the industry as well. “The immediate impact of the judgment is that, as ...
POLITICO Pro Morning Health Care, presented by Lilly: Brexit wobble — WHO DG candidates compete
November 4, 2016, Politico Pro
Brian Kelly and Grant Castle are quoted in a Politico Pro “Morning Health Care” article regarding the High Court ruling that the UK government does not have the legal power to invoke Article 50 without Parliamentary approval. According to Kelly, “This presents an opportunity for individual companies and the industry to engage with members of Parliament to ensure ...
Spanner In Works For UK Gov’t’s Brexit Plans; Industry Looks To Ongoing Talks With Ministers
November 3, 2016, The Pink Sheet
Brian Kelly is quoted by The Pink Sheet in an article regarding the UK High Court’s ruling that its government does not have the right to trigger Article 50 without Parliamentary approval. According to Kelly, the judgment presented "an opportunity for individual companies and the [life sciences] industry to engage with members of Parliament to ensure that their ...
October 21, 2016
WASHINGTON—Covington represented India-based Piramal Enterprises and its wholly owned Critical Care subsidiary in the UK in the acquisition of five anesthesia and pain management injectable products from Janssen Pharmaceutica NV, in an all cash deal for an upfront consideration of US$155 million, and up to an additional US$20 million. The products to be acquired ...
October 7, 2016
LONDON—Covington advised AstraZeneca on its agreement with Cilag GmbH International, an affiliate of Johnson & Johnson, for the divestment of the rights to Rhinocort Aqua outside the U.S. Rhinocort Aqua is a nasal spray indicated for allergic and non-allergic rhinitis (inflammation of the inside of the nose), and for the treatment of nasal polyps (swelling of ...
October 6, 2016, EP Vantage
Grant Castle is quoted in an EP Vantage article regarding the effect of Brexit on life science funding and strategy. According to Castle, “Particularly if the UK heads for a ‘hard Brexit,’ the UK will be a less attractive venue for investment by pharma. It’s one of the sad side effects of all this.”
October 2016, Digital Health Legal
Covington Represents MRCT in Royalty Monetization Deal
July 15, 2016
NEW YORK—Covington advised Medical Research Council Technology, a UK-based independent life science medical research charity, in its sale of a portion of the royalty stream associated with its cancer drug Keytruda® for $150 million (£115.6 million). Keytruda® (pembrolizumab), is a new generation treatment which stimulates the body’s immune system to fight ...
UK science brains seek truce after Brexit
June 30, 2016, Politico
Grant Castle is quoted in a Politico article regarding Britain’s desire to continue its dominance in health research. Commenting on the possibility of having Britain stay in the single market, Castle says, “I don’t think that’s a practicality now.” He continues, “I would think that access to the country would be tightened…given the strength of feeling on ...
June 28, 2016, Bloomberg
Grant Castle is quoted in a Bloomberg article regarding the implications of Brexit on the future of the pharmaceutical industry and the drug approval process. According to Castle, the best that the UK regulator could hope for would be an observer status on European Medicines Agency committees. That loss of influence could make the UK less appealing, because it ...
June 27, 2016, The Legal Intelligencer
Grant Castle is quoted in a Legal Intelligencer article regarding the regulatory impact of Brexit. Commenting on the Food and Drug sector, Castle says, “The UK will inevitably diminish in significance when it comes to the regulation of pharmaceuticals and a venue where drug companies are going to want to be based. Historically, U.S. companies wanted to operate ...
June 27, 2016, Covington Alert
Last week, the UK voted in an advisory referendum to leave the European Union. The next steps are not yet clear, but the referendum may have significant implications for the pharmaceutical industry in the UK and for international companies operating in the UK. Its impact will very much depend on the form a post-Brexit UK will take, the relationship that the UK ...
June 24, 2016, Politico
Grant Castle is quoted in a Politico article regarding the effect of Brexit on the future location of the European Medicines Agency. Castle predicts that the EMA is inevitably going to leave the UK. “Given the strength of feeling on immigration,” it looked unlikely the country would opt for a European Economic Area relationship, since that would mean continuing ...
UK Votes to Leave the EU
June 24, 2016, Covington Alert
The UK has voted to leave the European Union in an advisory referendum. 52% leave - 48% remain. Were the UK to leave the EU, this would have significant implications for the UK and for international businesses operating in the UK. The longer term impact of the decision on the regulatory framework for the UK will depend, in part, on the relationship that the UK ...
June 3, 2016
NEW YORK—Covington advised the underwriters in connection with Repligen’s $115 million debt offering. The senior convertible notes due in 2021 were placed at 2.125 percent. Repligen is a bioprocessing company focused on the manufacture of Protein A ligands used by life science companies to purify biologic drugs such as monoclonal antibodies, recombinant ...
EU Law and Life Sciences - Cosmetics: Managing Online Sales to Protect Your Brand
May 12, 2016, Webinar
May 11, 2016, This article was published in Scrip Regulatory Affairs
May 8, 2016, Financial Times
Peter Bogaert and Grant Castle are quoted in a Financial Times article regarding the effect Brexit would have on the UK pharma industry. According to Bogaert, commenting on the important relationship between the European Medicines Agency and the UK’s Medicines and Healthcare Products Regulatory Agency, “Brexit would be a loss for both sides.” Castle adds that ...
