Archives for the month of: August, 2015

This week’s sector video comes from fellow United Life Sciences partner, One Nucleus.

Back in July, delegates from across the life science sector gathered at the Wellcome Genome Campus Conference Centre in Hinxton for this year’s ON Helix conference. Watch highlights from the day in the video below.

Do you have a video you would like the sector to see? Contact us.

Celebrate_coverTaken from our recently published report, Celebrating UK bioscience, the story of AstraZeneca’s newly approved first-in-class Lynparza (olaparib) for ovarian cancer showcases the critical role played by the UK bioscience sector in the development of cutting edge therapies. It also highlights the promise of personalised medicine.

Lynparza is one of a new generation of targeted medicines aimed at patients with specific genetic mutations that mean they’re most likely to benefit from treatment. The drug is approved for women suffering from ovarian cancer thanks to expertise and partnerships spanning the entire UK bioscience sector: from academic research excellence at University of Cambridge, through funding and support from cancer research charity Cancer Research UK (CRUK), biotech entrepreneurship and UK venture capital backing at KuDOS Pharmaceuticals Ltd., and the clinical development expertise and resources of UK drugs giant AstraZeneca.

Knocking out cancer’s repair mechanism

Lynparza’s approval in December 2014 for patients with advanced, pre-treated ovarian cancer offered a much-needed treatment option for many patients suffering from this relatively rare disease. Lynparza was shown in trials to prolong survival for six months or more among women with advanced, BRCA-mutated ovarian cancer.

The drug is a poly ADP-ribose polymerase (PARP) inhibitor, which kills cancer cells by knocking out their ability to repair damaged DNA. Cancer cells displaying mutations in the BRCA1 and BRCA2 genes are thought to be particularly vulnerable to this form of attack. Crucially, inhibiting PARP – an important DNA repair signalling molecule – doesn’t appear to affect healthy cells, unlike traditional treatments that directly attack cells, such as chemo- or radiotherapy.

Lynparza’s mechanism of action means it has potential across a wide range of tumour types whose cells have DNA repair deficiencies.

A PARP enzyme bound to a DNA double strand break. A PARP inhibitor kills cancer cells by knocking out their ability to repair damaged DNA.

A PARP enzyme bound to a DNA double strand break. A PARP inhibitor kills cancer cells by knocking out their ability to repair damaged DNA.

A team effort from across UK bioscience

Lynparza emerged from work in the 1990s by Professor Stephen Jackson and his team at the University of Cambridge. With research funding from CRUK (then known as Cancer Research Campaign), Professor Jackson’s group was looking at the role of various DNA repair proteins in cancer cells that help these cells survive. As the potential of such proteins as targets for drug therapy became clearer, Professor Jackson set up KuDOS Pharmaceuticals Ltd., initially within his Cambridge labs, in 1997. CRUK’s technology transfer arm, known today as Cancer Research Technology (CRT), provided seed funding. Two years later, the company attracted a combined £5 million from Advent Venture Partners, Schroder Ventures Life Sciences, and 3i Group. The start-up more than trebled its head-count and moved into new laboratories at the Cambridge Science Park. KuDOS continued to collaborate with Professor Jackson at Cambridge University.

In 2005, KU59436 – the precursor to olaparib – was only in Phase I trials, a relatively early phase of development. But AstraZeneca was engaged in a flurry of pipeline-enhancing dealmaking. It liked KuDOS’ DNA repair platform and the early clinical candidate. In December that year, AstraZeneca paid over £120 million to buy the company outright.

The collaboration with CRT continued and has further evolved since. In 2010, AstraZeneca and CRT allied to discover drugs targeting cancer metabolism – how cancer cells use energy to grow – and expanded this alliance in 2013 for a further two years. Indeed, Professor Jackson pointed out on the day of Lynparza’s approval in 2014 that the achievement “…shows how, by collaborating with a partner such as AstraZeneca, basic academic research, such as that carried out by the research team at the University of Cambridge, can lead to major medical developments.”

