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October 2019


Dr Deborah O'Neil, Chief Executive and Scientific Officer, NovaBiotics Ltd

In 2018, 7 of the top 10 best-selling drugs were monoclonal antibodies (mAbs). Humira (adalimumab), which neutralises inflammatory mediator tumour necrosis alpha, is currently the world’s best-selling drug, bringing in over $20 billion in sales revenue for Abbvie in 2018. mAbs were the first precision drugs and remain popular because of their specificity to the antigen or discrete disease target against which they have been generated. The blueprint for these transformative therapies was not developed by man, but by nature - specifically, the immune system. Immunotherapy and mAbs have evolved since the approval of the first anti-CD3 mAb, Orthoclone-OKT3, in 1986. From murine to chimeric to fully human proteins, many lessons have been learned about the druggability, immunogenicity, toxicity, and efficacy of mAb therapies throughout this journey.

Immunotherapy has revolutionised treatment paradigms for chronic inflammatory diseases (Humira, Remicade, Stelara, Dupixent, Entyvio, Cosentyx, etc.) and cancer (Herceptin, Avastin, Rituxan, Keytruda, Opdivo, Perjeta, etc.), and the mAb market, accordingly, is now worth a very healthy $122 billion and set to expand to $200 billion by 2024. There are over 80 marketed mAb therapies, and an unprecedented 11 new mAbs were approved (around one-third of all new approvals) by the FDA in 2018. What of the future for mAbs though? Will they continue to dominate? Undoubtedly, yes, but the market is set to change significantly over the next few years.

Firstly, biosimilars for a number of the top 10 players, including Remicade, Herceptin, Avastin, and Rituxan, will have a big impact and knock their blockbuster ‘originator’ mAbs
out of their top slots. These biosimilars will actually expand the total number of marketed mAbs for the targets/ indications these drugs act on and are approved for. As lower priced therapies, access should also continue to expand, and even Humira will be overtaken by its biosimilars in due course.

Secondly, a bigger step forward than biosimilars from originator mAbs are the alternative mAb scaffolds that appear to be on the horizon. They have similar ‘war heads’ and act on the same targets as the current leading mAb drugs, but with completely re-engineered elements, such as the fragment crystallisable region, to improve specificity, toxicity, etc. These are new drugs in their own right, not biosimilars, with ‘ultrahuman’ antibodies among them.

Lastly, there will be more mAbs for new indications. Looking at the most recently approved mAbs and those in development, there is an expansion away from cancer and inflammation and towards more mAbs being developed and approved for other therapeutic areas and against novel targets. These include infection, with an anti-CD4 mAb for HIV (Trogarzo), central nervous system, with three migraine mAb treatments approved in 2018 (Aimovig, Ajovy, and Emgality) and at least another two in development (previously covered in our sister publication, EBR, in July 2018), and also Ocrevus for the treatment of multiple sclerosis. There have also been ‘first’ mAb approvals for rare/orphan diseases, including immunotherapies for nocturnal hemoglobinuria (Ultomiris) and X¬- linked hypophosphatemia (Crysvita).

As the number and volume of mAb therapies continue to rise, so too will the need for greater efficiency and quality in their manufacture to meet with clinical demand, market pull, and regulatory requirements. How novel, real-time analytical methods can meet at least some of these demands is discussed by Kurt Pickle at IDEX Health & Science (IPT October, page 6). Mochao Zhao at Merck also explains how the adoption of single-use technologies in membrane-based purification can drive higher productivity and flexibility in mAb manufacturing (IPT October, page 14).

Immunotherapy and mAbs are on an upward trajectory and will maintain their top 10 positions overall - whether they are originator therapies, biosimilars, or new scaffold molecules; however, unless these game-changing drugs can be manufactured efficiently
and to the highest quality, they will not translate to cost-effective, commercially viable treatments that are accessible for the majority of the patients whose lives could potentially be transformed by them.

May 2012


Pam Barnacle: The pharmaceutical industry is undergoing one of the greatest periods of upheaval in its history. Challenges such as the patent cliff, falling research productivity, tougher regulatory regimes and pricing pressures are forcing the industry to dramatically rethink how it operates. In an interview for this edition of IPT, Ashish Goel at Infosys gives some cause for optimism by referring to a number of emerging technologies that should help companies get through these difficult times.

For example, cloud computing will enable companies to run more efficient IT infrastructures without having to manage legacy programmes or make large, upfront capital investments, thus freeing up time to spend on the pharma business itself. Some of the more forward-looking companies have, as Ashish says, already invested in cloud computing and are reaping the benefits; Pfizer, for example, has experimented with using the cloud to conduct clinical research, as well as deliver real-time information to customers.

