UK’s biotech Archives - European Industrial Pharmacists Group (EIPG)

Approval of the Data Governance Act, and EMA’s consultation on the protection of personal data in the CTIS


by Giuliana Miglierini The Data Governance Act (DGA) was approved and adopted in May 2022 by the European Council, following the positive position of the EU Parliament; the new legislation will entry into force after being signed by the presidents Read more

The transition towards EMA's new Digital Application Dataset Integration (DADI) user interface


by Giuliana Miglierini The Digital Application Dataset Integration (DADI) network project is aimed to replace the current PDF-based electronic applications forms (eAFs) used for regulatory submissions with new web-forms accessible through the DADI user interface. The European Medicines Agency (EMA) has Read more

IVD regulation in force: new MDCG guidelines and criticalities for innovation in diagnostics


by Giuliana Miglierini The new regulation on in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746) entered into force on 26 May 2022. The new rules define a completely renewed framework for the development, validation and use of these important Read more

A record year for biotech investments in UK, a year after the Brexit

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by Giuliana Miglierini

One year after the Brexit, the UK’s economic landscape is far from being suffering for leaving the European Union. On the contrary, 2021 has been a record year for many sectors, including UK’s biotech and life sciences. A recent report from the BioIndustry Association (BIA) and Clarivate shows that £4.5 billion was raised in public and private financings in the field, £1.7 bln (60%) more than in 2020.

There is an obvious gap that we must plug in the UK’s financing environment. The large fundraises seen in 2021 are largely the result of welcome overseas investment, meaning that significant value creation will also be offshored. History has handed the UK two world-leading sectors: life sciences and finance. A symbiosis should exist between these two, but it doesn’t, yet. There is great opportunity to turbo-charge the UK’s biotech and life sciences sector and capture more of its economic value for the UK by building better connections between the UK’s financial institutions and our innovative scaling businesses”, said Steve Bates OBE, Chief Executive of the BIA.

A higher attractiveness than the US

More in detail, UK companies attracted more than half of all biotech venture capital in 2021, for a total value in the period 1 December 2020 – 30 November 2021 of £2,518 million (+81%from 2020; 56% of total investments). Even higher has been the increase of Initial Public Offerings (IPOs), for a total of £1,304 million (+434% from 2020; 29% of total); all other public financings raised £684 million (15% of total). Thirteen investment deals were more than £100meach (vs 3 in 2020), and a further 27 raised more than £20 million each (vs 12 in 2020).

The positive trends of investments marked in 2021 are not unique to the UK; the level of venture capital investments raised 10% in the last year compared to 2020, reaching the global value of £28.1 billion for the biotech sector. The attractiveness of the UK reached 79%, compared to 49% for the US’s Boston Massachusetts cluster, while the San Francisco one marked -21%; total investments in the US reached £18.8 billion (+11%). Negative trends characterised Europe (-12%venture investments, for a total of £5 billion) and China (-12%, £3.4 bln).

We value the significant investment that comes from overseas, but we must complement it with the full financial firepower of the City of London so that more companies stay in the UK. This is why our ambitious 2021 Life Sciences Vision sets out our firm commitment to helping UK life sciences and biotech firms access long-term scale-up capital from investors here at home, who are committed to building successful companies. Scaling up UK companies will help both grow our economy and improve access to innovative diagnostics and treatments.”, added George Freeman MP, Minister for Science, Research and Innovation.

Venture capitals looking for new opportunities

The UK has been a key point of innovation during the pandemic, generating many new vaccines and treatment opportunities. The interest of investors in UK’s science is acknowledged by the£128 million invested into startup companies, more than four times the amount seen in previous years. A trend that paralleled later-stage rounds of financings into mature projects.

The bigger deal (£195 mln fundraise prior to the London IPO) involved Oxford Nanopore, a company specialised in the development of innovative sensing techniques based on the use of nanopores embedded in high-tech electronics. These can be used to sequence small or large fragments of DNA and RNA, for example; the platform may be also adapted for the detection of other types of molecules, e.g. proteins.

At the second place is the Exscientia’s deal (£158 mln, round D). The company offers AI-driven drug discovery services aimed to deeply innovate how new medicines are developed. Its AI platform is being used to completely design from scratch new molecules; algorithms are used also to optimise properties in parallel, rather than sequentially, and to reduce the overall development time thanks to the higher capacity of analysis of complex data.

Vaccitech attracted the third deal (£118 mln, round B); the company is the spin-off of the Oxford University specifically created to commercialise the technology platform behind the Oxford/AstraZeneca Covid-19 vaccine.

