Archives for the month of: June, 2013

The most important news for UK bioscience companies from this week’s government Spending Review for 2015/16 was the confirmation of the continuation of the highly successful Biomedical Catalyst. This news, trailed the day before, is very welcome and follows a successful campaign, led by the BIA working with members and the sector, to impress upon policymakers at every level the need to re-fund the policy.

The Biomedical Catalyst is having a positive impact on the UK bioscience sector – demonstrably accelerating medical research projects and leveraging significant private capital (at least £55 million after rounds one and two). The scheme supports R&D in a wide variety of therapeutic areas and projects at every stage of development. The Technology Strategy Board (TSB) and Medical Research Council continue to work openly and collaboratively with the sector and further funding represents a significant boost.

Continuation of the Biomedical Catalyst is contained within an extra £185 million announced for the TSB for 2015/16 which will include support for the UK’s Catapult centres. The exact funding split is not yet known but against a backdrop of £11.5 billion of public cuts the securing of additional money to support UK innovation is recognition of the TSB’s work and the strength of medical research translation.

BMC-infogBeyond the Biomedical Catalyst and the headlines about road, rail and energy infrastructure, a number of other announcements on science funding were made by the Treasury, the most relevant of which include:

  • Preserving the science ring-fence for 2015/16 in cash terms at £4.6 billion.
  • Increasing the science capital funding in real terms to £1.1 billion in 2015/16 and in line with inflation to 2016/17.
  • Department of Health to provide £150 million of capital investment in 2015/16 to fund health research infrastructure in areas of dementia, genomics and imaging.
  • Pharmavision – the creation of a large scale facility for the development of biologic medicines (this is the National Biologics Industry Innovation Centre – a policy issue the BIA’s Manufacturing Advisory Committee is closely involved in).

In a very constrained public funding environment the importance of showcasing the competitive strength the UK holds in life sciences remains important. The BIA will now work with members and the sector  to maximise the value of the spending settlement.

Biomedical Catalyst update

Update on the campaign to re-fill the Biomedical Catalyst: Thank you to all of you who have contributed your voice to the campaign to ensure the continuation of the Biomedical Catalyst. Ahead of Wednesday’s spending review we’re updating members on progress on the campaign so far. I was delighted that the government’s life sciences adviser, George Freeman MP, asked for copies of our letters ahead to use in his discussions with the Chancellor. Wednesday’s Spending Review is an important moment and will provide commentary in light of the chancellor’s announcement this week.

PPRS consulation and VBP: Last week the Department of Health published for consultation on a statutory Pharmaceutical Price Regulation Scheme (PPRS) scheme proposing significant cuts to drug prices and new directions to NICE that it will in future apply a broader definition of value in its appraisals of new medicines. This is a significant development as the ABPI continues to negotiate a new voluntary scheme for the industry. The BIA will respond to the consultation before the deadline of 31 July and I’ll be seeking members views. With medicine prices in the UK already amongst the lowest in Europe, and the proportion of the NHS budget spent on new medicines is set to fall, not rise, in real terms over the coming years, ensuring the UK remains an attractive ecosystem in which to research, develop, manufacture and commercialise innovative medicines is in the interests of not only BIA members but UK patients and the UK economy. The ABPI are hosting an update on this on Tuesday to participate in the call you will need to register by clicking here.

Manufacturing discussed at Ministerial Industry Strategy group: Last week I attended the bi-yearly Ministerial Industry Strategy Group. Ministers agreed to industry’s call to create a small, focussed short-life working group tasked with the development of a plan to support and develop pharmaceutical, biopharmaceutical and cell therapy manufacturing in the UK. The working group will report back to ministers in November 2013. The BIA will be leading the secretariat for this group and if you are interested in being part of it please contact Rob Winder.

Our programme of high level meetings with senior parliamentarians continued last week as several members outlined the concerns of the sector to shadow Chancellor Ed Balls MP and his shadow Treasury team. We had a good informed discussion on the Biomedical Catalyst, the benefits of R&D tax credit changes and the importance of uptake. It was good to engage as the team develop their policies ahead of manifesto process for the next election.

I’d like to thank London Bioscience Innovation Centre (LBIC) for allowing us to visit them on Thursday and for a lively and informal lunch where surprise guest Andy Richards dropped in. My monthly webinar recorded there with John Burt the CEO of Polytherics is available here.

