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Seven pharma trends for 2018

Published on 22/12/17 at 10:46am

Pharmafile.com looks ahead to signpost what we expect will be the key industry trends through the course of 2018.

The value of medicine or how to aggressively price a medicine

Your stance on the pricing debate depends entirely on the angle from which you stand: are pharma companies simply reaping a reward for the expensive R&D process, or are they taking advantage of the national authority’s duty to provide its population with the best medical innovations science has to offer? In reality, the answer is that it’s six of one and half a dozen of the other. However, that’s an answer that is unlikely to satisfy anyone.

It is inevitable that pricing debates will be taken up again in earnest next year, not least because one of the major stories to break towards the end of 2017 was the announcement that Spark Therapeutics historic approval for the first gene therapy for an inherited disorder was given by the FDA. Why is that significant in the pricing debate? Only because it might break a few pencil leads at HTA offices if the rumoured $1 million price tag per patient is followed through on.

Beyond the question marks over the pricing of highly innovative treatments, there will likely be the usual fudging of the system in the US, seeing some ludicrous pricing practices by shady companies. The uproar over the pricing strategy of Mylan and its EpiPen product have seen the larger companies distance themselves from using aggressive pricing strategies this year, but as states such as California take the problem into its own hands, it may not be enough to end the debate moving through 2018.

A record-breaking year for US drug approvals?

Alongside pricing, access of patients to new treatments has been a major talking point in the US, not least due to President Trump’s vocal pledges to cut regulation in order to speed the approval of medicines through the FDA. The plans proposed to achieve this were met with considerable criticism, but one way or another, the US regulator has managed to live up to these promises, having approved 45 treatments at the time of writing, matching the record set in 2016. On top of this, the FDA smashed its own record for most generic approvals earlier this year.

Some of this success may be down to FDA Commissioner Scott Gottlieb’s leadership, who joined the organisation in May. Under his direction, expect even more total approvals by the end of next year as the FDA looks to integrate major changes to the way it regulates medicines and medical devices – especially in the cancer space, where Gottlieb has recently outlined plans to allow for already-approved treatments to be authorised in a second indication based on supplemental applications.

Across the Atlantic, Europe has kept pace with its US counterpart this year, but with the relocation of the European Medicines Agency to Amsterdam as a result of Brexit, many experts are expecting that the organisation’s operational capacity – and its ability to maintain levels of drug approvals – will take a hit in 2018.

Technology continues to amaze

The rapid advancement of technology in the world shows no signs of slowly down, and even pharma – an industry not exactly known for its tech-savviness – is benefiting greatly from the new solutions it brings. This year we have seen a continued stream of new developments that widen accessibility and adoption or bring entirely new solutions to age-old problems, such as the MasSpec Pen, a device developed at the University of Texas which can identify cancerous tissue in just ten seconds, or Takeda and Cognition Kit’s wearable tech for studying depression (don’t miss our interview with Jennifer Barnett, CSO of Cambridge Cognition to discuss the technology as part of our May issue’s mental health feature).

The FDA also approved its first-ever medical device accessory for the Apple Watch this year in AliveCor’s ECG Kardia Band, providing users with a medically-reputable way to monitor their heart health themselves. We even saw video games become a viable therapy, with Akili’s digital product showing statistically significant results in the treatment of ADHD in paediatric patients in clinical trials.

And of course, with smartphone access having become the norm in Western nations and beyond, treatment providers and healthcare organisations alike have begun to ramp up efforts to leverage the technology. 2017 saw the first, large-scale smartphone based clinical study run by Novartis, while Abilify received FDA approval for its MyCite digital pill – a remarkable technology in itself – which can transmit data to a companion smartphone app. In the UK, the budget-strained NHS is looking to take advantage of this to cut costs by enabling users to access various aspects of the service’s functionality via their phone, such as arranging GP appointments. Expect even more tech solutions – particularly smartphone and app integration – to only become more prevalent as 2018 rolls on.

Mergers and acquisitions set to return with a bang?

Remember the many big acquisitions from 2017 that swept away the headlines for months at a time? No? Well, you’d be excused for drawing a blank for trying to remember even a handful of big deals from the year. There really were only a few that were significant and, even then, the biggest of the lot, Johnson & Johnson’s $30 billion protracted hunt for Actelion, only just edged into January, with most of the details having emerged at the end of the previous year.