IPOs reached record values

Oxford Nanopore and Exscentia also represent the higher values for IPOs operated by UK biotech companies in 2021. The former deal worth £350 million, representing the largest amount raised in a listing on the London Stock Exchange by a biotech company. Exscentia attracted a £256mln value at Nasdaq; the total amount raised by UK biotech through IPOs in 2021 reached £1.3billion (42.8% of all the money raised by UK biotechs at IPO in the past decade, a huge amount if compared to the £244 million raised in 2020).

Three companies were listed at the London’s Alternative Investment Market (AIM): Poolberg Pharma (£25 mln) is a clinical stage infectious diseases pharmaceutical company, aiming to become a “one-stop shop” to find Phase II ready products for development and commercialisation. Arecor Therapeutics (£20 mln) has developed a proprietary platform for the reformulation of already available medicines, while BiVictriX Therapeutics (£7,5 mln) is developing new targeted cancer therapies.

When looking at the international scenario, 133 companies raised £19 billion in IPOs in 2021 at the global level (+30% vs 2020). In the US, 86 companies raised £9.7 billion; the most attractive biotech clusters were again Boston Massachusetts and San Francisco. The number of IPOs in Europein creased to 29 (vs 12 in 2020), for a total of £3.3 billion raised (+218% vs 2020); to this instance, according to BIA’s report the UK accounted for 31% of the European IPOs and 40% of the capital raised. No significant changes involved listed companies in China (14), but on this market the average IPO was three-times larger than that achieved by the average American or European listing.

Follow-on financing of quoted biotech companies almost halved in 2021 compared to the previous, record year (£684 million vs £1.18 billion raised, respectively).

A main contribution came from Blackstone’s investement in Autolus at the Nasdaq (£183 million) to support the development of the company’s CAR-T cell therapy currently in Phase III stage of development. A strategic investment of £50 million in Oxford Biomedica, received from the Serum Institute of India, will support the expansion of the advanced therapy manufacturing facilities near Oxford.

Mergers & Acquisitions and Licensing deals

Jazz Pharmaceuticals acquired in 2021 GW Pharma, a company specialised in the development and commercialisation of cannabinoid-based epilepsy treatments. The biotech Kymab, thoseplatform is used for the development of fully-human monoclonal antibodies, was acquired by Sanofi in a deal involving £1,073 million upfront payment and up to $350 million in milestone payments.

The licensing deal signed between AstraZeneca and VaxEquity would allow the multinational company to use the University College London spin-out’s saRNA platform for the development of up to 26 drug targets.

Early-stage biotech companies are often supported by research grants; to this instance UK’s biotech received in 2021 over £50m in non-dilutive grant funding.


A golden era for UK’s life sciences and a new Code of practice for its pharmaceutical industry

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by Giuliana Miglierini

Less than a year has gone since the Brexit, and the UK innovation landscape is experiencing a new, vivid era of expansion under the stimulus of a strong demand from global investors. According to recent data of the BioIndustry Association (BIA) and Clarivate, the second quarter of 2021 (March – May) saw £1.56 billion investments, a record value for a quarter since the trade association began recording this data.

A record year for investments
The first semester has registered a total of £2.39 bln investments, almost the same amount raised in the entire 2020 (£2.81 bln). “The scale of these financings suggests 2021 will be another record year of investment into UK biotech companies. We continue to see deals being driven predominantly by investors from outside of the UK. Our hope is that the Government’s impending Life Science Sector Vision will be a platform for the UK’s financial institutions to add further fuel to take this sector into a golden age.”, said Dr Martin Turner, Head of Policy and Public Affairs at the BIA.
More in detail, UK biotech and life science companies raised £1,07 billion in venture capital; thirteen deals overcame £20 million, and four of them even £100 mln. The 60% of the total biotech venture capital invested in Europe is represented by UK companies; furthermore, £431 million was raised through three NASDAQ IPOs and £58 mln in follow-on public financings. “These figures show that our life sciences sector is booming, demonstrating the confidence that global investors have in the UK. The extraordinary innovation underway in the sector will not only increase our resilience against future healthcare challenges, but will boost the economy, create highly skilled jobs across the country, and enhance our status as a science superpower”, said Life Sciences Minister Nadhim Zahawi.
Biotech shares on the London Stock Exchange also continued to out-perform the wider market in the first half of 2021, according to the report prepared by Radnor Capital Partners on behalf of the BIA.