AstraZeneca has further deepened its partnership with UK academic expertise, setting up a joint research facility with the MRC, the AstraZeneca MRC UK Centre for Lead Discovery, in Cambridge. That Centre is working with CRUK to screen for new cancer medicines in a five-year collaboration that provides CRUK scientists with access to over two million compounds from AstraZeneca libraries.

Another tool against cancer, multiple new research avenues

Scientists’ understanding of the potential of PARP inhibitors in treating cancer has much further to go. There may be several other mutations, as yet unidentified, that mark out patients likely to benefit most from this type of treatment. The combination treatment options are also growing exponentially as new therapies are approved.

There are further challenges however, even after approval, to ensure that Lynparza and related targeted treatments are accessible to those who need them. In June 2015 NICE opened its consultation on draft guidance on olaparib for ovarian, fallopian tube and peritoneal cancer and at the time of publication it has not recommended funding the drug on the NHS. Professor Peter Johnson, Cancer Research UK’s chief clinician, commented saying, “NICE’s provisional decision is hard to understand. This is a great example of a personalised medicine which offers a new treatment for a type of cancer where we have made little progress in the last decade and where there is a clear need for different approaches. The NHS can’t afford to ignore important innovations like this”.

Like to find out more? The full version of the Lynparza story, along with five other case studies, can be found in our report,“Celebrating UK bioscience: unravelling the stories behind UK bioscience success”.

UK Bio Web banner 720 x 215_FOMI hope you’ve all been busy enjoying the great British summer.

If you’re still looking for a holiday read – or need to refresh your memory following some time off – today we published our latest quarterly policy and regulatory affairs report, capturing key BIA activity from April to July. This latest document covers the fallout from May’s General Election, our annual Parliament Day back in June and July’s launch of the new All Party Parliamentary Group for Life Sciences, as well as updates on the latest legislative developments and regulatory policy proposals at EU and UK level. Have a look and as ever we’re keen to know if there are policy topics of particular interest to your company – get in touch with the policy team.

Also on reports, earlier this month the Cell Therapy Catapult has published its annual survey of the GMP licensed cell and gene manufacturing capability and capacity in the UK, which shows growth in the cell therapy industry to April 2015. It’s great to see evidence of the expansion of the UK’s cell and gene therapy sector, with a 25% increase in the numbers of highly-skilled staff at cell therapy facilities and the addition of 2 cell therapy manufacturing centres – the UK is establishing itself as a top location to undertake translational research.

I was also pleased to hear BioCity Nottingham have begun work on a new £30m state-of-the-art facility next door to the current site. The new building will increase BioCity Nottingham’s overall capacity in a fantastic boost to the UK biotech ecosystem.

Elsewhere in the UK, congratulations to Edinburgh-based BIA member Synpromics, who recently announced they had received £2.1m from Enterprise Investment Scheme (EIS) specialist Private Equity firm, Calculus Capital. The BIA has made a continued case for ensuring that tax-advantaged schemes incentivise investment in high risk, innovative sectors such as biotech, where the wider benefits for patients and the economy are vast. See our latest quarterly report (mentioned above) for the latest developments regarding tax-advantaged venture capital schemes announced in the Emergency Budget.

At the Comprehensive Spending Review on 25 November, the Chancellor will set out where this Government will make significant cuts to public spending in an effort to reduce the deficit. In all likelihood our sector, like all others, will see cuts to public funding – but it is important that we continue to make the case to set out why the life sciences is important to the UK and to illustrate that the different routes for funding all play an important role in our R&D ecosystem. Over the next weeks the BIA will use several opportunities to make representations to Ministers, the Treasury and the Commons Science & Technology Select Committee about the importance of Government support for our sector. This tranche of work includes – as part of a coalition of life science stakeholders – an open cross-sector letter to the Chancellor of the Exchequer George Osborne. We are seeking CEO signatories to illustrate wide backing from our sector to protect the UK’s science base in the face of significant public cuts. We have already been in contact with many of you – thanks to those who have already expressed an interest in signing – and are keen to add to the list. If you are a CEO of an active R&D or manufacturing company and interested in adding your support, please email Zoe Freeman by this Friday for more details.

