June 1, 2012 (Vol. 32, No. 11)

Advantages Include 30 Leading Universities and Womb-to-Tomb Electronic Health Records

2012 is looking like a better year for the U.K.’s biopharm sector. Recently, a pharma heavyweight entered the ring and is banking on the region’s biomanufacturing abilities.

GlaxoSmithKline recently announced an investment of over £500 million in U.K. biopharmaceutical manufacturing. Since the money is going to be spent in the U.K. rather than Asia, building a new site in Ulverston, Cumbria and making an additional investment in GSK manufacturing in Scotland, many in this sector did a double take and asked why.

One reason is that the commercial climate for biopharm has shifted, with the U.K. government implementing its “patent box”, which includes a lower rate (10%) of corporation tax for profits arising from U.K.-owned IP. Additionally, the U.K. government’s £180 million Biomedical Catalyst fund launched in April, which targets the funding gap known as the “valley of death”, is another boost for the sector.

However, there are other reasons for setting up shop in the U.K. “GSK is a world-leading company, looking to access well-trained scientists and some of the best science in the world,” Rhona Allison, senior director, life and chemical sciences at Scottish Enterprise, Scotland’s main economic development agency, explains. “In Scotland for example, if you compare academic citations to GDP, Scotland comes out as the world’s number one research center, so there is a distinct business benefit to being in the U.K.

“GSK announced it was going to set up 10 strategic partnerships globally,” Allison continues. “The U.K. has secured the first four, three in Scotland and one in London. This demonstrates our competitive strengths.”

Nigel Gaymond, a veteran of the global life science industry, adds, “The U.K. accounts for 30 of the world’s 200 leading universities, according to QS rankings, yet it is geographically the size of New England. This is therefore an unparalleled super cluster of scientific research.”

The Golden Triangle

The U.K. has a number of biotech centers in London, Oxford, and Cambridge. This is known as the Golden Triangle because geographically these centers are arranged in a triangle with both Oxford and Cambridge just 60 miles north of London.

“The U.K. is geographically quite small, and many people don’t realize that all three Golden Triangle clusters will easily fit into the MassBio cluster,” comments Glyn Edwards, interim CEO of U.K. bioscience trade organization the BioIndustry Association. “However, despite the U.K.’s small size, we have many good companies with world-leading technologies.”

London is traditionally a financial center but does have a number of leading universities, which are biotech powerhouses. Additionally, in 2015 a major new biomedical research site, the Francis Crick Institute, will be opening its doors to 1,500 scientists.

There are also a number of biotech incubator centers that allow bioscience research to be commercialized. These include the London BioScience Innovation Centre, QMB (Queen Mary Bioenterprises) Innovation Centre, and the Imperial Incubator.

“Nobody thinks of London as a global biotech hub, yet some of the world’s top universities are here doing great work in areas such as oncology, neuroscience, and regenerative medicine,” says Tony Jones, Ph.D., director of business development at the biotech networking organization One Nucleus.

“We don’t have vast science parks but we do have three incubators. I believe in the next decade, London is very much going to be where the innovation is started, since coming up with the clever ideas is what we’re good at in the U.K. When the companies want to grow, they’ll move out along the major routes toward the BioPark at Welwyn or the BioScience Catalyst at Stevenage and also to Cambridge, so it will create a corridor of innovation similar to the IT corridor that arose in the U.K. in the seventies.”

For the U.K. to remain competitive, according to Dr. Jones, it must produce innovations that can be incorporated as part of the global value chain in creating new therapeutics. Successful biotech companies in London that illustrate this approach are PolyTherics and Stabilitech.

PolyTherics licenses its glycopolymer-conjugation technologies to enable partners to develop improved biopharmaceuticals through PK/PD optimization, antibody drug conjugates, and bi-specific products, as well as targeted drug delivery. Stabilitech has a thermal stabilization technology that enables vaccines, biopharmaceuticals, and potentially cell therapies to be stored at a range of temperatures.

New laboratories at the Stevenage Bioscience Catalyst

The Dreaming Spires

The Oxford part of the Golden Triangle boasts several science parks, with the main ones being Milton Park, the Oxford Science Park, and Begbroke Science Park. The science there also has a distinct flavor.