A new Vision of the life sciences sector
The UK government published it’s new Life Science Vision on 7 July, a 10-year strategy for the sector which builds on the success of the previous 2017 Life Sciences Industrial Strategy.
The same approach used to fight the Covid-19 pandemic will be used as a blueprint to tackle some persisting health issues such as dementia and cancer, for a total of seven critical missions. The others include early diagnosis and treatments, comprehensive of immune therapies and cancer vaccines, vaccine discovery, treatment and prevention of cardiovascular diseases and its major risk factors (i.e. obesity), reducing mortality and morbidity from respiratory disease, addressing the underlying biology of ageing, increasing the understanding of mental health conditions and redefining tools to fight them.
The new strategy also includes planned investments for a total of £1 billion, to be dispensed under the Life Sciences Investment Programme (LSIP). The programme is expected to boost further private sector investment, and the creation of a world leading UK life sciences venture capital ecosystem. The investments will be delivered through British Patient Capital (BPC), part of the government-owned British Business Bank, which will allocate the £200 million to specialist funds. Some other £800 mln will result from the collaboration between BPC and Abu Dhabi’s Mubadala Investment Company, one of the world’s leading sovereign investors. The LSIP will have access to a scientific advisory panel composed of leading industry figures, chaired by Professor Sir John Bell and in charged to share insight on key scientific trends.
“We are indebted to the ingenuity of UK life sciences and its pioneers, with the discovery of the Oxford-AstraZeneca vaccine and the seamless collaboration between our scientists, industry, regulators and NHS saving millions of lives during the pandemic. We must make sure this is the norm and use this new way of working to search for life-changing breakthroughs against diseases such as cancer, dementia and obesity, as we have done with Covid”, said Prime Minister Boris Johnson.
“Crucially, we’re going to build a pro-enterprise environment where our life sciences firms can access the finance to grow, are incentivised to onshore manufacturing, and can commercialise breakthrough products right here in the UK – rather than elsewhere – as we cement the UK’s position as a science superpower”, added Business Secretary Kwasi Kwarteng.
Central to the new Vision is the emulation of the approach used by the UK Vaccines Taskforce to fully exploit the private sector expertise while removing unnecessary bureaucracy. New regulatory freedoms and opportunities are expected for the UK life science business sector as a result of the country’s new position outside the EU. The UK’s regulatory agency MHRA is expected to act as an independent, sovereign regulator with great agility and with a focus on getting vaccines, drugs, and technologies to patients as safely and quickly as possible.
“The BIA’s focus will be to increase the expert pool of UK based capital needed for innovative UK life science firms to grow to scale. This will enable UK investors and pension savers, to secure the economic benefit from this burgeoning golden age for UK life sciences while at the same time enabling NHS patients to secure the health benefit of global biotech innovation”, said BIA’s Chief Executive and former member of the Vaccine Taskforce Steve Bates.

A new Code of Practice for the pharmaceutical industry
The renewal of the UK’s landscape in life sciences also pass through the new Code of Practice for the Pharmaceutical Industry, which has become operative since 1st July 2021 without transition period, with the exception of companies wishing to continue with ongoing Medical and Educational Goods and Services where the transition period will close on 31 December 2021.
The Code published by the Association of British Pharmaceutical Industry (ABPI) is operated under the supervision of the Prescription Medicines Code of Practice Authority (PMCPA), established by ABPI in 1993 as an independent organism. The previous version of the code was released in 2019.
The Code provides indication on the acceptable practices for the promotion of prescription medicines to both health professionals and other relevant decision makers. Requirements for interactions with health professionals and standards for the provision of information about prescription medicines to the public and patients (including patient organisations) are also included.
There are four principles inspiring the document, first among which the benefit and safety of patients. Integrity and commitment towards responsible, professional, ethics and transparent relationships, transparency and respect will guide the future activities of the UK pharmaceutical industry in the promotion of medicines.
Even if the Code refers only to activities carried out by the industry, its indications should also inspire individuals and organisations in their interactions with the pharmaceutical environment.
Training of personnel and robust operating procedures to review all materials and validate their compliance to the rules highlighted by the Code and other legal requirements are other principles inspiring the document. The Code incorporates some other references important in the field of the promotion of pharmaceutical products, among which those contained in the Codes of Practice of the International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA), the European Federation of Pharmaceutical Industries and Associations’ (EFPIA), the WHO’s Ethical Criteria for Medicinal Drug Promotion, the EU’s Directive 2001/83/EC and 2004/27/EC on human medicinal products, and the Human Medicines Regulations 2012 No. 1916.