This month marks the 40th anniversary since César Milstein and Georges Köhler’s Nature paper first described their technique for producing monoclonal antibodies. Initially beginning life as a laboratory tool for studying the immune system, monoclonal antibodies now form the basis of drugs for numerous diseases, with a market worth $75bn a year. In celebration of the anniversary, the MRC have published a story on their website explaining the significant milestones in the story of monoclonal antibody technology and its success in forming the basis of some of the best-selling drugs of all time. Our recent Celebrate report also covers the role of monoclonal antibodies in the development of the world’s best-selling drug, Humira, and Multiple Sclerosis treatment, Lemtrada.

Celebrating another anniversary, the EMA’s SME initiative is ten years old. To mark the occasion, EMA has launched an online survey to gather feedback on the programme. If you’re interested in contributing, the EMA is inviting feedback on current issues faced by SMEs, areas for further development and identification of new regulatory tools that could support innovation in the SME sector. The deadline for completing the survey is 25 September.

Over the summer, the Science Industry Partnership (SIP) Board of employers has now reported on the first year of the SIP – which spans April 2014 to April 2015 – and produced a short summary setting out the considerable achievements so far, and what we can expect in Year 2 and beyond. Some great highlights from the first year. I’d recommend you take a look.

On IP matters, the BIA has submitted a response to the Preparatory Committee for the Unified Patent Court (UPC)’s consultation on proposed rules and court fees and recoverable costs. In our response we call for lower fees for SMEs to ease the burden on small businesses, clarification on how value-based fees would be determined and a clear definition of SMEs to inform the work of the court.

Finally, for those who may have missed it, a reminder that we are currently seeking nominations to the BIA Board. Further details here if you’re interested. All nominations must be received by next Wednesday 2 September.

I’ll be back with my next update on 7 September, when Newscast will resume its normal weekly service following the summer. Until then, enjoy the bank holiday next week.



This week’s video showcase features a BBC interview with Professor Mark Baker, Director of the Centre for Clinical Practice, at the National Institute for Health and Care Excellence (NICE).

Earlier this week, NICE issued new guidelines on antibiotic prescribing for the NHS in England, which aims to change prescribing practice to help slow the emergence of antimicrobial resistance and ensure that antimicrobials remain an effective treatment for infection.

Click on the image below to watch the video on the BBC website.


Do you have a video you would like the sector to see? Contact us.

Celebrate_coverContinuing our celebration of UK bioscience success, adapted from our report Celebrating UK bioscience which was launched in June, today’s blog tells the story of Keytruda and the pivotal role of UK science as we enter a new frontier of cancer treatment.

Harnessing the immune system to target cancer offers a new, powerful approach to tackling the disease, beyond the traditional methods of directly destroying cancer cells. One of the most promising recent advances in cancer immunotherapy, and indeed in cancer drug development more broadly, has been the emergence of “checkpoint inhibitors”. These therapies are designed to scupper cancer cells’ clever methods of hiding from the body’s immune system. Cancer cells exploit checkpoints within the immune system that are designed to prevent it from going into overdrive, effectively dampening the immune response. Checkpoint inhibitors release these immune system “brakes”, allowing the body’s defence network to spot and attack invasive tumour cells.

Keytruda, recently approved for the treatment of life threatening forms of skin cancer, is a leading example of this new class of therapies. Not only does UK science and its exploitation form a key part of its development, but it is one example of a number of emerging therapies coming out of UK bioscience that are changing the face of future cancer treatment.

Accelerated approval for first-in-class drug

In September 2014, Keytruda (pembrolizumab) became the first in a new class of checkpoint inhibitors to receive US regulatory approval. This antibody targets the programmed death-1 (PD-1) pathway – a checkpoint normally involved in preventing tissue damage during chronic inflammation. Keytruda was shown in trials to shrink tumours, sometimes for six months or more, in almost a quarter of patients suffering from advanced, life threatening forms of skin cancer.