“The strength in Oxford is biotech, and it has been very successful in this niche with a number of companies,” says Jon Rees, CEO of U.K. trade association OBN. Bright stars in Oxford include Circassia and Oxford Nanopore Technologies.

Circassia is developing T-cell vaccines designed to treat allergies and autoimmune conditions. Several of the company’s products are currently in Phase II/III studies, and in April the firm received $56 million after achieving key development milestones.

Oxford Nanopore is developing a platform technology based on nanopore sensing of single molecules. Its products GridION and MinION array nanopores across artificial membranes for DNA sequencing, protein analysis, and other applications.

Oxford boasts a number of firms including Oxford Nanopore, which will launch the MinION DNA sequencing system later this year.

East of Oxford by 80 miles, Cambridge also has its own biotech offering and many science parks of varying sizes such as Granta Park, Chesterford Research Park, and Babraham Bioincubator.

“Key focus areas for One Nucleus include oncology, healthcare technologies, CNS and aging, infectious diseases, and vaccines and therapeutic antibody development,” says Harriet Fear, CEO of One Nucleus. “A company in Cambridge that illustrates one of these technical strengths perfectly is Kymab, a spin-out from The Wellcome Trust Sanger Institute.

“The company provides a multistrain transgenic mouse platform, known as Kymouse™, for the production of fully human monoclonal antibodies and is introducing Kymouse HK™ and Kymouse HL™ strains this year. These are mice engineered with the majority of the variable regions from the human immunoglobulin heavy chain in combination with either kappa or lambda human light chains providing human-like functionality and usage.”

Another company to watch in Cambridge, according to Fear and Gaymond, is Horizon Discovery, a provider of research tools to support the development of personalized medicines.

The Babraham Bioincubator is just one of many science parks in Cambridge, U.K.

North of the Border

Further North in the U.K., there are sizeable clusters of biotech firms in Scotland, sited at science parks such as the Edinburgh BioQuarter, a $1 billion investment into the co-location of Edinburgh University Medical School and commercial life science R&D space, BioCity Scotland, and the Dundee MediPark.

Scotland specializes in drug discovery and also has a growing cell therapy base. “As pharma needs and their model changes they are increasingly accessing and funding early-stage research,” Allison comments, “so there is a lot of work with commercial potential focused around the research institutes, as well as biotech companies in Scotland.”

One of the advantages of developing drugs in Scotland, according to Allison, is the ability to access the whole supply chain from R&D to manufacture and then translational and clinical studies. For example, drug manufacture with close access to patients for clinical trials either co-located or in a relatively small area. This is particularly attractive for cell-therapy trials, and there are currently six cell and regenerative medicine clinical studies ongoing in Scotland. In addition, 60% of Europe’s safety testing of biopharmaceuticals is carried out in Scotland.

“Scotland has electronic health records for our 5.3 million population, which records all patient contact with the healthcare system from ‘womb to tomb’,” says Allison.

“Link this with access to well-characterized cohorts of patients in specific disease areas (for example Generation Scotland has access to over 30,000 Scot’s biological samples with full genotyped and phenotyped information) and very competitive clinical trial permission times of around 14–18 working days, and you can imagine how powerful (and cost-effective) many companies are finding this for first-in-man, Phase II, and postmarketing studies.”

Allison notes that the WOSCOPS 15-year follow-up study demonstrates this power, as it cost a fraction of the original study, and in a fraction of the time demonstrated the long-term benefits to patients using statins.

Up-and-coming companies in Scotland that highlight these areas include MGB Biopharma, Angel Biotechnology, and Roslin Cells.

MGB is developing a new small molecule antibiotic class known as DNA minor groove binders. Its lead candidate, MGB-BP03, has shown promising preclinical potency and activity against MRSA, VRE, and Clostridium difficile. The company recently announced that MGB-BP03 will be advancing into clinical trials at the end of this year—initially for oral treatment of C. difficile and later as a parenteral formulation for the other indications.

Angel is a contract manufacturer specializing in producing biopharm proteins and cell therapies. The firm produced the ReN001 stem cell therapy from ReNeuron. This is currently being used in Scotland in the Phase I PISCES study, a fully regulated clinical trial of a neural stem cell therapy to treat stroke patients.

