Welcome to the latest edition of our weekly EuroBiotech Report. This week data arrived to back up what everyone knew: 2014 was financially a much better year for European biotechs. The IPO window finally opened; 15 companies jumped through and €719.8 million ($835.3 million) of public investors' money landed in European biotechs' bank accounts. From 2009 to 2013, local life science IPOs raised just €303 million. The effect of the IPO uptick trickled down to VC funding. Last year, British biotechs raised $713 million, 41% more than in 2013. The "golden triangle" snagged most of the cash, but companies outside the south-east life science hub drove the jump in funding. A trio of developments offered hope the upward swing will continue in 2015. Neil Woodford's fund contributed to a £34.75 million investment in microbiome player 4D Pharma (AIM:DDDD), while Advanced Accelerator Applications and Bone Therapeutics unveiled IPO plans. U.K. Prime Minister David Cameron called for lighter regulations to stop drug development being so "abhorrently expensive and time consuming." And more. Nick Taylor (email | Twitter)
1. EU IPO figures for 2014 dwarf previous 5 years combined
2. U.K. biotech VC funding jumps 41% to blast past $700M mark
3. Invesco, Woodford back £35M investment in microbiome pipeline
4. AAA, Bone Therapeutics look to leap through IPO window
5. Ebola experience prompts U.K. PM to call for lighter regulations
And more >>
The biotech IPO boom was slow to cross the Atlantic. From 2009 to 2013, European biotechs raised €303 million ($350 million) in home-turf IPOs, around 10% of the amount their U.S. peers pocketed in just one of those years. The situation improved dramatically in 2014, though.
Biotech market analyst Biocom reports local IPOs by European biotechs generated €719.8 million in 2014, more than twice as much as was raised in the previous 5 years combined. Circassia (LON:CIR) alone bagged almost as much in its March IPO as the 26 biotechs that braved the inhospitable public European markets from 2009 to 2013. The London-based vaccine developer raised £200 million, making it the biggest of the 15 life science IPOs on European markets in 2014.
Circassia's IPO also helped London pip Paris to the title of most active financial center for biotech IPOs. London hosted 6 life science IPOs in 2014, compared to 5 in Paris. And that small difference gave London more public life science companies overall. London exchanges now house 33 public life science companies. Paris has 32. The other four European life science IPOs in 2014 took place in Amsterdam, Brussels, Oslo and Zurich.
|UniQure CEO Jörn Aldag|
By Biocom's tally, a further 7 European biotechs chose to list in the U.S. UniQure ($QURE) CEO Jörn Aldag told Biocom the appeal of the U.S. is partly due to its scale. When uniQure came to list, it looked for an exchange with multiple comparable companies. The fragmentation of European stock exchanges--and in uniQure's case the lack of listed gene therapy companies in the region--made the U.S. the only choice.
"If setting up a standard stock exchange for biotech stocks in Europe could be achieved, it would then be easier for U.S. investors to get to grips with the regulations at the stock exchange center. It would certainly also be easier for European investors to compare 10 to 15 biotech stocks with one another in a common stock market segment," Aldag said. - read the Biocom release, figures and more
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|SV Life Sciences' Kate Bingham|
The United Kingdom biotech sector finally has some venture funding numbers to crow about. After a tricky few years, British life science companies raised $713 million (£470 million) in 2014, a 41% jump over 2013, according to figures compiled by London & Partners.
As expected, companies based in Cambridge, London and Oxford--the cities collectively dubbed the "golden triangle"--bagged most of the cash, but their dominance dipped year on year. The region sucked in 70% of all U.K. life science venture funding last year, down from 87% in 2013. VC funding outside the south-east life science hub soared 215%--off an admittedly low base of $66.7 million--to drive the U.K. as a whole to a 41% increase.
The funding jump is comparable to what happened in the U.S.--where biotech investments were up 29% over an already impressive 2013--and has been hailed as a tipping point. "The U.K. biotech sector is coming of age. There are a lot of very exciting new companies conducting highly innovative and nimble R&D programmes to tackle some of our toughest diseases such as cancer, infection, inflammation and pain," SV Life Sciences managing partner Kate Bingham said in a statement.