I am delighted we have secured Boris Johnson, the Mayor of London, and Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO), as the keynote speakers for our UK Bioscience Forum on 10 October. Our one day conference is the place to be for bioscience companies doing business in the UK this autumn and attendees can benefit from our early-bird delegate rates by registering before 19 July.

This week it’s CF Week with our supported charity for the year, the Cystic Fibrosis Trust. You can support them by donating here and here’s my blog about why we chose to support them.

Best
Steve

The BioIndustry Association (BIA), the UK’s trade association for innovative bioscience businesses, highlighted the opportunities for jobs and growth in biopharmaceutical manufacturing as it met with UK government ministers today.

Ministers agreed to industry’s call to create a small, focussed short-life working group tasked with the development of a plan to support and develop pharmaceutical, biopharmaceutical and cell therapy manufacturing in the UK. The working group will report back to ministers in November 2013. The working group members will be drawn from companies with a UK pharmaceutical, biopharmaceutical or cell therapy manufacturing presence or a desire to create one, with representatives from large and small companies and will also include senior level representatives from all relevant government departments.

The BIA estimates that around 250 companies are actively involved in the high value biopharmaceutical manufacturing sector.

At the meeting, Steve Bates, BIA Chief Executive Officer, informed Science Minister David Willetts and Health Minister Earl Howe, that the UK biopharmaceutical manufacturing sector has a strong track record of producing medicines of the highest quality that are exported around the globe. It also has an excellent contract service sector supporting the manufacturing supply chain.

The UK pipeline of biological medicines is the second strongest in the world behind that of the US, representing about 10 per cent of the total in development globally. The successful Biomedical Catalyst fund is an excellent mechanism to enhance this pipeline of cutting edge molecules.

In the coming years as new types of medicinal products are developed the sector will grow to deliver the ability to manufacture cell therapies, tissue therapies and next generation biopharmaceuticals.

The UK also has a world-leading academic base in bioprocessing in universities including UCL, Manchester, Sheffield, Loughborough, Kent and Newcastle.

Additionally, world-class companies have significant investments in this highly skilled, specialist manufacturing sector around the UK. These include MedImmune, Eli Lilly, Eden Biodesign (a subsidiary of Actavis Inc.) and Novartis Vaccines on Merseyside, Fujifilm Diosynth Biotechnologies in Billingham, Lonza in Slough, Oxford BioMedica in Oxford, Cobra Biologics in Keele and GE in Cardiff.

And, often overlooked but also important is the fact that the UK has globally respected regulators and inspectors at the Medicines and Healthcare Products Regulatory Agency (MHRA) overseeing the quality and standards of UK output.

It is great to see this sector is supported by government through initiatives such as the new Cell Therapy Catapult in London and the plans for a National Biologics Industry Innovation Centre. When you put these elements into a supportive business environment in terms of the patent box, R&D tax credits and strong intellectual property protection, the UK has a real opportunity here. This is evidenced by GlaxoSmithKline’s announcement to invest £500 million in new biopharmaceutical manufacturing facilities in the UK as a direct result of the government’s patent box policy.

If we want to keep and attract R&D to the UK it is vital we build a strong manufacturing base to translate the pipeline of products and capture the greatest value for the UK. As manufacturing gets more complex and medicines become more personal the skill sets to develop medicines need manufacturing experience alongside clinical trials design and curing edge medicine.

To seize this exciting challenge the UK must however work to:

  • Ensure the UK remains globally competitive with other countries who offer incentives to globally mobile corporations to place advanced manufacturing in their jurisdictions
  • Inspire UK young people to understand the exciting opportunities for careers in this area and educate and train them with the skills they need
  • Sell the UK biopharmaceutical manufacturing sector story effectively to the global players making investment decisions – the UK has a proven ability to do this to time, scale and quality.
  • Challenge ourselves in the sector to innovate faster than the competition to maintain global competitiveness.

On Tuesday 18 June the Financial Times ran an opinion piece by Shankar Balasubramanian, Wellcome Trust Investigator at the University of Cambridge and a founder of Solexa and Cambridge Epigenetix, explaining why cuts to the science budget in the upcoming spending review would be harmful to the economy.