Another emerging technology is social media, which is providing companies with a channel through which to communicate with their customers. A variety of pharma companies are already using social media in disease-specific online communities, where different stakeholders – patients, healthcare professionals and key opinion leaders – can interact with each other. Ashish notes that there is also strong potential for the use of social media tools to improve collaboration in R&D. With externalisation becoming a core drug discovery strategy for most companies, scientists are increasingly having to collaborate beyond their own enterprise boundaries and social media tools provide an excellent way of enabling this.

When RNA interference was first identified in mammalian cells, it was heralded as the 'next big thing' in the biopharm arena. However, since then, reality has set in and problems such as side effects and delivery have burst this initial bubble of optimism. In an article questioning whether RNAi has lived up to its early promise, Devin Leake and Anja van Brabant Smith at Thermo Fisher Scientific Bioscience Division note that, while early predictions for the impact of RNAi may have been over-hyped, it has proved itself as a valuable research tool. Moreover, recent advances in delivery systems are starting to support RNAi’s potential as a therapeutic agent and, as a new class of regulatory molecules, non-coding RNAs may lead to the discovery of new drug targets.

The logistics of obtaining donated blood for transfusion is fraught with difficulties – fluctuations in supply and demand, transportation to where it's needed, a limited shelf-life, screening for transmittable diseases, and so on. One 'blue-sky' solution to these logistical problems would be to develop a technology that enabled the on-demand, on-site production of disease-free red blood cells. Andy Wylde and Adrian Stacey at TAP Biosystems review a system incorporating micro-bioreactors that is bringing the reality of cost-efficient, ex vivo production of red blood cells one step closer – therefore raising the possibility that pathogen-free blood transfusions could be supplied wherever and whenever they are needed.

February 2012


Pam Barnacle: In their new book Abundance: The Future Is Better Than You Think, the authors Peter Diamandis and Steven Kotler argue that the world is on the brink of a number of technological breakthroughs that will bring 'abundance' to everyone on the planet. They base their optimism on four main forces that combined should enable the equivalent of 200 years of progress to be made over the next 20 years: exponential technologies (including biotechnology), DIY innovators (such as Craig Venter), technophilanthropists (notably Bill Gates) and the 'rising billion' – the poorest people in the world who collectively constitute a huge market.

After several gloomy years when the biopharm sector has been dogged by negative issues, maybe it's time to start thinking more along the lines of Messrs Diamandis and Kotler, and look to a future that is better than we think. Already, just a few months into 2012, signs are emerging that the industry is undergoing a paradigm shift and viewing the years ahead with a little more optimism.

Speaking at the UK Structural Genomics Consortium (SGC) conference Drug discovery: a job too complex for academia or industry alone?, Dr Patrick Vallance of GSK surprised the audience by commenting that early R&D pipelines are in fact much fuller than people realised. The challenge, he said, had shifted from making medicines that work against good targets to coping with bringing compounds through the development stages. Several companies, including GSK, had a large number of new molecules coming through to Phase 2, and the question was whether companies had the money, capacity and ability to take these through clinical studies.

A second note of optimism came at the 2012 Economist Pharma Summit, this year entitled Finding New Directions. Looking at 'disruptive innovation' from a patient perspective, Freda Lewis-Hall from Merck noted that innovation didn't have to move forward in leaps and bounds but could come in the form of small incremental advances in technology that, retrospectively, turn out to be shape-shifting. Taking the case of Lipitor, it was initially regarded as a minor incremental advance in statin therapy but turned out to be a multi-billion dollar product that made a significant contribution to reducing the incidence of heart disease. Also, she said, innovation did not always have to mean new technologies but, instead, new ways of thinking about existing technologies – Viagra being the classic example, having originally been viewed as a failed experiment but subsequently proving to represent a major advance in the treatment of erectile dysfunction, an area of significant unmet medical need.

The theme of innovation was also taken up at the Pharma Summit by Sir Tachi Yamada, an industry veteran and former President of the Global Health Programme at the Gates Foundation. Speaking specifically about emerging markets (the rising billion referred to by Diamandis and Kotler), he noted that the problems here were so huge that revolutionary – rather than evolutionary – innovation was needed. Furthermore, the methods available for providing healthcare were so very different from the developed world that the industry had to think in terms of real innovation in the mechanisms of delivery, as well as in science and technology.

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