The benefits Keytruda offers for these patients, who have few other treatment options, prompted the US regulator, the Food and Drug Administration (FDA) to approve the drug almost two months earlier than expected, via an accelerated review process reserved for breakthrough therapies. European approval followed in May 2015, though the drug was made available to UK patients two months earlier. It was the first product to receive a “positive Scientific Opinion” from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK’s Early Access to Medicines (EAMS) scheme.

A patient receiving immunotherapy cancer treatment

A patient receiving immunotherapy cancer treatment

The pivotal role of UK science in Keytruda’s development

Keytruda is sold by Merck & Co. Inc., and has changed hands several times during its path to market. But a key step in the drug’s early development occurred at the UK medical research charity MRC Technology (MRCT). In 2006, MRCT applied an antibody humanisation technology, conceived by Sir Greg Winter and his team at the MRC’s Laboratory of Molecular Biology, to a compound belonging to Dutch pharmaceuticals group Organon.

The technique, known as CDR grafting, involved identifying and then inserting the coding sequences responsible for the antibody’s desired binding properties – e.g. to PD-1 in this case – into a human antibody scaffold. CDR grafting has now been used to humanise over 55 antibodies, including three further marketed therapies. Multiple sclerosis treatment Tysabri (natalizumab), rheumatoid arthritis drug Actemra (tocilizumab) and Entyvio (vedolizumab), sold for ulcerative colitis and Crohn’s disease, are all examples of treatments that are available thanks in part to UK bioscience.

Organon was attracted to MRCT’s technology and to what was already a highly experienced and well established antibody engineering group. Under a licensing contract signed in 2006, the Dutch group agreed to pay milestones, as well as small royalties on sales of any resulting therapy. In 2008, MRCT delivered to its partner the humanised antibody that would become Keytruda.

By then, though, the first of the two multi-billion dollar deals on Keytruda’s path to market had already occurred. Organon was acquired by Schering Plough in March 2007 for $14.4 billion. Two years later, in November 2009, Merck bought Schering Plough for $41.1 billion. Both deals were driven in part by the buyers’ need to access biotechnology expertise, as big drug firms (until then focused on chemistry-based, small molecule pharmaceutical drugs) began to wake up to the promise of large molecule biological therapies like antibodies and other proteins.

A new frontier of cancer treatment

Keytruda’s story is only just beginning. Its contribution to the fight against cancer – like that of checkpoint inhibitors more broadly – has much further to go.

Cancer treatment is increasingly about combining a variety of therapeutic approaches in what amounts to a multipronged attack. Checkpoint inhibition and other immunotherapies may offer more potent and durable effects than older therapies that block cancer cell growth or kill cells directly, but both contribute to the growing toolbox available to fight the disease.

The UK biotech sector continues to contribute to cutting edge research around checkpoint inhibition and other novel approaches to fighting cancer. One example is Oxford-based PsiOxus Therapeutics Ltd. This company is using an oncolytic (cancer destroying) vaccine technology platform to design and develop cancer-targeting viruses. A recent funding round will allow the start-up to test whether its oncolytic virus, in combination with a checkpoint inhibitor, may provide some hope for patients with metastatic colorectal cancer.

As we head into a new frontier of cancer treatment, UK bioscience is helping drive game-changing cancer treatments.

Like to find out more? The full version of the Keytruda story, along with five other case studies, can be found in our report, “Celebrating UK bioscience: unravelling the stories behind UK bioscience success”.

It’s been almost three years since the announcement was made as part of the government’s Strategy for UK Life Sciences to create a National centre aimed to significantly increase the UK’s manufacturing capability in biologics.

In this time, the Centre for Process Innovation (CPI) along with various partners and stakeholders, have been working tirelessly to make this aim a reality and in September 2015 the National Biologics Manufacturing Centre will open its doors giving companies access to state of the art facilities, equipment, and expertise to help develop, prove and commercialise the next generation of biologic products and processes.

Today’s video showcase features a time lapse of its construction.

For further information on the National Biologics Manufacturing Centre, visit the CPI website.

Do you have a video you would like the sector to see? Contact us.