Almost 50 BIA members signed a letter, below, in response raising the need to ensure that the translation of basic research was also funded.

Sir,
Shankar Balasubramanian is absolutely right that government support for UK science is of continued importance (‘Cutting the UK science budget would be a false economy’, June 18). Public funding into the UK’s world leading medical research base demonstrably supports the development of new products and technologies to address some of the most serious diseases and conditions such as cancer, Alzheimer’s and diabetes.

It is also important for government to back the translation of that basic research and provide companies with the support they need to take these early stage ideas to the next level. The Biomedical Catalyst is one such policy that has accelerated medical research, supported collaboration in life sciences and demonstrably leveraged significant private capital into the UK since its introduction in April 2012.

To date £64 million has been allocated to business-led projects at various stages of development in a wide range of disease areas. The Biomedical Catalyst has had a truly catalytic effect on funding into the sector and has enabled innovative companies to leverage in at least £55 million of private investment.

The Biomedical Catalyst has not only ensured that highly innovative medical research translation continues to take place in the UK but also brought together the Medical Research Council and Technology Strategy Board providing a welcome focus on linking academia together with industry.

The existing funding for the Biomedical Catalyst has now almost all been allocated and it is vital that the Chancellor uses the opportunity of the Spending Review on 26 June to re-fund it and ensure its success continues. Such a move would be widely welcomed by the sector, would maintain the UK’s competitive strengths, be a cost-effective use of public funds and, most importantly, support the translation of the next generation of innovative treatments for patients worldwide.

  • Steve Bates, Chief Executive Officer, BioIndustry Association, London
  • Tim Edwards, Chairman, BioIndustry Association, London and Chairman, Atopix Therapeutics Limited, Abingdon, Oxfordshire
  • Davidson Ateh, Chief Executive Officer, BioMoti, London
  • Dr John Beadle, Chief Executive Officer, PsiOxus Therapeutics Ltd, Abingdon, Oxfordshire
  • Amanda Bettison, Head of Business Operations, Crescendo Biologics, Cambridge
  • Richard Bungay, Chief Executive Officer, Chroma Therapeutics Ltd, Abingdon
  • John Burt, Chief Executive Officer, PolyTherics, London
  • Mark Carnegie-Brown, Chief Executive Officer, Glide Pharma, Abingdon, Oxfordshire
  • Kevin Cox, Chief Executive Officer, Imanova, London
  • Dr Michael J Davies, Chief Medical Officer and Company Director, Blueberry Therapeutics Ltd, Alderley Edge, Cheshire
  • John Dawson, Chief Executive Officer, Oxford BioMedica plc, The Oxford Science Park
  • Clive Dix, Chairman, Touchlight Genetics Ltd, London, Crescendo Biologics Ltd, Cambridge and Conformetrix Ltd, Manchester,
  • Ted Fjallman, Development Director, Prokarium, London
  • David Flanders, Chief Executive Officer, Eagle Genomics Ltd, Cambridge
  • Dr Ian Fotheringham, President, Ingenza Ltd, Roslin, Midlothian
  • Jeremy Haigh, European COO, R&D, Amgen, Uxbridge
  • Robert Hawkins, Professor of Oncology University of Manchester and Cellular Therapeutics Ltd, Manchester
  • David Hipkiss, Chief Executive Officer, Prosonix Limited, Oxford
  • Edward Hodgkin, Partner, Syncona Partners LLP, London
  • Michael Hunt, Chief Executive Officer, ReNeuron, Guildford
  • Harren Jhoti, President, Astex Pharmaceuticals, Cambridge
  • Dr Kevin Johnson, Partner, Index Ventures, London
  • Paul Kemp, Chief Executive Officer, Intercytex Ltd, Manchester
  • Simon Kerry, PhD, MBA, Chief Executive Officer, Karus Therapeutics Ltd, Abingdon, Oxfordshire
  • Dr Gareth King, Chief Executive Officer, Critical Pharmaceuticals, Nottingham
  • Dr Melanie Lee, PhD, CBE, FMedSci, DSc(Hons), Chief Executive Officer, Syntaxin Ltd, Abingdon, Oxfordshire
  • Dr Andrew Lightfoot, Chief Executive Officer, Peptinnovate, Stevenage Bioscience Catalyst
  • Dr Eddy Littler, Chief Executive Officer, Domainex Ltd, Cambridge
  • Louise Makin, Chief Executive Officer, BTG plc, London
  • Dr John March, Chief Executive Officer, BigDNA Ltd, Edinburgh
  • Dr Allan Marchington, Partner, Apposite Capital, London
  • Brendan Martin, General Manager, Genzyme Therapeutics, Oxford
  • Dr Dave Mead, Business Development Director, Novozymes Biopharma UK Ltd, Nottingham
  • Prof Andrew David Miller, King’s College London and Chief Executive Officer and Chief Scientific Officer of GlobalAcorn Ltd, London
  • Dr Andrew Muir, Partner, Rainbow Seed Fund, UK
  • John Nicholson, Chairman and CEO, Genronix Ltd, Manchester
  • Dr Richard Pither, Chief Executive Officer, Cytox Ltd, Harwell, Oxfordshire
  • Dr Mike Romanos, Chief Executive Officer, Crescendo Biologics, Cambridge
  • Stephen Rees, Chief Operating Officer and Board Member, Enkam Pharmaceuticals A/S, UK
  • Michael L Roberts PhD, Chief Executive, Synpromics Ltd, Edinburgh
  • Gregg Sando, Chief Executive, Cell Medica Limited, London
  • Thomas Reese Saylor, Chief Executive Officer, Arecor Limited, Cambridge
  • Dr Andreas Schatzlein, Chief Executive Officer, Nanomerics Ltd, St Albans
  • Carl-Johan Spak, Chief Executive Officer, Prokarium Ltd, Keele
  • Carl Sterritt, Chief Executive Officer, Shield Therapeutics, Newcastle Upon Tyne
  • Patrick Verheyen, Head, Johnson & Johnson, Innovation, London
  • Malcolm Weir, Chief Executive Officer, Heptares Therapeutics Ltd, Welwyn Garden City, Herts
  • Dr Will West, Chief Executive Officer, CellCentric Ltd, Cambridge