Covington Represents Underwriters in Senseonics' IPO
March 24, 2016
NEW YORK - Covington advised the underwriters in the $45 million initial public offering of common stock of Senseonics Holdings, Inc. The offering closed on March 23, 2016. Shares of Senseonics trade on the NYSE MKT under the ticker “SENS.” Senseonics develops continuous glucose monitoring systems for patients with diabetes. Its Eversense product consists of ...
March 1, 2016
LONDON — Covington advised AstraZeneca on an agreement with ProStrakan Group, a subsidiary of Kyowa Hakko Kirin Co. Ltd., for the rights to Moventig (naloxegol) in the European Union (EU), Iceland, Norway, Switzerland and Liechtenstein. Moventig is the first once-daily, oral peripherally-acting mu-opioid receptor antagonist (PAMORA) approved in Europe for the ...
Downer? Could the UK Psychoactive Substances Act spell disaster for the food & supplements industry?
February 26, 2016, Nutra Ingredients
Brian Kelly is quoted extensively in this Nutra Ingredients article discussing the UK Psychoactive Substances Act and its possible effect on the food supplements industry. According to Kelly, “Despite criticism and proposed amendments about unintended targets the law has been pushed through. It’s a poorly drafted law when it comes to food.” He continues, “You ...
Fate of EU drugs agency hangs in Brexit balance
February 17, 2016, Politico
Grant Castle and Robin Blaney are quoted in this Politico article discussing the potential impact of “Brexit” on the pharmaceutical sector in the UK and Europe. According to Castle, the “only rational alternative” to EU membership is for the U.K. to become a member of the European Economic Area, as this arrangement would make it so the practical and operational ...
February 8, 2016
BRUSSELS — Erika Mann, a former Member of the European Parliament and policymaker with over 20 years of experience, has joined Covington in its Brussels office as a senior European policy advisor in the firm’s global Public Policy and Government Affairs practice. Most recently, Ms. Mann served as Managing Director of Public Policy for Facebook in Brussels from ...
January 28, 2016
WASHINGTON, DC - Law360 has named six Covington practice groups among its “Practice Groups of the Year.” The practice groups recognized by Law360 are as follows: Government Contracts Insurance International Trade Life Sciences Product Liability Sports
Covington Advises AstraZeneca on mRNA Collaboration
January 13, 2016
LONDON — Covington advised AstraZeneca, along with its global biologics research and development arm, MedImmune, on a new collaboration with Moderna Therapeutics to discover, co-develop and co-commercialize messenger RNA (mRNA) therapeutic candidates for the treatment of a range of cancers. The collaboration is in addition to the agreement announced by the ...
December 17, 2015
LONDON, 17 December, 2015 — Covington advised AstraZeneca on its acquisition of Takeda’s respiratory business. Under the terms of the agreement, AstraZeneca will make a payment of $575 million, and approximately 200 staff will transfer to AstraZeneca upon completion. The deal will include the expansion of rights to roflumilast (marketed as Daliresp in the ...
Covington Advises Allergy Therapeutics on £11.5 Million Placement and License Agreement
November 23, 2015
LONDON, November 23, 2015 — Covington represented Allergy Therapeutics, the AIM-listed specialty pharmaceutical company specializing in allergy vaccines, in the placement of ordinary shares raising approximately £11.5 million. The placement was conducted through an accelerated bookbuilding process with Panmure Gordon & Co acting as financial adviser, nominated ...
September 30, 2015
NEW YORK - Covington advised the underwriters in the $106.1 million initial public offering by Austrian-based Nabriva Therapeutics AG of 10,350,000 million American Depositary Shares, representing 1,035,000 shares of Nabriva’s common stock. This was the first U.S. initial public offering by an Austrian company. The ADSs are now listed on the NASDAQ Global Market ...
September 3, 2015
NEW YORK, September 3, 2015 — UCB and Lannett Company, Inc. announced they have entered into a definitive agreement providing for the acquisition of UCB’s U.S. specialty generics subsidiary, Kremers Urban Pharmaceuticals Inc., by Lannett. UCB will receive upfront cash proceeds of US $1.23 billion upon closing, which is subject to regulatory approval and other ...
Gefährliche Mixtur
August 2015, JUVE
Quoting Adem Koyuncu on anti-corruption issues in the pharma sector.
European Union: Pharmaceuticals
August 2015, An Extract from The European Antitrust Review 2016
Relationship between pharmaceutical companies and wholesalers/distributors: Assessing the competition law aspects
2015, Webinar, 24th Annual EU Pharmaceutical Forum
July 30, 2014, Legal Business
Lucinda Osborne, Gregor Frizzell, Christopher Walter and Miranda Cole are mentioned regarding their representation of AstraZeneca on its £1.2bn acquisition of Spanish healthcare group Almirall’s respiratory unit.
April 7, 2014, The Lawyer
Covington's Paul Claydon and Guy Dingley are mentioned regarding their representation of Horizon Discovery on their IPO.
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- Awarded “Life Sciences Practice Group of the Year” by Law360 in 2012, 2013, 2014, 2015, 2016, 2019, and 2020.
- Awarded “Compliance Practice Group of the Year” by Law360 in 2020.
- Recognized as a leading life sciences law firm by Chambers, Legal 500, Law360 and LMG Life Sciences
- More than 30 individual attorneys – across a range of practice areas, including corporate/commercial, regulatory/compliance, intellectual property and litigation – recognized for excellence in life sciences by the leading legal industry surveys

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