Beyond that? Well, there was Gilead’s $11.9 billion deal for Kite Pharma, which saw the biotech finally unload some of its hep C cash to bolster its portfolio. After gaining approval for Yescarta on the back of some impressive data, there are already many people talking up the deal as the best of the year – in reality, it was just one of the only significant deals.

What awaits for 2018? It is thought that President Trump managing to push his tax reform through the US Senate could see previously cautious US pharma companies bring their money back to North American shores for an almighty acquisition splurge. In particular, Pfizer has played it cool for the past year, waiting for the right moment to splash the cash after its previously failed attempt at a mega-tax inversion. It is unlikely to be the only company to make significant moves, as an M&A carousel loosens everyone’s pockets.

Personalised medicine to show even more potential

2017 proved historic in that it was the year that we saw approval of the first CAR T therapies for the treatment of cancer: Novartis’ Kymriah and Gilead’s Yescarta, which the latter snatched up through its previously mentioned acquisition of Kite Pharma. A form of gene-editing, the revolutionary therapies have been deemed cost-effective in their field despite their massive price tags, and could mean big things for the future of cancer treatment, and lay the groundwork for future breakthroughs.

Analysts estimate that the CAR-T space could reach $8.5 billion by 2028, and the sector is almost certain to become more crowded over the coming year as other players step into the ring with their own versions of the therapy – among them, Juno Therapeutics and the partnership of Celgene and Bluebird bio. Don’t miss our in-depth feature on the technology from our November issue.

2017 also ended on a high for gene-editing therapies with the aforementioned FDA approval of Spark Therapeutics’ Luxturna for the treatment of confirmed biallelic RPE65 mutation-associated retinal dystrophy – an inherited eye disorder which can lead to complete blindness, making it the first treatment of its kind approved for a congenital disease. These ground-breaking approvals in the US only seem to suggest this is only a taste of things to come as the potential of these therapies continues to be unlocked.

However, while cancer immunotherapies continue to captivate the industry with their successes compared to other more traditional treatments, 2017 was characterised by a slew of failures for major firms in trials for the PD-1/L1 field, among them AstraZeneca’s infamous Mystic trial failure, MSD’s Keytruda in head and neck cancer, and Roche’s Tecentriq in bladder cancer.

The North American opioid crisis

When looking at trends occurring across the year, lists can often be littered with positive news on breakthrough treatments or on the exciting major acquisitions expected. Unfortunately, 2018 looks set to be another year dogged by the opioid crisis. There are precious few positive to take from the ongoing situation, with headlines dominated by record numbers of drug deaths and lawsuits against pharma companies involved in the production of opioid-based painkillers.

However, Gottlieb’s appointment as FDA head has seen a real change in the dynamic of the agency’s role towards dealing with the epidemic. One major step was the unprecedented step of asking Endo Pharmaceutical to voluntarily remove its product from the market, due to the potential for it to be abused. It was a highly unusual move but acted a signal from the US regulator to the wider market that it was taking its responsibility to help combat the crisis seriously. The same message was delivered from the president, though it came a little later, when Trump announced that the opioid epidemic was to be considered a national emergency – the crisis even claimed the scalp of a nominee to become ‘drug czar’.

Despite these steps, addiction and the damage done only tend to play out in the long-term, so there will be further headlines dominated by the crisis. Expect there to be further innovations trialled and for the crisis to engulf other areas of the globe.

Nothing is certain except uncertainty (just ask those who live in the UK)

Brexit took up headlines absolutely everywhere in Europe and the uncertainty affected markets across the globe. All manner of industries are going to be impacted, or have already started instigating contingency plans, due to the withdrawal of the UK from the EU. As the ruling Conservative party managed to squeak past the first round of negotiations, parliament torpedoed Prime Minister Theresa May’s hopes of being able to sign-off on any final deal without the House’s approval – all adding to the veracity of the smooth and cohesive Brexit process promised by those who campaigned for the Leave vote.

Many industries have not been best pleased by many aspects of the process. The UK pharmaceutical industry, in particular, has been left particularly aggrieved by the fact that the impact on its processes seemed to have registered only as an after-thought. The impact of the Brexit decision was driven home by the EMA headquarters’ decision to leave London for Amsterdam.

The UK industry has been soothed recently by the publication of John Bell’s Life Sciences Industry Strategy report and the signing of some fairly significant deals that demonstrate the nation’s ability to still attract investment. However, more movement will be needed in 2018 to show that the sector won’t be a net loser in the Brexit gamble – expect plenty more action in this area, especially as the UK has to figure out exactly how it is going to approve medicines post-Brexit.

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