Matthew Foyon CNBC

The long awaited Myriad gene patenting decision in the US Supreme Court came out last Thursday and we’ve got BIA expert insight on what this means for BIA member companies here from our Intellectual Property Advisory Committee (IPAC). The impact is likely to be smaller than some of the headlines claim largely because technology has moved on as most claims for isolated DNA will be of the cDNA type which is patentable.

Last week our Head of Regulatory Affairs, Christiane Abouzeid took part in the EuropaBio meeting with Stefano Soro, Head of the Unit ‘Medicinal products: quality, safety and efficacy’ of the European Commission’s Directorate-General Health and Consumers. Christiane, as Chair of EuropaBio’s Clinical Trials Topic Group, led the discussions on the Commission’s proposal for a Clinical Trials Regulation. During the meeting Mr Soro said that the Commission will push to keep the Clinical Trials Regulation close to the original proposal and there was a need to reach common agreement by end of the year. Christiane has prepared a briefing paper to update BIA members on the latest developments regarding the European Parliament’s Environment, Public Health and Food Safety (ENVI) Committee vote on the proposed Clinical Trials Regulation and the House of Commons Science and Technology Committee’s clinical trials evidence sessions. She has also outlined some of the next steps in our engagement on these issues.

Thank you to all who have made their voices heard in our campaign to ensure the Biomedical Catalyst continues – I know the message is being heard in Whitehall Westminster and it’s helpful to have that message amplified in the media – so I was great to see the Biomedical Catalyst plugged by Matthey Foy, Partner at SR One, when he appeared on CNBC’s Squawk Box last week (pictured).

Last week the Science Ministers and Presidents of the Science Academies in the G8 countries met in London to discuss the role of science in tackling global challenges. The UK government raised the topic of antibiotic resistance and how to address this. The vibrant UK bioscience base is eager to play its part in addressing this global challenge and UK biotech companies, such as Discuva and Cantab Anti-infectives for example, are using Biomedical Catalyst funding to discover and develop new antibiotic classes for Gram-negative bacteria. However, it will be essential to get the incentives right globally for investment in this area. For instance, we need different incentives for biotech companies to develop drugs that will only be used infrequently and sparingly rather than paid for every pill used.