In another showcase of UK bioscience success, adapted from our Celebrate report which was launched in June, today’s blog tells the story of Lemtrada and its role in the treatment of Multiple Sclerosis (MS).

Lemtrada (alemtuzumab), previously known as CAMPATH, is a humanised monoclonal antibody whose target is CD52, a protein found on mature lymphocytes (a type of immune system cell). It was originally developed for use with bone marrow and solid organ transplantation and in leukaemia and is still used, under the CAMPATH name, for these conditions. However, it has a new role under the name Lemtrada, as a treatment for multiple sclerosis (MS), which was approved in May 2014 by the National Institute for Health and Care Excellence (NICE). Clinical trials, published in The Lancet in 2012, revealed that Lemtrada is making a real impact in the treatment of this difficult and disabling condition.

Celebrate_coverThese publications, and ongoing research, are the culmination of many years of effort by scientists in the UK and elsewhere. Indeed, according to the co-discoverer of the CAMPATH family of antibodies, Geoff Hale, over 2,000 people (from researchers and clinicians to patent lawyers) have been involved in the development of this important treatment. He also acknowledges the invaluable contribution of the patients who took part in early clinical trials of what was, at the time, a very experimental drug.

From the lab to the clinic

The origins of CAMPATH-1 lay in the need for a treatment for graft-versus-host disease (GvHD), a complication of bone marrow transplantation. In 1979, Herman Waldman and Geoff Hale at the Department of Pathology at Cambridge University, funded by the MRC, isolated monoclonal antibodies from rats, which could eliminate donor T lymphocyte (“T”) cells from bone marrow prior to transplantation. It is the attack of these donor T cells on the recipient that causes GvHD. One of these antibodies, CAMPATH-1M, gave virtually complete elimination of the T cells and was selected for further development. The Cambridge lab then came up with another antibody, called CAMPATH-1G, which gave good results in two leukaemia patients and pointed the way to a new direction in this research – the need for a humanised version of the CAMPATH antibody.

As it happened, Michael Neuberger and Greg Winter at the MRC Laboratory of Molecular Biology (just over the road from the pathology labs in Cambridge) were working on producing fully humanised monoclonal antibodies as an important step up from the rat or mouse versions. The two teams worked together to develop humanised CAMPATH (CAMPATH-1H). In 1990, the Therapeutic Antibody Centre (TAC) was set up to take care of large scale production of the CAMPATH antibody.

Shortly after the TAC opened, Waldman and Hale were approached about a young woman with a rare autoimmune disease, with a view to trying CAMPATH-1H, as no other treatment had worked for her. After just a short course of the antibody, the patient responded with complete remission. This was the start of the development of CAMPATH-1H for other autoimmune diseases, including rheumatoid arthritis and, later, multiple sclerosis.Lemtrada commercial development

Lemtrada in Multiple Sclerosis

In 1991, Alastair Compston’s group at the Department of Neurology in Cambridge was contacted about CAMPATH-1H by a middle-aged patient with MS. She went, within a few months, from being confined to a wheelchair to being able to ski. Magnetic resonance imaging (MRI) scans showed a reduction in the inflammation that is one of the hallmarks of MS. The researchers began a pilot trial and, by 1998, 29 patients had been treated with CAMPATH-1H.

A coloured MRI scan of the brain of a patient suffering from MS. The black/orange lesions highlight the destruction of the myelin sheaths around the axon nerve fibres of the brain and spinal cord which cause MS. Lemtrada has been shown to slow down this damage to the brain tissue.

A coloured MRI scan of the brain of a patient suffering from MS. The black/orange lesions highlight the destruction of the myelin sheaths around the axon nerve fibres of the brain and spinal cord which cause MS. Lemtrada has been shown to slow down this damage to the brain tissue.

Further research followed, culminating in two Phase III trials and in 2014 NICE recommended Lemtrada as treatment for relapsing-remitting MS. The antibody is given by infusion once a year, for five days in the first year and three days in the second. For the patient, this compares favourably with other treatments, which involve oral tablets or weekly injections. Recently, Genzyme announced magnetic resonance imaging data that show that Lemtrada is associated with a slowing of brain atrophy (loss of neurons and connections) in MS.

