Life Sciences

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 ...

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 ...

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 ...

April 1, 2019, Life Sciences Law Review

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 ...

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 ...

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 ...

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 ...

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).

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 ...

March 2017

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 ...

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 ...

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

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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

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 ...

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 ...

August 2015, JUVE

Quoting Adem Koyuncu on anti-corruption issues in the pharma sector.

August 2015, An Extract from The European Antitrust Review 2016

2015, Webinar, 24th Annual EU Pharmaceutical Forum

July 30, 2014, Bloomberg

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.

2013