I’ve a busy week ahead with the Biomedical Catalyst and manufacturing on the agenda for our regular meeting with Ministers, a meeting with members with Shadow Chancellor Ed Balls and a day at London Bioscience Innovation Centre from where I’ll be joined for my monthly webinar by guest John Burt CEO of Polytherics – where he’ll give an insight into his plans for what he tells me is London’s largest privately owned biotech.

As part of our continued support for our charity partner, the Cystic Fibrosis Trust, we are holding a charity golf day on 28 June. There are places available for individuals and teams, so please register now to join the fun and support a great charity.

Finally, a number of individuals from our sector were recognised in the Queen’s Birthday Honours List. These include BIA member Ruth McKernan, head of Pfizer’s Neusentis business, as well as Neil Woodford, of Invesco Perpetual, Fiona Fox, head of the Science Media Centre, and Professor Michael Stratton, of the Wellcome Trust Sanger Institute. Congratulations to them all.

Best
Steve

Yesterday the US Supreme Court issued its much anticipated opinion in the Myriad case (Association for Molecular Pathology v. Myriad Genetics Inc., U.S., No. 12-398, 6/13/13). The Supreme Court had been asked to address a single question: “Are human genes patentable?” The patents at issue were three patents owned by Myriad on the BRCA1 and BRCA2 genes, mutations of which are associated with significantly increased risk of breast and /or ovarian cancer. The US Federal Circuit had found Myriad’s claims to isolated DNA and cDNA to be patent eligible, in contrast to the District Court.

The Supreme Court found that naturally occurring DNA segments are “products of nature”, and so are not patentable in the US, regardless of the amount of effort involved in discovering such sequences, even though these sequences had been isolated from the human body. This means that the long-standing US Patent Office practice of recognising the patent eligibility of genes will need to be changed.  It also contrasts with the European position, where there is no absolute bar on patenting genes which have been isolated from the human body if – which can be a significant challenge – the normal patent requirements of novelty, inventive step and industrial applicability are met.

The Supreme Court agreed with the Federal Court’s view that cDNA claims can be valid. The Supreme Court found that cDNA, i.e. synthetically created exon-only strands of nucleotide sequences, is not a “product of nature” because it is not naturally occurring, and so can be patent eligible.

As expected, the Supreme Court did not make any rulings in relation to broader patent eligibility issues such as claims for methods of interpreting genetic testing results, testing drug efficacy or manipulating genes. Nor did it comment on the patentability – or otherwise – of DNA in which scientists have altered the order of the naturally occurring nucleotides.

The Supreme Court’s decision not to ban the patenting of cDNA sequences will be a relief to many in the innovative life science industry on both sides of the Atlantic. Although naturally occurring gene sequences are no longer considered patentable, the trend for a number of years now has been to move away from drafting such claims, or at least not to rely exclusively on such claims, in favour of more complex patent claims involving non-native genetic constructs, and incorporating sequence changes to make the sequences appear less “natural”. The practical ramifications of this decision are unlikely therefore to be as far-reaching as many reports in the popular press would suggest.

The BIA’s Intellectual Property Advisory Committee is monitoring and assessing the likely impact of the Myriad decision on behalf of the membership.

George Osborne and Sir Paul Nurse at teh Francis Crick Institute topping out ceremony

George Osborne and Sir Paul Nurse at the Francis Crick Institute topping out ceremony

As the Francis Crick Institute held its topping out ceremony last week I was delighted to see that one of the strategic priorities is to develop effective partnerships with industry. This is vital if it is to become the world’s leading centres for biomedical research. I have already had initial discussion on practical ways of developing this “permeability” for bioscience companies with Sir Paul Nurse, the Director of the Francis Crick Institute and look forward to working with them in the coming months.

The Chancellor George Osborne MP press released from the event that the Institute is exactly the kind of long-term investment he will look to prioritise in the coming Spending Round saying: “The spending review is about making choices, and for me science is a personal priority. By bringing together our Nobel-prize winning scientists, our world-class companies and entrepreneurial start-ups, we can drive innovation and create the economic dynamism Britain needs to win in the global race. We are making difficult decisions on things like welfare so that we can invest in areas like science”. I hope he sees the benefit of continuing the Biomedical Catalyst in the same light.