30 years on from its beginnings in the lab, Lemtrada’s benefits for patients continue to grow.

Like to find out more? The full version of the Lemtrada story, along with five other case studies, can be found in our report, “Celebrating UK bioscience: unravelling the stories behind UK bioscience success”.

BMC_infographic_NewscastFollowing Saturday’s announcement of Round 8 Biomedical Catalyst winners – in what was the last round of the current Biomedical Catalyst (BMC) funding allocation – today we published a new report which provides a retrospective of the current scheme. The report features ten case studies from companies who have been recipients of BMC funding.

To date the BMC scheme has awarded over £250 million to accelerate medical research. Over 180 business-led projects have been supported with funds worth over £130 million and with a total project value of over £240 million. This means that over £100m of additional private capital, in the form of matched funding, has been leveraged as a condition of the Biomedical Catalyst awards. Furthermore, beyond the Biomedical Catalyst awards, post-award funded companies and academics have realised in excess of a further billion pounds in the form of additional private finance, grant funding, via licencing or acquisition.

The Biomedical Catalyst fills a crucial structural gap in the UK investment pathway, early in company development where private sector investors will not venture alone. If this is removed or diluted, already invested SMEs will fall again into the funding valley of death and the whole life sciences ecosystem, and UK economic growth will suffer. As we head towards this year’s Spending Review our message is clear: the Biomedical Catalyst must be continued.

Many congratulations to all BIA members who received funding from Round 8, including Crescendo Biologics, Critical Pharmaceuticals, Domainex, Eva Diagnostics, MISSION Therapeutics and Peptinnovate.

The report is available to download here, complete with updated infographics (pictured above).

Also published recently, the seventh MHRA Innovation Office case study features BIA member, the Cell Therapy Catapult. The advent of induced pluripotent stem cells (iPS) sees medicine go beyond its traditional boundaries. But de-risking therapies like iPS so that their full potential can benefit public health, means overcoming many challenges. The case study showcases how MHRA’s advice and guidance helped the Cell Therapy Catapult to overcome these challenges, meet the regulatory requirements facing the development of a stem cell bank for iPS and undertake clinical trials currently taking place in Japan. You can read it in full here.

In other news, the Academy of Medical Sciences have launched a call for evidence to gather external input into their project on ‘How does society use evidence to judge the risks and benefits of medicines?’. The deadline for submission is 21 September. See their website for further details.

Finally, a reminder that we’re currently seeking nominations to the BIA Board. More information here, and please do pass on to any colleagues who may be interested.

As I head off on holiday, Newscast will be taking a break next week – back on 24 August.



Collaboration is at the heart of innovation – bringing the best minds together to advance next-generation science and ultimately make an impact to patients’ lives.

This week’s video showcase features BIA member, Pfizer. Watch the video to find out more about their collaborative research model, designed to share insights and drive discoveries.

Do you have a video you would like the sector to see? Contact us.

Celebrate_coverBioscience is a fundamentally important sector for the UK’s health and wealth. Back in June, the BIA published a report which aimed to unravel the stories behind just some examples of UK bioscience success. These are only a snapshot of the full spectrum of UK bioscience successes, past or ongoing, but help illuminate where UK bioscience is shaping scientific innovation and is delivering benefits to humanity. Over the next few weeks, we’ll be showcasing these stories on the blog, starting with Humira – the world’s top-selling medicine and its UK heritage.

Humira (adalimumab) is the world’s top-selling medicine. The treatment helps almost half a million patients across the world to live with a range of debilitating and often painful conditions, including rheumatoid arthritis (RA) and Crohn’s disease.

Humira’s target is tumour necrosis factor alpha (TNF-α), a protein that can cause excessive inflammation associated with auto-immune diseases like RA. In 2003 Humira became the first “fully human monoclonal antibody” to gain approval.