SV Life Sciences contributed to the bumper year by investing in Bicycle Therapeutics and KalVista Pharmaceuticals. Like in the U.S., a few big investments made up a sizable chunk of the U.K. total. Adaptimmune and Cell Medica raised $104 million and £50 million, respectively, which accounted for around one-quarter of all the venture money collected by U.K. life science players last year. - read the Telegraph's coverage, MedCity release and FierceBiotech's U.S. article
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|4D Pharma CEO Duncan Peyton|
4D Pharma (AIM:DDDD) has tapped investors for the third time in 12 months. The latest fundraising sees Neil Woodford's fund and his former employer Invesco Asset Management commit cash toward a £34.75 million ($52.6 million) placement of shares.
Manchester, U.K.-based 4D is raising the cash to finance development of its microbiome pipeline and technology. Having acquired a live biotherapeutic to treat irritable bowel syndrome (IBS) after its last share placement, 4D now has two candidates on the cusp of clinical trials. IBS drug Blautix and pediatric Crohn's disease therapy Thetanix are both due to enter clinical trials in the second quarter of 2015. A third drug--pediatric colitis treatment Rosburix--is scheduled to join them in 2016.
The £34.75 million placement--which takes 4D's fundraising total since it went public in February to £72.75 million--will finance the early-phase trials. 4D will use the rest of the cash to add in-house development capabilities and scale up the MicroRx discovery platform, which it began working on in May in an attempt to build a library of bacteria. The library now contains some bacteria that have shown preclinical potential as treatments for rheumatoid arthritis and forms of asthma.
With Johnson & Johnson ($JNJ) and others paying close attention to the microbiome, a pipeline of clinical-phase live biotherapeutics and a platform capable of generating more could prove to be attractive assets. British biotech heavyweights Invesco Asset Management and Woodford Investment Management have seen enough potential to open their well-worn checkbooks once again. - read the release
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|AAA CEO Stefano Buono|
Another pair of European drug developers are readying IPOs. Advanced Accelerator Applications (AAA) is heading to Nasdaq in the hope of raising up to $90 million (€69 million), while Bone Therapeutics is aiming to pocket around €25 million from European investors.
Both companies are seeking money to finance late-phase clinical trials and commercialization plans. Saint-Genis-Pouilly, France-based AAA expects to wrap up a Phase III trial of its labeled somatostatin analogue peptide Lutathera in patients with inoperable progressive midgut neuroendocrine tumors in the first quarter of 2016. Lutathera is designed to target the somatostatin receptors that are found in certain tumors and deliver a radioactive particle to kill the cells.
AAA plans to set aside more than half of its IPO haul for manufacturing, commercialization and distribution capabilities for Lutathera. A further $10 million is earmarked for a Phase III trial of Lutathera in patients with pancreatic neuroendocrine tumors. And $5 million will go toward development of a companion PET diagnostic for Lutathera and midstage trials of Annexin V-128. AAA is testing the diagnostic Annexin V-128 in people with rheumatoid arthritis and ankylosing spondylitis.
Bone Therapeutics is staying closer to home for its IPO. The Gosselies, Belgium-based bone regeneration specialist plans to list in Brussels and Paris to raise money for its mid- to late-phase pipeline. Lead candidate Preob--a treatment derived from a patient's own mesenchymal stem cells--is in Phase III trials for osteonecrosis and nonunion fractures. - read the AAA F1/A, plus Bone Therapeutics' IPO filing and trial news
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|U.K. Prime Minister David Cameron|
U.K. Prime Minister David Cameron has called for lighter regulations to cut the time and expense of developing drugs. The Prime Minister's office told Bloomberg Cameron regards the current model of drug development, approval and licensing as "abhorrently expensive and time consuming."
