In spite of the challenges posed by the Covid-19 pandemic, the European biotech industry has emerged stronger than ever this year. These were the key moments for the sector in 2021.
The year 2021 has seen skyrocketing fortunes for many European biotech players. Investment firms, for instance, raised far more funding than in 2020, which was already a record year on its own. Large funding rounds are becoming commonplace for private biotechs, with examples including a €130M (£100M) Series C financing from the UK oncology firm Artios Pharma and a €143M ($165M) Series C cash infusion from the French DNA manufacturer DNA Script.
On the flip side, public biotech stocks are in a months-long slump resulting from fears over inflation, drug pricing, and other factors. Many firms have hit serious clinical trial setbacks, including Galapagos in Belgium, the Swedish hair-loss company Follicum, and the Swiss firm Polyphor, which is preparing to be absorbed into the US firm Enbiotix after disappointing results from drug candidates for bacterial infections and cancer.
Meanwhile, fresh waves of Covid-19 dog efforts to return to normality. The rise of highly infectious, mutated variants of Covid-19 threatens the defenses built up so far with Covid tests, vaccines, and treatments.
Nonetheless, the biotech industry is powering through in its mission to treat illnesses and make society more sustainable. Read on for a month-by-month recap of the biggest moments from Europe’s biotech sector over the year 2021.
The French big pharma Sanofi acquired the UK firm Kymab for up to €1.2B. Kymab’s pipeline included a phase IIa-stage antibody drug for the treatment of the inflammatory skin condition atopic dermatitis. In 2020, Kymab had won a series of high-profile patent battles with the US giant Regeneron over the production of antibody drugs.
By the end of January, the UK and EU regulatory agencies had approved the use of three Covid-19 vaccines in people over 18, including vaccines from BioNTech/Pfizer, Moderna, and AstraZeneca. Over subsequent months, many rollout obstacles would emerge, including supply bottlenecks, geopolitical spats, and safety concerns.
The Dublin-based giant Jazz Pharmaceuticals took over the UK firm GW Pharmaceuticals in a deal worth €6B. The main prize for Jazz was GW’s epilepsy treatment Epidiolex, a potential blockbuster that made history as the first cannabis-derived medicine to be approved by the FDA in 2018.
The Belgian biotech Galapagos and its US partner Gilead halted two phase III trials of the drug ziritaxestat in patients with idiopathic pulmonary fibrosis. The decision was prompted by the conclusion that the drug’s benefit-risk profile wasn’t good enough to continue. This was yet another huge setback for the partners after the FDA’s rejection of their lead drug filgotinib in 2020.
Two approvals bolstered treatments for multiple sclerosis. First, the EU approved the antibody drug Kesimpta (ofatumumab), developed by Novartis and licensed from the Danish firm Genmab, which is the first of its class able to be self-administered at home. Second, Janssen’s drug Ponvory (ponesinod) was approved by the FDA. Janssen got hold of the drug when it acquired the Swiss company Actelion for $30B in 2017.
A report from the non-profit group the Good Food Institute revealed that companies around the world developing protein alternatives hauled in €2.6B ($3.1B) in 2020 — triple the total of 2019. More than €320M ($360M) of this sum went to firms developing cultured meat, where meat is grown directly from animal cells. The upwards trend is likely to repeat in 2021 as the Israeli cultured meat player Future Meat Technologies raised a staggering €307M ($347M) Series B round in December.
The US firm bluebird bio abandoned the commercial rollout of its gene therapy Zynteglo in Germany after the nation’s health authority proposed a lower price than bluebird bio would accept. This decision was a major blow to the gene therapy sector that may have repercussions for access to future gene therapies in Europe.
The UK company Exscientia raised a massive Series D round worth €434M to advance artificial intelligence technology that speeds up drug discovery. The firm would go on to raise another €442M ($510M) in a huge initial public offering (IPO) on the Nasdaq in September.
In one of May’s biggest European biotech fundraises, a Nasdaq IPO and global share offering infused the French company Valneva with €145.8M. The company would use the cash to fund the development of its late-stage vaccine candidates for Covid-19 and insect-borne diseases Lyme disease and chikungunya.
An EU vote greenlit the first insect-derived food product for human consumption. The approval went to dried yellow mealworm developed by the French biotech Agronutris, which can be consumed as a whole snack or as an ingredient in biscuits, smoothies, or pasta products.
The FDA gave accelerated approval to Biogen’s Alzheimer’s drug Aduhelm. The move shocked life sciences observers around the world as Aduhelm’s benefits were backed up by questionable clinical evidence. Sales of the drug have been poor since its commercialization began in the US, and the EMA has recommended that the EU reject the drug. Biogen aims to prove Aduhelm slows disease progression in an upcoming confirmation trial.
The German messenger RNA (mRNA) specialist CureVac saw its stock price halve as its Covid-19 vaccine candidate provided just 47% protection against Covid-19 infections. The phase IIb/III trial results paled in comparison to the over 80% protection afforded by approved vaccines. CureVac would later abandon the candidate and switch focus to a second-generation Covid-19 vaccine.