In the 1990s, TNF, and its potential as a drug target, were well understood. The issue was how to avoid the toxicity drawbacks of antibodies that were produced using non-human cell lines. The story behind how this challenge was overcome is a showcase for UK scientific excellence.

A new technology for making medicines

Working at the Medical Research Council (MRC)’s Laboratory of Molecular Biology in Cambridge during the 1980s, UK antibody pioneer and prize-winning scientist Sir Greg Winter and fellow scientist John McCafferty invented new techniques to create and isolate humanised and fully human antibodies for therapeutic use.

Key to Humira’s discovery was the “phage display” method. This uses special viruses called bacteriophages as vehicles to display proteins of interest (e.g. human antibody fragments) on their outside, so they can be screened for interactions with other proteins or molecules. Antibody “libraries” containing millions of different human antibody fragments displayed on phages are thereby used to isolate very targeted, specific leads with therapeutic potential. These fragments are then used to build full-sized antibodies using humanisation technologies.

Sir Greg and John McCafferty co-founded Cambridge Antibody Technology (CAT) in 1989, along with David Chiswell, to allow the phage display technology to be fully exploited to create new medicines.

The partnership that created Humira

Meanwhile, with phage display poised to revolutionise antibody drug discovery in the early 1990s, a group of scientists at BASF Bioresearch Corporation (BBC) (part of what was then the pharmaceuticals division of Germany’s BASF) in Worcester, Massachusetts, were looking for ways to produce fully human antibodies to TNF. They knew the target well, had lots of it, and already had a murine (mouse-derived) antibody to this target in clinical tests.

In 1993, BBC partnered with CAT to access its phage display technology. Thus began Humira’s gestation – first as clinical candidate D2E7 from early 1995, then, as the compound approached commercialisation, as Humira – HUman Monoclonal antibody In Rheumatoid Arthritis.

A patient self injecting a dose of Humira

A patient self injecting a dose of Humira

Overcoming the odds: Humira’s path to market

Humira’s journey from the CAT laboratories to a multi-billion dollar global blockbuster wasn’t a straightforward one. Few drug development stories are.

The research collaboration between the CAT team in Cambridge, UK and BBC in the US worked very well. Yet BASF was primarily a chemicals conglomerate and was not particularly interested in pursuing this compound developed by a research offshoot on the other side of the Atlantic. So at the very end of 2000, after a flurry of almost-deals with other players, BASF’s pharmaceuticals division, known as Knoll, was sold to Abbott Laboratories in a virtual auction.

By that time, D2E7 was already in the final stages of clinical development. Abbott’s management understood the compound’s potential value. Three years later, the regulators, too, saw what Humira could offer patients suffering from inflammatory disease – the drug was approved six months earlier than expected, without debate. Humira was a rare good news story for an industry often beleaguered by regulatory delay and clinical failure. Humira “is the most important drug launch in our 115-year history,” said Jeffrey Leiden, MD, PhD, then Abbott’s chief scientific officer and executive vice president of its pharmaceuticals division.

As sales took off, CAT and Abbott became embroiled in a fierce royalty dispute, but CAT held its ground. This UK biotech’s technology and expertise had been validated to an extraordinary degree. In 2005, AstraZeneca bought CAT for £702 million. Following Abbott’s decision in 2011 to separate into two publically traded companies, Humira is now manufactured and sold by AbbVie.

Helping patients and improving lives across multiple conditions

Humira approval timeline by indicationHumira’s full potential is still unfolding: AbbVie is testing the drug in a rare, painful chronic skin condition called hidradenitis suppurativa (sometimes referred to as ‘acne inversa’), for which there is no approved treatment or cure, and in uveitis, inflammation of the eye.

In 2014 Humira’s sales reached almost £12 billion and they are still growing. Humira’s success; and that of anti-TNF therapies more broadly, has also led to a deeper understanding of the inflammatory process, in turn helping create other therapies for inflammatory joint diseases – and further choices for patients.

Two decades after CAT helped create Humira, this drug continues to improve lives and break records.

Like to find out more? The full version of the Humira case study can be found in our report, “Celebrating UK bioscience: unravelling the stories behind UK bioscience success”.