Roslin Cells produces cells and recently relocated to a 1,000 square meter facility at the Edinburgh BioQuarter to extend its clinical-grade stem cell production capability and the development of new cell therapies. It is also developing the capacity to produce induced pluripotent stem cells from selected donors for drug discovery.

Advanced biologics production at Angel Biotechnology’s cGMP manufacturing facility in Scotland.

Barriers to Success

One of the advantages of being in the U.K., according to Gaymond, is its compact size. “There is a tendency to undervalue the excellence of the high-speed train links to biotech hubs from London. For example, both Manchester and Liverpool in the Northwest can be reached in a couple of hours and offer life science capabilities that merit attention.”

This, though, can have its downside, as Dr. Jones explains. “The U.K. has an issue with scale and consequently its cost base. Space can be relatively expensive to rent or buy because of market demand for office and lab space. This means that realistically the U.K. cannot compete with Asia in terms of having vast, low-cost manufacturing facilities but can stand ahead on high-end innovation.”

“Our difficulty in Oxford is that we’re full and there is a lack of lab space in our science parks,” Rees comments. “However, there is now a move to increase our footprint, and there are currently up to seven new projects that may provide useful lab space. This is the first time in five years that there have been serious plans for expansion and the Oxford cluster hasn’t grown because of lack of space here and companies have had to move further down into the Thames Valley to gain the space they need.”

“There is a great deal of new physical infrastructure being put in place in the east of England,” Fear adds. “This includes the Biomedical Campus being built at Addenbrookes in Cambridge and the expansion of the Babraham site, as well as the new Bioscience Catalyst next to the GSK site at Stevenage. This space to grow will ensure the U.K. can remain competitive.”

Another issue in the U.K.—which is something being felt globally—is the lack of funding, with many opinion leaders stating that this sector needs enough cash to ensure that research can be translated from concept to commercialization.

“We have excellent VCs in the U.K., just not enough of them,” explains Edwards. “Our public markets are also still very weak, but the upside is that the U.K. government is continuing to support the biopharm sector through initiatives such as the BioMedical Catalyst. Additionally, we have recently seen both the Wellcome Trust and Cancer Research Technology start venture funds to support early-stage research.”

“We should accept that much of the initial tech transfer needs to be funded by the public purse because ultimately these products will help the U.K. economy and alleviate human suffering,” Rees continues. “The universities should be out-licensing their technology more readily and PIs in the U.K. should be able to progress their careers based on how many industrial collaborations they have, as well as publication numbers. This would improve early-stage preclinical development in the U.K. and help us stay competitive.”

Many of the U.K.’s key opinion leaders believe the U.K. biopharma industry has in the past not been good at marketing its benefits, and because of its size, the U.K. should now be promoted as a “super cluster” rather than a series of centers of excellence.

“While harnessing our own strengths such as capital efficiency and breakthrough science, there are attributes to be learned from our U.S. friends,” Gaymond says. “These include having a scale of ambition that is truly global and celebrating our successes more aggressively. We are not only a font of worldclass innovation, but also produce some outstanding worldclass companies such as Shire and BTG, as well as some truly innovative young companies like Oxford Nanopore, Touchlight Genetics, and Horizon Discovery.”

Another advantage that has been underexploited is the U.K.’s National Health Service (NHS). “We have a large patient population that has extensive medical records, so the U.K. is potentially a cost-effective place to do high-quality clinical development work,” Edwards comments.

The Future

Many biotech experts are upbeat about the U.K. biopharm sector’s future and do not view Asia as a threat to the industry. “China has huge markets for new drugs, so instead of the U.K. competing for a slice of the current pie, the pie will be much bigger and this is a great opportunity,” Edwards says.

“Since the U.K. has been active in this sector for over 20 years, we now have a new generation of senior managers in biotech who have the skills to take the U.K. to the next level so I’m hopeful that we are prepared for the next decade,” Rees adds.

“Biopharm companies in the U.K. are more optimistic,” Edwards concludes. “This is because they see that we are part of a global village and Asia offers not only a larger market for products but also inward investment by Asian companies that want access to our worldclass science. We just have to be prepared to be part of that value chain, if we want to remain competitive.”

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