Cameron gave a glimpse of what his government might try to do about the persistent problem of drug development costs and timelines last year when his life science minister unveiled an independent review into the U.K. system. The panel isn't expected to report its findings until the summer, but the government has already said it foresees U.K. hospitals playing a bigger role in drug testing.
Since then, Cameron has seen biopharma companies and regulators fast-track drugs and vaccines against Ebola into the clinic. The Prime Minister's office made the comments about the need for lighter regulations during a visit to Washington, DC, to discuss Ebola with President Obama. Cameron wants day-to-day drug development timelines to become more like the speedy response to Ebola.
Whether Cameron gets to personally oversee these changes depends on the outcome of the general election in May. But having set the review in motion prior to the election, the incumbent government hopes changes will happen regardless of who is in power. - read the Bloomberg article
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UCB (EBR:UCB) licensed a peptide-based immunotherapy programme for Type 1 diabetes from King's College London. The candidate is ready to enter Phase I trials. Release
Hungary's Gedeon Richter talked up Phase III data for its antipsychotic cariprazine. Richter is developing the drug--which FDA rejected in 2013--with Actavis ($ACT). FierceBiotech
Neuroptis wrapped up preclinical work on its treatment for dry eye syndrome. The French biotech is now working with a contractor to produce enough of the drug to start clinical trials. Release
Autolus spun out of University College London (UCL) with £30 million ($45 million), a big-name leadership team and CAR-T assets. The startup plans to use UCL's clinical trial and manufacturing infrastructure to speed its lead candidate into Phase I. FierceBiotech
Hybrigenics started a Phase II trial of inecalcitol in patients with chronic myeloid leukemia. The trial is aiming to enrol 54 patients at 5 sites in France over the coming year. Reuters
Roche ($RHHBY) agreed to buy Trophos for up to €470 million ($545 million). The deal completes a turnaround at Trophos, which was on the cusp of being bought by Actelion (SIX:ATLN) in 2011 before a Phase III flop scuttled the deal. FierceBiotech
Ultimovacs raised NOK 45 million ($5.9 million) to develop its therapeutic cancer vaccine. The Oslo, Norway-based biotech is running Phase I/II trials of the vaccine in patients with prostate cancer, non-small cell lung cancer and melanoma. Release
Galapagos (AMS:GLPG) received a €2.5 million ($2.9 million) grant for antibiotic development. The Belgian biotech is collaborating with the University of Antwerp and aims to move a candidate with the potential to counter MRSA into Phase I this year. Release
Oxford Pharmascience (AIM:OXP) committed to dosing the first patients in a proof-of-concept trial of its immediate-release formulation of painkiller naproxen in the next few months. Release
BioInvent International (OMXS:BINV) struck a deal with nonprofit Cancer Research UK to trial its drug in patients with chronic lymphocytic leukaemia and non-Hodgkin lymphoma. The Phase I/II trial will be funded and run by CRUK, its commercial arm Cancer Research Technology and Leukaemia & Lymphoma Research. Release
Addex Therapeutics (SIX:ADXN) teamed up with the Dystonia Medical Research Foundation to research the use of dipraglurant to treat movement disorder dystonia. The partners are working toward a Phase II trial. Release
Neil Woodford's fund invested £5 million ($7.5 million) in NovaBiotics. The Scottish biotech will use the cash to advance its antimicrobial pipeline. Release
The European Medicines Agency awarded orphan drug status to Aprea's ovarian cancer drug, APR-246. Aprea--part of a Karolinska Development's (STO:KDEV) portfolio--is running a Phase Ib/II trial of the drug. Release
C4X Discovery (AIM:C4XD) struck a deal with Evotec (ETR:EVT) to develop drug candidates for stress-related addictive disorders. Evotec will optimize Orexin-1 selective inhibitors discovered by C4X. Release
D-Pharm (TASE:DPRM) raised NIS 12.8 million ($3.2 million) from shareholders. Clal Biotechnology (TASE:CBI) contributed two-thirds of the money, which D-Pharm will use to prepare its mid-phase acute ischemic stroke candidate for the next stage of development. Release
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