As previewed in my blog last week Dr Julian Huppert MP’s parliamentary debate on science and research in the UK was encouraging. I was delighted to hear Julian’s support for the Biomedical Catalyst, which has been well received in our sector and has leveraged in significant amounts of additional private funding for companies, It shows that the BIA campaign for its continuation is having an effect at Westminster. I was also pleased to hear his positive comments on our Citizens’ Innovation Funds (CIFs) proposal. CIFs are a proposed tax-advantaged investment scheme providing an opportunity to leverage the patriotic potential of the British public to invest in innovative UK companies and provide additional private investment to the new products and technologies of tomorrow.

I am certain that those of you that attended our joint conference with the MHRA found it to be an excellent event. I know we have received a lot of positive feedback and we plan to make the presentations available soon.

Next Thursday we have our Hot Issues Curry Night discussion on R&D tax credits and the Patent Box. Andrew Groves of the HMRC will be joining Colin Hailey a Partner at Confluence Tax and member of our Finance and Tax Advisory Committee, and Jason Rutt, Head of Patents at Rouse to discuss how the patent box is workingg in its early months of operation. As there are bound to be questions on all sides as the new policy comes into place I think this is an excellent opportunity to gain insight into HMRC thinking. For more details and to register visit the BIA website.

At the same time think tank IPPR has published the final report of the Commission on the Future of Higher Education. It argues that R&D tax credits are not sufficiently targeted at those areas where the country needs to raise its research and innovation rate if the economy is to be rebalanced and recommends reducing the R&D Credit for large companies, reducing the ‘Patent Box’ tax break from 20% to 15%, as well as changes to the TSB’s Catapults. I’ll be keen to get the sector’s reaction to their proposals on the night.

It’s just five weeks now to our CEO and Investor Forum. If you are interested in attending please contact Cathrine Smyth.

Best
Steve

Last week the Financial Conduct Authority (FCA) (the successor to the Financial Services Authority) confirmed that Enterprise Investment Schemes (EIS) and Venture Capital Trusts (VCTs) will not be limited in their promotion to only “sophisticated” and high-net worth investors. This followed a consultation in late 2012 to which the BIA provided a response which specifically called for EISs and VCTs to be out of the scope of the new marketing restrictions and this announcement is therefore a very welcome result.

Many small, equity backed bioscience companies in BIA membership rely on a diverse range of investment sources including those raised by these instruments, particularly the EIS. Therefore, any suggestion that such products would, in future, only be promoted to “sophisticated” investors would potentially impact upon the funds raised under these schemes and result in less available finance for innovative bioscience companies.

This would obviously have been an unwelcome move and the BIA made representations to this effect and specifically raised the issue with Ministers in HM Treasury. In this we were guided by the expertise of our Finance and Taxation Advisory Committee. While recognising these proposals were brought forward because of the levels of unsuitable advice provided to investors that had been uncovered by FSA studies, it is the BIA’s view that restricting their promotion to “sophisticated” investors runs contrary to the growth agenda and we specifically asked for them to be excluded from any new restrictions. It is very good to see these concerns were taken on board in the final announcement.

Taking action against the minority of advisers who fail to adhere to a respectable standard of advice rather than closing off opportunities for retail investors to support potentially high-growth sectors would appear a better approach. Moreover, more could be done to actively engage the general public with UK innovation and provide them with the opportunity to invest in innovative UK companies.

This is the concept behind the BIA’s Citizens’ Innovation Funds (CIFs) proposal – engaging the public with innovation and allowing them to invest in UK excellence if they wish to. An independent survey, outlined in our most recent report, highlights the appetite of the public to be given the opportunity to support such companies. For example, nine out of ten who expressed a preference feel the government should provide the general public with the opportunity to invest in innovation.

The policy got a boost earlier this week at a Parliamentary debate on support for science and research held by the MP for Cambridge Dr Julian Huppert. Dr Huppert spoke of the need for government support for the UK’s world leading science and research base ahead of the Spending Review in late June and also outlined his positive view of the CIFs proposal, commenting that government should examine the introduction of such a scheme in the UK.

The BIA will continue to work with members and other stakeholders to promote this and other policies to support the continued growth of UK bioscience companies.