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

U.K. Biopharma Bouncing Back

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

  • The Dreaming Spires

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

    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.

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

    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.

  • North of the Border

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

    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.

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