A report from the EMA revealed that the success rate for small biotechs applying for regulatory approval from the EMA has risen by over 100% since 2016. This trend is due in part to increased access to sophisticated technology and funding for small players.
The launch of the firm Muna Therapeutics was accompanied by the biggest-ever Series A round seen in the Danish biotech ecosystem, at €62M. Muna’s round served as a hallmark of how much the Nordic biotech scene has started to attract foreign venture capital investments.
Valneva’s vaccine for the mosquito-borne disease chikungunya became the first to succeed in phase III, triggering the production of protective antibodies in 98.5% of participants. The company aims to apply for accelerated approval for the vaccine from the FDA.
The FDA gave the green light to Danish company Ascendis Pharma for a slow-release formulation of growth hormone, called Skytrofa. The treatment is the first to provide a weekly alternative to daily growth hormone injections for children with a deficiency in that hormone.
As the highly infectious delta variant of Covid-19 swept the world and immune protection from approved vaccines began to wane, Pfizer and BioNTech’s mRNA vaccine became the first to receive the FDA nod for use as a booster shot. The EMA followed suit soon after, and Moderna and Johnson & Johnson’s vaccines would get similar authorizations over subsequent months.
At the same time as Exscientia’s debut on the Nasdaq, another UK firm, Oxford Nanopore Technologies, went public on the London Stock Exchange. The DNA sequencing behemoth bagged €407.4M (£330M) from its listing, highlighting that it’s still possible to pull off headline IPOs outside of the US within the life sciences sector.
The FDA slapped a hold on clinical trials of the US biotech Allogene due to safety concerns surrounding a gene-edited, off-the-shelf CAR-T cell therapy. A biopsy from a blood cancer patient infused with Allogene’s therapy in a clinical trial revealed CAR-T cells with an unexplained chromosomal change. Stock prices plunged for Allogene and Cellectis, the French company that licensed Allogene the gene editing technology.
Just months after its blood cancer drug Pepaxto received an accelerated FDA approval in February, the Swedish company Oncopeptides was forced to withdraw Pepaxto from the market. This was after the FDA halted Oncopeptides’ confirmatory trial of the peptide-drug conjugate treatment over safety concerns. Oncopeptides shut down its US operations and the firm’s stock price plummeted by over 70%.
The Spanish firm Sanifit was acquired by the Swiss drug developer Vifor Pharma for up to €375M in Spanish biopharma’s biggest-ever takeover. Vifor snapped up a phase III-stage treatment for vascular calcification in patients with end-stage kidney disease. This deal was the cherry on top for a glut of acquisitions in Spain’s life sciences sector this year.
The German heavyweight Evotec raised €376M in a standout Nasdaq IPO to fund its in-house R&D, the expansion of its manufacturing capacity, and investments in other companies. The company’s unusually diverse business model has made it relatively resilient to ongoing stock price falls hitting public biotechs globally.
A heavily mutated form of Covid-19 called the omicron variant reared its head, threatening a fresh pandemic wave around the world. The variant showed the ability to partially penetrate the protection of current vaccines against Covid-19, in addition to several antibody treatments.
As 2021 drew to a close, the European life sciences investors Eir Ventures, Apollo Health Ventures, and Merck’s venture capital arm M Ventures unveiled impressive new funds dedicated to speeding up life sciences innovation. These rounds cemented a stunning year of fundraising for European life sciences investors.
Bring on 2022
Next year is likely to see the intense arms race continue between the Covid-19 virus and our vaccine and drug capabilities. At the same time, we will urgently need innovations that can reduce society’s environmental footprint — a fact hammered home in the United Nations Climate Change Conference of the Parties (COP26) that took place in November 2021.
The biotech industry is providing many reasons for optimism in the face of these challenges. In the case of healthcare, mRNA technology has undergone a baptism by fire during the pandemic. Once the technology matures, the ease of manufacturing mRNA molecules compared to traditional vaccines could allow us to more rapidly adjust vaccines to changing viruses. Meanwhile, research is ongoing in vaccines that can provide immunity against all variants of Covid-19, not just specific strains.
There’s also a surge in research activity surrounding synthetic biology and cell therapies, fuelled in part by falling computational and DNA sequencing costs. Firms such as DNA Script and Touchlight Genetics are gunning to make the manufacture of DNA faster and cheaper while companies focused on lab automation, cell encapsulation, and cell reprogramming strive to have a similar effect on cell therapy manufacture. One of the biggest obstacles for the flourishing sector right now is a lack of skilled staff to help the process along.
In terms of biotechnology focusing on sustainability, progress is on the march. October saw the foundation of the world’s first research institution dedicated to capturing carbon dioxide from the air and turning the greenhouse gas into valuable commodities such as industrial chemicals. As the COP26 closed in November, Sofinnova and the European Circular Bioeconomy Fund raised capital to fuel innovations promoting sustainability. And in early December, 13 companies developing cultured meat founded an association called Cellular Agriculture Europe in a bid to unite and organize the sector.
One thing is certain: despite all the challenges, there is a lot to look forward to for the European biotech industry.
We hope you enjoyed this recap of 2021. A massive thanks to all our loyal readers out there! Stay safe and have a happy new year.
Cover image via Elena Resko. Inline images via Shutterstock